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Paris (AFP)
The American pharmaceutical giant Pfizer, which manufactures the Covid-19 vaccine developed by the German BioNTech, now considers that each vial contains six doses compared to five previously.
The difficulty of obtaining this sixth dose in practice means that many countries disagree with Pfizer and face a drop in supply.
– How many doses? –
Until recently, each vial of BioNTech-Pfizer vaccine was considered officially to contain five doses.
After thawing, the contents of each vial are diluted with 1.8 ml of saline solution, creating a total of 2.25 ml of solution for injection. With each dose of 0.3 ml, there are in theory just over seven doses.
But theory and practice are different. Medical staff are unable to measure doses so precisely to obtain seven doses that they can inject into people.
But they found they could – with the right equipment – reliably get six doses from the vials.
European and American regulators now consider the vials to contain six doses and have authorized the use of the sixth dose.
However, the European Medicines Agency noted that this sixth dose depends on the availability of specific syringes.
– Doses and not vials –
Pfizer has revised upwards its production target for this year from 1.3 billion doses to 2 billion. While part of this reflects plans to further increase production, it also reflects the effect of the label change on the vials.
Pfizer said its contracts specify delivery of a number of doses of the vaccine, not vials.
This means that customers are now receiving fewer vials than before the change was approved by regulators.
– ‘Niche’ syringes –
But to get this sixth medical dose, a special syringe is needed with little “dead space”. Dead space is the amount of product left in the syringe when the plunger is fully depressed.
To get the sixth dose of BioNTech-Pfizer vaccine syringes with very low dead spaces it is needed, but medical device maker Becton Dickinson (BD) says there is a supply crisis for them.
“Low dead space syringes are niche products and there is … traditionally minimal market demand based on the needs of healthcare providers,” a company spokesperson said.
The manufacturing capacity of these syringes is limited and it will take time to increase production.
Many vaccination centers in France have not received low dead space syringes and are struggling to get a sixth dose with regular syringes.
If Pfizer delivers fewer vials “we will vaccinate fewer people than expected” initially, warned Du Côté de la Science, a group of French doctors and researchers who sought to influence the public debate in France on the pandemic.
– Governments on their guard –
Pfizer’s decision sparked an uproar in Belgium.
Nursing homes that hope to step up their vaccination campaign through the use of the sixth vial dose are now receiving fewer vials than initially promised, a director told AFP.
The Swedish health authority has demanded an explanation from Pfizer, but has so far not frozen its payments.
The French Ministry of Health has launched an effort to acquire the necessary syringes and has developed training materials to help medical staff learn the method of obtaining the sixth dose.
The European Commission says it has already launched a joint procurement initiative which should allow Member States to purchase the necessary syringes.
burs-aue / rl / bp
© 2021 AFP
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