The boosters target the omicron BA.1 sublineage.
Assuming the European Commission follows CHMP’s recommendations, the European vaccine campaign will use bivalent vaccines targeting the original version of the omicron variant.
U.S. regulators, by contrast, have backed the use of bivalent vaccine boosters that target the BA.4/BA.5 sublineages of omicron. While Pfizer/BioNTech (NYSE:/PFE, Nasdaq: BNTX) and Moderna (Nasdaq:MRNA) have both developed vaccine boosters based on BA.4/BA.5, there is currently no human data for those vaccines. Instead, FDA is relying on data from earlier vaccine versions and preclinical data.
EMA’s recommended that the updated boosters be used in individuals at least 12 years of age who have received at least two doses of COVID-19 vaccines.
The updated COVID-19 vaccine boosters are likely to have superior protection against omicron.
European regulators note that side effects associated with the updated vaccines were comparable to those associated with the original versions.
EU aims to make “a broad range of adapted vaccines” available to target various SARS-CoV-2 variants.
European regulators could also authorize boosters targeting the BA.4 and BA.5 omicron subvariants.
In reviewing the bivalent Comirnaty vaccine from Pfizer and BioNTech targeting BA.1 and the original coronavirus, CHMP reviewed data from two studies. One of those trials focused on adults 55 and older who had previously received three doses of Comirnaty before receiving the adapted booster. The immune response was superior for the BA.1 subvariant and comparable for the original SARS-CoV-2 strain.
CHMP also considered data from a study with more than 600 people between 18 and 55 who had received three prior doses of Comirnaty. Recipients of a monovalent BA.1 vaccine had a superior immune response than those receiving the original Cormirnaty vaccine.
The organization also reviewed clinical trial data from recipients of Moderna’s updated Spikevax vaccine based on omicron BA.1. The adapted vaccine also induced a more robust immune response than the original Spikevax vaccine.
Authorizing the BA.1-adapted vaccines represents a “quantum leap in the fight against the pandemic,” said German Health Minister Karl Lauterbach. “Now vaccines can be used that work very well against all the known virus variants.”
Pfizer and BioNTech announced in July that they were pursuing authorization of the updated COVID-19 vaccine.
The UK, Switzerland and Australia have also authorized updated COVID-19 vaccines.