The British health regulator has expanded the conditional marketing authorisation (CMA) for Novavax’s Nuvaxovid as a booster dose in adults, along with Pfizer and BioNTech’s bivalent Covid-19 booster dose in people aged 12 years and above
Novavax, Pfizer-BioNTech Covid-19 vaccines approved in UK. (Credit: Guido Hofmann on Unsplash)
UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved the Covid-19 vaccine booster shots from vaccine makers Novavax and Pfizer and BioNTech.
The British health regulator has expanded the conditional marketing authorisation (CMA) for Novavax’s Nuvaxovid Covid-19 vaccine as a booster dose in adults, after the primary series.
The MHRA approval was supported by data from a Phase 2 clinical trial conducted in the US and Australia, a separate Phase 2 trial in South Africa, and the COV-BOOST trial in the UK.
In the Phase 2 trials, the company administered a single booster dose of Nuvaxovid to healthy adult participants, about six months after their primary two-dose vaccination.
The third or booster dose produced increased immune responses against the original ancestral strain of SARS-CoV-2, comparable to protection in Phase 3 clinical trials.
In the COV-BOOST trial, the heterologous booster dose of Nuvaxovid, administered after a primary two-dose vaccination series, has increased antibody titres, said Novavax.
Novavax president and chief executive officer Stanley C Erck said: “Our protein-based vaccine, developed using an innovative approach to traditional technology, may have a prominent role to play in Covid-19 boosting.
“As we continue to explore best practices for managing Covid-19 long term, we have ongoing trials further exploring Nuvaxovid’s immunogenicity as a booster dose.
“Currently available clinical and preclinical data indicate that our vaccine induces robust immune responses against Omicron variants, including BA.4/5.”
The MHRA also approved Pfizer and BioNTech’s bivalent Covid-19 vaccine for use as a booster dose in people aged 12 years and above.
The booster dose was intended to offer protection from both Omicron BA.4 and BA.5 sub-variants, along with the original SARS-CoV-2 strain.
MHRA has already approved bivalent vaccines targeting Omicron BA.1 sub-variant from Pfizer-BioNTech and Moderna.
The current approval marks the first bivalent vaccine candidate targeting BA.4/5 sub-variant to be approved in the UK.
Pfizer and BioNTech’s bivalent Covid-19 vaccine targeting BA.4/5 produced a strong antibody response, compared to the original shot, reported Reuters.
MHRA stated: “All approved Covid booster vaccines help to improve the protection obtained from earlier doses of the vaccine and help give longer-term protection against getting seriously ill from Covid-19.”
Last month, the US Food and Drug Administration (FDA) authorised the use of the bivalent Covid-19 vaccines from Moderna and Pfizer-BioNTech as a single booster dose.