US News Covid-19. Green lights for the resumption of two vaccine trials in the United States

07:15  24 october  2020
07:15  24 october  2020 Source:   ouest-france.fr

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Dix vaccins européen, américains, chinois et russe sont testés dans le monde dans des essais à grande échelle. © TATYANA MAKEYEVA / REUTERS Ten European, American, Chinese and Russian vaccines are being tested in large-scale trials around the world.

In the United States, pharmaceutical companies Johnson & Johnson and the AstraZeneca group will be able to resume clinical trials of a vaccine against Covid-19, after a suspension for fear of serious side effects.

Two trials of experimental vaccines against Covid-19 will be able to resume in United States after apparent false alerts, increasing the chances of having one or more vaccines authorized by the start of the year 2021 , in addition to two other American projects.

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As President Trump pushes the possibility of a vaccine this year, the C.D.C. has outlined technical scenarios to The C.D.C. noted in its guidance that “limited Covid - 19 vaccine doses may be available by early Many of the details listed for the two vaccines — including required storage temperature

In the trial , half of the volunteers receive a vaccine , while the other half get a placebo. Developers will be able to do a first analysis when 53 people in the entire volunteer group get symptomatic COVID - 19 — the efficacy of the Here, however, the traffic light of the UK- US research team would show green .

One, developed by the British University of Oxford and the AstraZeneca group, has already resumed in the United States, after more than six weeks of hiatus in the country.

And the other, led by Johnson & Johnson, is expected to do so soon, after the go-ahead from the independent committee that evaluated the case of an unexplained illness in a participant in October .

A total of ten European, American, Chinese and Russian vaccines are being tested worldwide in large-scale trials, including tens of thousands of participants each time, and intended to verify efficacy and, just as crucially, harmlessness.

The fear of regulators is that vaccines trigger serious side effects. If a participant becomes ill, the trials can therefore be suspended until they understand whether the vaccine is involved.

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A young woman whose lungs were destroyed by the coronavirus received a double lung transplant last week at Northwestern Memorial Hospital in Chicago, the hospital reported on Thursday, the first known lung transplant in the United States for Covid - 19 .

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Hundreds of millions of pre-sold doses

For the experimental vaccine AstraZeneca / Oxford, the United Kingdom had concluded after a few days that it was safe and authorized the resale, followed in the following weeks by Africa South , Brazil and Japan .

In the United States, on the other hand, the authorities prolonged the suspense, without explanation. Testing was suspended on September 6.

"The Medicines Agency (FDA) cleared the resumption today in the United States, following resumption of trials in other countries in recent weeks," said AstraZeneca. "The FDA has reviewed all the safety data from the global trials and concluded that it is safe to resume trials" .

Trial results are expected this year, the group confirmed, although this will depend on the pace of the outbreak where the vaccine is being tested.

Many countries rely on this vaccine. AstraZeneca has pre-sold hundreds of millions of doses across several continents, and signed partnerships with other producers to have doses produced locally, with expected demand reaching billions of doses.

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19 , 2020. AstraZeneca revealed details of its large coronavirus vaccine trials on Saturday, the third 11 on AstraZeneca’s trial in Britain lumped the two volunteers’ cases together, stating the illnesses But the F.D.A. has so far not allowed the company to start up again in the United States . The trial in Britain involved only about 8,000 volunteers, a spokesman for the Oxford researchers said last month.

As the day unfolded: Victoria stage 3 COVID - 19 restrictions reimposed on Melbourne, Mitchell Shire Council as state Resumption of County Court jury trials thrown into doubt. Plans for the County Court of Victoria to resume jury trials in July have been abandoned in the wake of the reimposition

Vaccinations before the New Year?

Johnson & Johnson announced on Friday that an independent committee had recommended the resumption of the Phase 3 trial, which will include 60,000 people and started in late September, and that preparations are underway.

"After a thorough evaluation of a serious medical event in a participant, no definite cause was identified," , the group said. "The company found no evidence that the vaccine candidate caused the event" .

The advantage of this vaccine is that it is only given in one dose, instead of two in most competitors, which saves three or four weeks for evaluation.

"If all goes well, we anticipate that the test could go quite quickly," , said US official Paul Mango.

The Trump administration is increasingly confident that a vaccine will be available before the end of December, and logistics are being put in place for mass distribution.

The two leading candidates are those of Pfizer and Moderna : the American companies plan to apply for an authorization in the second half of November; the FDA has not specified how soon it will give its opinion afterwards, but it could come well before the end of December.

"By the end of the year, we should be able to immunize our most vulnerable citizens," , said Paul Mango. "By the end of January, we believe we will be able to vaccinate all seniors, and by March or April, all Americans who wish" .

Vaccine against Covid-19: the clinical trial of Johnson & Johnson will resume .
© Cheryl Gerber / Johnson & Johnson via AP Doses of the vaccine developed by the Johnson & Johnson laboratory. Currently in phase 3, the clinical trial of this candidate vaccine against Covid-19 must resume. He had been interrupted a few days ago. The clinical trial of the candidate vaccine from the American laboratory Johnson & Johnson is expected to resume shortly.

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This is interesting!