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The EU is buying an additional 100 million doses of the Pfizer/BioNTech vaccine, European Commission President Ursula von der Leyen announced Tuesday.
Sold as Comirnaty, the two-dose vaccination is currently the only coronavirus shot approved for use in the EU. The Commission initially secured 200 million doses as part of an advance purchase agreement — set to be delivered by September — but had been in talks to buy an additional 100 million.
The completed deal could translate to even more new doses beyond the official figure. Officially, each vial contains enough of the formula for five doses. But as health professionals discovered they could draw enough for a sixth dose, regulators have started approving use of the leftovers, including the U.S. Food and Drug Administration.
The European Medicines Agency said including excess solution in the bottle is necessary to ensure properly drawing five doses. However, in its initial assessment of Comirnaty, the EU regulator asked the drugmakers to submit additional data showing that six doses can reliably be extracted from the vial, an EMA spokesperson said in an email.
A request from the drugmaker to change the dosing is expected “in the next days,” the spokesperson said, which will be “assessed rapidly” by the EMA’s human medicines panel. If the evidence shows six doses can be reliably extracted, the EMA will recommend changing the terms of the authorization.
But not everyone is waiting for the EMA’s green light. On Monday, Italy’s medicines regulator backed drawing a sixth dose, given the use of the right syringe — though it said residue from different jars should not be mixed.
This article has been updated with a response from the European Medicines Agency about an expected request to change the terms of the authorization to six doses per vial.
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