Vaccines, the true facts!

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Pfizer says its COVID-19 vaccine is 90.7 percent effective at preventing
symptomatic disease in kids ages five to 11. An analysis of Pfizer’s
clinical trials of 2,268 participants, released by the FDA on Friday,
also showed that none of the participants reported cases of severe
disease or the COVID-19-related multi-inflammatory syndrome that has
been seen in children. The company had previously announced that its
analysis shows the vaccine is safe and elicits “robust” neutralizing
antibodies. The vaccine follows a two-dose regimen of 10 milligram
doses—a third of the dosage that is given to adults. U.S. regulators
will soon consider authorizing the use of Pfizer’s vaccine for kids in
this age group. An FDA advisory panel is expected to make a
recommendation next week. In the meantime, the White House has announced
its plan to roll out the vaccine for kids by working with pediatricians,
children’s hospitals, school clinics, and other health care centers. On
October 21 the CDC cleared the way to begin rolling out booster shots
for the Johnson & Johnson and Moderna vaccines as soon as Friday. On
Thursday evening, CDC Director Rochelle Walensky signed off on
recommendations that people over 18 can get a second dose of the Johnson
& Johnson vaccine at least two months after their initial dose. The
panel also unanimously recommended allowing Moderna boosters for people
over 65 and those ages 18 to 64 with underlying conditions or frequent
exposure to the virus. People who are eligible for a booster dose will
also be allowed to get a booster dose of a different vaccine than the
one they initially received. This decision comes in the wake of new data
showing the Moderna and Pfizer boosters are much more effective than a
second dose of the Johnson & Johnson jab. The CDC’s decision came just
one day after the FDA granted emergency use authorization of booster
shots for the Johnson & Johnson and Moderna vaccines. COVID-19 vaccines
have reached consumers in record time. Though the process can typically
take 10 to 15 years, the U.S. Food and Drug Administration has granted
emergency authorization to vaccines made by Pfizer, Moderna, and Johnson
& Johnson in less than a year. Before now, the fastest-ever vaccine—for
mumps—took four years to develop in the 1960s.

Even after a vaccine is authorized or fully licensed, it faces potential
roadblocks when it comes to scaling up production and distribution,
which also includes deciding which populations should get it first—and
at what cost.

Yet several efforts are underway to help produce and distribute the
vaccines more quickly. Here’s everything you need to know—including
primers on how vaccines and clinical trials work, the latest news on
vaccine distribution and safety, and a detailed breakdown of each of the
candidates that have reached phase three and beyond.

Vaccines and clinical trials
More than 60 vaccines are still going through a three-stage clinical
trial process that’s required before they are sent to regulatory
agencies for approval. Given the urgent need, some vaccine developers
have compressed the clinical process for SARS-CoV-2 by running trial
phases simultaneously.

The COVID-19 candidates, like all vaccines, essentially aim to instruct
the immune system to mount a defense, which is sometimes stronger than
what would be provided through natural infection and comes with fewer
health consequences.

To do so, traditional vaccines use the whole coronavirus, but in a
killed or weakened state. Others use only part of the virus—whether a
protein or a fragment. Some transfer the instructions for coronavirus
proteins into an unrelated virus that is unlikely or even incapable of
causing disease. Finally, cutting-edge vaccines under development rely
on deploying pieces of the coronavirus’s genetic material, enabling our
cells to temporarily make coronavirus proteins needed to stimulate our
immune systems. (Find out more about vaccines and how they work.)

U.S. vaccine rollout
Latest news

In the United States, more than 66 percent of the population has
received at least one dose, and more than 57 percent are fully
vaccinated. As of October 22, the U.S. had administered more than 411
million shots of the authorized vaccines and had distributed more than
498 million doses.

U.S. regulators are inching closer to authorizing Pfizer’s COVID-19
vaccine for emergency use in children ages five to 11. On October 22
the FDA released Pfizer’s analysis of its clinical trials of 2,268
participants showing that the vaccine is 90.7 percent effective at
preventing symptomatic disease in kids in this age group. The analysis
also showed that none of the participants reported cases of severe
disease or the COVID-19-related multi-inflammatory syndrome that has
been seen in children.

The company had previously announced that its analysis shows the vaccine
is safe and elicits “robust” neutralizing antibodies. The vaccine
follows a two-dose regimen of 10 milligram doses—a third of the dosage
that is given to adults.

A key FDA advisory committee will discuss Pfizer's data on October 26,
with a final ruling to come in the following days or weeks. The White
House has announced its plans to roll out the vaccines by working with
more than 25,000 pediatricians and other primary care sites, children’s
hospitals, pharmacies, school clinics, and more.

On October 21 CDC director Rochelle Walensky issued a ruling that clears
the way for booster shots of the Moderna and Johnson & Johnson vaccines
to begin rolling out immediately. Anyone 18 and older will be able to
get a second dose of the Johnson & Johnson vaccine at least two months
after their first dose. Meanwhile, U.S. regulators’ recommendation for
the Moderna vaccine is narrower: A third dose can be administered at
least six months after the second one to people age 65 and older and to
those ages 18 to 64 who are at high risk of severe COVID-19 due to
underlying conditions. It also includes people ages 18 to 64 who are at
high risk of exposure because of where they work or live, such as
health-care workers or incarcerated people. These guidelines are the
same as those approved for Pfizer’s booster doses.

The CDC also endorsed a “mix and match” approach to booster doses, which
will, for example, allow people who received a Johnson & Johnson jab to
seek a Pfizer or Moderna booster instead. Only people who are eligible
for booster doses will be authorized to mix and match. U.S. regulators
based the decision on evidence from a new National Institutes of Health
study suggesting that booster doses of the Moderna or Pfizer vaccines
are more effective for people who originally received the Johnson &
Johnson shot.

The CDC’s recommendations align with the FDA emergency use authorization
that had been issued the previous day.

U.S. regulators have already authorized a third dose of Pfizer’s vaccine
for certain populations. On September 24, CDC director Rochelle Walensky
overruled her agency’s advisory committee to endorse administering
booster shots to people in occupational or institutional settings that
put them at high risk for disease, such as health-care workers or
teachers. U.S. regulators have also granted emergency use authorization
of booster shots to people who are age 65 and older, those in long-term
care facilities, and people ages 50 to 64 with conditions that make them
more vulnerable to severe disease. The CDC has said that people ages 18
to 49 can receive booster shots only if their personal benefits outweigh
the risks of vaccination, which can include rare side effects like
myocarditis.

The decision roughly aligns with earlier recommendations from the FDA
advisory committee, which expressed skepticism that Pfizer had provided
adequate data supporting the need for the boosters in the general
population. They also didn’t think there was enough data on the safety
of boosters among younger people, who are more susceptible to side
effects from the vaccines such as myocarditis. Instead, the panel
indicated their support for a limited use of boosters among populations
that are more at risk of breakthrough infections.

Vaccines still remain effective at preventing most severe illness, even
for breakthrough infections of the Delta variant. But there's concern
over the potential for transmission. On July 30, the CDC published
preliminary data from a Massachusetts COVID-19 outbreak that suggests
vaccinated individuals who are infected with the Delta variant may carry
similar viral loads as an unvaccinated infected individual. On September
29, a preprint study showed that vaccination reduces transmission of the
Delta variant but that impact dwindles over time, indicating that
boosters could help control transmission.

Walensky said in August that the Biden administration wanted to roll out
booster shots in an attempt to stay ahead of the virus. Although the
data shows that the vaccine still offer strong protection against severe
disease, Walensky said the data consistently demonstrate a waning
effectiveness against mild and moderate disease as well as declining
efficacy against the Delta variant. Walensky pointed to data from other
countries—including Israel—indicating that protections against severe
disease “could decrease in the months ahead.”

On September 2, White House adviser Anthony Fauci said in a press
briefing that it’s likely that people will need three doses of the mRNA
vaccines for full protection against COVID-19. He cited recent studies
from Israel showing a decline in infections among people who received a
third dose.

However, the WHO called for a moratorium on booster shots through
September to help efforts to vaccinate at least 10 percent of people in
every country. The organization asked wealthy nations to share their
doses instead of administering boosters. “We cannot and should not
accept countries that have already used most of the global supply of
vaccines using even more of it while the world’s most vulnerable people
remain unprotected,” WHO Director General Tedros Adhanom Ghebreyesus
said in a press conference.

