US approval of fall boosters comes amid uptick in COVID-19 cases

The US Food and Drug Administration (FDA) approved two of three updated COVID-19 booster shots Monday, setting the stage for a fall vaccine push to combat the still-circulating virus.

The Centers for Disease Control and Prevention (CDC) will provide recommendations this week, with companies ready to roll out the doses soon after.

Public health efforts to vaccinate individuals against the virus come amid an uptick in cases and hospitalizations, though nowhere near pandemic levels, as new variants continue to emerge and circulate the globe.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”

However, experts differ on whether these annual boosters provide full protection.

"The annual booster idea is out of convenience but not supported by the data of waning immunity after six months," said Dr. Eric Topol, director and founder of the Scripps Research Translational Institute in California.

He believes they have value despite the waning immunity. But some experts shrugged at the annual recommendations.

Dr. Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia (CHOP) has previously, and repeatedly, said that protection from memory cells is sufficient to protect against severe disease for most healthy Americans.

Offit, who also sits on the FDA's external advisory committee, has said as much during advisory meetings. He says that includes those who have received at least three doses, or who have hybrid immunity — an infection at least once plus received two doses of the vaccines.

Offit told Yahoo Finance that memory cell protection appears to still be working, since the variants have not changed in a key way that would render prior protection useless.

"It looks like we still have 80% to 85% conservation (with the BA.2.86 variant), that's why you're still protected against severe disease. It hasn't mutated away from recognition by T-cells," he said.

He added that coronaviruses tend to be winter viruses, so the assumption has been that it will eventually settle into that pattern. But Topol told Yahoo Finance it might take a while until that happens.

"I don’t see any good support for seasonality of this virus over the [next] four years, with simultaneous waves in both hemispheres," Topol said.

Two waves, one campaign

Since 2020, the US has been experiencing late summer and mid-winter upticks in cases, with the latter accounting for a greater rise.

In 2022, the FDA authorized mRNA vaccines from Moderna (MRNA) and Pfizer/BioNTech (PFE/BNTX) at the end of August. By that time, the summer wave was waning, with cases down 5% week over week, according to World Health Organization data.

Despite these two waves per year, the FDA asks companies to prepare for a vaccine push only in the fall and votes on which variant to target in the summer. The CDC subsequently provides guidance on who should get doses.

Experts agree that the elderly, immunocompromised, or those with chronic health problems are more in need of regular boosters — if they are able to produce an immune response from the vaccine at all, which can be harder with age or some illnesses.

Angela Rasmussen, a virologist and research scientist at the Vaccine and Infectious Disease Organization, told Yahoo Finance that even if the country pursued two boosting campaigns a year, it wouldn't help.

"To have two boosters a year wouldn't necessarily add to that extra protection. You may not even need an annual COVID booster if you've already had several boosters and you've already had COVID — which, at this point, many people have," she said.

But beyond that, there isn't enough data to further narrow the recommendations, or to make a better decision about who to boost and when.

Dr. Céline Gounder, an infectious disease expert and epidemiologist, told Yahoo Finance that the two waves could also represent different age groups being impacted, but there is no data to prove it.

"This is a surveillance problem. We don't have the data, but I suspect the summer wave probably skews younger. That's not necessarily what you want to do, in terms of timing [for general public boosting]," Gounder said.

And when counting cases, it isn't necessary to do so with every case like at the start of the pandemic. Getting a general idea of when and where the upticks are — and how severe — is important. From there, creating a profile, such as age, underlying illnesses, or other identifying factors, can help inform experts of any trends.

That, Gounder said, would help with the timing and targeting of boosters.

Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor, told Yahoo Finance he wishes the updated booster had been available to combat the current wave.

"Now is the time we need the XBB [booster], not waiting until the end of this month," Hotez said, noting that the dominant variant is already changing.

The CDC's variant tracker shows the XBB.1.5, which dominated in May and June when the decision for boosters was made, now only accounts for 3% of cases. The EG.5, meanwhile, is now 21.5% of cases. A new variant, BA.2.86, has caught the attention of global health experts, but it has not yet been widely detected in the U.S.

It's why Hotez is concerned about the timing of boosters.

"Especially now with all the big events comping up. The opening of the NFL season, the UN General Assembly meeting — now is the time we would have needed it," he said.

Booster readiness

The Biden Administration is hoping that making doses available means individuals will take them the same way they take the flu vaccine.

"And that's not the case. We know this is not the case. So there needs to be a more targeted approach," Gounder said.

Only 17% of Americans got a COVID booster in 2022, according to the CDC.

The current strategy creates inequity in access, because the message isn't being targeted, said Gounder, who previously served on the president's COVID-19 transition team.

"And that is really lacking in the response," she said.

Meanwhile, the companies and vaccine producers prepare for a regulatory green light by producing millions of doses, and in some cases pre-positioning them around the country in order to release them as soon as they are allowed.

This year, for the first time, the vaccines are being sold on the commercial market rather than being supplied by the US government. Two of the three vaccines have been fully approved. The third, Novavax (NVAX), still has its emergency use authorization (EUA) but has not yet received full approval. It also did not receive the go-ahead for the updated doses Monday, but will still participate in a CDC advisory meeting Tuesday.

Still, the market is not as vast and global as it was during the pandemic.

Hotez, co-creator of the vaccine Corbevax being produced and used in India, says that in addition, there is a lack of diversity in the available options of vaccines. That, too, can skew the protection, as mRNA has a fast and strong upswing in protection, and an equally quick waning period.

But the companies can't do more than monitor emerging variants and test their respective vaccines on them.

Novavax said its vaccines have proven to provide protection against emerging subvariants EG.5.1 and XBB.1.16.6, in addition to XBB.1.5, XBB.1.16 and XBB.2.3, according to a spokesperson.

All three companies — Pfizer, Moderna, and Novavax — said their vaccines are ready for use as soon as the FDA and CDC give the go-ahead, and that other countries have also asked for, or already approved, an updated booster.

Regarding the two waves — none have had any internal discussions, per spokespeople, on the topic.

Moderna believes that getting vaccinated for COVID and flu at the same time makes a lot of sense, a spokesperson said.

The company has been working on a combination flu and COVID vaccine.

Pfizer CEO Albert Bourla said during the most recent earnings call with investors that “the vast majority of respiratory vaccinations happen during the fall and winter respiratory disease season, which starts in September, and we expect COVID-19 vaccinations to follow this pattern going forward.”

A spokesperson noted that once a vaccine is approved, "individuals would be able to access the vaccine at any point during the year."

Follow Anjalee on Twitter @AnjKhem.

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