Wednesday, October 20, 2021
COVID-19 Boosters
FDA OKs Mixing COVID Vaccine Boosters, Backs Moderna, J&J Boosters
More Americans would be eligible for booster doses of COVID-19 vaccines and could get any brand of vaccine they choose, according to an authorization Wednesday from the Food and Drug Administration.
The Centers for Disease Control and Prevention still needs to sign off before booster shots of the Moderna and Johnson & Johnson vaccines become available. A vaccine advisory panel, meeting Thursday, will consider the same authorization, which would then need approval from the CDC's director.
Plenty of booster doses will be available for people who want them, the White House has said.
The FDA wants the same groups of people to be eligible for a booster shot of Moderna as can already get a third dose of the very similar Pfizer-BioNTech vaccine. The Moderna booster dose would be half the original dose, at 50 micrograms.
More Americans would be eligible for booster doses of COVID-19 vaccines and could get any brand of vaccine they choose, according to an authorization Wednesday from the Food and Drug Administration.
The Centers for Disease Control and Prevention still needs to sign off before booster shots of the Moderna and Johnson & Johnson vaccines become available. A vaccine advisory panel, meeting Thursday, will consider the same authorization, which would then need approval from the CDC's director.
Plenty of booster doses will be available for people who want them, the White House has said.
The FDA wants the same groups of people to be eligible for a booster shot of Moderna as can already get a third dose of the very similar Pfizer-BioNTech vaccine. The Moderna booster dose would be half the original dose, at 50 micrograms.
The new recommendations would also allow anyone to choose which brand they want for a booster dose, rather than sticking with the vaccine they got originally.
Demand for mixing is high.
"Lots of people have been wanting to do this," said Dr. William Schaffner, an infectious disease specialist at Vanderbilt University Medical Center in Nashville, Tennessee.
Allowing mixing ofthe Moderna, Pfizer-BioNTech and Johnson & Johnson COVID-19 vaccines will accelerate efforts to provide booster shots and will combat public confusion, he said.
Data on the safety and effectiveness of mixing vaccines remains extremely limited. The National Institutes of Health presented a study last week that included just 50 people in each category: Moderna after two doses of Pfizer-BioNTech, J&J after Moderna, etc.
Dr. Paul Offit, a vaccine specialist at Children's Hospital of Philadelphia who sits on an FDA vaccine advisory committee, said he wishes there were more data to support mixing and matching. But there's never as much data as decision-makers would like, and in the middle of a pandemic it makes sense to take a few risks in hopes of saving lives, he said.
"The data we have been presented (throughout the pandemic), even though it's a little less than we would be presented normally, has held up," Offit said in an interview. "These vaccines have been much better than we had hoped."
Dr. Cody Meissner, another member of the FDA vaccine advisory committee, said that though data is limited, the agency had to make a decision to address the ongoing national emergency. About 1,000 Americans are still dying every day from COVID-19, he noted.
It's reasonable for people to "mix and match," particularly if they received J&J for their first shot, said Meissner, also a pediatric infectious disease expert at Tufts University School of Medicine in Boston
The NIH study, which is still preliminary, suggests that getting a different vaccine after a single dose of J&J or two doses of the others triggers the immune system to produce more antibodies. The study has not been going on long enough to know the durability of that protection or how the combinations will work in the real world.
The boost seemed particularly beneficial for people who got J&J and then one of the other two. Recent data suggests that J&J, initially provided as a "one and done" vaccine, becomes significantly more effective with a second dose.
Still, Meissner said, more good will come from getting additional people vaccinated than from providing extra doses to those already fully vaccinated.
"Boosters are not going to get the pandemic under control," he said. "It's going to be vaccinating everybody who's eligible."
The CDChas long said that it is preferable to stick to the same vaccine for the initial two doses of Pfizer-BioNTech or Moderna but that people could mix if necessary. The two vaccines are very similar, both relying on mRNA technology.
Both vaccines require two doses to reach full effectiveness, though their protection against mild disease appears to wane after about six months among people with weakened immune systems, such as those over 65 or with medical conditions like diabetes or lung disease.
The CDC has endorsed booster shots of Pfizer-BioNTech for people in high-risk categories or whose jobs put them at risk for catching COVID-19 who received that vaccine for their earlier doses. The same approval is likely to come later this week from the CDC committee and then the director for those who received the Moderna vaccine.
The COVID-19 vaccine made by Johnson & Johnson uses a different technology and is presumed safe to get as a first or follow-on shot to the other two. A similar vaccine made by AstraZeneca has been tested in larger studies in Europe in combination with Moderna and Pfizer-BioNTech and was found to be safe.
A decision to allow boosting with any available COVID-19 vaccine will simplify implementation of the process and make it easier to get them to people, said Dr. Kelly Moore, CEO of Immunize.org, which educates health care professionals about U.S. vaccine recommendations.
"Remember, only about 15 million people got J&J. It’s less widely available than mRNA vaccines," she said, "so a decision to restrict boosters to the same product would have created access challenges."
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
Source: USA Today
