FDA Directs Pfizer, Moderna, Novavax to Update COVID-19 Vaccines to Target Current Dominant Variant

Kos Temenes
By Kos Temenes
June 18, 2023Vaccines
FDA Directs Pfizer, Moderna, Novavax to Update COVID-19 Vaccines to Target Current Dominant Variant
COVID-19 vaccines at George Washington University Hospital in Washington in a Dec. 14, 2020, file photograph. (Jacquelyn Martin/Pool/AFP via Getty Images)

U.S. Food and Drug Administration (FDA) advisers made a unanimous recommendation that updated COVID-19 shots, which are to be launched for a vaccination campaign this fall, are to target one of the dominant variants.

The shots are to be aimed at the XBB coronavirus variants, which are reportedly the current most dominant variants, according to the FDA, with a vote of 21–0 in favor.

A subsequent discussion by the committee hinted at a preferred strategy against the XBB.1.5 Omicron subvariant that, according to manufacturers, could be ready soonest for application.

Versions of the respective vaccines targeting XBB.1.5, as well as other current subvariants, are currently already being developed by COVID vaccine makers, including Pfizer (PFE.N)/BioNTech (22UAy.DE), Moderna (MRNA.O) and Novavax (NVAX.O), based on preclinical data presented by all three manufacturers.

Melinda Wharton, vaccine policy official at U.S. Centers for Disease Control and Prevention (CDC), has said shots aimed at XBB.1.5 to be the most feasible option without delays in availability.

If officials are to agree on targeting XBB.1.5 in this year’s campaign, it would prove most helpful to Novavax, due to the composition of its vaccine. Typically, protein-based vaccines require a longer manufacturing process than rival mRNA-based shots.

However, should officials decide to go in a different direction, it could mean that Novavax could once again be lagging behind its rivals.

FDA official Dr. Peter Marks indicated the agency was likely to settle on XBB.1.5, which manufacturers suggested could be ready for inoculations soonest.

“The fact that most of the manufacturers are ready to work on XBB.1.5 is an added reason to select this strain or this variant given the immunologic data,” said meeting chair Dr. Arnold Monto.

According to a release issued by Novavax after the meeting, it anticipates a timely delivery this fall on its BB-targeted COVID shots.

Documents released earlier this month by FDA staff reviewers also suggest this year’s target should be aimed at the XBB subvariant and subsequent offshoots. These allegedly account for most current U.S. infections, and are said to be descendents of the Omicron variant, which is claimed to have caused a massive spike in COVID cases early last year.

U.S. health regulators are aiming to more closely align the next COVID shots with the circulating virus.

Pfizer, in its presentation, said supply of its monovalent shots targeting the XBB.1.5 subvariant could commence as early as the end of July. Moderna said it was prepared to supply a new variant-containing shot for fall season.

A so-called monovalent vaccine is divergent from the most recent bivalent COVID boosters in that it’s aimed at a single target, as opposed to boosters that, according to vaccine-makers, targeted both the virus’s original strain and Omicron.

Recommendations from experts outside the FDA will be taken into consideration before a final decision on composition of the shots is made.

The proceedings on June 15 follow a recent recommendation by an advisory group to the World Health Organization (WHO), which also suggested aiming shots in this year’s campaign at XBB subvariants. The recommendation was endorsed by European medicine regulators.

Despite the CDC widely recommending booster shots last year, panel member Dr. Paul Offit questioned the necessity for shots to be recommended for “everybody every season.” He added that the highest-risk groups would potentially benefit more from an annual booster.

Government data through early May shows that less than 20 percent of Americans, or just over 50 million people, received booster shots during the 2022–2023 vaccination season. The rate was higher among the older population.

Nonetheless, according to Morningstar analyst Karen Andersen, 75 million doses are expected to be sold between Moderna and Pfizer in the United States during the 2023–2024 campaign.

Both Moderna and Pfizer estimate the U.S. annual COVID-19 market to be around 100 million doses.

COVID deaths and hospitalizations have declined in 2023, while reports of vaccine injuries and deaths have increased exponentially.

A recent study also indicates that people “up to date” with their COVID-19 vaccinations are more likely to get infected, the Epoch Times reported.

The U.S. government in May ended its COVID Public Health Emergency, under which millions of Americans received vaccines, tests, and treatments at no cost.

Reuters contributed to this article

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