FDA panel backs limiting COVID-19 booster shots
Extra vaccine dose endorsed only for people 65 and older and those at high risk
A Food and Drug Administration expert advisory panel Friday called for trimming President Joe Biden’s plan to give booster shots to most vaccinated Americans to bolster immunity against COVID-19, instead recommending only those whose age, job or health put them at high risk receive an additional shot.
After rejecting the proposal of a Pfizer booster for everyone over age 16, the committee unanimously recommended emergency use authorization for a third shot to those age 65 and older and health care workers and others with occupational exposure to the virus.
Biden last month had called for Americans who had the most widely used two-dose Pfizer and Moderna vaccines to get boosters eight months after their last shot, with the rollout to begin as early as Monday. Dr. Anthony Fauci, the president’s top medical adviser, cited evidence of waning vaccine protection.
But although federal regulators just weeks ago approved boosters for people with weakened immune systems, medical experts within the administration and around the country, including 16 of Friday’s 18 voting panelists, questioned the need for everyone to have them.
“There are a lot of questions to be answered,” said Dr. Arnold Monto, professor of public health and epidemiology at the University of Michigan and
chairman of the FDA’s Vaccines and Related Biological Products Advisory Committee, comprised of medical experts outside the agency.
The committee’s vote was the first key test of Biden’s booster plan, which he said was contingent on regulatory approval by both the FDA and Centers for Disease Control and Prevention, who are expected to make decisions next week. The committee on Friday was asked only if Pfizer’s vaccine approval should be modified to allow for a third booster shot at least six months after the first two given three weeks apart for those ages 16 and older.
Booster consideration for the Moderna and Johnson & Johnson vaccines wasn’t up for debate.
Though the committee vote isn’t binding, the FDA was expected to follow the panel’s advice, which also was expected to shape the CDC’s expert vaccine panel discussion next week.
The booster question comes as the more contagious delta variant of the virus that causes COVID-19 spawned mass outbreaks this summer across the U.S. and other countries, dimming hopes that vaccines would quickly end the pandemic that continues to ravage the world. Biden, who campaigned on promises to better manage the U.S. response, has seen his approval ratings sag as infections spread.
The U.S. last month authorized third shots for organ transplant recipients, cancer patients and others with weakened immunity who are age 12 and up and received the Pfizer shots, or at least 18 and got Moderna’s vaccine. Israel began offering third shots to residents 60 and older in July and lowered the age to 12 late last month. Canada, France and Germany also have discussed booster plans.
But those decisions have been controversial. World Health Organization Director General Tedros Adhanom Ghebreyesus has asked wealthy industrial nations like the U.S. with higher vaccination rates to delay booster shots until at least the end of the year and help poorer countries with little access to the shots catch up. Otherwise, he said, the virus will continue to spread, mutate, and eventually evade the current vaccines’ protection.
Many medical experts in the U.S. and abroad have echoed WHO’s call. But Biden’s boostersfor-all plan also drew fire on procedural and scientific grounds.
Critics called it inappropriate for the White House to trumpet a booster plan before federal regulators weighed the evidence it’s needed, drawing parallels to similar meddling complaints leveled at the Trump administration.
Two top FDA vaccine regulators, Marion Gruber and Philip Krause, announced they will leave the agency this fall, reportedly in frustration over White House interference on boosters. In a Sept. 13 article they cosigned with 16 other health experts in the medical journal The Lancet, they argued that “current evidence does not ... appear to show a need for boosting in the general population, in which efficacy against severe disease remains high.”
Friday’s panel heard presentations from Pfizer and from health scientists in Israel showing evidence of waning vaccine protection over time, significant restoration after a third shot and no serious indications of worrisome side effects, including rare but concerning heart inflammation seen mostly in boys and young men.
“There is real erosion of vaccine protection over time,” said Dr. William C. Gruber, a Pfizer senior vice president.
The panel also heard from FDA and CDC staff and a British scientist suggesting the evidence of a need for boosters is less clear.
“COVID-19 vaccines continue to maintain high protection against severe disease, hospitalization and death,” said Dr. Sarah Oliver of the CDC’s National Center for Immunization and Respiratory Diseases. She added that while protection against infection appears lower in recent months, it’s unclear whether that’s due to the more transmissible delta variant or waning vaccine potency over time.
Committee members said they were uncomfortable with the lack of clear evidence and the small sample sizes of studies demonstrating the need and safety of boosters for all.
“There are too many questions,” said Dr. Oveta A. Fuller, an associate professor of microbiology and immunology at the University of Michigan, “for me to feel comfortable to say yes to this.”