The U.S. Food and Drug Administration (FDA) continues to be aggressive in the nation’s fight against the spread of the Omicron variant of COVID-19. With the number of positive cases more than doubling between Dec. 26 and Jan. 2, the agency is entering 2022 by taking these three giant steps:
Amending the emergency use authorization (EUA) for the Pfizer-BioNTech vaccine to 12-15-year-olds.
Shortening the time between a primary vaccination of the Pfizer vaccine and a booster dose to five months.
Allowing for a third primary series dose for certain immunocompromised children 5-11 years of age.
If you’re looking for the biggest reason the FDA is pushing booster vaccinations now, the director of the FDA’s Center for Biologics Evaluation and Research said you don’t have to look any further than the Omicron variant.
“The omicron variant appears to be more resistant to the antibody levels produced in response to the primary series doses from the current vaccines,” said Dr. Peter Marks, adding that a third protective dose is beneficial for “some of our youngest and most vulnerable individuals.”
Vaccine expert agrees with FDA changes
ConsumerAffairs reached out to a vaccine expert Mark Cameron, an associate professor at the Case Western Reserve University School of Medicine, to get his take on the FDA’s changes.
“I’m encouraged by this announcement for several reasons, not the least of which is because it’s not a single bandaid solution, it’s more of a patch across multiple leaks in the proverbial omicron dam,” he said.
"But also, it drives home the point that the FDA can react relatively quickly to real-time changes in this pandemic by looking at the wide variety of data sources available to it, including previous approvals, peer-reviewed studies, and perhaps most importantly, high-quality real-world data reflecting the moment we are in fighting this ever-changing virus."
What people need to know
The new FDA advisory comes with several things people should take into account regarding booster shots and vaccinations for younger people. Those include:
Boosters are now authorized for everyone 12 years of age and older. The agency said it reviewed real-world data from more than 6,000 adolescents in Israel who received a booster over the same time frame and determined that the protective health benefits of the Pfizer-BioNTech booster provides “continued protection” against not only COVID-19 itself, but any related serious consequences that can occur such as hospitalization and death.
At this time, only the Pfizer-BioNTech COVID-19 vaccine is authorized and recommended for children aged 5-11. There are no changes for people who have received the Johnson & Johnson or the Moderna vaccine. The booster interval recommendations for those remain the same: two months for Johnson & Johnson and six months for Moderna.
No changes for young children who are fully vaccinated and not immunocompromised. The FDA said children aged 5 through 11 who fit that definition do not need a third dose at this time, but officials said they would continue to review the situation and let the public know if data emerges suggesting booster doses are needed for that group.
No new side effects. While myocarditis and pericarditis were previously listed as potential risks, the agency says no new cases were reported in the Israeli study.