Vaccine mandates and masking

On September 9, the White House announced a plan to impose broad new
COVID-19 vaccine mandates aimed at the nearly 80 million Americans who
have not yet gotten a shot. One key element is a new Department of Labor
rule that will require all companies with more than 100 employees to
ensure employees are either vaccinated or regularly tested for COVID-19.
The Biden administration has also issued executive orders requiring
vaccination of all federal employees and government contractors.
Healthcare facilities that receive funding from Medicare and Medicaid
will also be required to vaccinate staff. The Washington Post reports
that businesses that ignore the new policy could face penalties of up to
$14,000 per violation. They will also be required to give employees paid
time off to get vaccinated.

The urgent need to vaccinate more Americans was buttressed by a trio of
studies released by the Centers for Disease Control and Prevention on
September 10. As the Washington Post reports, the studies show that
people who are not fully vaccinated are more than 10 times more likely
to be hospitalized and 11 times more likely to die of COVID-19.
Hospitalizations are also 10 times higher among unvaccinated adolescents
compared to the fully vaccinated. A real-world study also showed that
Moderna’s vaccine is slightly more effective in preventing
hospitalization.

The FDA granted full approval to Pfizer’s vaccine on August 23, making
it the first COVID-19 vaccine to reach that milestone. The decision
cleared the way for companies and schools to enact vaccine mandates and
may persuade the vaccine-hesitant to finally get a shot. Public health
experts say it also allows physicians the latitude to prescribe the
vaccine as they see fit, including as a third dose booster shot for
vulnerable patients. However, the CDC has since warned physicians
against these off-label uses.

State and local governments are also implementing vaccine mandates among
their employees. On August 11, California became the first state to
require all teachers and school staff to either get a vaccine or undergo
weekly COVID-19 testing. The mandate goes into effect on October 15.
California also plans to mandate vaccines for all schoolchildren once
regulators have fully approved the vaccine for younger age groups.

On July 27, the Centers for Disease Control and Prevention updated its
recommendations on masks. The agency now urges their universal use in
indoor public spaces by people living in regions with at least
“substantial” COVID-19 transmission, where 50 or more new cases per
100,000 people have been reported over the past seven days.

The CDC also recommends indoor masking in public spaces for vaccinated
people who live with anyone vulnerable to the disease, such as
unvaccinated children and immunocompromised individuals. All teachers,
students, and staff in schools, whether vaccinated or not, should also
wear masks, according to the new CDC guidance.

Unvaccinated individuals likely still account for the greatest viral
transmission, since the total number of breakthrough cases is relatively
low, CDC director Rochelle Walensky, stressed during the July 27
briefing.

Approvals

The U.S. has already amended the emergency use authorizations for the
Pfizer and Moderna vaccines to allow administration of a third dose to
people who have had solid organ transplants or who are equally
immunocompromised. The two-dose regimen seems to be less effective in
protecting against COVID-19 for people with weakened immune systems, who
are more likely to become seriously ill from the disease. The CDC
endorsed the FDA’s decision on August 13 following a meeting of its
vaccine advisory committee.

Meanwhile, the National Institutes of Health have launched phase two
clinical trials to assess whether a third dose of the Moderna or Pfizer
vaccines would produce a protective antibody response among kidney
transplant recipients whose immune systems did not respond to the first
two doses.

The CDC has approved Pfizer’s vaccine for emergency use in adolescents
ages 12 to 15, which is seen as key to helping the country reach herd
immunity. States, which are still responsible for rollout decision
making, subsequently widened eligibility to include all people 12 and
older.

Global vaccine rollout
The World Health Organization is also coordinating global efforts to
administer vaccines, with an eye toward delivering two billion doses by
the end of 2021. It is leading an initiative through the COVAX Facility
to ensure that all countries have equitable access. COVAX has
distributed more than 378 million doses to 144 participants. The WHO has
approved the Pfizer-BioNTech, AstraZeneca-Oxford, Johnson & Johnson,
Moderna, Sinopharm, and Sinovac vaccines for emergency use.

On September 22, the U.S. announced that it will purchase another 500
million doses of the Pfizer vaccine to donate to low- and middle-income
countries. The Associated Press reports that this brings the country’s
total commitment to 1.1 billion doses through 2022. The news arrives as
the nation faces scrutiny for considering the use of booster doses even
as other countries lag behind in vaccination due to supply issues.

COVAX had previously acknowledged a shortfall of 190 million doses. In a
joint statement released in May, COVAX administrators said the
consequences of that shortfall “could be catastrophic.” They called on
world leaders to share more doses and commit additional funding to the
global effort.

On June 13, national leaders at the G7 summit announced plans to donate
870 million doses to the global vaccination effort, with the aim to
deliver at least half of them by the end of 2021. Pfizer, Moderna, and
Johnson & Johnson have also pledged to collectively provide around 3.5
billion doses of their vaccines to low- and middle-income countries by
the end of 2022. The European Union also said it would donate at least
100 million doses by the end of 2021. On August 6, China pledged to
provide two billion doses of its COVID-19 vaccines this year and donate
$100 million to COVAX.

Vaccine safety
On July 13, the U.S. Food and Drug Administration added a warning label
to Johnson & Johnson’s vaccine after it was linked to rare cases of
Guillain-Barré Syndrome, a rare autoimmune disorder that can lead to
paralysis. There have been 100 preliminary reports of the syndrome among
the approximately 12.5 million people who have received the vaccine. The
FDA said that the benefits of receiving the vaccine outweigh the risks.

The FDA has also added a warning label to the Pfizer and Moderna
vaccines about rare cases of heart inflammation in adolescents and young
adults. The news comes after the CDC’s Advisory Committee on
Immunization Practices announced that it has identified more than 300
cases of myocarditis and pericarditis that it acknowledged are likely
linked to the vaccines. The agency says these cases are rare but higher
than expected. It also said the benefits of the shots outweigh the
risks.

An earlier CDC report released February 19 revealed that severe
reactions to the Pfizer-BioNTech and Moderna COVID-19 vaccines are
rare. The report documented only 4.5 cases of anaphylaxis per million
doses of vaccine administered during the reporting period, which the
CDC notes is comparable with rates for other types of vaccines. U.K.
regulators have also published safety data for the Pfizer-BioNTech
vaccine showing that most side effects are mild and consistent with
what is typical of other vaccines. Still, as a precautionary measure,
U.K. officials have advised people with a history of serious allergic
reactions not to get the Pfizer-BioNTech vaccine.

In April, the European Medicines Agency issued statements saying that
unusual blood clots should be listed as a very rare but possible side
effect of both the AstraZeneca and Johnson & Johnson vaccines. In a
review of 86 reported cases related to the AstraZeneca vaccine, the
EMA’s safety committee found a potential link between it and the clots,
with most known cases occurring in women under age 60 within two weeks
of receiving the first dose. The EMA continues to stress that the odds
of developing a clot after vaccination are extremely low, and that the
benefits of getting vaccinated outweigh the risks. They also recommend
that people seek immediate medical attention if they experience symptoms
related to clotting, including persistent pain, shortness of breath, and
headaches or blurred vision.

On August 27, a study published in the British Medical Journal affirmed
the EMA’s risk-benefit analysis, showing that there’s a much higher risk
of developing blood clots after SARS-CoV-2 infection than after
immunization with the AstraZeneca or Pfizer vaccines.

On August 11, the CDC officially recommended that people who are
pregnant, breastfeeding, or may become pregnant get a COVID-19 vaccine.
A new analysis of data from the vaccine rollout found no increased risk
of miscarriage among people who received an mRNA vaccine before 20 weeks
of pregnancy. Earlier studies also showed that the vaccine is safe later
in pregnancy as well—for both pregnant people and their babies. The CDC
emphasized the urgency of vaccination among these groups in a health
alert issued on September 29, reporting new data showing a rise in
COVID-19-related deaths among pregnant people.

Vaccine prospects
Here are some of the vaccines that have made it to phase three and
beyond:

Johnson & Johnson
Name: JNJ-78436735

Who: One of the world’s largest multinational corporations, based in New
Jersey, specializing in healthcare and pharmaceutical products.

