FDA advisors recommend targeting XBB variant with Covid vaccines this fall.

A woman receives a booster dose of the Moderna coronavirus disease (COVID-19) vaccine at a vaccination centre in Antwerp, Belgium, February 1, 2022.

Johanna Geron | Reuters

The U.S. Food and Drug Administration’s independent panel of advisors on Thursday recommended updating Covid shots for the fall and winter to target one specific variant – the XBB variants – which are currently the dominant strains of the virus nationwide.

The committee unanimously voted for the new shots to be monovalent, designed to protect against one variant of Covid, and to target a member of the XBB family.

These XBB variants of Covid are descended from the omicron variant and are some of the most immune-evasive strains to date.

The panel of advisors also agreed to specifically target a variant called XBB.1.5, which accounted for nearly 40% of all Covid cases in the U.S. as of early June.

Advisors noted that XBB.1.5 appears most ideal for the fall since vaccine manufacturers Pfizer, Moderna, and Novavax have already started to develop jabs targeting the strain.

The FDA typically follows the advice of its advisory committees, but is not required to do so. The final decision on strain selection is still unclear.

The panel’s recommendation is a win for Pfizer, Moderna, and Novavax, as they have been conducting trials on their respective XBB.1.5 shots ahead of the meeting.

This recommendation coincides with a broader shift in how the pandemic is impacting the country and the world, as Covid cases and deaths have dropped to new lows and governments have rolled back health mandates.

However, the FDA is concerned about a potential Covid wave during the winter, and updated vaccines targeting high circulating variants are seen as a way to restore protective immunity against the virus.

It’s a similar approach to selecting strains for the annual flu shot, where researchers assess circulating flu virus strains.

There is uncertainty about which age groups the FDA and CDC will advise to receive the updated shots.

During the meeting, Pfizer, Moderna, and Novavax presented preliminary data on their updated shots targeting XBB variants.

Moderna’s data showed that a monovalent vaccine targeting XBB.1.5 produced a more robust immune response than the authorized bivalent shot. Pfizer and Novavax also presented positive data on their monovalent vaccines.

It remains to be seen how many Americans will choose to take the updated shots later this year, as current booster uptake has been limited.

Pfizer, Moderna, and Novavax shot data

During the meeting, Pfizer, Moderna, and Novavax presented preliminary data on updated versions of their shots designed to target XBB variants.

Moderna has been evaluating shots targeting XBB.1.5 and XBB.1.16, and the data showed a strong immune response against the XBB variants.

Pfizer and Novavax also presented positive trial results for their monovalent vaccines targeting XBB variants.

Pfizer provided specific timelines for delivering their updated vaccines, depending on the strain selected by the FDA.

Novavax has also shown promising preclinical trial data indicating the effectiveness of their monovalent vaccines.

Overall, the data from Pfizer, Moderna, and Novavax support the use of monovalent vaccines targeting XBB variants in the fall.

Reference

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