EU reviews BioNTech request for ‘extra dose’

THE HAGUE, NETHERLANDS (AP) — The European Union (EU) medicines watchdog said on Thursday that German company BioNTech has applied for clearance in the 27-nation bloc to administer up to six doses of its COVID-19 vaccine from each vial, instead of the five doses currently approved.

In an email to The Associated Press (AP), the European Medicines Agency (EMA) said that BioNTech, which developed its vaccine together with United States (US) drugmaker Pfizer, has “submitted a request for change” which will be reviewed by the agency’s human medicines committee “in the shortest possible timeframe.”

It said that if the committee establishes that six doses can be consistently extracted from each vial of vaccine, it will recommend changing the authorization that clears the vaccine for use in EU nations.

In a written statement, Pfizer said its vials contain enough vaccine for at least five doses and the amount remaining can vary depending on the type of needles and syringes used.

“Decisions regarding label updates and/or other temporary approvals regarding dose preparation and administration belong to local health authorities,” the company said.

German weekly Der Spiegel first reported this week that BioNTech has asked European regulators to change the conditions of approval to allow doctors to use excess vaccine in the vials to draw a sixth dose if possible, rather than tip the leftovers away after five as currently required.

This could result in hundreds of thousands of additional doses in Germany alone during the first quarter, Spiegel reported.