Saturday, June 3, 2023

FDA Takes Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine

The FDA has announced the expansion of the Pfizer-BioNTech vaccine booster (Courtesy of Scott Eisen/CVS Health via AP Images)

NATIONWIDE — The U.S. Food and Drug Administration (FDA) has taken multiple actions in order to expand the use of the Pfizer-BioNTech COVID-19 vaccine.

On Monday, Jan. 3, the FDA released a statement regarding the amending of the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine, outlying the different measures its taken in order to facilitate this expansion. These steps include:

  • Shorten the wait time to five months between completion of the primary vaccination series and the booster vaccine for the Pfizer-BioNTech COVID-19 vaccine.
  • Expand the single booster dose to include individuals who are ages 12 through 15 years old.
  • Allow for a third series dose for certain immunocompromised children between the ages of 5 and 11 years old.

“Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind,” said Acting FDA Commissioner Janet Woodcock, M.D. “With the current wave of the omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing and social distancing to in order to effectively fight COVID-19.”

The EUA booster expansion for those ages 12 years and older comes after the FDA determined that the benefits for the single-dose booster of the Pfizer-BioNTech vaccine outweigh any potential risks. The determination was made after analyzing data from Israel, which included safety data for those ages 12 through 15 years old, who received the booster vaccine at least five months following their primary series. Another additional data point that was taken into consideration was the current surge in COVID-19 cases among the adolescent population.

It is important to note that while children ages 5-11 years old who are immunocompromised and are considered fully vaccinated, those who are not considered immunocompromised do not need a third dose of the vaccine at this time. However, the FDA continues to review data regarding the efficacy of it in the pediatric population.

“Based on the FDA’s assessment of currently available data, a booster dose of the currently authorized vaccines may help provide better protection against both the Delta and Omicron variants. In particular, the omicron variant appears to be slightly more resistant to the antibody levels produced in response to the primary series doses from the current vaccines,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “With this in mind, the FDA has extended the range of individuals eligible to receive a booster, shortened the length of time between the completion of the Pfizer primary series for individuals to receive a booster and is authorizing a third protective vaccine dose for some of our youngest and most vulnerable individuals.”

  • To learn more or to schedule an appointment to receive a COVID-19 vaccine, contact your healthcare provider or visit the website for Vaccinate Virginia.
  • For more information regarding current vaccinations for COVID-19, visit the website for the Food and Drug Administration (FDA).
  • To find the latest data from the Centers for Disease Control and Prevention (CDC), click here.
  • To see the current COVID-19 map courtesy of Johns Hopkins University & Medicine, click here.

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