Five or six doses? Controversy over Pfizer vaccination vials

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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 in obtaining the sixth dose in practice means that many countries are at odds with Pfizer and have a decline in supply.

– How many doses? –

Until recently, each vial of the BioNTech-Pfizer vaccine was officially considered 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 injectable solution. With each dose of 0.3 ml, in theory there are just over seven doses.

But theory and practice are different. Medical staff cannot measure the doses so accurately to get seven doses that they can inject into people.

But finding that they – with the right equipment – could reliably get six doses out of the vials.

Both European and American regulators believe that the vials contain six doses and approve the use of the sixth dose.

However, the European Medicines Agency has noted that this sixth dose depends on the availability of specific syringes.

Doses not vials –

Pfizer has increased its production target for this year from 1.3 billion doses to 2 billion. Part of it reflects plans to further increase production, but it also reflects the effect of the label change on vials.

According to Pfizer, the contracts stipulate the delivery of a certain number of vaccine doses and not vials.

This means that customers now receive fewer vials than they did before the regulators approved the change.

– ‘Niche’ spray –

But to obtain the sixth dose of medicine, a special syringe with a low “dead space” is needed. The dead space is the amount of product left in the syringe when the plunger is completely pushed down.

To get the sixth dose of BioNTech-Pfizer vaccine syringes with very low dead spaces, medical device manufacturer Becton Dickinson (BD) believes there is a stock crisis for them.

“Low dead space sprayers are niche products and there has been … traditionally minimal market demand based on the needs of the healthcare provider,” a company spokesman said.

The manufacturing capacity of these syringes is limited and it will take time to increase the production.

Many vaccination centers in France have not been given low spaces for dead spaces and find it difficult to get a sixth dose with regular syringes.

If Pfizer initially delivers fewer bottles, we will vaccinate fewer people than planned, Du Cote de la Science, a group of French doctors and researchers who wanted to influence the public debate in France over the pandemic, warned.

Governments on their guard –

Pfizer’s decision sparked outcry in Belgium.

Nursing homes hoping to intensify their vaccination campaign thanks to the use of the sixth dose in vials are now getting fewer vials than initially promised, one director told AFP.

The Swedish health authority has demanded an explanation from Pfizer, but so far has not frozen its payments.

The French Ministry of Health has made an effort to procure the necessary syringes and developed training materials to help medical staff learn the method to obtain the sixth dose.

The European Commission says it has already launched a joint supply initiative to allow member states to buy the necessary syringes.

burs-aue / rl / bp

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