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AstraZeneca vaccine: several months of difference for authorization depending on the country, why so many differences

2020-12-31T11:52:39.917Z


The product, which has just been licensed in the UK and Argentina, is not expected to hit the European market until February, nor in the UK.


Expected by many countries, AstraZeneca's vaccine against Covid-19 will not be available everywhere at the same time.

Several announcements that fell on Wednesday confirmed this.

The United Kingdom and then Argentina announced that they would immediately issue a marketing authorization.

But the product is unlikely to be given the green light to arrive in Europe in January, the European Medicines Agency (EMA) said.

As for the United States, it will not be until April.

For the Pfizer-BioNTech vaccine, the schedule has not been the same depending on the country.

But the time differences were then much less important.

The decisions for the United Kingdom, the European Union and the United States were all rendered within twenty days (respectively on December 2, 11 and then 21).

Missing data

Regarding the product developed by the British group AstraZeneca with the University of Oxford, these deadlines spread over time are explained first of all by regulatory constraints.

"Additional scientific information on issues related to the quality, safety and efficacy of the vaccine is deemed necessary to enhance the rigor required for a conditional marketing authorization and this has been requested of the company" , the European Medicines Agency said on Wednesday.

The day before, the authority had indicated that "no formal marketing authorization has yet been submitted".

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In the United States, the recruitment of participants in the last phase of the clinical trial is about to be completed with 29,000 registered, said Wednesday Moncef Slaoui, chief advisor of the American vaccination program.

The effectiveness of the product in the elderly, in particular, is still the subject of questions.

On December 8, when the results of the product appeared in The Lancet, it was still not known "how well the vaccine works in people over the age of 55," reported the Washington Post.

"AstraZeneca communication blunders"

The same day, The New York Times recounted a series of "AstraZeneca communication blunders that damaged the company's relationship" with health authorities. "

“The company was slow to provide the Food and Drug Administration with proof that the vaccine was not associated with neurological symptoms that appeared in two participants in the clinical trial,” the American daily revealed, for example.

In November, interim results announced by the manufacturer had also seemed paradoxical.

The vaccine was 90% effective with half a dose and then a full dose a month later, but only 62% with two full doses.

This had raised big questions about how the clinical trial had been conducted, leading the group to announce the launch of an "additional study".

An impact on the vaccination campaign?

The British eagerness could also be explained by diplomatic and logistical reasons.

As the BBC noted on Wednesday, authorities have more "confidence in the supply" of the AstraZeneca vaccine because it is manufactured in the UK, while that of the Pfizer-BioNTech alliance is to be shipped from Belgium .

It is also much cheaper and easier to use than that of Pfizer and that of Moderna, on which the EMA is due to vote on January 6, because it does not need to be stored at temperatures of -20 or even -70 degrees.

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The additional delays for the European Union (including France) and the United States may slow down the rate of vaccination.

In France, it is already considered too long by many doctors and elected officials.

The EU had in fact pre-ordered from AstraZeneca 300 million doses (plus 100 million optional), distributed in the various countries in proportion to their population.

This represents 50% more than for Pfizer (200 million doses plus 100 million optional also).

“The laboratory had to repeat tests to find the right dose.

[…] It was due to arrive here around mid-February, but in reality it will be very clearly later in large quantities ”, recognized this Tuesday in the Express the president of the Scientific Council, Jean-François Delfraissy.

Source: leparis

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