The American pharmaceutical company Pfizer, which developed together with the German company BioNtech one of the first two vaccines against COVID-19 authorized in Europe, now considers that each vial contains six doses, compared to five so far, a controversial decision.
– How many doses?
Until recently, each vial of the Pfizer / BioNtech “Comirnaty” vaccine officially contained five doses. The thawed vaccine must be diluted with 1.8 ml of sodium chloride solution for injection.
“After dilution, the bottle contains 2.25 ml”, state the laboratories. Therefore, at a rate of 0.3 ml per dose, it would theoretically be possible to extract 7 doses.
Medical staff realized that they could – under specific conditions – get at least a sixth dose in each vial.
The European Medicines Agency (EMA) updated European labeling on January 8 to indicate that the vials contain six doses.
This authorization is valid for the EU Member States. The FDA, the US drug agency, has also approved the use of this sixth dose, Pfizer said.
However, the EMA said the sixth dose “depends on the availability of specific syringes.”
– What does Pfizer say? –
“Our initial goal of 1.3 billion doses of vaccine has been revised to reach 2 billion doses by the end of 2021,” the drugmaker now says.
These forecasts are based on updating the labeling – from five to six doses per vial – but also on “the continuous improvement of production processes and the expansion of our current facilities.”
The group stresses that it will fulfill its delivery commitments “in accordance with the orders that have been made” and that “these have always been based on a total number of doses and not vials.”
Specifically, this means that Pfizer / BioNtech will deliver fewer vials to its customers for the same price.
– The sixth dose is not guaranteed –
However getting six doses and not five is not always guaranteed because you need a syringe with a very small “dead space” (less than 35 microliters).
“Dead space” is the volume left in the syringe when the plunger is fully depressed. Ideally, use a syringe in which the needle is not detachable.
However, healthcare personnel are not equipped as standard with this type of syringe.
The US group Becton Dickinson, the world’s largest producer of syringes, has indicated that these are specialized products whose demand “is traditionally minimal.”
In a message sent to AFP, a company spokesman, Troy Kirkpatrick, explained that “these products have a limited production capacity and it would take time” to increase it.
“The sixth dose requires adequate equipment to extract it systematically. Not all centers have received this type of needles and syringes, and it is extremely difficult for them to perform this sixth dose!” Clarisse Audigier Valette, pneumooncologist and head of the covid-19 unit at the Toulon Hospital Center (southern France).
Under these conditions, if Pfizer delivers fewer vials than initially planned, “we will vaccinate fewer people than expected,” said the French medical collective Du Côté de la Science.
– Governments on guard –
In Belgium, Pfizer’s decision has caused controversy. In mid-January, nursing homes that hoped to accelerate the rate of vaccination thanks to this sixth dose were deprived of the number of vials initially promised, an official of the residence told AFP.
The Swedish public health authority asked for clarification, but said that Sweden had not already frozen its payments to Pfizer, as suggested by a Swedish newspaper.
“We hope to get a clarification from the European Commission before having to pay [a Pfizer/Biotech]. If not, we will have to talk to the lab, “said Anders Tegnell of the Swedish Public Health Agency.
He also indicated that the payment term did not expire for “a few weeks.”
In France, the Ministry of Health assures that it has issued requests “for supplies to dispose of new types of syringes”, and prepares files to familiarize healthcare professionals with “the rather particular technical gesture” that is required.
On the part of the European Commission, a spokesman in charge of health issues said that the commission had “launched a common public procurement procedure” and “closed framework agreements” that “already allow member states to acquire the necessary equipment”. that is to say, adapted syringes and needles.
burs-aue / mab-pc / es