Pfizer and BioNTech get positive CHMP opinion for updated bivalent BA.4/BA.5-adapted COVID-19 vaccine booster 

Pfizer (NYSE: PFE) and its partner BioNTech (Nasdaq:BNTX) could potentially win authorization to market a 30-µg booster dose of their omicron BA.4/BA.5 bivalent-adapted COVID-19 vaccine after the Committee for Medicinal Products for Human Use (CHMP) backed the vaccine for individuals 12 and older.

The European Commission will likely make a final decision on the updated vaccine soon.

The updated vaccine has won emergency use authorization in the U.S. for use as a booster.

The new vaccine contains 15-µg of mRNA encoding the spike protein of the original form of SARS-CoV-2 and 15-µg of mRNA encoding the spike protein of the omicron BA.4/BA.5 sublineages.

Earlier this month, Pfizer and BioNatech announced they received a positive CHMP opinion for an omicron BA.1-adapted bivalent COVID-19 vaccine booster.

“Due to our multifaceted approach helping to address emerging variants and subvariants of concern, public health authorities in the EU will have our bivalent booster options, pending authorization, to facilitate flexible vaccination strategies for maximal coverage across the region,” said Pfizer CEO Albert Bourla in a news release.

CHMP’s endorsement of the BA.4/BA.5 bivalent-adapted COVID-19 vaccine was based on data from Pfizer’s and BioNTech’s omicron BA.1-adapted bivalent vaccine in addition to pre-clinical and manufacturing data from the omicron BA.4/BA.5-adapted bivalent vaccine.

The BA.4/Ba.5-adapted vaccine fared well in pre-clinical studies against the BA.1, BA.2, BA.4 and BA.5 omicron sublineages.

Many countries, including the U.S., UK, Switzerland and Australia, have also backed updated COVID-19 vaccines.

PFE shares edged up 0.52% to $48.09 in mid-day trading, while BNTX shares were down 1.33% to $148.90.

In late August, Moderna (Nasdaq:MRNA) announced that it was suing Pfizer (NYSE:PFE) and its partner BioNTech (Nasdaq:BNTX) over patent infringement in U.S. and German courts.

Moderna’s vaccine, like the Pfizer-BioNtech vaccine, uses an mRNA backbone. Pfizer disputes that its vaccine jointly developed with BioNTech was based on Moderna’s.

BA.4 and BA.5 continue to drive the majority of SARS-CoV-2 infections internationally.