What: A single-dose vector vaccine. (Here’s how the Johnson & Johnson
vaccine works.)

Latest news: On October 21 the CDC cleared the way for the U.S. to begin
rolling out booster shots of Johnson & Johnson’s vaccine. The agency
endorsed the FDA’s emergency use authorization of a second dose of the
vaccine for all people ages 18 and older at least two months after a
first dose.

U.S. regulators also authorized mixing and matching vaccines—such as
administering booster doses of the either Moderna or Pfizer vaccine to
people who originally received the Johnson & Johnson vaccine. A preprint
analysis of a National Institutes of Health study shows that a booster
dose of the mRNA vaccines elicit a stronger immune response than another
dose of the Johnson & Johnson shot.

The news comes just weeks after Johnson & Johnson announced results of
its studies of booster doses. When administered two months after the
first jab, the booster is 100 percent effective against severe disease
and causes antibody levels to rise four to six times higher than after
the first shot. The second dose was also shown to be 75 percent
effective against all symptomatic disease globally and 94 percent
effective in the U.S. The company said that a booster shot administered
six months after the first dose produced a 12-fold increase in antibody
levels.

The company also said that real-world evidence and data from its
clinical trials show that its single-dose vaccine remains effective
against COVID-19. The press release cited a study published to a
preprint server, which shows that the vaccine remains 79 percent
effective in preventing COVID-19 and 81 percent effective in preventing
hospitalizations. Johnson & Johnson said these data are consistent with
findings from its clinical trials, which showed 75 percent efficacy
against severe disease and 89 percent efficacy against hospitalization.

Approval status: Approved for use in the U.S., Bahrain, Canada, and the
European Union.

Distribution: On March 2, the U.S. announced that Johnson & Johnson has
partnered with its competitor Merck to increase the supply of its
COVID-19 vaccine. Merck will dedicate two facilities to producing the
vaccine, which could double the amount of available doses. Biden said
that the additional doses will allow the U.S. to vaccinate all adults by
the end of May.

On June 11, the New York Times reported that the FDA has told Johnson &
Johnson to throw out 60 million doses made at its plant in Baltimore.
The news came a day after CNN reported that the U.S. hasn’t sent any
shipments of the vaccine since the first week of May due to a lack of
supply caused by earlier issues at the plant. On June 10, Johnson &
Johnson also announced that the FDA has approved an extension of the
shelf life of its vaccine from three to four and a half months.

Efficacy: On July 20, the New York Times reported on a preliminary study
showing that Johnson & Johnson’s vaccine is less effective against the
Delta and Lambda variants than it was against the original virus strain.
The paper notes that the results were obtained in a lab experiment and
may not reflect the vaccine’s real-world efficacy.

The results are also at odds with an earlier study conducted by Johnson
& Johnson showing that its vaccine offers strong protection against
Delta. Those studies showed a slight drop in efficacy compared to the
original virus, but say it is more effective against Delta than the Beta
variant of concern. The studies also showed that the protections last
for at least eight months.

On February 24, an FDA analysis confirmed Johnson & Johnson’s earlier
report that its vaccine is safe and effective in preventing COVID-19.
The report found the vaccine is 72-percent effective in preventing
COVID-19 based on U.S. trials, and 85-percent effective in preventing
severe disease across all regions. It also shows that the vaccine was
64-percent effective in preventing disease in the company’s South
African trials, which is higher than had previously been reported.

On June 9, a study published in the journal Nature showed that Johnson &
Johnson’s vaccine is effective in protecting against virus variants,
including the Beta and Gamma variants of concern. The study showed that
the vaccine elicits neutralizing antibodies and a T-cell response among
people who live in areas where the variants are widely circulating,
including Brazil and South Africa.

Safety: On July 13, U.S. regulators added a warning to Johnson &
Johnson’s vaccine in response to rare reports linking the shot to
Guillain-Barré Syndrome, a disorder in which the body’s immune system
attacks the nerves. The FDA said there have been about a hundred
preliminary reports of the syndrome among the 12.8 million people who
have received the Johnson & Johnson vaccine. It added that the benefits
of receiving the vaccine still outweigh the risks.

CDC officials told the Washington Post that the cases have mostly been
reported about two weeks after vaccination among men, many aged 50 or
older, and that these cases will be discussed during an upcoming meeting
of the CDC’s advisory committee.

In the spring, the vaccine’s rollout was briefly halted in the U.S. and
across Europe as regulators investigated reports of blood clotting among
people who have received the shot. The FDA and CDC reviewed 15 cases of
blood clots. The cases—which the agencies noted are “extremely
rare”—occurred in women between the ages of 18 and 48 within six to 13
days after vaccination. The Europeans Medicines Agency also said that
the cases it reviewed occurred in people under 60—mostly women—within
three weeks of vaccination.

On April 23, the U.S. FDA and CDC lifted the pause on Johnson &
Johnson’s vaccine and said that immunizations can resume immediately.
The agencies said that the risk of blood clots is “very low” and that
the benefits of getting the vaccine outweigh the risks. It will add
information about the increased risk of blood clots to the vaccine’s
label. The decision came days after the European Medicines Agency said
that blood clots should be listed as a “very rare” side effect of
Johnson & Johnson’s COVID-19 vaccine.

Clinical trials status: On September 23, 2020, Johnson & Johnson
announced the launch of its phase three “ENSEMBLE” trial to evaluate the
safety of the vaccine—and how well it works—among up to 60,000 adults
from a variety of countries. The trial will include “significant
representation” from older populations and those with underlying
conditions that make them more susceptible to COVID-19.

On October 12, 2020, Johnson & Johnson announced that it paused phase
three trials for an independent safety review due to an unexplained
illness in a participant. The company didn’t provide any details, in
part to protect the patient’s privacy, but said that illnesses and
accidents are expected in large clinical studies. What’s more, study
pauses are routine for clinical trials and aren’t typically reported.
Later that month, the company announced it would resume trials, which
were fully enrolled with 45,000 participants by December 17.

On April 2, Johnson & Johnson announced that it has begun vaccinating
children age 12 to 17 as part of its phase 2a clinical trial. The
company said it will initially test the vaccine in adolescents age 16 to
17 before expanding it to younger children.

Moderna Therapeutics
Name: mRNA-1273

Who: A Massachusetts-based biotech company, in collaboration with the
National Institutes of Health.

What: A nucleic-acid vaccine that requires two doses.

Latest news: On October 21 the CDC cleared the way for some people to
get booster shots of the Moderna vaccine. The agency endorsed the FDA’s
emergency use authorization of booster doses forall people ages 65 and
older as well as those ages 18 to 64 who are at risk of severe COVID-19
because of their underlying conditions. It also includes people ages 18
to 64 who are at high risk of exposure because of where they work or
live, such as health-care workers or incarcerated people.

Moderna has previously said that its phase two clinical trials showed
that a third dose administered six months after the second “induce
robust antibody responses” and increased protections against the
variants of concern. It has also said that a study of the phase two
clinical trials of its three booster candidates produced robust antibody
responses against the virus, including the Gamma, Beta, and Delta
variants of concern.

Approval status: On December 18, the FDA granted emergency approval to
Moderna’s COVID-19 vaccine, a day after an advisory panel decided 20-0,
with one abstention, that the benefits of the vaccine outweigh the
risks, such as the mild side effects reported in their clinical trial.
The vaccine has also been approved in the European Union, Canada, the
U.K., Israel, and by the WHO.

On June 1, Moderna announced that it has applied for full FDA approval
of its COVID-19 vaccine for use in people age 18 and older. The company
also plans to file for emergency use authorization for teens ages 12 to
17. A study of clinical trials among adolescents in this age group shows
that its vaccine is safe and 100 percent effective. The study also
showed the vaccine is 93 percent effective among participants in this
age group two weeks after the first dose.

On October 5, Moderna announced that European Union regulators have
authorized a third dose of its COVID-19 vaccine for “severely
immunocompromised” people age 12 and older.

Distribution: Moderna’s candidate was the second vaccine to receive
emergency authorization in the U.S., joining Pfizer’s candidate. On
December 11, the Trump administration purchased an additional 100
million doses of Moderna’s vaccine. Two months later, the Biden
administration procured an additional 100 million doses, for a total of
300 million by the end of July.

