EMA on alert over new variants of COVID: Official

"According to the data, Europe is still experiencing the circulation of the Omicron BA.5 variant, although the peak of the summer wave was a few weeks ago in many of the member states," Marco Cavaleri, Head of the EMA's health threats and vaccines strategy, told an online press conference from Amsterdam on Friday.

"The EMA keeps monitoring the situation to better understand the trend of the new wave and to be prepared for new waves, which are always extremely difficult to predict," he said.

The official cited the situation in India as an example, where the Omicron subvariant BA2.75 is spreading faster than other variants, Xinhua news agency reported.

"As the virus continues to mutate at high speed, we keep track of all new variants to be able to anticipate on variants of concern," Cavaleri added.

"In particular, the BA2.75 currently spreading in India needs to be carefully monitored."

On Thursday, the EMA 's human medicines committee (CHMP) recommended the use of two vaccines adapted against the Omicron variant of Covid-19 from Pfizer/BioNTech and Moderna.

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. 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 CHMP's opinion on Comirnaty Original/Omicron BA.1 is based on 2 studies. One study in adults over 55 years old who had previously received 3 doses of Comirnaty (primary vaccination and a booster) found that the immune response to the Omicron BA.1 subvariant was higher after a second booster dose of Comirnaty Original/Omicron BA.1 than after a second dose of the original Comirnaty vaccine (as measured by the level of antibodies against Omicron BA.1). In addition, the immune response to the original SARS-CoV-2 strain was comparable for both vaccines. The study involved more than 1,800 people, of whom about 300 received Comirnaty Original/Omicron BA.1 in its final composition.

Further data from a study involving over 600 people aged between 18 and 55 years who had previously received 3 doses of Comirnaty showed that the immune response to Omicron BA.1 was higher in people who received a booster with a vaccine containing only the Omicron BA.1 component than in those given a booster with the original Comirnaty vaccine.

Based on these data, it was concluded that the immune response to Omicron BA.1 following a booster with Comirnaty Original/Omicron BA.1 in people aged 18 to 55 years would be at least equal to that in people aged over 55. Further, based on previous data in younger people, it was also concluded that the immune response to a booster dose with Comirnaty Original/Omicron BA.1 in adolescents would be at least equal to that in adults.