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Covid-19: suspension, clinical trials, approval ... Where is the race for vaccines?

2020-10-24T18:00:13.938Z


The chances of having a vaccine by the start of 2021 have increased since the resumption of two experimental trials in the United States. The o


This is the biggest unknown, in the fight against the coronavirus: when will a vaccine - an antidote concentrating all hopes in the face of an intensifying epidemic - finally see the light of day?

At this point, no vaccine has received approval for large-scale commercial distribution, but there are ten (European, American, Chinese and Russian) to be tested in tens of thousands of volunteers.

This means that in the space of a few months, this handful of laboratories have achieved the feat of developing a vaccine from the genetic sequencing of the coronavirus and launching this phase of large-scale testing.

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This step, known as “phase 3”, dedicated to verifying the effectiveness of the product, as well as its absence of serious side effects and its optimal dosage, is the last before that expected by all scientists: its validation, allowing a approval and marketing of the vaccine.

While in France, no type 3 test has yet started, Le Parisien takes stock of the most advanced vaccines in this race against time and especially against a virus, which has, to date, at least 1,145,000 deaths worldwide.

Pfizer and Moderna, leading the way

The Trump administration, which initially counted on a vaccine available before the November 3 election, had to reduce its ambitions, but continues to bet on an antidote available in the United States before the end of the year, in particular thanks to two American laboratories: Pfizer and Moderna.

These two groups consider themselves capable of applying for a respective marketing authorization in mid-November.

On Thursday, the biotechnology company Moderna also announced that of the 30,000 volunteers recruited for the phase 3 trial, more than 25,000 had already received the second dose of the vaccine, injected four weeks after the first.

These two companies will then be dependent on validation from the FDA (American Medicines Agency) which, according to the local press, could be issued before the end of December, which would constitute a green light for its marketing.

"By the end of the year, we should be able to vaccinate our most vulnerable citizens," said Paul Mango, of the US Department of Health, adding that "by the end of January, we think we will be capable of vaccinating all seniors and, by March or April, all Americans who wish ”.

AstraZeneca vaccine on track

The suspension of its clinical trial on September 9 gave the British authorities a cold sweat when this vaccine was one of the most advanced.

In September, the trials of the product developed by the British University of Oxford and the AstraZeneca group were put on hold after the appearance of a "potentially unexplained disease", which we do not know if it could have happened. act as a serious side effect, in a participant in the UK.

Finally, the country, then South Africa, Brazil and Japan had over the days resumed testing, imitated this week by the United States, after more than six weeks of interruption.

According to the AstraZeneca laboratory, the results of the trial are still expected for this year.

This vaccine is particularly awaited in the world, while hundreds of millions of doses have already been pre-sold on several continents.

Johnson & Johnson, soon to resume clinical trials

The American group Johnson & Johnson (J&J), for its part, began its phase 3 at the end of September, on 60,000 volunteers and since October 12 has been suspended from testing, due to a possible side effect in one of the participants.

The laboratory remains optimistic, however: Friday, he announced that an independent committee had recommended the resumption of his trial and that he was already preparing to relaunch in the adventure.

"After a thorough evaluation of a serious medical event in a participant, no certain cause was identified," assured the group, according to which there was "no evidence that the vaccine candidate caused the event. ".

Johnson & Johnson could catch up quickly enough on its competitors: its vaccine is only composed of one dose, against two at most of the other laboratories in the running, which would allow it to gain nearly a month on the evaluation of its clinical trials.

China promises one billion doses by early 2021

The CoronaVac, developed by the Chinese private laboratory Sinovac, is currently being tested in phase 3, as part of four separate clinical trials, on tens of thousands of volunteers - 60,000 according to Beijing - from several countries, including Brazil, the Indonesia or Turkey, for lack of sufficient patients in China.

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At the end of this phase, an approval of the vaccine will allow it to be placed on the market, even if this product has already been used urgently in several hospitals and inoculated to hundreds of thousands of Chinese whose use was considered to be at risk. facing the coronavirus.

Several Chinese manufacturers are already on the move for its large-scale manufacture, so much so that China estimates that it will be able, by 2021, to produce nearly one billion doses of vaccine each year.

Sputnik V, available "from January 1, 2021"?

Russian President Vladimir Putin's announcement in August that a Russian vaccine against Covid-19 would be marketed by early next year had triggered a great deal of skepticism in the community. scientific community.

Moscow has never ceased to recall this deadline ever since.

“From January 1, 2021, this vaccine will be available to the population […].

We continue to pass the third phase of testing.

[…] According to our specialists, the first two phases were already sufficient to certify this vaccine and start using it, ”notably proclaimed at the microphone of Europe 1 Artem Studennikov, the Minister-Counselor of the Russian Embassy, ​​the October 6.

He evokes a vaccine which he considers to be "100% operational" which would have been "registered and certified in Russia" several weeks ago and already used on "several important officials and senior state officials", as well as on teachers and doctors, according to him.

Sputnik V trials are due to begin at the end of October on 2,000 Venezuelan volunteers, including the president's son, and this week the head of state said that a massive vaccination campaign will take place in December in his country, thanks to vaccines supplied by Russia and China.

Novavax, the latest arrival

Recently, the Novavax vaccine joined the lead in this speed race.

At the beginning of August, the American biotechnology company, one of the six companies in which the American state has invested considerably since March, announced that its experimental vaccine had provoked a robust immune response, during its initial testing phase.

Before taking a new step at the end of September: Novavax then announced that it had started a clinical trial in the United Kingdom, including 10,000 participants aged 18 to 84.

Source: leparis

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