Pfizer, CDC experts don't see eye to eye on COVID-19 boosters, threatening key revenue stream: analysts

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When will someone need a COVID-19 booster? Not only is it a pertinent question among the vaccinated, but also among analysts eager to track pandemic vaccine sales for years to come. 

In Pfizer’s eyes, it could be that those inoculated with the drugmaker’s BioNTech-partnered shot will need a dose as early as this fall. However, a key CDC advisory panel may not see eye to eye, Bernstein analysts pointed out in a note sent to clients on Monday. 

No one is completely sure when a booster will be needed, but it’s possible that some of those who were vaccinated early on may need an extra jab as early as September, or roughly 8 to 12 months after their initial regimen, CEO Albert Bourla recently told Axios. Bourla warned those predictions are preliminary. 

Several variants of SARS-CoV-2—the coronavirus behind COVID-19—have been found to spread more rapidly than the original strain, which has caused some concerns about how well the currently-deployed jabs will hold up. Pandemic heavyweights have quickly kicked off research into boosters, whether that's an extra dose of their original shots or a modified version.

RELATED: First Moderna, now Pfizer-BioNTech working on booster shot amid rise of COVID-19 variants

Pfizer is working on two different booster-shot strategies that it anticipates could carry sales beyond the immediate pandemic need. Those are a third 30 mg dose of its current vaccine and an updated jab that targets the Beta variant, first identified in South Africa. The company is expecting immunogenicity data for both studies as early as July.  

The drugmaker has generally argued that boosters will be required “as antibody blood concentration wanes to ensure the broad population can't carry the virus and thus quench the epidemic faster,” the Bernstein analysts, led by Ronny Gal, wrote to clients. That’s not the industry’s standard, and it’s also not what the CDC’s Advisory Committee on Immunization Practices (ACIP) suggested at its meeting last week, the analysts wrote.

It’s likely that a booster will be necessary once there’s a demonstrated decline in efficacy, not just a waning antibody response, CDC experts said. Boosters may also be needed if there’s a variant that’s able to evade the jabs, according to slides presented by Sara Oliver, M.D., a medical epidemiologist with CDC's National Center for Immunization and Respiratory Diseases.

At the moment, there’s no evidence to suggest a booster is needed, the experts said. Still, boosters could soon be appropriate for some populations. To be sure, the nation's top public health officials will continue monitoring the situation.

RELATED: Pfizer expects higher COVID-19 vaccine prices and yearly boosters, CFO says. And that means big sales long-term

“For now, it seems that if the ACIP view is accepted, frequent boosting would be recommended only for special risk groups (elderly, immune-suppressed) or if we learn symptomatic disease quickly follows antibody decline (which is less likely),” the Bernstein analysts said in the note. 

A Pfizer spokesperson told Fierce Pharma that the company's "current thinking is that until we see a reduction in SARS-CoV-2 circulation and COVID-19 disease, we think it is possible that a third dose, a boost of our vaccine, could be needed to help provide protection against COVID-19," subject to regulatory approval. 

The jury is still out on when exactly the protection from Pfizer’s mRNA shot will begin to fade, although there’s mounting evidence that it may not be anytime soon. 

According to one new study published Monday in Nature, the vaccines from Pfizer-BioNTech and Moderna appear to trigger a strong and durable immune response in the body. The researchers found that vaccination led to high levels of neutralizing antibodies effective against three variants of the virus, including the Beta variant. 

Boosters are expected to serve as a key revenue driver in the years to come for COVID-19 vaccine heavyweights such as Pfizer and Moderna. Pfizer executives have said the company sees the vaccine market evolving as the pandemic wanes, and that the company will likely be able to charge more per dose than it was getting under pandemic supply deals.