FDA Amends EUA for Pfizer-BioNTech Booster Vaccine

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The FDA announced that it has amended its Emergency Use Authorization to allow for certain populations to receive the Pfizer-BioNTech (Comirnaty) vaccine booster shot six months following completion of the initial two-shot series of the same vaccine (Courtesy of UnSplash)

NATIONWIDE — On Wednesday, Sept. 22 the Food and Drug Administration (FDA) announced that it has amended its Emergency Use Authorization (EUA) to allow for a single booster dose of the Pfizer-BioNTech COVID-19 vaccination for those who completed the original two-shot series of the same vaccine.

The EUA amendment states that certain populations will be eligible for the booster at least six months following the completion of the two-shot primary series. These groups include:

  • Those who are 65 years or older
  • Those who are 18 through 64 years of age who are considered high risk of severe COVID-19
  • Individuals 18 through 64 years whose frequent institutional or occupational exposure to the virus puts them at high risk of serious complications of COVID-19, which includes severe strains of the virus

It is important to note that his EUA amendment only applies to the Pfizer-BioNTech vaccine, also known as Comirnaty, and not the Moderna two-dose or Johnson & Johnson single-dose vaccines.

In the process of this amendment, the FDA notes that it considered data that was submitted by the manufacturer, information presented to it during a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), and after deliberation. It was ultimately decided that the totality of evidence shows that a booster vaccine for Comirnaty would be effective.

In the Sept. 22 announcement, the FDA states, “[The] known and potential benefits of a booster dose outweigh the known and potential risks in the populations that the FDA is authorizing for use.”

Safety of the booster vaccine was determined evaluation 306 participants, ages 18 through 55 years old, and twelve participants who were 65 years and older. The participants were followed for a two month period.

The study showed that the most commonly reported side effects in the clinical trial were pain/redness/swelling at the injection site, fatigue, headache, muscle or joint pain, and chills. Additionally, the FDA notes that swelling of the underarm lymph nodes were observed in higher frequency following the booster dose than after the primary two-dose series.

On August 13, it was announced by the Virginia Department of Health (VDH) that state residents who have significantly compromised immune systems third dose of the Pfizer-BioNTech or Moderna mRNA vaccines.

In that announcement, State Health Commissioner M. Norman Oliver, M.D., M.A., said, “This is important additional protection for people who have impaired immune systems. As COVID-19 cases rise across Virginia and the country, everyone who is eligible should get appropriately vaccinated as soon as they can.”

A person is considered immunocompromised when they have deficiencies due to certain medical conditions that weakens their immune system. Therefore, their immune system, even after receiving both doses of the aforementioned vaccines, is still not protected enough against the COVID-19 virus.

>While President Biden announced on Aug. 18 a plan to roll out vaccine boosters to all Americans by Sept. 20, with health care providers, nursing home residents and other seniors could be the first in line to receive the booster, that has not come to fruition.

“Now this will boost your immune response and will increase your protection from COVID-19,” Biden said. “It’s the best way to protect ourselves from new variants that could arise.”

In guidance updated on Sept. 1 by the Centers for Disease Control and Prevention (CDC) notes that the United States is waiting on providing booster vaccines because of the constant evolution of the virus. It notes that experts are still studying data regarding the virus, including the highly virulent Delta variant.

Additionally, the CDC notes that there is not enough evidence that would support for someone who has received the single-dose Johnson & Johnson vaccine to receive a booster of either Comirnaty nor Moderna.

At this time, the amended EUA is only applicable to the the Pfizer-BioNTech vaccine. As the two shots are not interchangeable, it is important to note that if you received the Moderna two-shot series, you cannot receive the Pfizer-BioNTech booster vaccine.

To learn more or to schedule an appointment, please consult your healthcare provider or visit the website for Vaccinate Virginia.

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