On Tuesday, the Food and Drug Administration (FDA) announced that it had granted emergency use authorization for Pfizer’s bivalent COVID-19 booster in children under age 5 who had previously received three monovalent injections, despite concerns from respected doctors about the dangers of COVID injections.
“Pfizer Inc. and BioNTech SE today announced that the United States Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) to provide a single booster dose of bivalent COVID-19 adapted Omicron BA.4/BA.5 from companies. vaccine in children 6 months to 4 years old (also referred to as under 5 years old) at least 2 months after completion of the primary vaccination course with three doses of the original Pfizer-BioNTech COVID-19 vaccine,” according to the company statement. .
“Emergency uses of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent have not been approved or cleared by the FDA, but have been cleared by the FDA under a emergency use authorization (EUA) to prevent coronavirus disease 2019 (COVID -19) in individuals 6 months of age and older Emergency uses are authorized only for the duration of the declaration of the existence of circumstances justifying the emergency use authorization of the medical product under section 564(b)(1) of the FD&C Act, unless the declaration is terminated or the authorization is revoked earlier, the company said.
Under the expanded EUA, the bivalent booster dose can be given to children at least 2 months after receiving a third dose of Pfizer’s monovalent vaccine. The FDA said children who have not yet completed their primary series should complete it with a dose of bivalent vaccine and are not eligible for a bivalent booster.
“[This] the authorization provides parents and caregivers of children aged 6 months to 4 years who received the three-dose primary series with the monovalent Pfizer-BioNTech COVID-19 vaccine the opportunity to update the protection of their children by receiving a booster dose with the Pfizer-BioNTech Bivalent COVID-19 vaccine”, Peter Marks, MD, Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a press release.
In the release, the FDA said immune response data from a study of 60 children ages 6 months to 4 years showed participants had an immune response to both strains 1 month after receiving the bivalent vaccine.
He also detailed the results of a clinical study that included 24 participants aged 6 months to 23 months and 36 participants aged 2 to 4 years. Common side effects in the first group included irritability, drowsiness, redness at the injection site, pain and swelling, decreased appetite, fatigue and fever; and the most common side effects in the latter group included fatigue, injection site pain, redness and swelling, diarrhea, vomiting, headache, joint pain, and chills.
Recall that the reformulated bivalent COVID boosters have not been tested on humans – only mice.
Thus, the bivalent boosters tested in these human studies were not exactly the same as the bivalent boosters currently being administered in clinics, pharmacies and other vaccination sites across the country. No, if you want human clinical trial data specifically on the BA.4/5 bivalent booster, you’re going to have to wait a bit. According to a company announcement on Aug. 31, the human clinical trial for the Moderna BA.4/5 bivalent booster is “fully enrolled and currently underway.” That same day, Gretchen Vogel reported for Sscience that the clinical trial for Pfizer-BioNTech’s bivalent booster BA.4/5 will begin in September of this month.
So what data specific to BA.4/BA.5 boosters did the FDA use to expand the EUAs to include BA.4/BA.5 boosters? Well, the answer is at least partly very “mouse”. Apparently, Moderna and Pfizer-BioNTech provided non-human animal data on BA.4/BA.5 boosters to the FDA to make their case for EUA. But they have yet to show this data to the rest of the scientific community or to the public.