On April 2, Moderna announced that the FDA has authorized it to increase
the number of doses in its vials from 10 to 11. Regulators are also
permitting the company to use new vials that allow for 15 doses. The FDA
also said that Moderna’s vaccine can now be kept at room temperature for
up to a day. The vaccine can otherwise be safely stored on ice or in a
normal refrigerator for 30 days. These changes are expected to help the
company distribute its vaccine more quickly.

The company also says it remains on track to deliver at least 500
million doses globally per year beginning in 2021, thanks in part to a
deal it has struck with Swiss manufacturer Lonza that will allow it to
manufacture up to a billion doses a year.

On July 16, the U.S. said it will begin shipping 3.5 million doses of
Moderna’s vaccine to Argentina as part of a bilateral deal between the
countries. The U.S. has also shared doses of its vaccines with Taiwan,
Brazil, El Salvador, Pakistan, and other countries.

Efficacy: On September 10, the CDC released a study of more than 32,000
real-world cases suggesting that Moderna’s vaccine is more effective at
preventing hospitalizations than the Pfizer or Johnson & Johnson
vaccines. The overall efficacy of Moderna’s vaccine was 95 percent,
compared to 80 percent for Pfizer and 60 percent for Johnson & Johnson.

The study backs up earlier studies suggesting that Moderna’s vaccine may
provide stronger protection than Pfizer’s jab. A study published on
August 30 found that Moderna’s vaccine produces significantly more
neutralizing antibodies than Pfizer’s, which might be attributed to the
higher dosage or the longer interval between the first and second doses.
On August 8, a preliminary Mayo Clinic study of more than 50,000
patients showed that the efficacy of Moderna’s vaccine dropped from 86
percent in early 2021 to 76 percent in July, when the Delta variant was
predominant. Meanwhile, the Pfizer vaccine’s efficacy dropped over the
same time period from 76 percent to 42 percent.

An earlier preprint analysis of Moderna’s vaccine also suggested that
antibody levels can predict the vaccine’s efficacy against COVID-19. The
study showed that people with breakthrough infections who had lower
levels of antibodies in their blood were more likely to develop
symptomatic infections than those with higher levels of antibodies. The
study authors tell Nature that the data doesn’t suggest a threshold of
antibodies that ensures protection but it does show a relationship
between higher levels of antibodies and lower risk of infection.

On August 12, a study published in the journal Science showed that
Moderna’s vaccine protects against COVID-19 for at least six months and
is effective against the Delta variant. The findings confirm earlier
studies and announcements made by the company that its vaccine remains
93 percent effective for at least six months after administration of the
second dose.

However, there is some doubt about whether people who received the
Moderna shot will need boosters. A study published in the journal Nature
on June 28 showed that the vaccine elicits “robust and prolonged” immune
responses—indicating that protection may last for years so long as the
virus doesn’t mutate to evade it.

On July 9, Nature reported on a study showing that two quarter-doses of
Moderna’s vaccine generates long-lasting neutralizing antibodies and T
cells. The results suggest that it might be possible to administer
fractional doses to help stretch the world’s vaccine supply,
particularly in low- and middle-income countries that are facing
shortages.

On February 17, the New England Journal of Medicine published a
preliminary report showing that Moderna’s vaccine remains effective in
protecting against the virus variant found in the U.K. However, it may
be less effective in protecting against the South African
variant—although researchers noted that further study is needed.

In December 2020, an FDA analysis of the phase three study of Moderna’s
vaccine confirmed that it is 94.1-percent effective in preventing mild
cases of COVID-19 and 100-percent effective at preventing severe cases
after taking two doses.

Safety: On June 23, the U.S. Food and Drug Administration said it plans
to add a warning label to the Pfizer and Moderna vaccines about rare
cases of heart inflammation in adolescents and young adults. The news
comes after the CDC convened an emergency meeting of its advisory
committee to discuss “rare but higher-than-expected” cases of
myocarditis and pericarditis among young people who have received the
vaccines. The committee acknowledged that these cases are likely linked
to the vaccines but that the benefits of the shots outweigh the risks.

Clinical trials status: Moderna announced on December 17 that it is
launching clinical trials to evaluate the vaccine’s safety in children
and people with cancer; it will also establish a “pregnancy registry” to
track the vaccine’s safety in people who are pregnant.

The company started the third phase of its clinical trials in July 2020.
Preliminary findings from its phase one trials showed that healthy
subjects—including elderly patients—produced coronavirus antibodies and
a reaction from T cells, another part of the human immune response.
Phase three is testing the vaccine in 30,000 U.S. participants. The
company also announced plans to test the safety and efficacy of a
booster shot that would be delivered a year after the first pair of
vaccine doses, according to CNBC. The trial will likely begin in July
2021.

On February 24, Moderna announced that it has shipped doses of a booster
vaccine to the U.S. National Institutes of Health for clinical trials.
The phase one trial will determine whether the booster can improve
immunity against the South Africa variant. Moderna is also investigating
using a third dose of its approved vaccine to protect against variants.

Pfizer
Name: BNT162b2

Who: One of the world’s largest pharmaceutical companies, based in New
York, in collaboration with German biotech company BioNTech.

What: A nucleic-acid vaccine that requires two doses taken 21 days
apart.

Latest news: On October 22, the FDA released Pfizer’s analysis of its
clinical trials in kids ages five to 11 showing that its COVID-19
vaccine is 90.7 percent effective in preventing symptomatic disease. The
company has officially requested that the FDA grant emergency use
authorization to its COVID-19 vaccine for kids ages five to 11. An FDA
advisory committee will consider the request in a meeting scheduled for
October 26, with a final decision to come in the following days or
weeks.

Pfizer has already submitted its initial data on the safety and efficacy
of its vaccine for children in that age group. The company said at the
time that an analysis of its clinical trials of 2,268 participants shows
the vaccine is safe and elicits “robust” neutralizing antibodies. The
vaccine follows a two-dose regimen of 10 milligram doses—a third of the
dosage that is given to adults.

Approval status: On December 2, the U.K. became the first Western
country to approve any COVID-19 vaccine when it authorized the
Pfizer-BioNTech candidate—making the drug the first mRNA vaccine in
history allowed for human use. The FDA granted emergency use
authorization to this vaccine on December 11, 2020, and fully approved
it on August 23, 2021. The vaccine has also been granted emergency
approval in Canada, the European Union, and other countries.

On May 12, the CDC approved Pfizer’s vaccine for emergency use in
adolescents ages 12 to 15. U.K. regulators have also approved this
vaccine for use in the same age group, while the European Union granted
conditional authorization.

On August 23, the FDA granted full approval to Pfizer’s vaccine, making
it the first COVID-19 vaccine to reach that milestone. Public health
experts say the decision could lead to a substantial increase in
vaccination rates among the hesitant as well as an influx of vaccine
mandates from businesses and schools across the country. The decision
also provides doctors more latitude in prescribing booster doses.

As of September 24 U.S. regulators granted emergency use authorization
of a third dose of Pfizer’s vaccine—but only for certain subgroups of
the national population, including older people and those with
underlying conditions.

The FDA authorized boosters for people age 65 and older as well as those
who are at risk of severe disease. The CDC later refined that
recommendation, ruling that all adults over 65 and those ages 50 to 64
with conditions that put them at higher risk of disease should get the
shot. CDC director Rochelle Walensky also endorsed boosters for people
in occupational or institutional settings that put them at high risk of
infection, such as health-care workers and teachers.

Distribution: Pfizer and BioNTech have signed several contracts with the
U.S. government to provide 300 million doses by July 31, 2021.

The European Union said on April 14 that it has begun negotiations with
Pfizer-BioNTech for 1.8 billion doses of their vaccines for 2022 and
2023. The move is part of the bloc’s plans to pivot away from the
AstraZeneca and Johnson & Johnson vaccines in favor of the mRNA
vaccines.

