The FDA Is Considering A New Plan To Make COVID Vaccines A Lot More Like Your Annual Flu Shot

In a decision that could come this week, the FDA is looking to step away from the confusing array of COVID shots and boosters that are currently recommended and create an easier-to-understand schedule.

In an effort to simplify the increasingly convoluted COVID vaccination picture, the Food and Drug Administration may soon propose a radical new approach. Following the model of the flu vaccine, this would involve one shot each year for most people, according to NPR, which reported on the planned strategy today

The annual shots could be designed to match whatever variant of COVID is currently circulating, much in the same way a new flu vaccine is formulated every year. A vaccine advisory committee will be discussing the issue on Thursday. 

While certain young children, older adults, and people who are immunocompromised might get two shots followed by boosters, other people might only get a single yearly shot, according to materials released prior to the meeting

During this week’s meeting, they hope to establish “a process for vaccine strain selection recommendations, similar in many ways to that used for seasonal influenza vaccines, based on prevailing and predicted variants that would take place by June to allow for vaccine production by September.”

“They’re trying to come up with a sensible plan based on the fact that frequent boosters are not practical, and that we now have a level of immunity in the population,” said Dr. Cesar Arias, the chief of infectious diseases at Houston Methodist Hospital. “We are in a different phase. It’s an endemic virus until further notice.”

“The population has voted with their feet,” Dr. William Schaffner, an infectious diseases expert at Vanderbilt University, added. “They have vaccine fatigue, and they’re not going to come in every four months or six months.” 

Current vaccine recommendations

The COVID-19 vaccination landscape is a complex one. In the United States alone, there are four approved vaccines: Two are mRNA vaccines (Moderna and Pfizer-BioNTech), while the other two (Janssen and Novavax) work by different methods. The mRNA vaccines require two initial doses spaced either three (Pfizer) or four (Moderna) weeks apart, while the Janssen and Novavax require only one initial dose.

The two mRNA vaccines were the only ones updated to include both the original and Omicron BA.4/BA.5 variants of SARS CoV-2 (known as bivalent vaccines). Right now the recommendation is to get just one bivalent booster after the original two mRNA doses, Schaffner said.

According to a December 2022 report from the COVID States Project, which was launched in 2020 by researchers to better inform COVID-19 decision-making, most Americans have not gotten the latest booster shot, although many said they intend to. The report also found that at least 5 in 6 US adults have some level of immunity to the virus, either from getting the vaccine or actually being infected. 

Are the vaccines effective?

The two mRNA vaccines, in particular, are very effective in preventing severe illness and death. The problem is that the immunity wanes quickly, especially in older people, hence the need for more boosters. “The durability of the coronavirus vaccination is not great,” Arias said. 

No one knows exactly how long immunity from the bivalent vaccine lasts given that it hasn’t been out that long. At the same time, the virus is constantly mutating — more so than influenza viruses. This means that vaccines can quickly become outdated as new variants take hold. 

Will once-a-year vaccinations be enough? 

It’s not ideal, but it’s better than nothing and it’s practical. The good news is that most people with healthy immune systems now have some kind of immunity to COVID, either from a vaccine or the illness itself, Schaffner said. 

And new vaccines may not be that critical if subvariants remain close to earlier versions. “Our vaccines are still doing a pretty good job of keeping us out of the hospital, so how different does a mutation have to be before we have to start over?” Schaffner asked. 

If a substantially new variant arises, health authorities will have to revisit these questions. For now, Schaffner said, “we’re tweaking the current vaccine so that our immune system gets a reminder but we don’t have to start all over again.” 

The FDA has proposed that experts consider circulating COVID variants in the spring, then issue a recommendation in time for manufacturers to produce a new vaccine by the fall. There’s also talk of a combined COVID/influenza vaccine, Schaffner said. Although COVID is not as seasonal as the flu, cases can ramp up in the winter when it’s easier to transmit viruses. 

A practical solution is needed 

In a perfect endemic world, annual boosters that conferred protection for 12 months would be ideal. The FDA plan has pluses and minuses, but many experts agree that a practical solution is called for. “I think it’s absolutely necessary,” Schaffner said.

Also, all the nations of the world should be acting together to have a coordinated response. Right now, though, different countries have different vaccines and different recommendations. Meanwhile, different strains dominate different regions at different times, any of which can cross borders at any time.

“There are global ramifications which make things more complicated,” Schaffner said. 

Expect more changes

The FDA Vaccine and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet on Thursday, Jan. 26, to discuss and presumably approve the new strategy.

“There will be a fair amount of discussion, not only about the scientific basis but do we know enough about COVID (how quickly it changes, what the composition of the vaccines should be, how early do you make that decision),” Schaffner said. 

Once a decision is made, the issue goes to the Centers for Disease Control and Prevention, which issues the actual recommendations, he added.

One thing is clear, Arias said: “This virus is going to stay. We are going to have to live with this. The question we all need to ask is: How are we going to live with this?” 

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