The American pharmaceutical company Pfizer, which together with the German company BioNtech developed 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, every ampoule of Pfizer / BioNtech ‘Comirnaty’ vaccine officially contained five doses. The thawed vaccine should be diluted with 1.8 ml of sodium chloride solution for injection.
“After dilution, the vial contains 2.25 ml”, the laboratories state. Therefore, at a rate of 0.3 ml per dose, it would theoretically be possible to extract 7 doses.
The medical staff realized that they could – under specific conditions – receive at least one sixth dose in each vial.
The European Medicines Agency (EMA) updated the European label on 8 January to indicate that the vials contain six doses.
This authorization is valid for EU Member States. The FDA, the US drug agency, has also approved the use of this sixth dose, Pfizer said.
However, the EMA stated that the sixth dose “depends on the availability of specific syringes”.
What does Pfizer say?
“Our initial target of 1.3 billion doses of vaccine has been revised to reach 2 billion doses by the end of 2021,” the pharmaceutical company now says.
These forecasts are based on updating the labeling – from five to six doses per bottle – but also on “continuous improvement of production processes and expansion of our current facilities”.
The group emphasizes that it will meet its delivery commitments “in accordance with the orders that have been placed” and that “they have always been based on a total number of doses and not on vials”.
Specific, this means that Pfizer / BioNtech will deliver fewer bottles to their customers at the same price.
The sixth dose is not guaranteed
However, getting six doses, 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 remaining in the syringe when the plunger is fully depressed. Ideally, use a syringe in which the needle is not removable.
However, medical personnel are not equipped as standard with this type of syringe.
The American group Becton Dickinson, the world’s largest manufacturer of syringes, said 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 limited production capacity and it would take time” to grow them.
“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 carry out this sixth dose! “, is alarmed on Twitter Clarisse Audigier Valette, pneumooncologist and head of the covid-19 unit at the Center of the Hospital in Toulon (southern France).
Under these conditions, if Pfizer delivers fewer vials than originally planned, “we will vaccinate fewer people than expected,” said the French medical team Du Côté de la Science.
Guard governments
In Belgium, Pfizer’s decision has caused controversy. In mid-January, nursing homes hoping to speed up the vaccination rate due to this sixth dose were deprived of the number of vials initially promised, a residence official told AFP.
The Swedish public health authority has asked for clarification, but said Sweden has not already frozen its payments to Pfizer, as a Swedish newspaper suggests.
“We hope to get clarification from the European Commission before paying [a Pfizer/Biotech]. If not, we will have to talk to the laboratory, “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 ensures that it has issued requests “for supplies to eliminate new types of syringes”. and prepares dossiers to familiarize healthcare professionals with the “rather particular technical gesture” that is needed.
A spokesman for the European Commission said that the Commission had “launched a joint procurement procedure” and “concluded framework agreements” which “already allow Member States to purchase the necessary equipment”. adapted syringes and needles.