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Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be administered at least six months after completion of the primary series in:
Comirnaty (COVID-19 Vaccine, mRNA), was approved by the FDA on Aug. 23, for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older. On Aug. 25, 2021, the FDA received a supplement from Pfizer Inc. to their biologics license application for Comirnaty seeking approval of a single booster dose to be administered approximately six months after completion of the primary vaccination series for individuals 16 years of age and older.
Additional analysis conducted by the manufacturer, as requested by the FDA, compared the rates of COVID-19 accrued during the current Delta variant surge among original clinical trial participants who completed the primary two-dose vaccination series early in the clinical trial to those who completed a two-dose series later in the study. The analysis submitted by the company showed that during the study period of July and August 2021, the incidence of COVID-19 was higher among the participants who completed their primary vaccine series earlier, compared to participants who completed it later. The FDA determined that the rate of breakthrough COVID-19 reported during this time period translates to a modest decrease in the efficacy of the vaccine among those vaccinated earlier.
Safety was evaluated in 306 participants 18 through 55 years of age and 12 participants 65 years of age and older who were followed for an average of over two months. The most commonly reported side effects by the clinical trial participants who received the booster dose of the vaccine were pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain and chills. Of note, swollen lymph nodes in the underarm were observed more frequently following the booster dose than after the primary two-dose series.
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA for individuals 16 years of age and older. The authorization was expanded on May 10, 2021 to include those 12 through 15 years of age, and again on Aug. 12, 2021 to include the use of a third dose of a three-dose primary series in certain immunocompromised individuals 12 years of age and older. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.
Today, the U.S. Food and Drug Administration took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. The agency is amending the emergency use authorizations (EUA) for COVID-19 vaccines to allow for the use of a single booster dose as follows:
To support the authorization for emergency use of a single booster dose of the Moderna COVID-19 Vaccine, the FDA analyzed immune response data from 149 participants 18 years of age and older from the original clinical studies who received a booster dose at least 6 months after their second dose and compared it to the immune responses of 1,055 study participants after completing their two-dose series. The antibody response of the 149 participants against SARS-CoV-2 virus 29 days after a booster dose of the vaccine demonstrated a booster response.
The FDA also evaluated an additional analysis from Moderna comparing the rates of COVID-19 accrued during the Delta variant surge during July and August 2021, which suggest that there is a waning of vaccine effectiveness over time.
Safety was evaluated in 171 participants 18 years of age and older who were followed for an average of approximately six months. The most commonly reported side effects by the clinical trial participants who received the booster dose of the vaccine were pain at the injection site, tiredness, headache, muscle and/or joint pain, chills, swollen lymph nodes in same arm as the injection, nausea and vomiting, and fever. Of note, swollen lymph nodes in the underarm were observed more frequently following the booster dose than after the primary two-dose series.
Ongoing analyses from the FDA and the Centers for Disease Control and Prevention (CDC) safety surveillance systems have identified increased risks of inflammatory heart conditions, myocarditis and pericarditis, following vaccination with the Moderna COVID-19 vaccine, particularly following the second dose. Typically, onset of symptoms has been a few days following vaccination. The observed risk is higher among males under 40 years of age, particularly males 18 through 24, than among females and older males.
The Moderna COVID-19 single booster dose is half of the dose that is administered for a primary series dose and is administered at least six months after completion of a primary series of the vaccine.
Earlier analyses from the FDA and CDC safety surveillance systems suggest an increased risk of a serious and rare type of blood clot in combination with low blood platelets following administration of the Janssen COVID-19 vaccine. This serious condition is called thrombocytopenia syndrome (TTS). People who developed TTS after receiving the vaccine had symptoms that began about one to two weeks after vaccination. Reporting of TTS has been highest in females ages 18 through 49 years. In addition, safety surveillance suggests an increased risk of a specific serious neurological disorder called Guillain Barr syndrome, within 42 days following receipt of the Janssen COVID-19 Vaccine.
A single booster dose of any of the available COVID-19 vaccines may be administered as a heterologous booster dose following completion of primary vaccination with a different available COVID-19 vaccine. The eligible population(s) and dosing interval for a heterologous booster dose are the same as those authorized for a booster dose of the vaccine used for primary vaccination.
For example, Janssen COVID-19 Vaccine recipients 18 years of age and older may receive a single booster dose of Janssen COVID-19 Vaccine, Moderna COVID-19 Vaccine (half dose) or Pfizer-BioNTech COVID-19 Vaccine at least two months after receiving their Janssen COVID-19 Vaccine primary vaccination.
In another example, Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 vaccine recipients falling into one of the authorized categories for boosters (65 years of age and older, 18 through 64 years of age at high-risk of severe COVID-19, and 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2) may receive a booster dose of Moderna COVID-19 Vaccine (half dose), Pfizer-BioNTech COVID-19 Vaccine or Janssen COVID-19 Vaccine at least six months after completing their primary vaccination.
The agency recognizes that health care providers and COVID-19 vaccine recipients will have questions about booster doses. The individual fact sheets for each available vaccine provide relevant information for health care providers and the vaccine recipients. The agency encourages health care providers to also follow the recommendations that will be provided by the CDC following a meeting of their Advisory Committee on Immunization Practices and formal recommendations signed by the CDC director.
Data show that COVID-19 boosters help broaden and strengthen protection against Omicron and other SARS-CoV-2 variants. ACIP reviewed the available safety data following the administration of over 25 million vaccine doses in adolescents; COVID-19 vaccines are safe and effective.
Data continue to show the importance of vaccination and booster doses to protect individuals both from infection and severe outcomes of COVID-19. For adults and adolescents eligible for a first booster dose, these shots are safe and provide substantial benefit. During the recent Omicron surge, those who were boosted were 21-times less likely to die from COVID-19 compared to those who were unvaccinated, and 7-times less likely to be hospitalized. CDC continues to recommend that all eligible adults, adolescents, and children 5 and older be up to date on their COVID-19 vaccines, which includes getting an initial booster when eligible.
These updated recommendations acknowledge the increased risk of severe disease in certain populations including those who are elderly or over the age of 50 with multiple underlying conditions, along with the currently available data on vaccine and booster effectiveness.
A booster club for a band, football team or similar group may qualify for a sales tax exemption on its purchases. After receiving exempt status, the club can hold two one-day tax-free sales or auctions each calendar year.
If your application is approved, we'll send a letter or email notification. The notification includes links to print additional verification letters and the exemption certificate (Form 01-339, Texas Sales and Use Tax Resale Certificate (PDF)) to present to vendors.
If a seller chooses not to accept an exemption certificate, ask the seller to provide a properly completed Assignment of Right to Refund so the organization can request a refund of the tax directly from the Comptroller.
Note: Information in this article was accurate at the time of original publication. Because information about COVID-19 changes rapidly, we encourage you to visit the websites of the Centers for Disease Control & Prevention (CDC), World Health Organization (WHO), and your state and local government for the latest information.