COVID-19: European regulator authorizes Pfizer vaccine against Omicron subvariants

COVID-19: European regulator authorizes Pfizer vaccine against Omicron subvariants


The European Medicines Agency (EMA) on Monday approved a Pfizer COVID-19 vaccine targeting the Omicron BA.4 and BA.5 sublines, for campaign use reminder this winter to ward off new anticipated waves. 

“The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended authorizing an adapted bivalent vaccine targeting Omicron BA.4 and BA.5 subvariants in addition to the original strain of SARS-CoV- 2,” the EMA said in a statement.

The serum is expected by the EMA to be “more effective than Comirnaty in eliciting an immune response against the BA.4 and BA.5 subvariants” , more benign but more easily transmitted.

The vaccine, an adapted version of the mRNA anti-Covid Comirnaty vaccine from Pfizer/BioNTech, is intended for people aged 12 and over who have received at least a first vaccination against Covid-19, EMA said.

As “new waves of infections are anticipated during the cold season”, this recommendation “will further expand the arsenal of vaccines available to protect people against Covid-19” within the EU, welcomed the European regulator.

The CHMP opinion on “Comirnaty Original/Omicron BA.4-5” will now be sent to the European Commission, which will adopt a final decision.

< p>The green light from the EMA closely follows the approval earlier this month of two other adapted vaccines by Pfizer and its rival Moderna, which target the original COVID-19 strain and the earlier BA.1 subvariant of Omicron.

Together with the recently authorized Original/Omicron BA.1 adapted vaccine, this new adapted vaccine is expected to help maintain optimal protection imale against COVID-19 as the virus evolves, according to the EMA.