FDA Advisor Calls for Latest Omicron Coronavirus Shots : Shots

The COVID-19 vaccine will be updated in hopes of targeting the Omicron strain, which will circulate later this year.

Stephen Felix/Associated Press

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Stephen Felix/Associated Press

The COVID-19 vaccine will be updated in hopes of targeting the Omicron strain, which will circulate later this year.

Stephen Felix/Associated Press

A panel of expert advisors from the Food and Drug Administration unanimously voted Thursday to recommend updating the COVID-19 vaccine to target the new subvariant of Omicron.

Currently available COVID-19 vaccines are known as “bivalent” vaccines because they are designed to target both the original strain of coronavirus and the Omicron submutant strain that circulated last winter.

However, an FDA panel has recommended that pharmaceutical companies abandon bivalent vaccine designs and instead move to “monovalent” vaccines that target only the ohmicon submutant. The idea is to roll out a newly formulated vaccine in anticipation of a possible increase in the number of infected people this fall.

The committee specifically supported targeting the subvariant XBB.1.5, which accounts for approximately 40% of new infections in the United States.

In their analysis, FDA scientists said data from vaccine makers showed that the latest monovalent formulations targeting the XBB submutant produced “more potent neutralizing antibodies against the XBB strain than current bivalent vaccines.” “It elicits a reaction,” he said.

Dr. Eric Rubin, a professor of immunology and infectious diseases at Harvard University and a member of the Advisory Board, said, “There doesn’t seem to be any particular advantage to bivalent vaccines.”

Although there was broad consensus on the move to monovalent vaccines, there was considerable debate among members on whether COVID-19 vaccines should be treated in the same way as influenza vaccines, which are improved annually in preparation for influenza season. There was a discussion of

“People understand the flu vaccine every year,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “It may not be every year at this point, but it looks like there will be more divergence from this situation by next fall.” [strain] And we may have to come back here. ”

But some feared that too close a similarity to the flu might actually cause confusion among the American public.

“This is not the flu,” said Dr. Paul Offitt, a panel member and professor of pediatrics at the Philadelphia Children’s Hospital. He noted that many Americans already have some protection against severe illness from COVID-19 due to previous infections, vaccinations, or both.

“I’m all for this vaccine update, but I think we need to define who really benefits from the booster, because not everyone,” he said.

It is not yet clear to whom federal officials will recommend the latest Omicron vaccine.

During the conference, the CDC shared data showing a decline in hospitalizations and deaths from the novel coronavirus in most groups since last April. However, it is disproportionately higher in people over the age of 75, suggesting that this group may need special protection. People with health problems such as chronic lung disease or diabetes may also be at increased risk.

The FDA will now consider the committee’s discussions and will likely issue an official recommendation on vaccine formulations in the coming days, which will point the way for vaccine makers.

If all goes according to plan, the new vaccine is expected to go on sale in the fall, around late September or early October.

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