On Tuesday 6 December, the Emergency Task Force (ETF) of the European Medicines Agency (EMA) issued a statement in which it considers that bivalent messenger RNA vaccines adapted to both the BA.4 and BA.5 strains of SARS-CoV-2 and the original strain of the virus, which have so far been used for booster vaccination, can be used to complete a primary vaccination course.
The ETF reviewed laboratory studies and data indicating that the immune response to these adapted bivalent vaccines in people who have not been exposed or vaccinated against SARS-CoV-2 was high. The safety of these vaccines is also comparable to the first messenger RNA vaccines with an established safety profile.
The EMA therefore says that the competent national authorities could decide to use these adapted vaccines for primary vaccination.
Further clinical and observational studies should provide more information on the efficacy and safety of bivalent vaccines used for primary vaccination.
This declaration is part of the response to a public health emergency and does not change the product information of the appropriate vaccines.
To date, two suitable bivalent mRNA vaccines are authorised in the EU. One of them has been developed by Pfizer and BioNTech (see EUROPE 13020/31), the other by Moderna (see EUROPE 13048/23).
Link to text: https://aeur.eu/f/4jb (Original version in French by Émilie Vanderhulst)