Prevention Injection For 2 Months

[Brigitta Martini]

Infantsand children with bleeding disorders such as hemophilia should get nirsevimab. But, as with all shots given into a muscle, parents should notify their child's healthcare provider so additional precautions can be taken.

Infants and children who have a moderate or severe acute illness usually should wait until they recover before getting nirsevimab. Your child's healthcare provider may decide to postpone giving nirsevimab until a future visit when your child feels better. Children with minor illnesses, such as a cold, can receive nirsevimab.

Nirsevimab reduces the risk of severe RSV disease by about 80%. One dose of nirsevimab protects infants for at least 5 months, the length of an average RSV season. Because nirsevimab does not activate the immune system, protection is most effective in the weeks right after nirsevimab is given and lessens over time. Nirsevimab does not provide long-term protection against RSV disease, but it does protect infants when they are most at risk of getting very sick from RSV. As children get older, they are less likely to get very sick from RSV.

Nirsevimab contains monoclonal antibodies, which are man-made proteins that protect against RSV. Though it does not activate the immune system the way an infection or vaccine would, a nirsevimab shot provides protection similar to that of a vaccine.

The protection that nirsevimab provides is called "passive immunity" because it does not come from the person's own immune system. Instead, the protection comes from antibodies produced outside a person's body.

On the other hand, the protection that vaccines provide is called "active immunity" because the antibodies are made by a person's own immune system. "Active immunity" requires a person's immune system to take action to defend itself.

Side effects after nirsevimab were uncommon in clinical trials. The most common side effects after nirsevimab are pain, redness, or swelling where the injection was given, and a rash. No serious allergic reactions occurred in the clinical trials.

If your child experienced side effects after receiving nirsevimab, it can be reported to the FDA or CDC. Your healthcare provider might file the report, or you can do it yourself by phone or through the MedWatch or VAERS websites.

Nirsevimab is covered by VFC, a federally funded program that provides vaccines at no cost to children who might not otherwise be vaccinated because of inability to pay. Children younger than 19 years of age are eligible for the VFC Program if they belong to one or more of the following groups:

Private health insurance. Many private health insurance plans cover nirsevimab, but there may be a cost to you depending on your plan. Contact your insurer to find out.

People who are 32 through 36 weeks pregnant during September through January should get one dose of maternal RSV vaccine to protect their babies. RSV season can vary around the country. If you live in Alaska, Florida, or outside the continental U.S., talk to your healthcare provider about when RSV season is expected where you live.

When someone gets an RSV vaccine, their body responds by making a protein that protects against the virus that causes RSV. The process takes about 2 weeks. When a pregnant person gets an RSV vaccine, their protective proteins (called antibodies) also pass to their baby. So babies who are born at least 2 weeks after their mother gets RSV vaccine are protected at birth, when infants are at the highest risk of severe RSV disease. The vaccine can reduce a baby's risk of being hospitalized from RSV by 57% in the first six months after birth.

Although not common, a dangerous high blood pressure condition called pre-eclampsia occurred in 1.8% of pregnant people who received the maternal RSV vaccine compared to 1.4% of pregnant people who received a placebo.

The clinical trials identified a small increase in the number of preterm births in vaccinated pregnant people. It is not clear if this is a true safety problem related to the RSV vaccine or if this occurred for reasons unrelated to vaccination.

To reduce the potential risk of preterm birth and complications from RSV disease, FDA approved the maternal RSV vaccine for use during weeks 32 through 36 of pregnancy while additional studies are conducted.

FDA is requiring the manufacturer to do additional studies that will look more closely at the potential risk of preterm births and pregnancy-related high blood pressure issues in mothers, including pre-eclampsia.

Severe allergic reactions to vaccines are rare but can happen after any vaccine and can be life-threatening. If you see signs of a severe allergic reaction after vaccination (hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, or weakness), seek immediate medical care by calling 911. As with any medicine or vaccine there is a very remote chance of the vaccine causing other serious injury or death after vaccination.

