The US Food and Drug Administration (FDA) has authorised updated Covid-19 vaccines from Pfizer and BioNTech, and Novavax.
Pfizer and BioNTech’s updated Covid-19 vaccine, customised for the LP.8.1 sublineage, is approved for individuals aged 65 years and above.
The updated vaccine is also indicated for people aged between five and 64 years with underlying health conditions, at high risk.
The FDA approval is based on clinical data showing the vaccine’s efficacy and safety, with enhanced immune response against several SARS-CoV-2 sublineages.
The LP.8.1 adaptation follows FDA guidance, prioritising the sublineage for upcoming vaccine seasons in the US.
BioNTech retains marketing rights for Comirnaty and its adapted versions across the US, EU, the UK, and other regions.
Pfizer and BioNTech will start distributing the vaccine immediately, ensuring its availability in various healthcare settings soon.
Novavax announced that its Nuvaxovid vaccine is indicated for adults aged 65 and above, or those aged 12 to 64 with high-risk conditions.
Nuvaxovid vaccine relies on protein-based technology targeting the JN.1 variant, enhanced by the Matrix-M adjuvant, which boosts immune response.
French pharmaceutical company Sanofi is advancing the commercialisation efforts, with Novavax receiving royalties.
The vaccine is stored between two and eight degrees Celsius for effective distribution.
Novavax president and CEO John Jacobs said: “With today’s approval, we will work with our partner Sanofi to provide access to a protein-based, non-mRNA Covid-19 vaccine for eligible individuals this fall.”
