The Hague, Netherlands (AP) – The European Union’s drug watchdog said on Thursday that the German company BioNTech had requested authorization 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, the European Medicines Agency said that BioNTech, which developed its vaccine together with the American pharmaceutical company Pfizer, “submitted a change request” that will be analyzed by the agency’s human medicines committee “In the shortest possible time. ”
He said that if the committee establishes that six doses can be consistently drawn from each vial of the vaccine, he will recommend changing the authorization that releases the vaccine for use in EU countries.
In a written statement, Pfizer said its vials contain enough vaccine for at least five doses and the amount remaining may vary depending on the type of needles and syringes used.
“Decisions on label updates and / or other temporary approvals in relation to dose preparation and administration rest with local health authorities,” said the company.
The German weekly Der Spiegel reported for the first time this week that BioNTech asked European regulators to change the conditions of approval to allow doctors to use the excess vaccine in the vials to extract a sixth dose, if possible, instead of dumping the leftovers after five, as currently required.
This could result in hundreds of thousands of additional doses in Germany alone during the first trimester, 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 removed from the bottles.
“The vaccine is manufactured with a volume sufficient for five doses,” the UK regulator MHRA said by email. “However, it is normal for some vials to contain a small excess of volume and, in some cases, this can allow a full sixth dose to be extracted.”
“However, care must be taken to ensure that a full 0.3 ml dose can be administered to the individual,” he added. “When this cannot be achieved when diluted as recommended, the bottle and its contents must be discarded after the fifth dose has been extracted.”
Mixing leftovers from various bottles is prohibited by all regulators, however.
German Health Minister Jens Spahn on Wednesday supported the idea of extracting additional doses, if possible.
BioNTech intentionally fills the vials with more vaccine than necessary to ensure that even inexperienced doctors can obtain at least five doses of them.
Meanwhile, an organization of prominent doctors in Britain has expressed anger that family doctors will have to reschedule tens of thousands of appointments for the second dose of vaccine for vulnerable patients following the British government’s decision on Wednesday extend the period between the two required doses to up to 12 weeks.
“This group of very elderly patients is at the greatest risk of death 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. “It is grossly and patently unfair for tens of thousands of our highest-risk patients to now try to reschedule their appointments.”
However, a senior vaccine researcher at Berlin’s Charite hospital, Dr. Leif-Erik Sander, said the UK strategy makes sense as a temporary strategy.
“That way, we could vaccinate (more people) more quickly and save valuable time in the fight against COVID-19,” said Sander.
He said that vaccines made by BioNTech-Pfizer and Moderna have a strong protective effect about 10 days after the first injection. The Modern vaccine has not yet been approved in the European Union or the United Kingdom
“In my opinion, booster vaccination can be postponed smoothly for a while, without expecting any significant reduction in effectiveness,” he said, noting that attention should be paid to ensure that everyone eventually receives their second dose. .
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Jordans reported from Bonn, Germany.