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Anti-Covid vaccine “90% effective”: 5 questions on the announcement of the Pfizer and BioNTech laboratories

The race for the vaccine against the Covid has just taken a further step. The Pfizer and BioNTech laboratories announced on Monday, November 9 a promising avenue by ensuring that their vaccine is effective, 90% according to them, against Covid-19.

An announcement that follows the results of an interim analysis of their phase 3 trial, the very last phase before the registration application. But many questions still remain unanswered. “The Obs” takes stock.

The two laboratories wish to solicit the American health authorities – the Food and Drug Administration (FDA) – the third week of November to obtain emergency use authorization.

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Pfizer said on its website that it is gathering the two months of safety data after the final dose required by the FDA, in order to qualify for emergency use authorization.

“We estimate that an average of two months of data security following the second and last dose of the candidate vaccine required by the FDA will be available the third week of November. “

In order to be able to hope for an authorization of the vaccine, “Efficiency, safety and regular production are the three essential conditions”. If approved by the authorities, the vaccine could be available in late 2020-early 2021.

However, the delivery of vaccines could be more complicated to set up. One of the difficulties lies in the low temperature (-80 ºC) at which the doses must be stored. This constraint induces logistical problems in order to keep the vaccine cold before distributing it.

  • How many doses can be produced?

“RNA vaccines have the interesting feature of being able to be produced very easily in very large quantities”, summarizes with AFP Daniel Floret, vice-president of the technical commission of vaccinations, at the High Authority of Health (HAS).

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Based on projections, the companies plan to deliver up to 50 million doses of vaccine globally by the end of 2020. Pharmaceutical group Pfizer estimates that it will have manufactured enough doses to be able immunize up to 25 million people, two doses being needed for one person. The group started production of the vaccine without being sure that the health authorities would give their authorization.

For the year 2021, Pfizer considers that about 1.3 billion doses could be produced, as noted by “The Financial Times”.

  • Who will it be primarily intended for?

According to Reuters information, Pfizer plans to seek authorization for emergency use of the vaccine for people between the ages of 16 and 85.

Some countries like the United States have already pre-ordered the vaccine. Donald Trump had signed a $ 1.95 billion contract with Pfizer for the delivery of 100 million doses, should the vaccine ever be approved. They will be delivered to the United States, which hopes to start vaccinating vulnerable people before the end of the year.

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On the European side, the Commission reached an agreement in September to obtain 200 million doses of the vaccine developed by Pfizer and BioNTech with an option for 100 million additional doses. She said Monday evening ‘EU will finalize ” soon “ its contract with Pfizer / BioNTech to purchase up to 300 million doses (Commission)

  • How would vaccination be organized in France?

If we still do not know when a vaccine could arrive in France, the health authorities are preparing. A public consultation was launched on Monday by the High Authority of Health to determine the modalities of the vaccination campaign, revealed Franceinfo. The body had already announced in July the audiences that would be priority, namely “Front-line health and medico-social professionals”.

The HAS also indicates that the people most at risk, “People over 65 and those with co-morbidity” would also be prioritized. Doctors, nurses and pharmacists will be authorized to vaccinate.

  • How does the vaccine work?

The technology used for the vaccine has never yet been proven. It involves injecting the body with strands of genetic instructions called messenger RNA, which is the molecule that tells our cells what to make.

The vaccine’s messenger RNA is inserted and takes control of this machinery to manufacture a specific antigen of the coronavirus: the “spicule” of the coronavirus, its tip so recognizable which is on its surface and allows it to attach itself to human cells to penetrate them. This spike will then be detected by the immune system which will produce antibodies, and these antibodies will stay for a certain period of time. At present, however, the duration of protection offered by the future vaccine is not known.

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Once the genetic material is injected, “The cells which are at the site of the injection will start to produce, in a transient manner, one of the proteins of the virus, in this case protein S, the spike protein”, explained to AFP Christophe D’Enfert, scientific director of the Pasteur Institute. The advantage is that with this method, it is unnecessary to cultivate a pathogen in the laboratory, it is the organism that does the work.

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