The Food and Drug Administration (FDA) could issue a ruling this coming week that the brand new COVID booster shots are now available to be distributed to the American people before it finishes its human trials.
The failure to complete the human studies for the new booster shots has sparked a large number of concerns about its soon-to-come 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,” explained an FDA adviser and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, Paul Offit, to the Wall Street Journal via a recently published report sent out Sunday.
The recently updated BioNTech and Pfizer vaccines contain 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 stated that it is now starting a human case study surrounding the booster shot this month, but such a study would not be finished until well after its slated approval and distribution to Americans.
Pfizer and BioNTech have put out a request to the FDA that they grant an emergency use authorization for its COVID vaccine adapted to the BA.4/BA.5 versions of the Omicron variant. Such an emergency request would allow the approval of this particular booster without the need for the more traditional studies that are historically required to approve such a vaccine.
This particular new boost dose is slated for use in those that are 12 years old and up and would be slated for shipment immediately, according to a recent 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,” explained the Chairman and CEO of Pfizer, Albert Bourla.
“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 went on to say.
This new data made public by the CDC unveils that the new BA.5 variant is the cause of over 88.7% of all new cases reported between August 21 and August 27. All while the previous BA.4 variant resulted in an additional 3.6% of new cases.
To go along with Pfizer/BioNTech, Moderna has also put in its own request to the FDA to get approval for its recently updated COVID vaccine that targets the most recent virus strains. If allowed, their version could ship as soon as 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,” explained the Chief Executive Officer of Moderna, Stéphane Bancel. “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 did state that it had launched its clinical trials for the booster early this month. It claimed in its press release 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.”
