Covid’s Next Big Wave Worries FDA Advisers Mapping Vaccine Plans

(Bloomberg) -- Health officials should be developing a consistent standard for Covid-19 vaccines as they prepare for the rapid emergence of new variants, U.S. Food and Drug Administration advisers said.

Chances are roughly 20% that there will be another “omicron-like” event in the next 12 months, according to research reviewed Wednesday by the FDA and its advisory panel on vaccines. A key portion of the spike protein that coronavirus uses to enter cells is changing at least twice as fast as one common influenza strain, which requires new types of shots every year because of mutations.

Many of the FDA advisers agreed that the agency needs to come up with a single standard for updating Covid-19 shots to prevent a confusing situation where vaccine manufacturers come out with different updates. Several panel members also said that a multiple-strain vaccine makes the most sense for the next iteration of the Covid shot, given the great uncertainties about future viral evolution.

“I feel like at some level, the companies kind of dictate the conversation,” said Paul Offit, a panel member from the Children's Hospital of Philadelphia. “It shouldn't come from them. It really has to come from us.”

Likely Scenario

A likely scenario is that the virus continues to evolve from the current BA.2 subvariant, leading to less dramatic seasonal waves.

BA.2 itself could still cause a surge in cases, White House medical adviser Anthony Fauci said in an interview with Bloomberg Television. Cold fall and winter weather may also contribute to a late-year wave, according to Fauci, who said he hopes that background immunity in the U.S. population will keep Covid hospitalizations low.

In the U.S., booster doses are becoming an increasingly relied-upon tool in the fight against Covid, especially as states and companies cut back on precautions such as masking and working from home. The rate of severe illness among people who received a fourth dose of Pfizer's vaccine was about three times lower than those who got only three, according to an Israeli study published in the New England Journal of Medicine. The study of data from around 1.2 million people 60 and older also found that people who received three doses reported twice as many infections as those with additional boosters.

High Stakes

However, the extra shots haven't been embraced everywhere. European public-health authorities said a fourth dose of Covid-19 vaccine should be kept to adults age 80 and older for now, saying there's no clear evidence to support an immediate booster for younger people. They didn't rule out a fourth dose in the future for healthy people ages 60 to 79.

“The current situation where we are feeling compelled to boost every four months potentially is not sustainable,” said panel member Mark Sawyer, a professor of pediatric infectious disease from the University of California in San Diego.

Additional shots hold high stakes for both Moderna Inc. and the vaccine partnership of Pfizer Inc. and BioNTech SE. The companies are working on omicron-specific boosters as well as shots that combine existing vaccines with the variant-specific formulation. If Covid shots end up being revised annually -- like seasonal flu shots -- that could lead to billions of dollars of additional sales for the drugmakers.

Before the meeting the FDA laid out proposed plans for making vaccine changes. The agency would routinely review the epidemiology of currently circulating variants in the U.S. and consult with advisers while working closely with drug manufacturers and public health agencies to provide clinical data. Any recommendations from the World Health Organization would also be discussed by the FDA and its advisers, according to the proposal.

The agency isn't obligated to follow the advisory panel's recommendations, though it typically does.