Covid-19 roundup: Pfizer, BioNTech kick off EUA dance for teen bivalent shot; Report details slow US booster rollout
While Moderna’s vaccine has been sent off for an EUA for teens and preteens, its rivals, Pfizer and BioNTech, are right on its heels with an EUA submission of their own.
On Monday, both companies announced that they finished submitting an EUA to the FDA for the bivalent booster for children aged five through 11 to counter the Omicron BA.4/BA.5 strains of Covid-19. Both companies have also started a “Phase I/II/III study” to evaluate the safety and tolerability of different dosing regimens for the booster in children from six months to 11 years old.
Pfizer and BioNTech have already rolled out some data on a three-dose vaccine series in children. The numbers posted in August showed that the regimen was 73.2% effective. However, the initial trials were conducted when Omicron BA.2 was the more dominant strain at the time.
The news also comes as Pfizer/BioNTech and Moderna are entering the legal arena, as Moderna alleged last month that Pfizer and BioNTech had copied parts of its vaccine technology that it had patented between 2010 and 2016.
Bivalent booster rollout in the US not off to an impressive start — report
As the bivalent boosters head off the line to be distributed, they reportedly have not been exactly flying off the shelves.
According to a report from Reuters, an estimated 4.4 million people have gotten the booster so far, with the campaign starting three weeks ago. The US government stated in the Reuters report that 25 million doses of the booster have been shipped out, mainly of the Pfizer/BioNTech shot.
The administration, however, has been looking to build up its supply of bivalent vaccines. This summer, according to HHS, the administration secured a purchase of 66 million doses of Moderna’s booster to be used in the fall and winter.
Moderna’s booster has also hit a snag. An FDA report detailed that because of a Form 483 hitting a Catalent facility in Indiana, the company has asked the FDA to further review vaccines that were made that the facility, with the vaccines eventually being cleared.
The inspection detailed several issues at the facility including improper cleaning and substances in vials, among other details.