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Covid-19: "It is not impossible that the Russian vaccine will be approved in Europe, but ..."

2021-02-02T05:37:58.009Z


Without denigrating them, Marie-Paule Kieny, the president of the “Covid-19 vaccine committee” which advises the government on its vaccine strategy,


"A vaccine, we do not look at his nationality".

Gabriel Attal left the door open to an order for the Sputnik V vaccine this Monday morning on France Info, against a background of shortage.

Subject to validation by the European Medicines Agency, of course.

We asked Marie-Paule Kieny, the president of the “Covid-19 vaccine committee”, which guides the government's vaccine strategy.

The virologist, director of research at Inserm, is pessimistic about the possibility of seeing the Russian drug arrive on French soil in the short term, despite Moscow's proposal to deliver 100 million vaccines to Europe in the second quarter.

The purchase of Chinese vaccines seems even more hypothetical.

Does the current shortage make you think it is desirable to order Russian and Chinese vaccines?

MARIE-PAULE KIENY.

To join the European panel, producers would have to apply for approval from the European Medicines Authority (EMA).

A preliminary application has been filed by the Russians for the Sputnik V vaccine, but not for the other vaccines.

If their files comply with the quality demands dictated by the EMA, there is no impossibility for these vaccines to be approved, but producers will also have to demonstrate that they have a legal establishment in the European Union. .

At this point, it does not seem appropriate to order for these vaccines if the goal is to have deliveries in 2021.

You carried out a scientific visit to Sputnik V at the end of November, which you described as positive.

Where are the discussions on this vaccine and when could it be put on the market in Europe and France?

The scientific and technical mission to Moscow, which I chaired, concluded that the Sputnik V vaccine was effective.

However, I doubt that it will be available in France in 2021. Note also that the Russian population to be immunized is large, and that the Russian government favors bilateral agreements with the countries it wishes to influence.

Chinese vaccines (CanSino, Sinovac and Sinopharm) do they present to you an interest for the French strategy?

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I would rather answer no, because of the expected delay for their approval.

Do we have as much data available and guarantees for Russian and Chinese vaccines as for the others on the market?

Regulatory authorities have different levels of requirement and the EMA, the FDA (

Editor's note: the American drug regulatory

authority

)

and the authorities of countries like Australia, Canada and others are among those that have the most stringent criteria.

The quality aspects of vaccine development, production - including raw materials - and clinical and preclinical data are fundamental.

It is at this price that we ensure the safety of drug and vaccine users.

I do not know the data and guarantees for Russian and Chinese vaccines available at this point.

Can these vaccines be a useful remedy or will they arrive too late in any case to meet the current shortage?

These vaccines will be very useful for vaccinating the Chinese and Russian populations, as well as those of other countries which have chosen to use these vaccines.

The vaccines available in France will be totally insufficient to immunize the entire world population.

Source: leparis

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