More Jabs: Pfizer, BioNTech Pushing New ‘All Variants’ Covid Vaccine

• The trial announcement was included in BioNTech’s financial results for the second quarter of 2022, where the German vaccine maker reported a total revenue of €3.2 billion ($3.26 billion)—lower than analyst estimates.
• BioNTech and its American partner Pfizer have started manufacturing “bivalent” Omicron BA.1 and BA.4/BA.5 vaccines that will offer protections both against the fast spreading newer variants and earlier variants, the company said.
• The company claims it will be able roll out the updated shots by October—in time for potential fall boosters—if it receives regulatory approval.
• Pfizer and BioNTech have already carried out clinical trials for their BA.1 Omicron-focussed vaccine—it was shown to produce higher neutralizing antibodies against the variant—and have submitted the findings to regulators.

As per the Food and Drug Administration (FDA), vaccine makers do not need to submit updated clinical trial data for the BA.4/BA.5 adapted shots. The agency will instead approve the modified vaccines using clinical data from the BA.1 vaccine trials. This will allow the updated vaccines to be approved quicker. However, the European Medicines Agency has said it doesn’t intend to follow the path of its American counterpart and will instead require vaccine makers to submit clinical data for each of the new updated shots…

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