EU reviews BioNTech request for ‘extra dose’ of virus shot

THE HAGUE, The Netherlands (AP) – The European Union’s medicine dog said on Thursday that the German company BioNTech had applied for approval in the block of 27 countries to administer up to six doses of its COVID-19 vaccine from each vial. , instead of the five doses currently approved.

The European Medicines Agency said in an email to The Associated Press that BioNTech, which developed its vaccine with US drugmaker Pfizer, had submitted a “request for change” made by the agency’s human medicine committee “will be reviewed within the shortest possible time period.”

It is said that if the committee determines that six doses can be consistently taken from each vial of vaccine, it will recommend changing the authorization that cleans the vaccine for use in EU countries.

In a written statement, Pfizer said the vials contained enough vaccine for at least five doses, and the amount left over could 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.

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

This could result in hundreds of thousands of extra doses in the first quarter, Spiegel reported.

Regulators in the United States, Switzerland and the United Kingdom already allow up to six doses of 0.3 milliliters each to be drawn from vials.

“The vaccine is being produced with enough volume for five doses,” British regulator MHRA said in an email. “However, it is normal for some vials to contain a slight excess, and in some cases a full sixth dose may be withdrawn.”

“However, care must be taken that a full dose of 0.3 ml can be administered to the individual,” he added. “Where it cannot be achieved when diluted as recommended, the vial and its contents should be discarded after the fifth dose has been withdrawn.”

However, mixing residues from multiple vials is prohibited by all regulators.

German Health Minister Jens Spahn on Wednesday supported the idea of ​​withdrawing additional doses if possible.

BioNTech deliberately fills the vials with more vaccination than is necessary to ensure that even inexperienced doctors can receive at least five doses.

Meanwhile, a leading medical organization in Britain has expressed anger that GPs have to book tens of thousands of second-dose vaccinations for vulnerable patients following the UK government’s decision to extend the period between the required two doses to 12. weeks.

“This group of very elderly patients are at greatest risk of dying if they contract COVID-19, which is why GPs are so concerned about them,” said Dr. Richard Vautrey, chairman of the British Medical Association’s general practitioners’ committee, said. “It is extremely unfair for tens of thousands of our patients at greatest risk to now try to reschedule their appointments.”

UK chief medical officers defend the decision to delay the second sting, saying that one dose of Pfizer / BioNTech vaccine provides at least 70% protection, and the second acts as a stimulant and prolongs immunity

In a letter to the medical profession, the best medical advisers for England, Scotland, Wales and Northern Ireland said the vaccine supply around the world was limited. A model in which we can vaccinate twice the number of people in the next 2-3 months is obviously much more preferable in the public health language than one where we vaccinate half the number, but with only a little more protection. ”

A senior researcher of vaccine at the Charite Hospital in Berlin, dr. Leif-Erik Sander, also said that the British strategy makes sense as a temporary strategy.

“In this way, we (more people) can be vaccinated faster and gain valuable time in the fight against COVID-19,” Sander said.

He said the vaccines made by BioNTech-Pfizer and Moderna have a strong protective effect about ten days after the first shot. The Modern vaccine has not yet been approved in the European Union or the United Kingdom

“In my opinion, the scheme vaccination can be delayed for a while without problems, without expecting any significant reduction in effectiveness,” he said, pointing out that attention should be paid to everyone finally getting their second dose. .


Jordans reported from Bonn, Germany. Jill Lawless contributed from London.


Follow AP coverage at, vaccination and