Adverse events following vaccination should be reported to the Vaccine Adverse Event Reporting System (VAERS), even if it's not clear that the vaccine caused the adverse event. You or your doctor can report an adverse event to CDC and FDA through VAERS. If you need further assistance reporting to VAERS, please email in...@VAERS.org or call 1-800-822-7967.

Beginning October 1, 2023, most people with coverage from Medicaid and Children's Health Insurance Program (CHIP) will be guaranteed coverage of all vaccines recommended by the Advisory Committee on Immunization Practice at no cost to them.

The maternal RSV vaccine will be covered by VFC, a federally funded program that provides vaccines to children who otherwise might not be vaccinated because of inability to pay. Pregnant teens enrolled in Medicaid will not be charged for the vaccine or administration. VFC-eligible teens not enrolled in Medicaid will get the vaccine at no charge but may be charged an administration fee. Children younger than 19 years of age are eligible for the VFC Program if they belong to one or more of the following groups:

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Today, the U.S. Food and Drug Administration approved Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV. Apretude is given first as two initiation injections administered one month apart, and then every two months thereafter. Patients can either start their treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to assess how well they tolerate the drug.

According to the U.S. Centers for Disease Control and Prevention, notable gains have been made in increasing PrEP use for HIV prevention in the U.S. and preliminary data show that in 2020, about 25% of the 1.2 million people for whom PrEP is recommended were prescribed it, compared to only about 3% in 2015. However, there remains significant room for improvement. PrEP requires high levels of adherence to be effective and certain high-risk individuals and groups, such as young men who have sex with men, are less likely to adhere to daily medication. Other interpersonal factors, such as substance use disorders, depression, poverty and efforts to conceal medication also can impact adherence. It is hoped that the availability of a long-acting injectable PrEP option will increase PrEP uptake and adherence in these groups.

The safety and efficacy of Apretude to reduce the risk of acquiring HIV were evaluated in two randomized, double-blind trials that compared Apretude to Truvada, a once daily oral medication for HIV PrEP. Trial 1 included HIV-uninfected men and transgender women who have sex with men and have high-risk behavior for HIV infection. Trial 2 included uninfected cisgender women at risk of acquiring HIV.

Participants who took Apretude started the trial with cabotegravir (oral, 30 mg tablet) and a placebo daily for up to five weeks, followed by Apretude 600mg injection at months one and two, then every two months thereafter and a daily placebo tablet.

Participants who took Truvada started the trial taking oral Truvada and placebo daily for up to five weeks, followed by oral Truvada daily and placebo intramuscular injection at months one and two and every two months thereafter.

In Trial 1, 4,566 cisgender men and transgender women who have sex with men received either Apretude or Truvada. The trial measured the rate of HIV infections among trial participants taking daily cabotegravir followed by Apretude injections every two months compared to daily oral Truvada. The trial showed participants who took Apretude had 69% less risk of getting infected with HIV when compared to participants who took Truvada.

In Trial 2, 3,224 cisgender women received either Apretude or Truvada. The trial measured the rate of HIV infections in participants who took oral cabotegravir and injections of Apretude compared to those who took Truvada orally. The trial showed participants who took Apretude had 90% less risk of getting infected with HIV when compared to participants who took Truvada.

Side effects occurring more frequently in participants who received Apretude compared to participants who received Truvada in either trial include injection site reactions, headache, pyrexia (fever), fatigue, back pain, myalgia and rash.

Apretude includes a boxed warning to not use the drug unless a negative HIV test is confirmed. It must only be prescribed to individuals confirmed to be HIV-negative immediately prior to starting the drug and before each injection to reduce the risk of developing drug resistance. Drug-resistant HIV variants have been identified in people with undiagnosed HIV when they use Apretude for HIV PrEeP. Individuals who become infected with HIV while receiving Apretude for PrEP must transition to a complete HIV treatment regimen. The drug labeling also includes warnings and precautions regarding hypersensitivity reactions, hepatotoxicity (liver damage) and depressive disorders.

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