Globally, Pfizer expects to be able to produce up to 50 million vaccine
doses in 2020 and 1.3 billion doses by the end of 2021. Questions have
been raised over the vaccine’s storage, which requires ultra-cold
freezers set at minus 70 degrees Celsius (-94 degrees F). On February
19, however, Pfizer and BioNTech said that their vaccine can remain
stable for two weeks at temperatures between minus 25? and minus 15?
(-13? to 5?), a common range in pharmaceutical freezers and
refrigerators. The finding would allow for easier distribution of the
vaccine in communities where ultra-cold storage requirements present a
challenge. The companies say they have submitted the new data to the FDA
for review.

Efficacy: On September 20, Pfizer announced that a study of its clinical
trials shows its vaccine is safe and highly effective in children ages
five to 11. Researchers determined that two low doses administered three
weeks apart elicit high levels of neutralizing antibodies among
children, with side effects comparable to those seen in people ages 16
to 25. The 10-milligram doses of vaccine are a third of what has been
approved among older age groups.

Pfizer also expects to release data soon on how well its vaccine works
among children ages six months to five years, according to CEO Albert
Bourla. In a public forum, he said the data could be available as early
as the end of October.

On August 25, Pfizer announced new data showing that a third dose of its
vaccine generates robust quantity of neutralizing antibodies that is
more than three times higher than what was observed one month after the
second dose.

A preprint study out of the United Kingdom shows that the Pfizer and
AstraZeneca vaccines remain protective against the Delta variant but
that their efficacy wanes over time. Among study participants, Pfizer’s
vaccine waned more rapidly. Within four to five months after a second
dose, the vaccine’s efficacy was on par with the AstraZeneca shot. The
study emphasizes, however, the both vaccines still significantly reduce
the risk of infection.

On July 8, a study published in Nature demonstrated that people who have
received both doses of the Pfizer or AstraZeneca vaccines remain fully
protected against severe disease, hospitalization, and death from the
Delta and Beta variants. However, a single dose of either vaccine was
not as protective.

The findings corroborate an earlier study published in Nature showing
that the Pfizer and Moderna vaccines elicit “robust and prolonged”
immune responses. As the New York Times reported at the time, the
findings suggested that people who are immunized with these vaccines may
not need booster shots as protection may last for years so long as the
virus doesn’t mutate to evade it.

On June 10, a study published in the journal Nature showed that two
doses of the Pfizer vaccine protects against several virus variants,
including the Delta and Eta variants. The news came a few days after the
CDC announced that the Pfizer and Moderna vaccines reduce the risk of
infection by 91 percent for fully vaccinated people.

In April, the CDC has released a study of the U.S. vaccine rollout
showing that the Pfizer-BioNTech and Moderna vaccines are 90 percent
effective in preventing symptomatic COVID-19 in real-world conditions.
The study analyzed the efficacy of the two mRNA vaccines among nearly
4,000 health-care workers, first responders, and other frontline workers
who were the first to receive the jab in the U.S. It also showed the
vaccines are 80-percent effective after one dose. The findings confirmed
earlier studies from the U.K. and Israel.

On December 10, the New England Journal of Medicine published the
results of Pfizer’s phase three study, showing the vaccine was safe and
95-percent effective in protecting against COVID-19 in people 16 and
older. Pfizer and BioNTech have also announced that a phase three trial
shows that their vaccine is safe and 100 percent efficacious among
children between the ages of 12 and 15, and that it elicited robust
antibody responses.

Safety: On June 23, the U.S. Food and Drug Administration said it plans
to add a warning label to the Pfizer and Moderna vaccines about rare
cases of heart inflammation in adolescents and young adults. The news
comes after the CDC convened an emergency meeting of its advisory
committee to discuss “rare but higher-than-expected” cases of
myocarditis and pericarditis among young people who have received the
vaccines. The committee acknowledged that these cases are likely linked
to the vaccines but that the benefits of the shots outweigh the risks.

Severe allergic reactions following immunization with the
Pfizer-BioNTech vaccine have been reported in many countries. White
House advisor Anthony Fauci told CNBC in December that some adverse
reactions are expected when a vaccine is distributed to a wider
population. Regulators in the U.S. and U.K. have also released reports
offering reassurances that severe reactions are rare.

Clinical trials status: On November 18, Pfizer and BioNTech announced
the conclusion of their phase three trials. The trials launched in July,
enrolling a diverse population in areas with significant SARS-CoV-2
transmission. Pfizer has expanded the trial to include 44,000 people
across multiple countries.

On February 18, Pfizer and BioNTech announced the launch of a phase
two/three clinical trial to study the vaccine’s safety and efficacy
among 4,000 pregnant women over the age of 18. The companies have also
launched a phase 1/2/3 study in children between the ages of six months
and 11 years.

On June 8, Pfizer said that it will expand its clinical trials to a
larger group of children under age 12. After a phase one study showed
that the vaccine was safe and effective in a group of 144 children, the
clinical trials will now enroll up to 4,500 children at more than 90
sites in the U.S., Finland, Poland, and Spain. Pfizer will test a dose
of 10 micrograms in children ages 5 to 11, and three micrograms for
children from six months to five years old.

The company expects to have data for the older group in September and
will likely file for emergency authorization for that group later that
month. Data for children ages two to five will likely come soon
afterward, while data for the youngest age group is not expected until
October or November.

On July 8, Pfizer and Biotech announced that they are developing an
updated version of the vaccine that specifically targets the Delta
variant. They anticipate clinical trials will begin in August.

AstraZeneca—University of Oxford
Name: ChAdOx1 nCoV-19

Who: The U.K. university, in collaboration with the biopharmaceutical
company AstraZeneca.

What: A viral vector vaccine that requires two doses.

Latest news: A preprint study out of the United Kingdom shows that the
Pfizer and AstraZeneca vaccines remain protective against the Delta
variant but that their efficacy wanes over time. Among study
participants, Pfizer’s vaccine waned more rapidly. Within four to five
months after a second dose, the vaccine’s efficacy was on par with the
AstraZeneca shot. The study emphasizes, however, the both vaccines still
significantly reduce the risk of infection.

Approval status: Approved for use in the United Kingdom, the European
Union, Argentina, India, and other countries.

Efficacy: On July 8, a study published in Nature demonstrated that
people who have received both doses of the AstraZeneca of Pfizer
vaccines remain fully protected from the Delta and Beta variants.
However, a single dose of either vaccine was not as protective.

On June 25, preliminary results from a British study showed that mixing
doses of the AstraZeneca and Pfizer vaccines provides strong protection
against COVID-19. Researchers told the New York Times that the
protection is strong regardless of the order in which the vaccines are
administered. The findings will be useful for those who are unable to
get a second AstraZeneca vaccine due to production delays and safety
concerns, although researchers say it’s still best to get two doses of
the same vaccine for now.

On March 24, AstraZeneca released the primary analysis of its U.S. phase
three clinical trials showing that its vaccine is 76 percent effective
at preventing COVID-19, slightly lower than the 79 percent efficacy it
had announced two days earlier based on a partial analysis of the data.
It is also 85 percent effective in people 65 and older and 100 percent
effective at preventing severe cases of the disease.

U.S. health officials had taken the unusual step of questioning the
decision to release the interim results, describing them as “outdated
and potentially misleading.” In a letter obtained by the Washington
Post, an independent panel of experts at the National Institutes of
Health that oversees U.S. clinical trials said that it had recommended
the company release a later analysis instead, showing the vaccine may be
69 to 74 percent effective.

On February 3, AstraZeneca and Oxford released a preprint study of a
phase three trial showing that their vaccine is 76-percent effective at
preventing COVID-19 after one dose, with no severe cases or
hospitalizations reported. The data also suggest that the vaccine may
reduce asymptomatic transmission of the virus. Weekly swabs of
participants testing for the presence of the virus found a 67-percent
reduction in positive swabs after the first dose.

The companies also said that the vaccine’s efficacy increased to 82
percent when the second dose was taken after 12 weeks or longer, rather
than the originally recommended four-week interval. The British
government has recommended the longer gap in its rollout of the vaccine
to prioritize getting the first shot to as many at-risk people as
possible.

On February 7, South Africa halted its use of the AstraZeneca-Oxford
vaccine after preliminary laboratory studies showed it offered only
minimal protection against the virus variant that is dominant in that
country. The finding was later confirmed by a study published in the New
England Journal of Medicine showing that the vaccine does not protect
against mild to moderate cases of COVID-19 caused by the South African
variant. Early data suggested that the vaccine will still effectively
protect against the variant that is prevalent throughout the U.K.

