Report: COVID Boosters Could Be Authorized For Use Before Human Testing Is Completed
Grace Thomson receives the coronavirus vaccine from Paula McMahon at the Louisa Jordan Hospital as the roll out begins on December 8, 2020 in Glasgow, Scotland.
Jeff J Mitchell – Pool /Getty Images

The Food and Drug Administration (FDA) could rule this week that COVID booster shots may be distributed to Americans before the completion of testing in humans.

The lack of human studies for the new booster has led to concerns about its upcoming release.

“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,” Paul Offit, an FDA adviser and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told the Wall Street Journal in a report published on Sunday.

The updated Pfizer and BioNTech vaccine contains mRNA of the original SARS-CoV-2 spike protein found in the current vaccine together with mRNA spike protein for the Omicron BA.4/BA.5 variant. Pfizer and BioNTech said it is starting a human study of the booster shot this month, though it would not be completed until after its potential approval and distribution to Americans.

Pfizer and BioNTech have requested that the FDA grant an emergency use authorization for its COVID vaccine adapted to the BA.4/BA.5 versions of the Omicron variant. The emergency request would allow the booster’s approval without the traditional studies required for such a vaccine.

The new booster dose is intended for individuals 12 years of age and older and would be available to ship immediately, according to a news release from the company.

“The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 Vaccine, has allowed us to develop, test and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed,” said Albert Bourla, Chairman and CEO of Pfizer.

“Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges,” he added.

The most recent data provided by the CDC reveals that the BA.5 variant is responsible for 88.7% of all new cases between August 21 and August 27. The BA.4 variant included an additional 3.6% of new cases.

In addition to Pfizer/BioNTech, Moderna has also requested FDA approval for its updated COVID vaccine targeting the latest coronavirus strains. If approved, it could ship in September.

“We have worked closely with the FDA to ensure that Americans will have access to Moderna’s updated, bivalent booster, which, if authorized, may offer higher, broader, and more durable protection against COVID-19 compared to the currently authorized booster,” said Stéphane Bancel, Chief Executive Officer of Moderna. “Moderna’s mRNA platform has enabled us to develop, study, and deploy bivalent booster vaccine candidates that demonstrate superior protection against all tested COVID variants, in record time. Our commitment to using cutting-edge science to protect the world against the ongoing COVID threat continues.”

Moderna noted that it launched a clinical trial of the booster earlier this month. Its press release stated that its application “is based on preclinical data as well as clinical trial data available for the company’s BA.1 Omicron-targeting bivalent booster candidate, mRNA-1273.214.”

Full human clinical trials are not required for emergency use approval. However, the push for booster approvals ahead of more developed human studies could cause hesitancy among some people eligible for the vaccine.

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