European Union governments have agreed to exercise an option to buy over 180 million doses of a version of the Covid-19 vaccine adapted for the Omicron variant developed by BioNTech and Pfizer, the head of the European Commission said.
Pfizer and BioNTech began development of a prototype Omicron-specific vaccine on November 25th, and said they could have it ready in March.
"The member states have agreed to trigger a first tranche of over 180 million extra doses of adapted vaccines, in our third contract with BioNTech-Pfizer," Ursula von der Leyen told a news conference on Thursday night at the end of a regular summit with EU leaders.
The EU's latest contract with Pfizer and BioNTech allows EU states to buy up to 1.8 billion doses through 2023, of which half have already been ordered and the other half are optional.
Pfizer said that no optional doses had been ordered yet and talks with the EU for their possible supply had so far not concerned adapted versions of the vaccine.
"At this time, discussions with the EC about the potential for additional supply pursuant to their option rights under our agreement are not specific to an adapted vaccine," Pfizer said in a statement on Friday.
"While we believe we can deliver an adapted vaccine in March 2022, we do not yet know whether this will be needed and availability will require authorisation by regulatory authorities," Pfizer said.
Spokespersons for the European Commission (EC) were not immediately available to give more details about the announcement.
The European Medicines Agency (EMA) has so far said that there is no conclusive evidence an adapted vaccine is needed against Omicron.
Covid pill approval
Meanwhile, the EU drug regulator will not decide whether to approve Merck & Co's Covid-19 pill until after Christmas, a source with knowledge of the matter said, as the region scrambles to boost its arsenal of drugs to fight the Omicron variant.
The EMA will, however, rule before Christmas on whether to give Gilead's intravenous antiviral drug Remdesivir full marketing approval, the source said.
If the Merck ruling on molnupiravir comes in the new year, that would be later than expected. In November, the agency said it expected to complete its review by the year-end.
Responding to requests for comment on the status of its reviews, the EMA said on Thursday it would publish the opinions adopted by its human medicines committee (CHMP) by Friday midday.
In November, the EMA issued guidance to member states on using the pill even before final EU-wide approval. It advised it should be given within five days of first symptoms to treat adults who do not need oxygen support and are at risk of their disease worsening.
That was before the US drugmaker released data suggesting the drug was significantly less effective than previously thought, reducing hospitalisations and deaths in its clinical trial of high-risk individuals by around 30 per cent.
Alongside vaccines, the at-home antiviral treatments are considered a critical weapon for fighting the virus nearly two years into the pandemic.
The decisions come as the EU struggles to tame a spike in infections, which threatens to overwhelm healthcare systems and as Omicron's rapid spread has prompted some governments to reimpose restrictions ahead of the Christmas holidays.
