The US Food and Drug Administration (FDA) approved two updated Covid vaccines this week – one from Moderna, and the other from Pfizer-BioNTech.
A third shot, made by Novavax, is still under review by the FDA, reports Reuters.
In June this year, the FDA advised that vaccines should be updated to a monovalent XBB.1.5 composition for the 2023-2024 vaccination season.
In the same month, Moderna presented clinical data showing its updated vaccine, Spikevax, resulted in robust immune responses across multiple XBB sublineages, including XBB.1.5 and XBB.1.16.
In August, it announced additional clinical trial data showing the shot had also elicited an immune response against EG.5 (or “Eris”) and FL.1.5.1, currently the dominant variants in the US.
Last week, the company shared additional clinical trial data confirming that the updated vaccine provided a strong immune response against BA.2.86, the highly mutated Omicron variant being closely watched by health officials, and which has been detected in several countries, including South Africa.
The biotech company said the shot had produced an 8.7-fold increase in protective antibodies against BA.2.86, reports CNBC.
The US Centres for Disease Control and Prevention (CDC) previously said the strain, also known as “Pirola”, may be more capable of escaping antibodies from earlier infections and vaccinations, but recent research now suggests it may actually be less immune-evasive than feared.
Spikevax has been authorised for people over 12, with Emergency Use Authorisation (EUA) for children from six months to 11. Moderna said the most common solicited local adverse event reported was injection site pain, as well as headaches, fatigue, myalgia and chills, all consistent with previous formulations.
Outside the US, regulatory applications for the vaccine are under review by other regulatory agencies, with decisions anticipated in the coming weeks.
Covid hospitalisations in the US jumped 18.8% during the week ending 19 August, and 87% over the past month, according to the CDC.
Eris accounted for 21.5% of all cases, while FL.1.5.1 accounted for 14.5%.
Last week, the CDC indicated BA.2.86 has been found in four states, but it’s still so rare it’s not listed as a standalone strain on the variant tracker.
Reuters article – US FDA authorizes Pfizer-BioNTech and Moderna's updated COVID shots (Open access)
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