(Reuters) -The European Medicines Agency (EMA) on Monday recommended a COVID-19 booster designed to combat Omicron offshoots BA.4/5, days after endorsing a pair of boosters tailored to target the older BA.1 variant.
The latest recommendation is for a so-called bivalent vaccine developed by Pfizer and BioNTech, which targets BA.4/5 as well as the strain of the virus that originally emerged in China in December 2019.
The EMA recommendation is to authorize the vaccines for people aged 12 and above who have received at least primary vaccination against COVID. The final go-ahead will be subject to European Commission approval, which is expected to come in shortly.
While existing coronavirus vaccines provide good protection against hospitalization and death, their effectiveness was reduced as the virus evolved.
Earlier this month, the EMA endorsed both Pfizer-BioNTech and Moderna’s BA.1 updated vaccines.
EU officials signaled in recent months they were open to initially using shots targeting the older BA.1 variant, given those specifically targeting newer Omicron offshoots BA.4/5 are further behind in development.
In contrast, the U.S. Food and Drug Administration (FDA) insisted it was only interested in vaccines targeting BA.4/5. Last week, Pfizer-BioNTech and Moderna secured U.S. approval for those.
Given BA.1 emerged first, data from human trials testing the adapted vaccines from sets of developers has been submitted to EU regulators. For the BA.4/5 adapted vaccines, regulatory submissions are largely based on lab and animal data.
Using animal and lab data to solicit regulatory approval for retooled vaccines is not without precedent – it is done regularly for flu vaccines that are revamped each year to combat new variants.
On Monday, the EMA said its backing of the Pfizer-BioNTech updated BA.4/5 shot relied partly on data from human clinical trials available on the companies’ BA.1-tailored vaccine.
(Reporting by Leroy Leo in Bengaluru and Natalie Grover in London; Editing by Vinay Dwivedi and Grant McCool)
