Pfizer (NYSE:PFE)
Pfizer (NYSE:PFE) and its partner BioNTech (NASDAQ:BNTX) are seeking EU approval and have sent a regulatory application to the European Medicines Agency (EMA) for their Omicron BA.4/BA.5-adapted bivalent COVID-19 booster vaccine. They are asking for conditional marketing authorization (CMA). People aged 12 and over are the intended recipients of this vaccine.
Pfizer (NYSE:PFE) and BioNTech submitted a EUA to the FDA last week for their Omicron BA.4/BA.5-adapted bivalent vaccination for the same age range.
Data from a phase II/III research evaluating Pfizer/bivalent BioNTech’s Omicron BA.1-adapted vaccine of a 30-g booster dosage are included in the filings, as are data from the preclinical, quality, and manufacturing stages of development. Clinical study data on the safety of multiple-variant vaccination candidates against previously-discussed variants (Alpha, Beta, and Delta) have also been presented.
The BA.4/BA.5-adapted bivalent booster vaccine developed by Pfizer/BioNTech contains the original vaccine’s 15 g of mRNA encoding the spike protein and 15 g of mRNA encoding the Omicron BA.4/BA.5 spike protein sequence. In its preclinical testing, the booster vaccination showed a significant neutralizing antibody response compared to Omicron BA.1, BA.2, and BA.4/BA.5 variations and the original strain.
Pfizer’s (NYSE:PFE) stock price has dropped 18.8% year to year, lagging below the industry’s 0.4%.
The market has fallen 22.9% this year, while BioNTech’s share price has fallen 44.1%.
Investors need to know that in July, the businesses submitted an application to the EMA requesting approval of their Omicron BA.1-dated bivalent COVID-19 vaccination based on safety, tolerability, and immunogenicity findings from phase II/III research. According to the results, the immunological response to a 30-g booster dose of the Omicron BA.1 version was significantly higher than that to the original vaccine, Comirnaty. The EMA is presently reviewing the application.
Pfizer/BioNTech has already ramped up production of the Omicron BA.1-adapted and Omicron BA.4/BA.5-adapted bivalent boosters and is prepared to begin shipping doses as soon as the EMA approves the necessary regulatory authorizations. The European Union (EU) will have access to bivalent vaccinations against Omicron BA.1 and Omicron BA.4/BA.5 by September.
Pfizer (NYSE:PFE) and BioNTech’s COVID-19 vaccines use mRNA technology. In response to the success of the Pfizer/BioNTech vaccine, Moderna MRNA has created a competing vaccination based on mRNA technology.
In Europe, the United States, Australia, and Canada, the Spikevax vaccine developed by Moderna has received approval for use in children and adolescents.
The bivalent BA.4/BA.5 Omicron-targeting COVID-19 vaccine, mRNA-1273.222, was submitted for EUA review by Moderna to the FDA last week for use in adults with a booster dosage of 50 g.
The company has increased production of mRNA-.1273.222 in the hopes of delivering dosages by September, should the FDA approve an expanded use application.
Featured Image : Megapixl © Dimitrisbar
Author Shariq Khan 
