Both companies have scaled production to deliver doses of Omicron BA.4/BA.5-adapted bivalent vaccinations and shipping after authorisation
The entrance to Pfizer World Headquarters in Manhattan, New York, New York. (Credit: Coolcaesar from Wikipedia)
Pfizer and BioNTech have submitted an application to the US Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine.
The application includes pre-clinical and manufacturing data from the businesses’ bivalent Omicron BA.4/BA.5-adapted vaccine as well as clinical data from their bivalent Omicron BA.1-adapted vaccine made for individuals 12 years of age and older.
It complies with FDA guidelines and intends to address the ongoing evolution of SARS-CoV-2.
Upon approval, the Omicron BA.4/BA.5-adapted bivalent vaccination will be available for shipping immediately.
The original SARS-CoV-2 spike protein is encoded by mRNA in the bivalent vaccine, together with mRNA encoding the spike protein of the Omicron BA.4/BA.5 variant.
According to pre-clinical findings, a booster dose of Pfizer and BioNTech’s adapted vaccine produces a potent neutralising antibody response against the original wild-type strain of Omicron as well as the BA.1, BA.2, and BA.4/BA.5 variants.
A clinical study examining the Omicron BA.4/BA.5-adapted bivalent vaccine’s immunogenicity, safety, and tolerability in people 12 years of age and older is anticipated to begin this month.
A 30-g booster dose of the firms’ vaccine candidate, which includes the current vaccine plus a vaccine that targets the Omicron BA.1 variant spike protein, was tested in a Phase 2/3 trial for safety, tolerability, and immunogenicity.
Compared to the firms’ existing Covid-19 vaccine, the Omicron BA.1-adapted bivalent vaccination elicited a superior immune response against the Omicron BA.1 variation.
The Omicron BA.1-adapted bivalent vaccination had a good safety profile and was well-tolerated.
Pfizer and BioNTech submitted an application for the Omicron BA.1-adapted bivalent Covid-19 vaccine in July after receiving advice from the EMA and International Coalition of Medicines Regulatory Authorities (ICMRA).
The Omicron vaccination has also begun a conditional marketing authorisation application with the European Medicines Agency (EMA), which is anticipated to be finished soon.
Both BioNTech and Pfizer worked together to develop the Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech’s unique mRNA technology.
Pfizer also announced that its company Hospira is recalling one lot of Propofol Injectable Emulsion (containing benzyl alcohol), 100mL Single Patient Use Glass Fliptop Vial.
The firm observed visible particulates in two vials during the annual examination of retention samples.