What you should know about omicron-specific Covid vaccines arriving this fall

As we dive into summer, public health experts say a booster shot targeting Covid’s Omicron variant may better protect Americans during a possible fall virus spike.

On Thursday, the U.S. Food and Drug Administration recommended drugmakers like Pfizer and Moderna to move ahead with the development of Omicron-specific booster vaccines for the coming fall. Both companies have already begun developing boosters based on omicron’s BA.1 and BA.2 subvariants – and the FDA encouraged them to push new booster formulations targeting the newer, more contagious BA.4 and BA.2 subvariants. Aim 5 of omicron.

The FDA noted that these recordings should be developed, tested, and hopefully approved for use “early to mid-fall 2022.” That timing could be important: In May, the Biden administration warned of a Covid surge this fall and winter that could lead to 100 million new infections and a spate of deaths.

In other words, chances are you’ll need a new Covid shot this coming fall. Here’s what experts say you should know, from how effective the vaccine is to how realistic the latest schedules look.

Will you protect these boosters from the new Omicron subvariants?

So far it’s unclear – but the clinical data from Pfizer and Moderna on the boosters they’ve already made for BA.1 and BA.2 is promising.

The data suggest that these vaccines offer significantly stronger immunity to their target subvariants than the primary vaccines that most Americans have already received. As with all vaccines, the goal isn’t necessarily to eradicate transmission entirely – no vaccine is 100% effective at preventing disease – but updated booster shots could further strengthen your protection against hospitalization or death.

The shots didn’t quite get the same results against the BA.4 and BA.5, but still generally performed well. The FDA’s hope is that updated boosters will fight these newer subvariants more effectively by the fall, and the Biden administration already has an agreement with Pfizer to purchase 105 million doses of the booster formulation, which will ultimately be approved by the US Department of Health and Human Services announced on Wednesday.

Of course, new variants or sub-variants could emerge by the fall, which drug manufacturers might send back to square one. But having vaccines that already target a specific strain of Covid is still a good first step, as it’s easier to update them for new strains than to create them in the first place.

“[It] puts us in a relatively good position,” says Dr. Ali Khan, epidemiologist and dean of the College of Public Health at the University of Nebraska Medical Center, told CNBC Make It.

Who is eligible for the new vaccines?

Crucially, the FDA’s announcement on Thursday noted that the Omicron-specific vaccines will likely only serve as booster shots, meaning the country’s current list of approved vaccines will likely be retained for primary immunization.

This means that you are only eligible for an omicron-specific booster dose if you are already up to date on your vaccinations. Manufacturers may also need time to develop enough booster vaccines for all age groups, which could mean vaccinating the population in stages, Khan says.

“If enough vaccine is available, this may not be necessary,” he adds. “It’s really hard to predict as it all boils down to manufacturing schedules at this point.”

According to Khan, the Centers for Disease Control and Prevention faces similar problems every year when developing new flu vaccines: They have to decide months in advance what the new flu vaccine will look like so they can make enough doses to meet demand through the fall .

“The flu decisions are being made just before spring, while we are now well into the summer to make this autumn decision about vaccinating against Covid,” says Khan.

Is this the start of the annual vaccination against Covid?

The short answer: Probably yes, says Dr. Michael Merson, Professor of Global Health at Duke University.

Once omicron-specific vaccines are approved for general use, it will be much easier for vaccine manufacturers to create new versions of their booster shots for the latest circulating Covid strains each year. And while protection from infection typically wears off four months after receiving a booster shot, vaccinated people have strong protection from hospitalization and death for much longer, according to CDC data.

“We have seen from the studies to date that with omicron we get longer protection against serious illness, hospitalization and death – which of course is the most important endpoint,” says Merson. “If our primary goal is what I think should be, then an annual vaccine would seem appropriate.”

If the goal is to prevent infections and minor illnesses, then getting vaccinated every few months would be the answer, but Merson “doesn’t think that’s a realistic goal at this time.”

In the past, experts have pointed to the decline as a target range as Covid has long been expected to fall into a seasonal pattern, getting worse in colder months and better in warmer months. Merson notes that that hasn’t happened exactly yet — but fall remains a target date, largely because it’s the earliest when drug manufacturing and approval processes could realistically be expected to proceed safely.

Until the FDA decides on the composition of the vaccine and reviews clinical data from several companies, the new vaccines won’t be mass-produced, he adds.

“They think there could be a vaccine by October. That’s not ideal. Ideally, you might want to have him a little sooner,” says Merson. “But at least it’s early enough for the winter season.”

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