THE HAGUE, The Netherlands (PA) – The European Union’s drug surveillance body said on Thursday that German company BioNTech had applied for authorization in the 27-nation bloc to administer up to six doses of COVID-19 vaccine in each vial, instead of the five currently approved doses.
In an email to The Associated Press, the European Medicines Agency said BioNTech, which developed its vaccine with US drug manufacturer Pfizer, has “submitted a request for an amendment” to be reviewed by the human medicines committee. of the Agency “as soon as possible. ”
He said that if the committee determines that six doses can be consistently withdrawn from each vaccine vial, it will recommend a change in the authorization to remove the vaccine for use in EU countries.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 remaining amount may vary depending on the type of needles and syringes used.
“Decisions to update labels and / or other temporary approvals regarding dose preparation and administration are the responsibility of 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 of approval to allow doctors to use the excess vaccine in vials to extract a sixth dose, if possible, rather than to overturn the debris after five, as is currently required.
This could lead to hundreds of thousands of additional doses in Germany alone in 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in the United States, Switzerland and the United Kingdom already allow up to six doses of 0.3 milliliters each to be withdrawn from vials.
“The vaccine is manufactured in sufficient volume for five doses,” the British MHRA said in an email. “However, it is normal for some vials to contain a slightly excessive volume, and in some cases this may allow a full sixth dose to be withdrawn.”
However, care must be taken to ensure that a full dose of 0.3 ml can be given to the individual, he added. “If this cannot be done when diluted as recommended, the vial and its contents should be discarded after withdrawal of the fifth dose.”
However, mixing of residues from several ampoules is prohibited by all regulators.
German Health Minister Jens Spahn on Wednesday backed the idea of taking additional doses, if possible.
BioNTech intentionally fills the vials with more vaccine than necessary to ensure that even inexperienced doctors can get at least five doses of them.
Meanwhile, a prominent medical organization in the UK has expressed anger that family doctors will have to book tens of thousands of appointments for the second dose of vaccines for vulnerable patients, following the British government’s decision to extend the period between two doses needed up to 12 weeks.
“This group of very elderly patients has the highest risk of death if they take COVID-19, which is why family doctors are so concerned about them,” said Dr Richard Vautrey, chairman of the British Medical Association’s GP committee. “It is extremely unfair for tens of thousands of our most at-risk patients to try to reschedule their appointments now.”
However, a senior vaccine researcher at Berlin Charite Hospital, Dr Leif-Erik Sander, said the UK’s strategy made 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 the vaccines made by BioNTech-Pfizer and Moderna have a strong protective effect about 10 days after the first shot. The Moderna vaccine has not yet been approved in the European Union or the United Kingdom
“In my opinion, booster vaccination can be delayed without problems for a while, without having to expect a significant reduction in effectiveness,” he said, noting that care should be taken to ensure that everyone in the trace receives the second dose. .
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Jordanians reported from Bonn, Germany.