‘FDA booster decision is overdue and welcome’

CHICAGO --- The Food & Drug Administration’s (FDA) expected authorization of Pfizer-BioNTech’s COVID-19 booster for all adults Thursday is overdue and will stem rising cases, say Northwestern Medicine experts. (The Centers for Disease Control is supposed to meet to discuss data and safety on Friday.) 

Experts also said the pandemic approval process needs to be streamlined to one combined advisory committee that focuses on pandemic control. 

Dr. Elizabeth McNally is director of the Center for Genetic Medicine at Northwestern University Feinberg School of Medicine.

“This decision by FDA is overdue, and it is very welcome,” said Dr. Elizabeth McNally, director of the Center for Genetic Medicine at Northwestern University Feinberg School of Medicine. “We’ve seen cases rising, and we’ve seen this in places where the weather has gotten colder, and people have moved inside. This shift to indoor activities is coinciding with waning immunity. I’ve been recommending to all my patients to get boosters, and the FDA decision will improve the uptake of that message. 

“The decision in September about boosters was confusing, and many people had trouble understanding whether they should or shouldn’t get boosters. This message is much clearer — get a booster! Getting boosters will hopefully let us gather more safely at the holidays. And for anyone who still hasn’t been vaccinated, it’s not too late.

“In our own research, we have seen that boosters produce about five times the amount of antibody as the second dose. So, we are very encouraged by these results and hope the boosters will carry us longer than the first two shots.”  

Dr. Robert Murphy is executive director of the Institute for Global Health at Northwestern University Feinberg School of Medicine.

“The FDA and the CDC are finally getting it right,” said Dr. Robert Murphy, executive director of the Institute for Global Health at Northwestern University Feinberg School of Medicine.

“The states led the way on this, approving boosters for all adults before the federal government figured it out. I’m glad to see everyone is in alignment so all adults can be protected as immunity wanes about six months after the initial two doses of the vaccination.

“This will help tamp down the COVID surge we are beginning to experience in the U.S. and keep the hospitals from being overwhelmed over the holiday season and beyond. This will end yet another period of vaccination confusion.

“The vaccines are only working for a limited period of time. We’ve got to keep up with the immunity. We don’t know if you need a booster every six months. The immunity to this virus is very fragile, and we’ve got to keep up or we will slide backwards. The cases have doubled in the U.S. yesterday over one day. Every adult needs a booster. 

“It’s time to restructure the whole pandemic approval process and streamline it to one new combined advisory committee that focuses on pandemic control. This process must move faster.” 

Dr. June McKoy is a professor of medicine in geriatrics at Northwestern University Feinberg School of Medicine.

“Expanding the booster will be a boon for older adults, especially with Thanksgiving, Christmas and Hanukkah on the horizon. These holidays bring young and old people together and place the elderly at risk, even those who are fully vaccinated. Why? Because we know that the vaccines’ protection wanes over time, with reports of fully vaccinated adults getting breakthrough COVID-19 infection. So, having all adults at a gathering who have received the booster will reduce the risk to older guests.”