As the latest COVID-19 vaccine, Novavax, jumps the final regulatory hurdle onto the US market, the US Food and Drug Administration has its eyes set on the COVID-19 vaccine plan for this fall and winter, when we're likely to see another wave of cases.
The FDA last month made arecommendationthat vaccine manufacturers should make a booster dose of COVID-19 vaccine that targets the omicron variant -- specifically, theBA.4 and BA.5 subvariants. BA.5, the most contagious version of the virus to date, now makes upthe majorityof COVID-19 cases in the US and seemslikely to leadto another summer surge of COVID-19 cases ahead of the anticipated fall or winter booster rollout.
The current advice for this summer is the same: Get the booster shots you're eligible for. (For everyone 50 and older, that means two boosters.) But the question at hand for health regulators was whether vaccine-makers should continue to use their original primary vaccine formulas (which will probably stay the same for the time being) for boosters, or if they should create a vaccine that targets omicron, which has been dominant worldwide for months and keeps mutating into more-contagious versions of itself.
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While there's still the chance we could be dealing with a whole new variant come fall or winter (you can never underestimate COVID-19), the FDA decided boosters targeting BA.5 should be the way forward.
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. And the vaccines based on earlier strains of the virus that causes COVID-19 (also called "ancestral" strains) are still protective against severe disease and death from omicron -- the most important function of vaccination in general.
While the details are being tested and ironed out, here's what we know about the fall COVID-19 vaccine strategy.
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 on BA.4/BA.5 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 more time and research is needed to see what effect they have in the US (which has already experienced a high number of cases this late spring and summer), BA.5 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 abouteverything we know about BA.5.
Specifically, the FDA is asking for abivalent(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 likely 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.
At a White House COVID-19 Response Teambriefing Tuesday, Dr. Ashish Jha said that if the timeline goes accordingly, he expects the first people to be eligible will start getting vaccinated in October, with other people becoming eligible in November or December.
But there is no authorized booster yet, so an exact timeline isn't available right now.
Moderna and Pfizer had both been working on boosters that target the general omicron variant. With the FDA's request to target omicron's newest strains, they will need to switch lanes to meet their target, hopefully in time for fall.
Novavax which justreceived CDC recommendationfor its primary two-dose vaccine also said it'sspeeding up workon a formula specifically targeting the new versions of omicron.
Pfizer announced last month that it struck a deal with the US government to provide more doses including ones that are adapted for omicron, pending FDA authorization.
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.
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Here's What We Know About COVID Vaccine Plans for the Fall - CNET
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