Pfizer and BioNTech’s COVID-19 vaccine targeting Omicron BA.4 and BA.5 has been recommended for authorisation by the EMA’s human medicines committee, shortly after the panel gave its blessing to jabs targeting the original BA.1 strain of the variant.
The European Commission is now expecting to make a final decision on the updated version of the two drugmakers’ original Comirnaty shot within the next couple of weeks.
The EMA said the decision by the CHMP will “further extend the arsenal of available vaccines to protect people against COVID-19 as the pandemic continues and new waves of infections are anticipated in the cold season.”
The new 30 µg booster shot is bivalent – with mRNA coding for spike protein from both the original wild-type SARS-CoV-2 virus as well as the BA.4/BA.5 subvariant – should be approved for use in people aged 12 years and above who have received at least a primary course of vaccination against COVID-19, according to the EMA’s update.
Pfizer and BioNTech said vaccine doses are ready for immediate shipping to support the start of the EU vaccination campaign.
“If the European Commission follows today’s recommendation by the CHMP, EU residents will have access to Omicron-adapted vaccines before the start of the winter season,” said Prof Ugur Sahin, BioNTech’s chief executive.
The companies said they are also planning to file the data with other regulatory authorities in the coming weeks and are also working on applications for an Omicron-adapted bivalent vaccine in children younger than 12 years of age.
The CHMP’s decision brings the EU’s regulator closer into alignment with the US FDA, which authorised bivalent vaccines from both Pfizer and Moderna directed against Omicron BA.4/BA.5 towards the end of August.
Like the FDA, the CHMP has decided to recommend authorisation on clinical data with Pfizer’s bivalent wild-type/BA.1 shot, complemented by immunogenicity and quality data for the BA.4/BA.5 component in an attempt to catch up with the evolution of the virus and try to get a head of a possible wave of infections this winter.
It’s worth noting however that the approach has attracted criticism from some quarters on the grounds that rolling out an vaccine which hasn’t been fully tested in humans could fuel anti-vaccination rhetoric.
The CHMP has said it has “concluded that Comirnaty Original/Omicron BA.4-5 is expected to be more effective than Comirnaty at triggering an immune response against the BA.4 and BA.5 subvariants.”
It also said the safety profile of the new jab is expected to be comparable to that of Comirnaty Original/Omicron BA.1, and of Comirnaty itself “for which a large amount of data is available.”
Ultimately, the decision about the use of Omicron-directed boosters will lie with EU member states, based on their own priorities, said the EMA.
In the UK, the government has started offering booster shots with wild-type/BA.1 vaccines from Pfizer/BioNTech and Moderna, with around 26 million people eligible.
Eventually, all UK citizens aged 50 or over will be offered a vaccine, along with younger people who are frontline health and social care workers or in vulnerable groups.
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