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EU review BioNTech requires “extra dose” to inject virus



The Hague, Netherlands (Associated Press)-The European Union’s drug supervisory agency said on Thursday that the German biotech company BioNTech has applied for customs clearance in the 27-nation group in order to inject up to six doses of COVID-19 vaccine from each vial instead of the current five doses Approved.

The European Medicines Agency said in an e-mail to the Associated Press that BioNTech, which co-developed a vaccine with US drugmaker Pfizer, has “submitted a request for change” and that the agency’s Human Medicines Committee will respond to the Review it. . ”

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It said that if the committee determines that six consecutive doses can be extracted from each vial of vaccine, it will recommend changes to the authorization to eliminate vaccines used in EU countries.

Pfizer said in a written statement that its medicine bottles contain at least five doses of sufficient vaccine, and the remaining amount may vary depending on the types of needles and syringes used.

The company stated: “The decision on label renewal and/or other provisional approval for dosage preparation and administration belongs to the local health authority.”

German weekly “Der Spiegel” (Der Spiegel) reported for the first time this week that BioNTech has asked European regulators to change the approval conditions to allow doctors to use an excessive amount of vaccine in a vial to draw a sixth dose, instead of taking the remaining dose according to current requirements. Five-point tip.

Spiegel reports that in Germany alone, this could result in an increase of thousands of doses in the first quarter.

Regulators in the United States, Switzerland, and the United Kingdom have allowed up to 6 doses of 0.3 ml each from the vial.

The British regulator MHRA said in an email: “The production volume of this vaccine is enough to hold five doses.” “However, it is normal for some vials to have a slight overdose. In some cases, this may be possible. The complete sixth dose will be extracted.”

It added: “However, care needs to be taken to ensure that the full dose of 0.3 ml can be administered to the individual.” “If the recommended dilution fails to achieve the goal, the vial and its contents should be discarded after the fifth dose has been extracted.”

However, all regulators prohibit mixing residues in multiple vials.

German Health Minister Jens Spahn (Jens Spahn) on Wednesday supported the idea of ​​extracting more doses if possible.

BioNTech deliberately injects excess vaccine into the vial to ensure that even inexperienced doctors can get at least five doses from it.

At the same time, a well-known British doctors organization expressed anger because the British government decided on Wednesday to extend the interval between two doses to 12 months, and family doctors will have to re-register tens of thousands of second doses for vulnerable patients. vaccine. week.

Dr. Richard Vautrey, Chairman of the General Practitioners Committee of the British Medical Association, said: “If this group of older patients are infected with COVID-19, the risk of death is the highest, which is why the GP is so concerned about them.” It is absolutely unfair for a patient with the greatest risk to reschedule an appointment, obviously unfair.”

The Chief Medical Officer of the United Kingdom defended the decision to postpone the second jab, saying that one dose of Pfizer/BioNTech vaccine can provide at least 70% protection, and the second dose can enhance immunity and extend immunity.

In a letter to the medical community, senior medical consultants in England, Scotland, Wales and Northern Ireland stated that global vaccine stocks are limited. “From a public health point of view, the model where we can vaccinate twice as many people in the next 2-3 months is obviously more popular than if we have half the number but only provide slightly greater protection. “

Dr. Leif-Erik Sander, a senior vaccine researcher at the Berlin Charity Hospital, also said that the British strategy is a temporary strategy.

“In this way, we can vaccinate (more people) faster and win precious time in the fight against COVID-19,” Sander said.

He said that the vaccines produced by BioNTech-Pfizer and Moderna have a strong protective effect about 10 days after the first injection. Moderna vaccine has not been approved in the EU or the UK

He said: “I think the booster vaccine can be delayed for a short while without problems, without expecting that the effect will be greatly reduced.” He pointed out that care should be taken to ensure that everyone will eventually get the second dose. .

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The Jordanian reports from Bonn, Germany. Jill Lawless is from London.

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Learn about AP’s report at the following URL: https://apnews.com/hub/coronavirus, Https://apnews.com/hub/coronavirus-vaccine And https://apnews.com/hub/understanding-the-outbreak


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