Pfizer and BioNTech’s bivalent Covid-19 vaccine is authorised as single booster dose for adults and adolescents aged 12 years and above, and Moderna’s bivalent candidate a booster dose in adults aged 18 years and above
Moderna, Pfizer-BioNTech booster shots approved in US. (Credit: Mat Napo on Unsplash)
The US Food and Drug Administration (FDA) has expanded the emergency use authorisation (EUA) for bivalent formulations of Moderna, and Pfizer-BioNTech Covid-19 vaccines.
The bivalent Covid-19 vaccines from both the companies contain mRNA from the original SARS-CoV-2 virus strain, along with omicron variant lineages BA.4 and BA.5.
Pfizer and BioNTech’s bivalent Covid-19 vaccine is now authorised as single booster dose for adults and adolescents aged 12 years and above, at least two months after vaccination.
The authorisation is based on data from Pfizer and BioNTech’s Omicron BA.1-adapted bivalent vaccine, along with pre-clinical data from their Omicron BA.4/BA.5-adapted bivalent vaccine.
Ina Phase 2/3 trial, the booster dose of Pfizer-BioNTech Omicron BA.1-adapted bivalent vaccine elicited a superior immune response against the Omicron BA.1 subvariant.
The companies are planning to file an application with the FDA in early October, seeking approval of their Omicron-adapted bivalent vaccine for children aged 5 to 11 years.
Pfizer chairman and chief executive officer Albert Bourla said: “As we head into the fall and winter season, with the potential for greater SARS-CoV-2 spread in schools and at work, it is important to stay up to date with vaccines as a first line of defence against Covid-19 illness.”
BioNTech CEO and co-founder Ugur Sahin said: “With today’s approval, a vaccine will shortly become available that addresses the currently prevalent Omicron sublineages with the aim of preserving protection against Covid-19.”
The US agency has authorised a booster dose of Moderna’s BA.4/.5 bivalent Covid-19 vaccine, dubbed mRNA-1273.222, for use in adults aged18 years and above.
The bivalent vaccine of 50µg dose contains 25µg of mRNA encoding for the spike protein of BA.4/.5 and 25µg encoding for the original strain of the SARS-CoV-2 virus.
Moderna said that its mRNA vaccine candidate has been developed under guidance from the US FDA, to target the BA.4/.5 subvariants of Omicron
The authorisation is based on pre-clinical data for mRNA-1273.222, along with data from a Phase 2/3 of mRNA-1273.214, Moderna’s another Omicron-targeting bivalent vaccine.
The US Department of Defence Joint Program Executive Office for Chemical, Biological, Radiological Nuclear Defense (JPEO-CBRND) are procuring these bivalent vaccine doses.
Moderna chief executive officer Stéphane Bancel said: “The FDA’s authorization of our updated bivalent booster, mRNA-1273.222, provides Americans with access to broader protection against Omicron variants.
“Receiving a booster that specifically targets the Omicron BA.4/.5 variant, currently the most prevalent strain of SARS-CoV-2, is an important public health measure that people can take to help protect themselves, especially as we head into a season filled with indoor gatherings. We are grateful to the FDA for their decisive leadership.”