EMA panel backs COVID-19 vaccines targeting Omicron BA.1

The EMA’s human medicines committee (CHMP) has recommended authorisation of two COVID-19 vaccines from Moderna and Pfizer/BioNTech that include sequences coding for Omicron spike protein as booster shots.

The European Commission said it will move ahead with an accelerated authorisation of the bivalent shots, which include mRNA for the wild-type SARS-CoV-2 spike protein as well as the original BA.1 subvariant of Omicron, in a divergence from the approach taken by the authorities in the US.

The FDA has just authorised vaccines from the two companies that will specifically target the BA.4 and BA.5 subvariants of Omicron, which have now displaced the earlier forms and for now are expected to remain dominant through the coming autumn and winter.

Moderna and Pfizer/BioNTech have clinical data supporting the efficacy of the BA.1-based bivalents, but only preclinical data for the BA.4/BA.5 version, although both companies believe they will work as anticipated against the new strain.

The EMA said in a statement that BA.4 and BA.5-directed vaccines are already under review or will be submitted soon, and that the clinical data submitted for the BA.1 shots would “support” their evaluation. Moderna’s BA.1 vaccine has already been approved in the UK, Switzerland and Australia.

“As the pandemic evolves, the EU’s strategy is to have a broad range of adapted vaccines that target different SARS-CoV-2 variants so member states have a plurality of options to meet their needs when they design their vaccination strategies,” said the regulator.

“This is a key element in the overall strategy to combat the pandemic as it is not possible to predict how the virus will evolve in the future and which variants will be circulating this winter.”

In another departure from the US approach, the EMA has said that the current monovalent vaccines – Pfizer/BoNTech’s Comirnaty and Moderna’s Spikevax – are still effective at preventing severe disease and so can be used in ongoing campaigns. The FDA has said that the original jabs are no longer authorised for use as booster doses in the US.

Member states will have to decide their own strategy on immunisation “taking into account factors such as infection and hospitalisation rates, the risk to vulnerable populations, vaccination coverage and vaccine availability,” said the EMA.

Both new vaccines can be administered to people aged 12 and over who have received at least primary vaccination against COVID-19.

The CHMP has meanwhile also said that Novavax’ latecomer COVID-19 shot Nuvaxovid, which targets only the original SARS-CoV-2 strain, can be used as a booster for adults, following its authorisation for primary vaccination last December.

In July, the EU recommended a second COVID-19 booster for everyone over 60, as well as medically vulnerable people, in response to a rise in infections and hospitalisations.

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