FDA Is Considering Annual COVID Vaccines. Here’s What We Know

Doling out COVID-19 vaccines is likely to get a whole lot simpler. A committee advising the Food and Drug Administration (FDA) voted unanimously last week to recommend giving the same vaccine formula to everyone, regardless of whether it’s the primary series or a booster shot.

The advisors also discussed, but didn’t vote on, the proposal to move forward with an annual vaccine strategy. If that happens, vaccine manufacturers will update their vaccines periodically to match circulating strains.

During the day-long meeting, the 21-member panel debated what that approach might look like, including the best time of year to give a yearly shot, and whether a routine immunization was even necessary.

The meeting ended with lots of lingering questions. We’ll learn more about how regulators decide to craft the vaccine strategy in the coming months, but here’s what we know so far.

How Will the FDA Simplify the COVID-19 Vaccine Program?

Currently, one formulation of vaccine is administered as a primary series, and another—the updated bivalent version—is given as a booster.

The committee members agreed that the vaccine program could be made simpler by standardizing the formulation. For now, that means that only the bivalent versions of each vaccine type would be available for all those seeking vaccination, whether they’re currently vaccinated or not.

“There is a lot of disharmony in the public about these vaccines—they are very confused about all of the formulations and different manufacturers. Hopefully this will solve some of that,” said James Hildreth, PhD, MD, a panelist and president of Meharry Medical College.

In the coming months and years, manufacturers are likely to change their vaccine compositions to protect against emerging variants of concern.

Will First-time mRNA Vaccine Recipients Still Need to Get Two Primary Shots?

If FDA and CDC officials decide to follow the lead of the advisory committee, the current primary series approach would change. Rather than giving an mRNA primary series of two shots spaced a few weeks apart, or a single Novavax dose, most adults would get just one shot of an updated vaccine.  

Instead of continuing to encourage primary series vaccination, the FDA is turning its focus on the more than 83% of people who haven±t yet gotten a booster. About 81% of people older than 5 years have had at least one COVID-19 shot, and the others are unlikely to roll up their sleeves for a primary series now. 

Will Vaccines Be Given Annually?

In short, we don’t know yet. The FDA asked the panel to weigh whether an annual vaccine campaign makes sense. While panelists mostly agreed that the vaccine should be periodically updated to match the most current circulating strains, there was less agreement on how often that should be.

“It’s hard to say that it’s going to be annual at this point,” said Eric Rubin, MD, PhD, a panelist and infectious diseases researcher at Harvard T.H. Chan School of Public Health.

Will Anyone Need More Than One Shot Per Year?

There is no clear answer yet to this question either. The FDA is considering giving one shot to each person annually, and two doses to older adults, people with compromised immunity, and young children who had not been previously vaccinated. The panel didn’t vote on that proposal.

Some panelists suggested that two doses of vaccine may not be sufficient to protect young, vaccine-naïve children. And healthy adults, argued Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, might not even need to get an annual shot.

People who are immunocompromised or have underlying health conditions have a higher risk of getting severely sick or dying from COVID-19, meaning they may need to get more frequent immunity top-offs to mount a protective immune response.

“We need more data to figure out exactly who should get the two-dose schedule and who should get the one,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. He acknowledged there is a range of immunocompromise—someone undergoing chemotherapy may need an additional dose, while those with diabetes may not, for instance.

There was some conversation about whether kids, older adults, or immunocompromised people should get a higher dose, rather than multiple normal doses. But the group didn’t see any data on that proposal.

Will COVID-19 Vaccines Be Administered at a Certain Time of Year?

The FDA proposed a June meeting to discuss which variants to target, so that updated vaccines will be ready to administer in the fall.

Unlike flu, which dependably spikes in the winter, COVID-19 surges have historically occurred at all times of the year. However, Marks said that vaccinating against COVID-19 in the fall could have the benefit of streamlining the vaccine program and increasing uptake

“When do we have to worry about the worst overwhelming of the hospitals? It will be when we have influenza, RSV, and potentially COVID at the same time,” Marks said.

The FDA said it expects COVID-19 vaccine manufacturers will be able to deliver updated vaccines quicker than those who make flu vaccines. In the meeting, Pfizer said it can deliver the vaccine in 100 days and Moderna said it could also meet that timeline. But Novavax creates a protein-based vaccine which may take longer to modify than the mRNA vaccines, and the company suggested choosing new strains by March, rather than June.

If the FDA chooses to run a seasonal COVID-19 vaccine campaign, it will be important to remind people who are unvaccinated that they can get a primary series in the spring and summer," said Michael Nelson, MD, PhD, chief of the division of asthma, allergy, and immunology at the University of Virginia School of Medicine.

Each of the manufacturers said they are currently studying combination flu and COVID-19 vaccines.

“We have to keep reminding ourselves this is not influenza,” said Bruce Gellin, MD, MPH, temporary voting member and Chief of Global Public Health Strategy for the Rockefeller Foundation’s pandemic prevention institute. If the FDA follows the flu model this year, that doesn’t mean the agency is “setting it in stone.”

Will the CDC Phase Out the Original COVID-19 Vaccine? 

If officials sign off on the vaccine simplification plan, the original vaccine will no longer be administered. The panelists generally agree that the current bivalent vaccine, which partially targets Omicron, is preferable to the original formula. But some said a next-generation vaccine that targets only circulating Omicron strains, and not the original Wuhan variant, could be even stronger. There’s not yet any data to support this, though, and that debate will likely be reignited as regulators decide on a vaccine formula for the fall.

Who Will the Major COVID Vaccine Manufacturers?

More than 97% of COVID-19 vaccines that have been administered were the mRNA vaccines by Moderna and Pfizer. Those vaccines will likely continue to be at the helm of the vaccine campaign in the near future.

Novavax’s COVID-19 vaccine has received less national attention, largely because it was a latecomer to the market. The protein-based vaccine boasts similar efficacy rates to mRNA vaccines, a good safety profile, and less stringent storage requirements.

mRNA vaccines have the benefit of being quickly modifiable and appear to work well. However, as the panelist Pamela McInnes, DDS, noted, the protection from these vaccines appears to be short-lived. She said scientists should continue studying whether protein-based vaccines induce broader coverage than others by boosting immune cells besides neutralizing antibodies.

Johnson & Johnson has scaled back its COVID-19 vaccine manufacturing and didn’t create a bivalent version of its vaccine, due in part to safety concerns and dwindling demand. The company is not likely to play a role in the future of COVID-19 vaccine campaign.

Under a one-shot-per-year model, people wouldn’t need to commit to one vaccine type anymore. That could give room for other vaccine companies to break into the market.

There’s not much data yet on how mixing and matching updated vaccines from different manufacturers will impact effectiveness. The FDA said that’s something it will look for when considering vaccine approval applications.

How Much Will These Vaccines Cost?

COVID-19 vaccines have so far been free to the public, thanks to federal funding. But this week, the Biden administration announced it will let the public health emergency lapse in May. Federal programs to provide free COVID-19 vaccines will likely end with it.

Moderna and Pfizer have stated they will charge $100 to $130 per vaccine dose. Medicare and Medicaid will cover the cost of COVID-19 shots for beneficiaries. Those with private insurance will also likely be able to access free vaccines, if given by in-network providers. Uninsured people may have to pay out of pocket.

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.