FDA Approves Additional Pfizer COVID-19 Vaccine Booster For Certain Populations

The FDA has amended the emergency use authorization for Pfizer-BioNTech’s COVID-19 vaccine (Comirnaty) to allow for an additional booster dose in certain populations, according to a press release from the FDA.¹ 

The booster may be administered 6 months after the completion of the primary series for patients who are 65 years or older, patients ages 18 to 64 who are at a high-risk of severe COVID-19 infection, and individuals ages 18 to 64 whose occupation exposes them to the virus and could put them at serious risk of complications.

“Today’s action demonstrates that science and the currently available data continue to guide the FDA’s decision-making for COVID-19 vaccines during this pandemic. After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for a booster dose in certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others,” Janet Woodcock, MD, acting commissioner at the FDA, said in a press release.

The FDA considered all information submitted by Pfizer and determined that the known potential benefits of the booster shot outweighed the potential risks of contracting COVID-19 in this population of individuals. Pfizer conducted additional analysis as requested by the FDA to compare the COVID-19 cases during the surge of the Delta variant to those in the ongoing clinical trial of patients who completed their 2 doses early or completed the 2 doses later in the study. Investigators found that patients who completed the 2 doses earlier had a higher incidence of COVID-19 compared with those who completed it later.

For a median period of 2 months, 306 patients between the ages 18 to 55 years and 12 patients who were 65 years or older were followed. The most frequently reported adverse effects from those in the booster population were that of pain, redness, and swelling at the injection site. Patients also experienced pain, fatigue, and headache. The most notable adverse effect was lymph nodes swelling in the underarm which was more prevalent in patients receiving the booster dose vs those who received 2 vaccines. 

On August 12, 2021, the FDA amended the emergency use authorization given to the Pfizer and Moderna vaccines to allow for an additional dose in patients who were immunocompromised. This included solid organ transplant recipients, or those with conditions determined to be at an equivalent level of immunocompromise. Notably, the emergency use does not apply to those who are not immunocompromised.²

Patients who are recent recipients of solid organ transplant do not have the ability to fight off infections and diseases, and are especially vulnerable to COVID-19 infection. As such, the FDA determined that the third dose may increase protection in this population. Additionally, the organization emphasized that those who are close to patients who are immunocompromised should get vaccinated in order to increase protection.

Patients who are immunocompromised should discuss monoclonal antibody treatment options with their providers if they are exposed to COVID-19. The FDA has authorized the use of this treatment for patients 12 years and older who have been exposed and are at a high risk of severe illness related to COVID-19.

References

1. FDA authorized booster dose of Pfizer-BioNTech COVID-19 vaccine for certain populations. News Release. FDA September 22, 2021. Accessed September 23, 2021. https://bit.ly/3AACT5n

2. Coronavirus (COVID-19) update: FDA authorizes additional vaccine dose for certain immunocompromised individuals. News Release. FDA. August 12, 2021. Accessed September 23, 2021. https://bit.ly/3kx386W