EMA recommends first adapted Covid-19 booster vaccines for approval in EU

The European Medicines Agency (EMA) said on September 1 that its human medicines committee (CHMP) had recommended authorising two vaccines adapted to provide broader protection against Covid-19. 

Comirnaty Original/Omicron BA.1 and Spikevax Bivalent Original/Omicron BA.1 are for use in people aged 12 years and above who have received at least primary vaccination against Covid-19, the agency said.

These vaccines are adapted versions of the original vaccines Comirnaty (Pfizer/BioNTech) and Spikevax (Moderna) to target the Omicron BA.1 subvariant in addition to the original strain of SARS-CoV-2.

The vaccines are adapted (that is, updated) to better match the circulating variants of SARS-CoV-2.

“Adapted vaccines can broaden protection against different variants and are therefore expected to help maintain optimal protection against Covid-19 as the virus evolves,” the EMA said.

Studies showed that Comirnaty Original/Omicron BA.1 and Spikevax Bivalent Original/Omicron BA.1 can trigger strong immune responses against Omicron BA.1 and the original SARS-CoV-2 strain in people previously vaccinated.

In particular, they were more effective at triggering immune responses against the BA.1 subvariant than the original vaccines.

Side effects observed with the adapted vaccines were comparable to those seen with the original ones and were typically mild and short-lived.

The two CHMP opinions will now be sent to the European Commission, which will adopt a final decision.

“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,” the EMA said.

“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.

“Other adapted vaccines incorporating different variants, such as the Omicron subvariants BA.4 and BA.5, are currently under review by EMA or will be submitted soon, and, if authorised, will further extend the arsenal of available vaccines,” the agency said.

The clinical data generated with the original/BA.1 bivalent vaccines recommended on September 1 will support the evaluation and authorisation of further adapted vaccines, the EMA said.

The original vaccines, Comirnaty and Spikevax, are still effective at preventing severe disease, hospitalisation and death associated with Covid-19 and will continue to be used within vaccination campaigns in the EU, in particular for primary vaccinations, it said.

National authorities in the EU member states will determine who should receive which vaccines and when, taking into account factors such as infection and hospitalisation rates, the risk to vulnerable populations, vaccination coverage and vaccine availability, the EMA said.

(Photo: Bulgaria’s Ministry of Health)

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