According to The Daily Wire, the lack of human studies for the new booster has lead to concerns about its 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,” said Paul Offit, an FDA adviser and director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
This updated vaccine booster is intended to protect people against the Omicron BA.4/BA.5 variant.
Pfizer and BioNTech said they were starting human testing, but it would not be completed until after the potential distribution to American citizens.
Both of the companies requested that the FDA allow the booster to be distributed early for emergency use, which would allow them to skip the traditional studies.
The new shot is intended for ages people 12 years of age and older, and would be available to ship immediately.
“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.
Moderna has also requested approval from the FDA for its updated vaccine targeting the latest strains.
Full clinical human trials are not required for emergency use approval.
The push for booster approvals ahead of schedule and without completed human studies may cause hesitancy among some people eligible for the vaccine.