The Food and Drug Administration will hold a meeting next week with its panel of advisers to discuss COVID-19 vaccine boosters, just days before the Biden administration’s target date for rolling out the first such shots to the general public.
Federal health officials on Aug. 18 announced a recommendation that Americans receive a COVID-19 booster shot months after they’re fully vaccinated, citing the surging Delta variant and data showing waning vaccine effectiveness.
Officials said they plan to roll out the boosters, which are pending clearance by the FDA and a recommendation from a key Centers for Disease Control and Prevention committee, the week of Sept. 20.
“Recent data makes clear that protection against mild and moderate disease has decreased over time,” Dr. Vivek Murthy, US surgeon general, said during a briefing with the White House COVID-19 response team while explaining the reasoning for the decision. “This is likely due to both waning immunity and the strength of the widespread Delta variant. Even though this new data affirms that vaccine protection remains high against the worst outcomes of COVID, we are concerned that this pattern of decline we are seeing will continue in the months ahead, which could lead to reduced protection against severe disease, hospitalization, and death.”
Here’s what you need to know about who the recommendation applies to and when and where you can get the shot when it’s time.
Where does the plan stand?
On Sept. 1, the FDA announced that the panel of outside advisers would meet on Sept. 17 to discuss boosters and the application submitted by Pfizer for authorization of its additional dose.
The agency noted in a statement announcing the meeting that in order for boosters to gain clearance, the vaccine manufacturers need to submit data on its safety and effectiveness.
But Biden administration officials have acknowledged that due to the regulatory process involved with approving the booster shots, doses from both Moderna and Pfizer may not meet the Sept. 20 goal.
In an interview with CBS’ “Face the Nation” Sunday, Dr. Anthony Fauci, the nation’s top infectious disease specialist, said Pfizer’s booster shot is on track to be cleared ahead of the week of Sept. 20, but Moderna’s could be delayed.
“We were hoping that we would get both the candidates, both products, Moderna and Pfizer rolled out by the week of the 20th,” Fauci said. “It is conceivable that we will only have one of them out, but the other will likely follow soon thereafter.”
Fauci said Moderna’s booster could be delayed because it needs to go through the full FDA authorization and CDC recommendation processes.
“Looks like Pfizer has their data in, likely would meet the deadline,” Fauci said. “We hope that Moderna would also be able to do it, so we could do it simultaneously, but if not, we’ll do it sequentially. So the bottom line is very likely at least part of the plan will be implemented, but ultimately the entire plan will be.”
Moderna, the Cambridge-based biotechnology firm, announced on Twitter on Friday that it had completed its submission to the FDA of its data on booster shots.
We are pleased to announce that today we completed our submission to the @US_FDA, which we began on Wednesday, for the evaluation of a booster dose of the Moderna COVID-19 vaccine. pic.twitter.com/4yIU7pIzyN— Moderna (@moderna_tx) September 3, 2021
Fauci told CNN on Sunday that Moderna’s booster shot rollout could follow Pfizer’s by one or two weeks.
With officials investigating whether they will recommend that a person’s booster is made by the same manufacturer that created their initial two-dose regimen, the timeline could mean delays for millions of Moderna recipients in receiving their booster shot.
Federal health officials are currently researching whether people can “mix and match” vaccines, Fauci said in the CBS interview.
“We’re lining up Pfizer against Pfizer, Pfizer for Moderna and vice versa,” Fauci said. “Hopefully within a reasonable period of time, measured in a couple of weeks, we will have that data. Right now we are suggesting — and hopefully it will work out that way — that if you got Pfizer you will then boost with Pfizer, if you get Moderna you’ll be boosting with Moderna. But we are doing the studies to determine if we can do just that, switch one with the other.”
Who does the recommendation apply to?
The recommendation applies to adults who have received one of the two mRNA vaccines developed by Pfizer-BioNTech and Moderna, officials said during the Aug. 18 briefing.
Murthy said that officials will wait for the FDA and the CDC committee before issuing guidance on whether eligible children should get booster shots. Pfizer’s vaccine has been approved for emergency use in people 12 and older.
“When it comes to 16 and 17 year olds — and minors in general — we are going to let the FDA weigh in on that, obviously do their thorough review, and then based on their recommendations, on [the Advisory Committee on Immunization Practices’] recommendations, we will have guidance to share for those who are under 18.”
The recommendation does not apply to the one-dose Johnson & Johnson vaccine, but officials anticipate boosters for that shot will likely be needed.
“The J&J vaccine was not administered in the US until March of 2021, and we expect more data on J&J in the coming weeks,” Murthy said. “With those data in hand, we will keep the public informed with a timely plan for J&J booster shots.”
When should you get the booster shot?
Officials are recommending people get a third booster shot eight months after their second mRNA vaccine.
For example, if you received your final dose on Feb. 1, you would be eligible to get the booster after Oct. 1, and if you got your second shot on March 12, you would be eligible to get the booster after Nov. 12, White House COVID-19 Coordinator Jeff Zients said during the briefing.
The plan prioritizes those who received the vaccine earliest and are the most vulnerable, such as health care providers, nursing home residents, and seniors , Murthy said.
Immunocompromised people are already receiving a third dose of the vaccine after the CDC last week recommended that those who did not develop a strong enough immune response to the two-dose mRNA vaccines receive an additional shot. Officials recommend that immunocompromised people receive their third dose at least 28 days after their second dose.
Where can you get one?
Zients said during the briefing that “it will be just as easy and convenient to get a booster shot as it is to get a first shot today.”
The US has enough vaccine supply for every American, Zients added, and boosters will be administered at roughly 80,000 places across the country, including over 40,000 local pharmacies.
Zients reiterated that the boosters, like the vaccines, will be free, regardless of immigration or health insurance status, and identification and health insurance information will not be required to get the booster.
After appearing with Health and Human Services Secretary Xavier Becerra in Lowell on Aug. 17, Marylou Sudders, the state’s secretary of Health and Human Services, said Massachusetts officials don’t plan to reopen mass vaccination sites to administer booster shots.
“Once the federal government formally puts out boosters, we’re ready,” Sudders said. “The CVS and Walmarts will all be providing booster shots, as well as our hospitals and pediatric practices.”
Sudders’ office later clarified that Sudders meant to say Walgreens, not Walmarts.
“At this point, we’re not seeing this [distributed] through mass vaccination sites,” she added. “We’re working it through health care. We have 900 places in Massachusetts where you can get vaccines right now.”
Travis Andersen of the Globe Staff and Globe Correspondent Camille Caldera contributed to this report.
Amanda Kaufman can be reached at firstname.lastname@example.org. Follow her on Twitter @amandakauf1.