New COVID-19 Boosters To Be Authorized Without Human Trials Completed

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Dylan Housman Deputy News Editor
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New variant-specific COVID-19 vaccine booster doses are set to be authorized by the Food and Drug Administration (FDA) before human testing is complete.

FDA Commissioner Robert Califf tweeted last week that the agency will not hold a meeting of its expert vaccine advisers to discuss the new boosters and that it will rely on existing clinical trial data and real-world results in its determination about Emergency Use Authorizations (EUAs) for Omicron-targeting booster shots. The Centers for Disease Control and Prevention (CDC) based its fall booster rollout plan on the assumption that the new vaccines would receive EUAs by Sept. 1.

“Real world evidence from the current mRNA COVID-19 vaccines, which have been administered to millions of individuals, show us that the vaccines are safe. As we know from prior experience, strain changes can be made without affecting safety,” Califf tweeted.

The typical process for granting an EUA to a new vaccine involves a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), the FDA’s group of outside experts that examines research and evidence pertaining to the vaccine’s safety and efficacy. The panel votes on whether to grant the EUA, and under what circumstances to grant it, and passes that recommendation onto the FDA commissioner for a final ruling.

Previous versions of COVID-19 boosters from Pfizer, Moderna and Johnson & Johnson went through that process. Typically, as Califf said, variant-specific doses can be authorized in an expedited fashion because they are almost identical to the vaccines already authorized by the FDA and recommended by the CDC. The flu vaccine undergoes a similar regulatory process, but flu vaccines often lose efficacy far faster than COVID-19 vaccines have, Dr. Paul Offit told The Wall Street Journal.

Offit, a pediatric infectious disease expert and director of the Vaccine Education Center at Philadelphia Children’s Hospital, said that flu vaccines aren’t a good comparison to COVID-19 vaccines because the original COVID-19 vaccines are still highly effective at preventing death or serious illness, even against new variants. “I’m uncomfortable that we would move forward — that we would give millions or tens of millions of doses to people — based on mouse data,” he told the WSJ.

Offit was referencing the “mouse data” which is the best trial data the FDA will have available when it grants the booster EUAs — rodent trials. (RELATED: Legendary Athlete Calls Biden Vaccine Policy ‘A Joke’, Stands Up For Novak Djokovic)

The CDC fall booster plan outlines a delivery procedure that could see the new booster shots become available as soon as next month. COVID-19 has evolved so rapidly, though, that a new variant may emerge not long after the Omicron-based boosters become available. In the two-and-a-half years of the pandemic so far, the Alpha, Beta and Delta variants, the original Omicron variant and the subsequent Omicron subvariants have all been the primary drivers of infection at various points.

The fall booster shots are also expected to be the last crop fully paid for by the federal government. President Joe Biden has opted to keep the national public health emergency for COVID-19 in place through at least the midterm elections later this year. Whether there will be high demand for the boosters remains to be seen — the most recent new vaccine rollout happened when the shots were authorized for toddlers, but uptake on those has been muted.