FDA: “COVID-19 Vaccine Boosters for All 18 Plus”
Published: Nov 19, 2021
By Heather McKenzie
There may be a crush at pharmacies and doctors’ offices in the coming days as the U.S. Food and Drug Administration (FDA) approved COVID-19 vaccine booster shots for all Americans ages 18 and over Friday morning.
As cases again begin to climb across the world, the decision would expand access to both of the vaccines developed by Pfizer and partner BioNTech as well as Moderna. According to the Centers for Disease Control and Prevention (CDC), the nation is seeing an alarming spike in recent weeks, with daily cases surging to 35%.
If the CDC signs off—the agency is expected to announce its decision Friday afternoon—those 18 and older could begin to receive boosters immediately.
Previously, third shots had only been available to senior citizens 65 and above and people 18 to 64 in certain groups deemed to be at a higher risk from the SARS-CoV-2 virus, such as the immunocompromised, those who live in long-term care settings, front-line healthcare workers, and others who work in high-risk positions, six months after they received their second dose.
“Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” said Acting FDA Commissioner Janet Woodcock, M.D., in a statement.
Friday’s decision would allow booster shots for those who received both the Pfizer-BioNTech and Moderna messenger RNA (mRNA) vaccines six months after their second vaccinations. The waiting period will only be two months for people who received the single-shot adenovirus vector vaccine from Johnson & Johnson (Janssen).
“The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and older,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. Marks added that streamlining the eligibility criteria will help to eliminate confusion over who may receive a booster shot.
The data to which Marks is referring is the same that led to the original booster approvals for both vaccines. In the case of Moderna, the FDA compared the immune response data from 149 original clinical study participants ages 18 and older who received a booster shot in this timeframe to those of 1,055 study participants after receiving a second dose. The antibody response to the SARS-CoV-2 virus 29 days following the booster dose was found to provide a booster response. A booster response to the Pfizer-BioNTech vaccine was also demonstrated for 200 participants ages 18 through 55 who received a single booster dose approximately six months after their second shot.
The FDA also assessed new real-world data that was not available when the companies originally submitted for booster authorization. This data enabled the agency to reassess the benefits and risks of using both vaccines in the general adult population. The FDA determined that the benefits of preventing hospitalization and death outweigh the risks of myocarditis and pericarditis in those 18 and older.