For immediate release:

Today, the US Food and Drug Administration has amended the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine as follows:

  • Expand the use of single booster immunization to include personal use between the ages of 12 and 15.
  • Reduces the time between the completion of the primary vaccination of the Pfizer-BioNTech COVID-19 vaccine and the booster immunization to at least 5 months.
  • Consider a third primary series dose for certain immunocompromised children between the ages of 5 and 11.

“Through the pandemic, the virus that causes COVID-19 is constantly evolving, so the need for the FDA to adapt quickly means using the best available science to keep in mind the health and safety of the American people. It means making informed decisions at. ” FDA Commissioner Janet Woodcock, Acting MD-19. “

What you need to know:

Boosters are currently licensed for people over 12 years old

Today’s action expands the use of a single booster immunization of the Pfizer-BioNTech COVID-19 vaccine to include personal use up to the age of 12.

  • Authorities have stated that a single booster of the Pfizer-BioNTech COVID-19 vaccine provides continuous protection against COVID-19 and prophylactic health benefits against related serious consequences such as hospitalization and death. Judging that it exceeds the risk. 12 to 15 years old.
  • The FDA has reviewed Israeli actual data, including safety data from more than 6,300 individuals aged 12 to 15 years, who received boosts at least 5 months after the completion of the primary double dose series.
  • These additional data allowed the FDA to reassess the benefits and risks of using boosters in the young adolescent population in the current surge of COVID-19 cases.
  • The data show that there are no new safety concerns following boost immunization in this population. There were no new cases of myocarditis or pericarditis reported so far in these individuals.

Booster interval for people over 12 years old has been updated to 5 months

The FDA also permits the use of a single dose of booster 5 months after the completion of the primary vaccination series of the Pfizer-BioNTech COVID-19 vaccine.

  • Since Pfizer first submitted safety and efficacy data for a single booster immunization after primary vaccination, additional real-world data on the increase in the number of COVID-19 cases with Omicron mutations in the United States has been available. Now available.
  • No new safety concerns have emerged from Israel’s population of more than 4.1 million individuals over the age of 16 who received boosters at least five months after the completion of the primary vaccination series.
  • In addition, peer-reviewed data from multiple laboratories show that boost immunization with the Pfizer-BioNTech COVID-19 vaccine significantly improves an individual’s antibody response to counter the Omicron variant. Therefore, allowing booster vaccination in 5 months instead of 6 months may improve individual protection against highly infectious Omicron variants faster. Demonstrated safety and efficacy of booster doses when administered 5 months after the primary vaccination series, and potential to help boost booster doses provide better protection against rapidly spreading Omicron variants Given the fact that there is, the FDA outweighs the known potential risks of giving boosters to individuals 12 years and older at least 5 months after the completion of the primary vaccination series.
  • Today’s actions apply to the Pfizer-BioNTech COVID-19 vaccine, but the FDA will continue to review data on all available vaccines and provide additional updates as needed.

Third primary series dose for specific immunocompromised children aged 5 to 11 years

Children aged 5 to 11 years who have undergone a solid organ transplant or have been diagnosed with a condition considered to be at the same level of immunodeficiency may not respond appropriately to the two initial vaccination series. Therefore, a third primary series dose is currently approved for this group. This allows these children to get the maximum potential benefit from vaccination.

  • The FDA has previously approved a third primary series dose for use as part of the primary immune series in individuals over the age of 12. The potential efficacy of additional doses in children aged 5 to 11 years was estimated from adult data.
  • Authorities used prior analysis conducted as part of the approval process for healthy children to inform them of the safety of this population, a third dose at least 28 days after the second dose of the double dose regimen. Determined the potential benefits of primary series administration, outweighing the potential and known risks of the vaccine. To date, the FDA and CDC have not seen new safety signals in this age group.
  • Children aged 5 to 11 years who are fully vaccinated and have not weakened immunity do not currently require a third dose, but data suggest that this pediatric population needs booster immunity. If this happens, the FDA will continue to review the information and contact the general public. ..

“Based on the FDA’s assessment of currently available data, boosters of the currently approved vaccine may help provide better protection against both delta and omicron types, especially omicron. The variant appears to be slightly resistant to the level of antibody produced in response to the dose of the primary series from the current vaccine, “said Peter Marks, director of the FDA’s Center for Biologics Evaluation. I am saying. research. “With this in mind, the FDA has expanded the range of individuals eligible to receive boosters, shortened the time to completion of the Pfizer primary series where individuals receive boosters, and gave some individuals a third preventive vaccine. Approved for administration. Our youngest and most vulnerable individual. “

Fact sheets for recipients, caregivers, and care providers contain information about potential side effects and the risk of myocarditis and pericarditis. The FDA and the US Centers for Disease Control and Prevention Some systems It is installed to continuously monitor the safety of the COVID-19 vaccine and allow rapid detection and investigation of potential safety concerns.

The most commonly reported side effects by individuals receiving additional doses or additional doses as part of the primary series were pain at the injection site, redness and swelling, and fatigue, headache, muscle or joint pain and chills. .. Notably, swelling of the lymph nodes in the armpit was observed more often after the additional dose than after the second dose in the first series of double doses.

After approval, the FDA will publish a document regarding the FDA’s decision on its website.

The EUA amendment has been granted to Pfizer.

Related information

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The FDA, an agency within the U.S. Department of Health and Welfare, by ensuring the safety, efficacy, and security of human and veterinary drugs, vaccines, and other human-used biological products, and medical devices. We protect public health. Authorities are also responsible for the safety and security of our food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.