What’s happening
Health officials are asking for new boosters that will target the BA.5 subvariant to be rolled out this fall.
Why it matters
COVID-19 is still making people sick and causing hospitalizations and deaths. The older vaccine formulas are still effective at preventing severe disease, but the mutating virus is whittling some of that protection away.
What’s next
The vaccine companies are still working on new formulas and will need to turn their safety and effectiveness data over to the FDA and CDC before new boosters roll out.
In an effort to combat the spread of COVID-19, health officials are preparing for a fall and winter vaccine rollout with omicron-specific boosters to target a more up-to-date version of the virus. The rollout could start as early as September.
The US Food and Drug Administration last month made a recommendation that vaccine manufacturers should make a booster dose of COVID-19 vaccine that targets the BA.4 and BA.5 subvariants of the omicron variant. BA.5 now makes up the majority of COVID-19 cases in the US and is leading another summer surge of COVID-19 cases.
The pressure on the timeline to come up with a new vaccine comes partly from talk about expanding the eligibility of who can get a second booster of the currently available vaccines (only adults 50 and older and younger immunocompromised people are eligible for a second booster, and the eligibility isn’t likely to be extended until there’s a new booster, The New York Times reports). The pressure also extends to the vaccine companies, specifically Moderna and Pfizer, which need to make sure their vaccines are ready before being authorized by the FDA and endorsed by the US Centers for Disease Control and Prevention.
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The US government is expected to roll out vaccine boosters based on need: People most at risk will be eligible for a new booster first, with other groups following in an order still to be determined by health officials. The US Department of Health and Human Services on Friday announced that it had ordered 66 million doses of Moderna’s bivalent booster candidate, purchased with reallocated money meant for other COVID-19 resources as health officials have failed to secure more funding from Congress.
While the US has also secured a previous order of 105 million doses of Pfizer, that isn’t enough doses for all people in the US, the HHS said in the press release. Agreements with both vaccine companies would open up millions more doses, but this “can only be exercised” with more funding from Congress.
Here’s what we know about the fall COVID-19 vaccine strategy.
What are the BA.4 and BA.5 subvariants?
Both BA.4 and BA.5 are considered part of the “original” omicron variant (BA.1) family. They’re newer versions of the virus that causes COVID-19. BA.5 quickly overtook the conversation because of its extreme contagiousness, and it’s now the dominant variant in the US. In a late June post, Dr. Eric Topol, professor of molecular medicine, called BA.5 “the worst version of the virus that we’ve seen.”
While we’re still living out the true effects of a BA.5 summer surge in the US, the new subvariant is thought to whittle away much of the infection protection people got prior sickness, even with other omicron variants.
Omicron caused such a huge number of cases last winter because it was the most contagious variant to date, evading some infection protection from prior illness and effectiveness of the vaccines. The fact that newer versions of omicron are proving to be even more contagious isn’t a big surprise, as this is the path COVID-19 has taken over the last two and half years.
Read more about everything we know about BA.5.
What is the FDA asking for?
Specifically, the FDA is asking for a bivalent (two-component) vaccine booster, which will include the BA.4/BA.5 spike protein in addition to an older strain. The FDA doesn’t make vaccines, so the agency will authorize individual vaccine types as companies create and test them, as it did for the original COVID-19 vaccines and booster doses.
The vaccines currently authorized or approved only use older or “ancestral” strains of the virus. These vaccines still provide good protection against severe disease and death, but the effectiveness against infection is becoming more limited as the virus keeps mutating.
When will the rollout start? Who will get a vaccine?
Health officials now have their eyes on a September start date, moving the date up slightly from the early October start date, White House COVID-19 Response Team Coordinator Dr. Ashish Jha said in a briefing earlier this month.
But there isn’t an authorized booster yet, so an exact timeline isn’t available right now. Whenever the modified vaccine (or vaccines) are authorized and recommended, we can expect people who are more at risk for severe disease (including older adults and people with some health conditions, for example) to become eligible first.
But like the authorization timeline, the eligibility criteria isn’t available yet. It’s also possible that eligibility could be complicated by the fact that the HHS said it hasn’t yet secured enough doses for all Americans because it needs more funding from Congress. The agency says it’ll have 171 million new vaccine booster doses available this fall. There are about 199 million adults age 18 and older who are fully vaccinated in the US, according to the CDC. This means that if every fully vaccinated adult also decides to get a new booster when they become eligible, there won’t be enough vaccine for 28 million adults without more doses purchased.
What are the vaccine companies doing? Which company will make the new vaccine?
Moderna and Pfizer are both working on boosters that target the omicron variant, and the US government has agreements with those companies so doses from both will be available this fall, pending regulatory approval.
Novavax, which just received CDC recommendation for its primary two-dose vaccine, also said it’s speeding up work on a formula specifically targeting the new versions of omicron. But the US hasn’t yet announced any plan to purchase or secure doses of Novavax, so it’s likely Moderna or Pfizer (or both) will be the available vaccine next campaign, at least initially.
Johnson & Johnson, while still available in the US, has been recommended only for people who can’t take, or don’t want to take, another COVID-19 vaccine over risk of a very rare but dangerous side effect. J&J didn’t respond to an earlier request for comment last month on the company’s plans for the fall in the US.
The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.