Safety: On June 9, a study published in the journal Nature Medicine
found that people who have received the AstraZeneca vaccine have a
slightly increased risk of a bleeding disorder. The analysis of 2.53
million people who received the vaccine found an incidence of 1.13 cases
per 100,000 vaccines. Researchers said the benefits of getting the
vaccine outweigh the risks. The study echoes and earlier safety review
conducted by the European Medicines Agency.

In Canada, meanwhile, on June 29 regulatory officials advised people
with a history of capillary leak syndrome against receiving the
AstraZeneca vaccine. Health Canada is also updating the vaccine’s label
to add the syndrome as a potential side effect.

Distribution: Project members say their candidate can be stored at
temperatures seen in common refrigeration. Oxford and AstraZeneca expect
to produce up to three billion doses of the vaccine in 2021.

On December 30, the U.K. announced changes to its vaccine delivery plan:
With COVID-19 infections spreading rapidly, the country said it would
prioritize delivering the first dose of either vaccine to as many
at-risk people as possible, based on data provided to and released by
health regulators. It will do so by delaying administration of the
second dose of the AstraZeneca-Oxford drug. A similar rule was issued
for the Pfizer-BioNTech vaccine, but regulators didn’t provide data to
back the new regimen. Overall, the U.K. still recommends that recipients
receive two doses of either vaccine for maximum benefit.

On February 15, the WHO listed the AstraZeneca-Oxford vaccine for
emergency use, which will allow the agency to begin rolling out the
vaccine in low-income countries through the COVAX Facility. Reuters
reports that COVAX plans to deliver nearly two billion doses to more
than 90 low- and middle-income countries by the end of the year.

On April 26, the Associated Press reported that the U.S. plans to share
its AstraZeneca vaccine stockpile with the rest of the world—up to 60
million doses. The U.S. has not yet authorized the company’s vaccine for
use.

The European Union also said on April 26 that it is suing AstraZeneca
over the delays in shipping hundreds of millions of doses of its
vaccine. According to the New York Times, AstraZeneca has said it will
only be able to deliver a third of the 300 million doses it had promised
Europe by the end of June. The lawsuit will hinge on whether AstraZeneca
can prove it has made its “best efforts” to deliver the doses on time,
according to the terms of the contract.

Clinical trials status: On December 11, AstraZeneca and Russia’s
Gamaleya Institute announced plans to work together to study the
possibility of combining Oxford’s vaccine with Gamaleya’s Sputnik V
vaccine. Since both use the same adenovirus, researchers will
investigate whether a combination of the two will improve efficacy.

The AstraZeneca-Oxford vaccine’s phase three trial aims to recruit up to
50,000 volunteers in Brazil, the U.K., the United States, and South
Africa. On September 8, AstraZeneca paused the trials for a safety
review due to an adverse reaction in one participant in the U.K., which
the company described as a “routine action.” After an investigation by
independent regulators, the trials resumed in the U.K., Brazil, South
Africa, and India in September and resumed in the U.S. a month later.

Novavax
Name: NVX-CoV2373

Who: A biotechnology company based in Gaithersburg, Maryland.

What: A protein vaccine that involves a nanoparticle carrier to better
aid delivery and uptake by cells.The vaccine is administered in two
doses, 21 days apart.

Latest news: On August 5, Novavax said that it will hold off on
submitting its vaccine to the FDA for emergency use authorization until
the fourth quarter of 2021 rather than the third quarter as the company
had previously announced. Reuters reports that Novavax also said that it
will file a separate application for booster shots once the emergency
use authorization submission is processed; the company said its booster
shot given six months after the two-dose regimen elicited a 4.6-fold
increase in antibodies. The company has filed for authorization from
regulators in India, Indonesia, and the Philippines.

The New York Times also reported that the federal government will not
fund further production of the Novavax vaccine until the company
resolves regulators’ concerns about its lagging production process.

Approval status: Not approved for use.

Efficacy and safety: On June 14, Novavax announced that its vaccine is
safe and 90.4 percent effective in protecting against COVID-19—including
the more contagious virus variants that are circulating. The vaccine is
also 100 percent effective at preventing moderate and severe disease
among 29,960 clinical trial participants age 18 and older in the U.S.
and Mexico.

On March 11, Novavax announced that a final analysis of its phase three
clinical trials in the U.K. shows that its vaccine is 96.4-percent
effective in preventing COVID-19. It also announced the findings of its
phase 2b clinical trial in South Africa, which showed the vaccine was
only 48.6-percent effective against the strains circulating there. Both
trials showed the vaccine is 100-percent effective at preventing severe
cases of the disease.

On January 28, Novavax had announced preliminary results of its phase
three trials in the U.K., which showed at the time that its vaccine is
89.3-percent effective in preventing COVID-19. On September 2, a study
of the company’s phase one trial published in the New England Journal of
Medicine found that the vaccine was safe and produced coronavirus
antibodies at a higher level than is seen among those who have recovered
from COVID-19. It also stimulated T cells, another arm of the human
immune response.

Clinical trials status: On September 24, Novavax announced the launch of
its phase three trial in the United Kingdom, which will evaluate the
vaccine in up to 10,000 people, both with and without underlying
conditions. Up to 400 participants will also be vaccinated against the
seasonal flu as part of a sub-study that will help determine whether it
is safe to give patients both vaccines at the same time. On November 30,
Novavax said it had completed enrollment in its phase three trial in the
U.K.

On December 28, Novavax announced the launch of a phase three study in
the U.S. and Mexico, which will evaluate the safety and efficacy of its
vaccine in up to 30,000 adults.

Sinopharm
Name: None

Who: China’s state-run pharmaceutical company, in collaboration with the
Wuhan Institute of Biological Products.

What: Two inactivated SARS-CoV-2 vaccines.

Latest news: On July 19, preliminary results from a study conducted in
Sri Lanka found that Sinopharm’s vaccine was less effective against the
Delta variant than the original SARS-CoV-2 strain. As Reuters reported,
the study showed that the vaccine elicited a 1.38-fold reduction in
antibody levels against the variant.

Distribution: Authorities in China have set a goal to vaccinate 50
million people by Lunar New Year in mid-February, despite the lack of
evidence that their available vaccines are safe and effective. Chinese
officials have said the vaccine will be free for Chinese citizens, and
that they will prioritize immunizations for high-risk groups such as the
elderly and people with underlying conditions.

On January 13, Hungary’s government announced that it had reached a deal
with Sinopharm to buy the company’s vaccine, following Hungary’s
criticisms of the pace of the European Commission’s vaccine rollout.

Approval status: China has approved one of the company’s vaccines for
general use and another for limited use. One of the Sinopharm vaccines
has also been approved by the World Health Organization as well as in
Bahrain, the United Arab Emirates, and other countries.

Sinopharm filed for final regulatory approval from China in late
November, two months after the New Yorker reported that hundreds of
thousands of Chinese civilians have already been vaccinated under the
government’s emergency-use approval. China began to inoculate medical
workers and other high-risk groups with the Sinopharm trial vaccines in
July, making it the first experimental vaccine available to civilians
beyond clinical volunteers.

Efficacy and safety: On May 7, the World Health Organization estimated
the Sinopharm vaccine’s efficacy to be 79 percent among all age groups,
affirming the company’s earlier announcement of the results of its phase
three study.

Preliminary findings from two randomized trials, published in the
Journal of the American Medical Association, have shown the vaccine can
trigger an antibody response with no serious adverse effects. The study
did not measure T cell-mediated immune responses. These results are
significant, though, as they are the first published data from human
clinical trials for a COVID-19 vaccine that uses a whole, inactivated
virus.

Clinical trials status: Sinopharm launched its first phase three trial
in July 2020 among 15,000 volunteers—aged 18 to 60, with no serious
underlying conditions—in the UAE. The company selected the UAE because
it has a diverse population made up of approximately 200 nationalities,
making it an ideal testing ground. Sinopharm will also undertake phase
three trials in locations such as Peru and Bahrain.

Sinovac
Name: CoronaVac

Who: A Chinese biopharmaceutical company, in collaboration with
Brazilian research center Butantan.

