FDA OKs Both Pfizer, Moderna Boosters for All Adults
The U.S. Food and Drug Administration on Friday granted emergency use of both the Pfizer and Moderna COVID-19 booster shots for all adults, clearing the way to additional vaccine protection for tens of millions of Americans.
The announcement came hours before the start of a meeting of the U.S. Centers for Disease Control and Prevention's independent panel of vaccine experts to discuss the safety and efficacy of booster doses. Once the panel makes it recommendations, CDC Director Dr. Rochelle Walensky needs to sign off on the approvals.
Both Pfizer and Moderna had applied for broader use of their booster shots within the past week. Any adult who received a second dose of either vaccine at least six months earlier should be able to get a booster as soon as this weekend.
"COVID-19 vaccines have proven to be the best and highly effective defense against COVID-19. 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," Acting FDA Commissioner Dr. Janet Woodcock, said in an agency news release.
In addition to offering more protection to more Americans, the decision should make it easier for Americans to know whether they are eligible for shots, added Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.
"Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one," he said in the agency news release.
Experts laud the move
"This comes as welcome news, especially with the holidays fast approaching as families gather together, triggering a spike in domestic and international travel," said Dr. Robert Glatter, an emergency room physician at Lenox Hill Hospital in New York City.
Dr. Elizabeth McNally, director of the Center for Genetic Medicine at Northwestern University Feinberg School of Medicine in Chicago, agreed.
"This decision by FDA is overdue, and it is very welcome," McNally said in a university news release. "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."
"In our own research, we have seen that boosters produce about five times the amount of antibody as the second dose," McNally added. "So, we are very encouraged by these results and hope the boosters will carry us longer than the first two shots."
Glatter noted that many Americans had already taken matters into their own hands with booster shots.
"The reality, however, is that many people have already received boosters in the past several months, even if they didn't qualify based on the FDA's initial ruling in September," Glatter added. "Because multigenerational families living in close quarters may be at higher risk for spread of the virus, seeking boosters before official FDA approval became commonplace, to mitigate risk sooner than later."
More than 32.5 million Americans have already gotten booster shots, with the number often outpacing the number of first shots given each day across the country, according to the CDC.
Several states beat FDA to the punch
Meanwhile, some state and local officials had already taken matters into their own hands: New York City health officials on Monday encouraged all adults who want boosters to seek them out. Arkansas, California, Colorado and New Mexico had already moved to expand access.
"The FDA and the CDC are finally getting it right," Dr. Robert Murphy, executive director of the Institute for Global Health at Northwestern University Feinberg School of Medicine, said in a university news release. "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," Murphy added.
President Joe Biden wanted to start offering boosters to all adults in September, but faced pushback from public health experts. However, there's growing evidence of reductions in protective antibodies in fully vaccinated people.
Still, some infectious disease experts remain unconvinced of the need for boosters for all adults.
"When it comes to authorizing and recommending boosters for the general healthy population it's unclear to me what the actual goal is. We know the boosters are beneficial in those in high-risk categories and in those who received the Johnson & Johnson vaccine but for the general healthy population it's unclear what we are trying to achieve," said Dr. Amesh Adalja, a senior scholar at John's Hopkins Center for Health Security in Baltimore. "While boosters may make a breakthrough infection less likely for a period of time post booster, it's unclear how durable that is.:
"The goal has to be preventing serious illness and I have seen no erosion of the vaccines ability to prevent serious illness in the healthy population [which is why there has been resistance to recommending them broadly], despite the demand and the politics favoring them," Adalja added. "Hopefully, the [CDC expert vaccine panel] brings clarity to this topic with a robust discussion."
Visit the U.S. Food and Drug Administration for more on COVID vaccines.
SOURCES: Amesh A. Adalja MD, Senior Scholar, Johns Hopkins Center for Health Security, Baltimore; U.S. Food and Drug Administration, news release, Nov. 19, 2021; Northwestern University, news release, Nov. 18, 2021; The New York Times