“The updated vaccine could be available as soon as September,” said Dr. Allison Arwady, the commissioner of Chicago Department of Public Health, on Tuesday discussing Omicron-specific COVID boosters.
After the Food and Drug Administration advised drug companies to formulate COVID-19 vaccines that would specifically target the omicron variant of the virus this summer, it appears that those shots could be making their way into arms within the next month.
Both Pfizer and Moderna have sought regulatory approval from the FDA to offer the "bivalent" shots, which would target both the original COVID-19 virus and the omicron subvariants that have become the dominant strains of COVID in the United States.
Here's everything we know about where things stand with booster shots in the United States.
Which Companies will Offer Omicron-Specific Boosters?
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Both BioNTech, manufacturers of the Pfizer COVID vaccine, and Moderna have asked the FDA to authorize their updated COVID booster shots, with both requests coming out this week.
The Pfizer and Moderna vaccines are both “bivalent vaccines,” designed to specifically target not only the original COVID-19 virus, but also to target omicron variants as well.
The move follows a recommendation from the FDA to modify vaccines to target the BA.4 and BA.5 subvariants, the latter of which is responsible for nearly 90% of COVID cases in the United States.
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When Will the New Boosters be Authorized?
Sources told NBC News this week that the FDA plans to evaluate and potentially authorize updated versions of both boosters sometime around Labor Day, citing two people familiar with the discussions.
The updated booster shots will likely be authorized for anyone over the age of 18 who has yet to get a second booster shot, and the Biden administration is preparing to distribute the boosters to eligible individuals under the age of 18 as well, officials said.
But a government rollout plan anticipates that people who've already gotten their initial vaccinations would qualify for one of the new combination shots, regardless of how many boosters they've already had.
Dr. Peter Marks, the FDA's vaccine chief, is aiming for a very simple message: “It’s probably going to be everyone who has not had a booster within the past X number of months should go out and get the booster in a timely manner,” he said. Officials still have to decide just how many months, though.
The final determination, however, is up to the CDC, which called a meeting of its influential vaccine advisers next Thursday and Friday to help decide.
Pfizer wants to open its updated boosters to everyone 12 and older who’s already had a primary series of today’s vaccine, while Moderna has applied only for adult use. The CDC will determine if people at highest risk should go first. Studies of doses for younger children are expected later in the year.
Why Chicago’s Top Doctor Says the Continued Dominance of BA.5 is Good News for Those Waiting on Authorization of Second Boosters
Since July 2, the BA.5 omicron subvariant has been the dominant strain of COVID in the United States, and according to Chicago’s top doctor, that is a good thing.
Dr. Allison Arwady, commissioner of the Chicago Department of Public Health, says that the continued dominance of BA.5 has prevented another COVID variant from taking a foothold, and could mean that boosters will be even more effective in preventing breakthrough infections and serious illness.
“My concern was that we may see a new variant emerge before we got the new vaccine, and you’d be right back where you started,” she said. “If this pattern can hold, and we can quickly roll out this updated vaccine in September, and we see a lot of good uptake, it would, I think, have the potential to really help cut the risk of breakthrough infections, and have a significant impact on transmission.”
According to the latest CDC estimates, the BA.5 subvariant is responsible for nearly 89% of COVID cases in the United States, with BA.4 and BA.4.6 making up a large chunk of the remaining 11% of current cases.
Should You Wait to Get Your Next Booster Dose Until Omicron-Specific Shots are Available?
There has been some confusion over whether individuals should wait until omicron-specific boosters are available in order to get their next shots, but according to most experts, individuals who are over the age of 50 or who are immunocompromised should go ahead and get shots sooner rather than later.
Currently, the CDC is recommending that adults between the ages of 18 and 49 get a booster shot five months after they’ve completed their sequence of Moderna or Pfizer vaccines, or two months after their Johnson & Johnson single-dose vaccine.
A second booster dose has not yet been recommended for those age groups, unless individuals have preexisting conditions that make them more susceptible to serious COVID illness. Those individuals would be eligible for boosters four months after receiving their first booster shot.
Children who are five years of age and older are recommended to receive a booster five months after receiving their two-dose Pfizer vaccine series. Children who have had the Moderna vaccine are considered up to date at this time.
The FDA’s updated guidance could potentially recommend omicron-specific boosters to adults under the age of 50 beginning in September, but it is unclear when that guidance could be released.