What: An inactivated vaccine.

Latest news: On July 15, Reuters reported that the leaders of a Chilean
study have recommended administering a third dose of Sinovac’s vaccine
as its efficacy has waned in the face of the Delta variant. The
vaccine’s level of protection is lower than others—late-stage trials
found that it is 51 percent effective in preventing COVID-19. Still,
Nature reports that it is 100 percent effective at preventing severe
disease and therefore is key to helping curb the pandemic.

Approval status: Approved for limited use by the WHO as well as in
China, Indonesia, Brazil, and other countries.

Efficacy and safety: Reports released in early January place CoronaVac’s
efficacy below that of other authorized vaccines. Results from a
late-stage clinical trial released on January 13 found that CoronaVac
had an efficacy of 50.4 percent, slightly more than the 50-percent
minimum recommended by the World Health Organization. The difference
comes down to the earlier estimate’s exclusion of trial participants who
got “very mild infections” but did not require clinical assistance.

On April 7, a preliminary study of CoronaVac’s vaccine rollout in
Brazil showed that the vaccine is about 50 percent effective in
protecting against COVID-19 in a region where the highly transmissible
P.1 variant is circulating.

Clinical trials status: CoronaVac entered phase three trials in July,
with plans to recruit nearly 9,000 healthcare professionals in Brazil,
in addition to phase three trials in Indonesia. A planned trial in
Bangladesh was delayed, after Bangladesh refused in October to
co-finance a late-stage trial.

Center for Genetic Engineering and Biotechnology
Name: Abdala

Who: A government-run research institute in Cuba.

What: A protein subunit vaccine that’s administered in three doses.

Latest news: On June 22, Cuba announced that the Abdala vaccine is 92.28
percent effective against COVID-19. Data has not yet been released, but
Reuters reports that Cuban regulators are expected to grant emergency
use authorization to both the Abdala and Soberana-02 vaccines. However,
the country has already begun administering the two vaccines among
health workers as part of an “intervention study.”

Clinical trials: In March Cuba launched phase three clinical trials for
the Abdala vaccine among 48,000 volunteers.

Finlay Institute for Vaccines
Name: Soberana-02

Who: A government-run research institute in Cuba.

What: A conjugate vaccine that uses part of the virus spike protein.

Latest news: On June 22, the New York Times reported that the
Soberana-02 vaccine was 62 percent effective at preventing COVID-19
after two of its three required doses. Results for all three doses is
expected within weeks.

Clinical trials: On March 4, Cuba became the first country in Latin
America to announce the launch of a phase three clinical trial for one
of its COVID-19 vaccines, the Miami Herald reported. The Cuban
government hasn’t released any data from early-stage trials but said the
phase three trial will be conducted in Havana among 44,000 volunteers.

CureVac
Name: CVnCoV

Who: A German biopharmaceutical company in partnership with Bayer, a
German multinational pharmaceutical company.

What: An mRNA vaccine that’s administered in two doses taken 28 days
apart.

Latest news: On June 16, CureVac reported disappointing results from a
study of its clinical trials showing its vaccine is 47 percent effective
in preventing COVID-19, falling short of the company’s own criteria for
success. CureVac attributed its results to the virus variants that are
now circulating. It sequenced 124 cases of COVID-19 among clinical trial
participants and found only one case was caused by the original
SARS-CoV-2 virus and more than half were caused by variants of concern.

The New York Times reports that CureVac still intends to apply for
approval from the European Medicines Agency. The company has a deal to
provide 405 million doses to the European Union if its vaccine is
authorized.

Approval status: Not approved for use.

Efficacy and safety: On January 11, CureVac announced that preliminary
results show its vaccine prompted robust antibody and T-cell responses
in rhesus macaques.

Clinical trials status: On December 14, CureVac announced it had begun
enrolling participants in a phase 2b/3 study to assess its vaccine’s
safety and efficacy in more than 35,000 participants in Europe and Latin
America. One week later, the company launched a separate phase three
trial in healthcare workers in Mainz, Germany.

Sanofi-GSK
Name: None

Who: A global biopharmaceutical company in partnership with a global
healthcare company.

What: An adjuvant-supported recombinant-protein vaccine.

Latest news: On May 27, Sanofi and GSK announced that they’ve started to
enroll participants in a phase three clinical study of their COVID-19
vaccine candidate. The study will test the safety and efficacy of the
vaccine in 35,000 volunteers ages 18 and older in the U.S., Asia,
Africa, and Latin America. The study’s broad geographic range will allow
the companies to evaluate the vaccine’s efficacy against the virus
variants that are circulating around the world.

Approval status: Not approved for use.

Efficacy and safety: On May 17, the companies announced that a study of
their phase two clinical trials shows the vaccine generated a high level
of neutralizing antibodies with no safety concerns.

Biological E. Limited
Name: None

Who: An Indian vaccine and pharmaceutical company in partnership with
the Baylor College of Medicine.

What: A protein-based subunit vaccine that requires two doses
administered 28 days apart.

Latest news: On April 26, the companies announced that they have
received approval to launch a phase three clinical trial of their
vaccine candidate. The trial will evaluate the efficacy and safety of
the vaccine among more than 1,200 volunteers ages 18 to 80 at 15 sites
across India.

Approval status: Not approved for use.

Distribution: If the vaccine is approved for use, it will be distributed
through the COVAX Facility, a global effort to ensure the equitable
distribution of COVID-19 vaccines.

Valneva SE
Name: VLA2001

Who: A vaccine developer based in France.

What: An inactivated virus, adjuvant-supported vaccine, with two doses
administered three weeks apart.

Latest news: On April 21, Valneva announced the launch of phase three
clinical trials to study the safety and efficacy of its COVID-19
vaccine. The trial will compare the efficacy of the vaccine to that of
AstraZeneca’s conditionally approved vaccine. Approximately 4,000
volunteers will receive two doses of either vaccine to determine the
immune response of each. Valneva says it hopes to file for regulatory
approval in the fall of 2021.

Approval status: Not approved for use.

Safety and efficacy: On April 6, Valneva announced that a study of its
phase 1 and 2 clinical trials show that its vaccine prompted a strong
immune response with no safety concerns.

Shenzhen Kangtai Biological Products
Name: None

Who: A China-based pharmaceuticals company.

What: An inactivated vaccine that requires two doses administered 28
days apart.

Latest news: On May 14, China approved the Kangtai shot for emergency
use, just weeks after the vaccine launched its phase three clinical
trials.

Approval status: Authorized for emergency use in China.

Clinical trials: Kangtai’s phase three clinical trials are underway,
testing the vaccine’s safety and efficacy among 28,000 adults age 18 and
older.

Medicago
Name: CoVLP

Who: A Canadian biotechnology company, in partnership with British
multinational pharmaceutical company GlaxoSmithKline.

What: A plant-derived recombinant vaccine with an adjuvant that requires
two doses administered 21 days apart.

Latest news: On March 16, Medicago and GlaxoSmithKline announced that
their vaccine had entered phase three clinical trials to study its
safety and efficacy in up to 30,000 volunteers in 10 countries,
including Canada and the U.S. In November 2020, the companies said that
their phase one clinical trials showed the vaccine produced antibody and
T-cell responses with no severe adverse events reported.

Bharat Biotech
Name: COVAXIN

Who: An Indian biotechnology company, in collaboration with the Indian
Council of Medical Research and the National Institute of Virology.

What: An inactivated vaccine, which requires two doses that are
administered 28 days apart.

Latest news: On March 3, Bharat Biotech announced that an interim
analysis of its phase three trial showed its vaccine is 81-percent
effective in protecting against COVID-19 after the second dose. A
separate preliminary study also indicated that the vaccine produces
antibodies that can neutralize the virus variant that originated in the
U.K.

Approval status: Authorized for emergency use in India.

Distribution: India has the second-highest caseload in the world—only
behind the U.S.—with more than 11 million people infected. As a result,
the country is embarking on an ambitious plan to vaccinate 300 million
frontline workers and vulnerable people by August 2021.

On January 12, Bharat Biotech announced that it had signed an agreement
with Precisa Medicamentos, a Brazilian pharmaceutical company, to sell
COVAXIN in Brazil.

