HAGUE, The Netherlands (PA) – The European Union’s drug surveillance dog said on Thursday that German company BioNTech has applied for permission from the 27-country bloc to administer up to six doses of the COVID-vaccine. 19 of each vial, instead of the currently approved five doses.
In an email to The Associated Press, the European Medicines Agency said BioNTech, which developed its vaccine together with US drug maker Pfizer, has “submitted a request for change” which will be reviewed. by the agency’s human medicines committee “as soon as possible.”
He said that if the committee establishes that six doses can be consistently extracted from each vaccine vial, it will recommend changing the authorization to remove the vaccine for use in EU nations.
In a written statement, Pfizer said its vials contain enough vaccine for at least five doses and that the remaining amount may vary depending on the type of needles and syringes used.
“Decisions on label updates and / or other temporary approvals on dose preparation and administration rest with local health authorities,” the company said.
German weekly Der Spiegel first reported this week that BioNTech has called on European regulators to change approval conditions to allow doctors to use excess vaccine in vials to get a sixth dose if possible, instead of leave the leftovers out of the five according to what is currently required.
This could result in hundreds of thousands of additional doses in Germany alone during 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 extracted from the vials.
“The vaccine is manufactured in sufficient volume for five doses,” British regulator MHRA said in an email. “However, it is normal for some vials to have a slight excess of volume and in some cases this could 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 if diluted as recommended, the vial and its contents should be discarded after the fifth dose has been removed.”
However, it is forbidden to mix the remains of multiple vials in all regulators.
German Health Minister Jens Spahn on Wednesday backed the idea of taking additional doses if possible.
BioNTech intentionally fills vials with more vaccine than necessary to ensure that even inexperienced doctors can get at least five doses.
Meanwhile, a major medical organization in Britain has expressed outrage that GPs will have to re-book tens of thousands of appointments to make double-dose vaccine shots for vulnerable patients following the government’s decision. British to extend the period between the two necessary doses to 12. weeks.
“This group of very elderly patients has the highest 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 Committee of General Practitioners. Association. “It is unfairly obvious to tens of thousands of our most at-risk patients to try to reschedule their appointments.”
However, a senior vaccine researcher at Charite Hospital in Berlin, Dr Leif-Erik Sander, said the UK strategy makes sense as a temporary strategy.
“That way we could vaccinate (more people) faster and gain valuable time in the fight against COVID-19,” Sander said.
He said vaccines made by BioNTech-Pfizer and Moderna have a strong protective effect about 10 days after the first shot. The Modern vaccine has not yet been approved in the European Union or the United Kingdom
“In my view, booster vaccination can be delayed smoothly for a while, without having to wait for any significant reduction in effectiveness,” he said, noting that care should be taken to ensure that everyone ends up getting his second dose. .
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Jordans reported from Bonn, Germany.