EU approves new BioNTech-Pfizer, Moderna jabs

The EU's drug regulator, the European Medicines Agency (EMA), said on Thursday that it had given the green light to two vaccines that target the omicron variant of COVID-19.

The vaccines were developed by the US-German partnership BioNTech-Pfizer and by the US company Moderna.

The vaccines are the first to target the omicron variant BA.1, as well as being effective against the original strain of the virus. Both also produced vaccines against the first iteration of the virus that were approved by the EMA.

The European Commission must still give its final approval, but this is expected to be given fairly swiftly.

What did the EMA say?

The new vaccines function as booster shots for people who have already had a full dose of the original coronavirus vaccine. The EMA recommended their use for anyone aged 12 years and above.

"These vaccines are adapted versions of the original vaccines Comirnaty (BioNTech-Pfizer) and Spikevax (Moderna) to target the omicron BA.1 subvariant in addition to the original strain of SARS-CoV-2," the Amsterdam-based regulator said.

It also said the studies of the vaccine's effect showed that they "trigger strong immune responses" and that "in particular, they were more effective at triggering immune responses against the BA.1 subvariant than the original vaccines."

European Commissioner for Health and Food Safety Stella Kyriakides welcomed the decision as "important to protect Europeans against the likely risk of autumn and winter waves of infections."

"We need to be ready to face another winter with COVID-19," she added.

What about the other omicron subvariants?

Vaccines designed to tackle the BA.4 and BA.5 subvariants are still being reviewed, the EMA said. A decision on these is expected in the next few weeks, Kyriakides said on Thursday.

The US Food and Drug Administration greenlit the BA.4/BA.5 vaccines on Wednesday.

The omicron BA.1 subvariant swept Europe last winter bringing a vast surge in cases. It has since been largely replaced by the BA.5 subvariant.

While US authorities decided to directly authorize the BA.4/BA.5 adapted shots, the EU has gone instead for the BA.1 vaccines of which large quantities of doses have already been produced.

German Health Minister Karl Lauterbach has said that the new vaccines will be available in Germany by next week.

The UK was the first country to approve a so-called bivalent vaccine — the Moderna shot — in August, followed then by Switzerland and Australia.

ab/nm (Reuters, dpa, AFP)