Omicron 4-5 vaccines, from Ema also ok for primary cycles in children and adults

“National authorities will be able to use them in their immunization campaigns if necessary”

Yes of the European Medicines Agency Ema to the use of bivalent anti-Covid vaccines adapted to Omicron 4-5 also for primary cycles in children and adults not yet vaccinated. This is the opinion expressed by the Emergency Task Force (ETF) of the EU regulatory body, according to which bivalent mRna vaccines targeting the original strain of the virus and the Omicron BA.4-5 subvariants of Sars-CoV-2, currently authorized only as a booster, they can also be used for initial, primary vaccination.

To reach this conclusion, the ETF reviewed laboratory (non-clinical) studies and data on the immune response following natural infection with Omicron Ba.4-5 in unvaccinated people who had not previously been infected with SARS-CoV- 2. The data suggest that primary vaccination with these adapted bivalent products “should give rise to a broad immune response in people who have not yet been exposed or vaccinated against Sars-CoV-2”, explains the EMA in a note. The ETF also noted that “the safety profile of the adapted vaccines, when used as a booster, is comparable to that of the original mRNA vaccines, for which the safety profile is well established”. Hence the conclusion that they can be used “in previously unvaccinated children and adults.”

On the basis of these considerations, the EMA concludes, “national authorities may decide to use these bivalent vaccines adapted for primary vaccination in their national immunization campaigns, if necessary. Further clinical research and observational studies should provide further information on the safety and efficacy of bivalent vaccines for primary vaccination”.