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Paris (AFP)
American pharmaceutical giant Pfizer, which is making the Covid-19 vaccine developed by BioNTech in Germany, now considers that each bottle contains six doses compared to the previous five.
The difficulty in obtaining the sixth dose in practice means that many countries are at odds with Pfizer and facing a drop in supply.
– How many doses? –
Until recently, each vial of the BioNTech-Pfizer vaccine officially contained five doses.
After thawing, the contents of each vial are diluted in 1.8 ml of saline, totaling 2.25 ml of solution for injection. In each 0.3 ml dose, in theory there are just over seven doses.
But theory and practice are different. Medical personnel cannot measure doses so accurately to obtain seven doses that they can inject into people.
But they found that they could – with the right equipment – get six doses of the bottles safely.
EU and US regulators now consider the bottles 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, not bottles –
Pfizer revised 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 changing the label on the bottles.
Pfizer said its contracts specify delivery of a certain number of doses of vaccine, not vials.
This means that customers are now receiving fewer bottles than before regulators approved the change.
– ‘Niche’ syringes –
But to obtain the sixth medical dose, a special syringe with a low “dead space” is needed. Dead space is the amount of product left in the syringe when the plunger is pushed all the way down.
To obtain the sixth dose of the BioNTech-Pfizer vaccine, vaccine syringes with very low dead spaces are required, but medical device manufacturer Becton Dickinson (BD) says there is a supply crisis for them.
“Low dead space syringes are niche products and there has traditionally been minimal market demand based on the needs of healthcare professionals,” said a company spokesman.
The manufacturing capacity of these syringes is limited and will take time to increase production.
Many vaccination centers in France have not received syringes with little dead space and are finding it difficult to obtain a sixth dose with normal syringes.
If Pfizer delivers fewer bottles, “we will vaccinate fewer people than planned” initially, warned Du Cote de la Science, a group of French doctors and researchers who sought to influence the public debate in France about the pandemic.
– Governments on guard –
Pfizer’s decision sparked protests in Belgium.
Nursing homes that hope to intensify their vaccination campaign thanks to the use of the sixth dose in vials are now receiving fewer vials than initially promised, a director told AFP.
Sweden’s health authority demanded an explanation from Pfizer, but so far has not frozen its payments.
The French Ministry of Health has launched an effort to acquire the necessary syringes and developed training materials to help the medical team learn the method for obtaining the sixth dose.
The European Commission says that it has already launched a joint supply initiative that should allow Member States to purchase the necessary syringes.
burs-aue / rl / bp
© 2021 AFP