As theNovavax, skips final regulatory hurdle in U.S. market, U.S. Food and Drug Administration has eyes on COVID-19 vaccine plan for this fall and winter when we’re likely to see another wave of cases.
Last month, the FDA recommended that vaccine makers do a booster dose of the COVID-19 vaccine targeting the omicron variant — specifically, the likely to drive to another summer surge of COVID-19 cases before the scheduled rollout of fall or winter recalls.. BA.5, the most contagious version of the virus to date, now accounts for the majority of COVID-19 cases in the United States and appears
The current advice for this summer is the same: get the booster shots you are entitled to. (For everyone 50 and over, that means two reminders.) But the question facing health regulators was whether vaccine makers should continue to use their original primary vaccine formulations (which will likely remain the same for now) for boosters, or if they were to create a vaccine targeting omicron, which has dominated the world for months and continues to mutate into more contagious versions of itself.
While it’s still possible we’re dealing with a whole new variant in the fall or winter (you can never underestimate COVID-19), the FDA has ruled that boosters targeting BA.5 should be the way to go.
The US government should deploy vaccine boosters as needed: those most at risk will be eligible for a new booster first. And vaccines based on earlier strains of the virus that cause COVID-19 (also called “ancestral” strains) still protect against serious illness and death by omicron – the most important function of vaccination in general.
While the details are tested and refined, here’s what we know about the fall COVID-19 vaccine strategy.
What are the BA.4 and BA.5 subvariants?
BA.4 and BA.5 are considered part of the family of “original” omicron variants (BA.1). These are newer versions of the virus that causes COVID-19. BA.5 quickly overtook BA.4/BA.5 conversation due to its extreme contagiousness, and it is now the dominant variant in the United States. In an article published in late June, Dr. Eric Topol, a professor of molecular medicine, called BA.5 “the worst version of the virus we’ve seen”.
While more time and research is needed to see what effect they have in the United States (which has already seen high numbers of cases in late spring and summer), BA.5 is thought to reduce much protection against infections that people have been sick with before. , even with other omicron variants.
Omicron caused such a high number of cases last winter because it was the most contagious variant to date, evading some protection against infection from previous illnesses and the effectiveness of vaccines. The fact that new versions of omicron are proving to be even more contagious is no big surprise, as this is the path COVID-19 has taken over the past two and a half years.
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What does the FDA require?
Specifically, the FDA is requesting a bivalent (two-component) vaccine recall, 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 likely license individual vaccine types as companies create and test them, just as it did the original COVID-19 vaccines and vaccine doses. reminder.
Currently licensed or licensed vaccines only use older or “ancestral” strains of the virus. These vaccines still offer good protection against serious illness and death, but their effectiveness against infection becomes more limited as the virus continues to mutate.
When will the rollout begin?
During a White House COVID-19 Response Team briefing on Tuesday, Dr. Ashish Jha said that if the schedule unfolds accordingly, he expects the first eligible people to start coming. get vaccinated in October, with others becoming eligible in November or December.
But there are no encores allowed yet, so an exact timeline is not available at this time.
What are vaccine manufacturers doing?
Both Moderna and Pfizer had been working on boosters targeting the general omicron variant. With the FDA’s request to target the new omicron strains, they will have to change course to achieve their goal, hopefully in time for the fall.
– who is coming for its main two-dose vaccine – also said it was accelerating work on a formula specifically targeting new versions of omicron.
Pfizer announced last month that it had reached an agreement with the US government to supply more doses – including those suitable for omicron, pending FDA clearance.
The information in this article is for educational and informational purposes only and is not intended to constitute medical or health advice. Always consult a physician or other qualified health care provider with any questions you may have about a medical condition or health goals.