(Reuters) – Europe’s medicines regulator gave the go-ahead on Friday for an extra sixth dose to be extracted from Pfizer-BioNTech COVID-19 vaccine vials, increasing the number of available shots at a time when supplies are short.
EU countries started inoculating people with the Pfizer-BioNTech vaccine two weeks ago, after the European Medicines Agency (EMA) recommended the shot’s conditional approval under the brand name Comirnaty with an authorisation that allows five doses to be extracted from each vial.
“EMA’s human medicines committee (CHMP) has recommended updating the product information for Comirnaty to clarify that each vial contains six doses of the vaccine,” EMA said.
Final approvals are up to the European Commission (EC), which typically follows recommendations from the EMA.
“Once endorsed by the EC, the label would state that after dilution, vials of Comirnaty contain six doses of 0.3 ml of vaccine,” Pfizer said in a statement.
Reuters had reported on Wednesday that the regulator was close to approving such a move.
This change in authorisation could allow 20% more doses to be available in the EU under an existing contract with Pfizer, EU lawmaker Peter Liese had said.
The European Union reached a deal with Pfizer and BioNTech for 300 million additional doses of the vaccine, the head of the European Commission said on Friday, in a move that would give the EU nearly half of the firms’ global output for 2021.
The move would allow EU governments to double their orders from Pfizer to 600 million doses, commission president Ursula von der Leyen said, as the 27-nation bloc races to ramp up the vaccination of its 450 million people. Each recipient of the Pfizer vaccine need two doses to develop maximum protection.
To extract the sixth dose from a single vial, low dead volume syringes or needles, which only retain a low amount of solution after an injection, should be used, EMA said, adding that there should be no pooling from multiple vials to make up a full dose.
(Reporting by Yadarisa Shabong in Bengaluru and Francesco Guarascio; Editing by Edmund Blair, Giles Elgood and Alex Richardson)