- The source, who asked to remain anonymous because discussions are not public, said the change to the authorisation could come "very soon".
- The company has submitted a request for change, which is being reviewed by the CHMP (human medicines committee) in the shortest possible timeframe.
BRUSSELS: The European drugs regulator could shortly approve an amendment to its approval of the Pfizer-BioNTech COVID-19 vaccine that would permit the extraction of six doses from a vial instead of five, an EU official told Reuters on Wednesday.
The source, who asked to remain anonymous because discussions are not public, said the change to the authorisation could come "very soon".
The European Medicines Agency (EMA) recommended on Dec. 21 the conditional approval of the Pfizer vaccine. Under that authorisation five doses should be extracted from each vial.
"The company has submitted a request for change, which is being reviewed by the CHMP (human medicines committee) in the shortest possible timeframe," an EMA spokeswoman said later on Wednesday, noting the agency had prompted Pfizer to submit data on the possible use of six doses per vial.
"If the CHMP finds that 6 doses can be extracted consistently, it will recommend a change to the current terms of the authorisation to support Member States in their roll-out of the vaccine," the spokeswoman added.
The change could add a requirement for the use of special syringes that allow the precise extraction of more doses from the same vial, the source said.
"The responsible people in the member states should order these special syringes (Low Dead Space Syringes) now," EU lawmaker Peter Liese said, adding they were widely available and could cost as little as 0.09 euros ($0.1) each.
This change in the recommended dosage could allow 20% more doses to be available in the EU under an existing contract with Pfizer, Liese said.
The EU has secured 200 million doses, and has taken up an option for another 100 million. It is also in talks for a new order of 50 to 100 million doses, EU officials told Reuters on Tuesday.
EU states could use EU vaccines in different ways from those recommended by EMA, but if they do so they face liability risks.