Efficacy and safety: On January 21, The Lancet published interim
findings from COVAXIN’s phase one study that showed the vaccine elicited
an immune response in participants. The study identified only one
serious adverse event, and it was unrelated to the vaccine.

Clinical trials status: On November 16, Bharat Biotech announced it has
begun phase three trials involving 26,000 participants at more than 25
centers across India.

The Gamaleya National Center of Epidemiology and Microbiology
Name: Sputnik V

Who: A Russian research institution, in partnership with the state-run
Russian Direct Investment Fund.

What: A viral vector vaccine that uses two strains of adenovirus and
requires a second injection after 21 days to boost the immune response.

Latest news: On March 4, the European Union announced that it is
starting a rolling review of the Sputnik V vaccine. The announcement
came after a handful of European countries said they would consider
approving the vaccine without E.U. approval. Hungary has already
authorized the vaccine.

Approval status: In August, Russia cleared the Sputnik V vaccine for
widespread use and claimed it as the first registered COVID-19 vaccine
on the market—before the vaccine’s phase three trials had begun and
despite the lack of published evidence at the time. It has since been
approved in Belarus, Argentina, Venezuela, and other countries.

Efficacy and safety: On February 2, the medical journal The Lancet
published the results of a phase three trial in Moscow that found the
Sputnik V vaccine is safe and 91.6-percent effective in preventing
COVID-19. The study, which involved more than 22,000 participants, also
showed the vaccine is 100-percent effective in preventing moderate or
severe cases of the disease, as no such cases were confirmed at least 21
days after receiving the first dose.

Distribution: Global demand for Sputnik V has soared in the weeks since
the vaccine’s efficacy data was published. The vaccine makers have
reached deals with more than 40 countries in Latin America, Eastern
Europe, Asia, and Africa. On February 19, the African Union announced
that Russia has offered them 300 million doses of the Sputnik V vaccine,
which they will make available starting in May.

Clinical trials status: On December 11, the Gamaleya Institute and
biopharmaceutical company AstraZeneca announced they will work together
to study the possibility of combining Sputnik V with the candidate that
AstraZeneca has developed with the University of Oxford. Since both
candidates use the same adenovirus, researchers will investigate whether
combining them will improve efficacy of the AstraZeneca vaccine, which
is 70.4-percent effective in preventing COVID-19.

Chumakov Center
Name: CoviVac

Who: A Russian research center.

What: An inactivated vaccine given in two doses, 14 days apart.

Approval status: On February 20, Russia approved the CoviVac vaccine for
use even though late-stage clinical trials to test its safety and
efficacy have not yet begun. Reuters reports that early-stage trials
with 200 participants showed the vaccine has no side effects.

Distribution: The Chumakov Center plans to produce half a million doses
per month.

Murdoch Children’s Research Institute
Name: Bacillus Calmette-Guerin BRACE trial

Who: The largest child health research institute in Australia, in
collaboration with the University of Melbourne.

What: For nearly a hundred years, the Bacillus Calmette-Guerin (BCG)
vaccine has been used to prevent tuberculosis by exposing patients to a
small dose of live bacteria. Evidence has emerged over the years that
this vaccine may boost the immune system and help the body fight off
other diseases as well.

Latest news: On November 10, a U.S. study published in the Journal of
Clinical Investigation found that among 6,201 healthcare workers in Los
Angeles, those who had previously received the BCG vaccine reported
symptoms of COVID-19 less often than those who hadn’t, a finding that
study authors say strengthens the case for further research. In October,
the U.K. launched a study of the BCG vaccine that is part of the
Australian-led trials. The study is seeking to recruit 1,000 frontline
health-care workers to test the vaccine’s effectiveness against
COVID-19.

Clinical trials status: In April, researchers from the Murdoch
Children’s Research Institute began a series of randomized controlled
trials that will test whether BCG might work on the coronavirus as well.
They aim to recruit 10,000 healthcare workers in the study. In an April
2020 scientific brief, the World Health Organization found that there is
no current evidence that the BCG vaccine protects people against
infection with the coronavirus.

Approval status: Not approved for use.

CanSino Biologics
Name: Ad5-nCoV

Who: A Chinese biopharmaceutical company.

What: A viral vector vaccine.

Latest news: A Russian pharmaceutical company Petrovax announced that
more than 90 percent of participants in Russian trials of Ad5-nCoV had
high levels of antibodies, but few additional details are currently
available. Indonesia has ordered 20 million doses of CanSino’s vaccine;
Mexico signed an agreement to buy 35 million doses.

Approval status: Though the company was still technically in phase two
of its trial, on June 25, CanSino became the first company to receive
limited approval to use its vaccine in people. The Chinese government
has approved the vaccine for military use only, for a period of one
year.

Efficacy and safety: Preliminary results from phase two trials,
published in The Lancet, have shown that the vaccine produces
“significant immune responses in the majority of recipients after a
single immunisation.” There were no serious adverse reactions
documented.

Clinical trials status: On December 21, CanSino announced that it has
recruited more than 20,000 participants for its phase three trials in
Pakistan, Russia, Mexico, and Chile. On August 15, Russian
biopharmaceutical company Petrovax announced it had launched the first
phase three clinical trial of Ad5-nCoV.

Vector Institute
Name: EpiVacCorona

Who: A Russian biotechnology institute.

What: A protein vaccine, namely it uses small fragments of viral
antigens called peptides to produce an immune response.

Latest news: On January 13, Russian state news agency TASS reported that
of the more than 2,000 volunteers who had received both doses of
EpiVacCorona’s two-dose regimen, none reported adverse reactions from
the vaccine. In November, Russia launched mass trials of its
EpiVacCorona vaccine; the trials will inoculate 150 people over the age
of 60 and 3,000 volunteers over the age of 18.

Approval status: On October 14, Russia granted regulatory approval to
EpiVacCorona even though the vaccine candidate has not published any
results and has not entered phase three of its clinical trials. It is
the second vaccine candidate that Russia has approved for use despite a
lack of published evidence about its safety and efficacy.

Zydus Cadila
Name: ZyCoV-D

Who: An Indian pharmaceutical company.

What: A DNA-based vaccine that is delivered by a skin patch.

Latest news: On January 3, Zydus Cadila announced it had received
approval from Indian regulators to launch a phase three trial testing
the safety and efficacy of its vaccine in about 30,000 volunteers.

Approval status: Not approved for use.

Safety and efficacy: In December, Zydus Cadila said that a combined
phase one/two study of its vaccine showed it was safe and prompted an
immunogenic response, but the company did not share any data.

Anhui Zhifei
Name: ZF2001

Who: A Chinese biopharmaceutical company, in partnership with the
Institute of Microbiology at the Chinese Academy of Sciences.

What: A subunit vaccine that uses pieces of protein from a pathogen to
trigger an immune response.

Latest news: In November, Chinese health officials announced the launch
of phase three trials for the Anhui Zhifei vaccine. The trials—which
will recruit 29,000 volunteers aged 18 or older—are expected to be
conducted in China, Indonesia, Pakistan, and Ecuador.

Approval status: Not approved for use.

Research Institute for Biological Safety Problems
Name: QazCovid-in

Who: A research institute in Kazakhstan.

What: An inactivated vaccine.

Latest news: On January 14, Kazakh health officials granted a nine-month
temporary registration to the QazCovid-In vaccine, despite a lack of
data from its ongoing phase three trials. Prime Minister Askar Mamin has
previously said he expects mass vaccination to begin in March 2021.

Approval status: Granted temporary registration in Kazakhstan.

Clinical trials status: In December, the institute announced that the
Kazakh Ministry of Health approved the launch of phase three trials,
which will assess the vaccine’s safety and efficacy in 3,000 volunteers.

Institute of Medical Biology at the Chinese Academy of Medical Sciences
Name: Unknown

Who: A Chinese research institute.

What: An inactivated vaccine that requires two doses taken 14 days
apart.

Latest news: In December, researchers launched phase three clinical
trials to test the efficacy and safety of the vaccine in 34,020
participants in Malaysia and Brazil.

Safety and efficacy: Preliminary results of the vaccine’s phase one
trial showed that it prompted an immune response with no serious adverse
incidents.