FDA Wants to Make the COVID Vaccine an Annual Shot Just Like the Flu

FDA Wants to Make the COVID Vaccine an Annual Shot Just Like the Flu
  • The FDA is proposing an annual COVID shot, similar to the annual flu shot.

  • The annual COVID shot would replace current booster recommendations.

  • Currently, just 16.2% of Americans over five have gotten their bivalent booster.

The Food and Drug Administration (FDA) has proposed a recommendation that Americans receive an annual COVID-19 vaccine each fall, similar to the current recommendations with the annual flu vaccine.

A briefing document released Monday shows that the FDA is suggesting that health officials stop using the original COVID-19 vaccine and use only the bivalent vaccine for primary and booster doses. The FDA’s advisory committee is scheduled to meet on Thursday to debate the future of the country’s COVID-19 vaccine strategy.

An annual shot would be a big departure from current recommendations, which generally suggest that Americans aged five and up receive the bivalent booster two months after their last COVID-19 vaccine. The recommendations around COVID boosters have been criticized for being confusing and hard to follow.

“It should be a very lively FDA advisory committee meeting,” says William Schaffner, M.D., an infectious disease specialist and professor at the Vanderbilt University School of Medicine.

But why might the COVID-19 vaccine become an annual shot, and what do doctors think? Here’s what you need to know.

If the proposal goes through, how often would you get the COVID shot?

There’s a lot that needs to be sorted out here, given that it’s simply a proposal at this point, says Thomas Russo, M.D., chief of infectious diseases at the University at Buffalo in New York.

However, the FDA’s briefing document says that people would only need one dose of the COVID-19 vaccine a year to "restore protective immunity for a period of time."

There is a slight caveat, though. The FDA notes in the briefing document that “two doses of an approved or authorized COVID-19 vaccine may be needed to induce the expected protective immunity for those who have a low likelihood of prior exposure (the very young) or those who may not generate a protective immune response (older and immunocompromised individuals).”

Basically, it’s not entirely clear at this point. “There’s some uncertainty if once a year is going to get it done or if our most vulnerable are going to need more than that,” Dr. Russo says. “Minimally, this is starting to develop the frame of mind, similar to the flu vaccine, that an annual booster is going to be the order of the day.”

Does this mean there won’t be any other boosters throughout the year?

There likely will be boosters available at other times of the year, depending on what the FDA concludes. However, availability may not be as simple as rolling up to your local pharmacy and getting vaccinated. As the briefing document points out, some people may need more than one booster to give them optimal protection. With that, the booster would need to be available for those people more than just once a year, Dr. Russo says—you just may need to go to your doctor’s office for that.

Under the FDA’s proposed plan, the composition of the annual COVID-19 vaccine would be chosen in June to try to help target whatever dominant variant is circulating.

Does the type you get matter?

It’s very likely that there will be more than one COVID booster available, similar to the current situation. While the briefing document proposes that only the bivalent booster be used, Dr. Russo says you still should be able to choose your manufacturer.

“With influenza vaccines, there are multiple manufacturers and different formulations,” he notes. “There are also variations for if you’re a senior or not. We may go in that direction with the COVID vaccine.”

How quickly could this change happen?

There’s a lot that needs to happen between now and recommending that the COVID-19 vaccine be an annual shot, Dr. Russo says. “I guarantee that there will be some push-back,” he says. “There isn’t data out there yet that establishes how often we need boosters for certain groups and if the lowest risk groups even need it on an annual basis.”

The briefing document didn’t establish a timeline to roll this out but, if the FDA decides that COVID vaccines should be an annual shot, the data would still need to move on to the Centers for Disease Control and Prevention (CDC) to create actual guidance. “This is going to be a very debated issue,” Dr. Schaffner says. “There are many points of view here.”

What if you got a booster in the last 6 months?

That would be a question for the CDC’s advisory committee, Dr. Schaffner says. As of now, the CDC recommends that people get a bivalent booster two months after their last COVID shot, but it’s unclear if you would need to get another booster if the COVID vaccine becomes an annual thing and you’d been boosted within six months.

Dr. Schaffner is hopeful that people will only need to get one shot for flu and COVID-19 in the future. “Manufacturers are now trying to create a combined influenza and COVID vaccine,” he points out. “The notion is that might be more attractive to people, because they will only have to roll up one sleeve rather than two.”

As of right now, Dr. Russo points out that “there has not been a great uptake with booster." According to CDC data, only 16.2% of Americans aged five and up have received their bivalent booster. “Ultimately, getting more people to at least get an annual shot—even though that may not be optimal—is better than if they are intermittently coming up with vaccine recommendations and there’s a lower uptake,” Dr. Russo says.

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