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WASHINGTONThe American biotech firm Moderna, one of nine companies in the final stages of clinical trials of a Covid-19 vaccine, became the first to publish full plans for its study following calls for greater transparency .
Pfizer, the other American company currently conducting phase 3 testing in the US, did the same shortly after and now there is additional pressure for the rest to do the same.
Phase 3 is the final stage before approval, in which a vaccine and a placebo are tested on thousands of participants to verify that the drug is safe and effective.
The vaccine race has become deeply politicized in the United States in the run-up to the November presidential election, when President Donald Trump touts a rapid vaccine in response to criticism for his handling of the pandemic.
Trump repeated Wednesday that the first vaccine would be approved in October, raising concerns that the White House will put pressure on the approval body, the Food and Drug Administration (FDA).
“I don’t trust Donald Trump,” his Democratic party rival Joe Biden said Wednesday.
Experts and officials in the Republican president’s administration agree that it is not possible to predict the outcomes of the trials that are taking place and it is highly unlikely that there will be solid data before the end of 2020.
Vaccine doses will initially be very limited, according to health authorities.
Moderna CEO Stephane Bancel said Thursday his company would know if its vaccine works in November.
October is possible but unlikely, he said. CNBC.
The test protocol published Thursday, which is 135 pages long and marked “confidential,” sets the parameters of the experiment.
The most important of these is how you will judge whether the results are conclusive.
Wait for it
The reality of an immunization trial is that it is necessary to wait until a certain number of volunteers become naturally infected, to compare the results of the placebo group with that of the group that received the vaccine.
So the decline in the infection rate in the United States could, in theory, delay the results, possibly until December, Bancel said.
As of Thursday, Moderna had recruited 25,296 volunteers. Among them, 10,025 had received their second dose, 28 days after the first.
It will take a few more weeks to recruit the full ratio of 30,000 participants and for them to receive their second doses.
Only Covid-19 infections recorded two weeks or more after the second dose are counted, so that the vaccine has enough time to take effect.
Interim analyzes performed by a committee of independent experts are planned during the course of the trial to verify whether a high statistical threshold of effectiveness has been reached and to monitor serious side effects.
The FDA has stated that its approval bar is a vaccine that reduces the risk of getting sick with Covid-19 by 50 percent.
Moderna’s trial protocol “has the key information (for) stopping rules, interim analyzes, and efficacy assumptions. Applaud their transparency, ”said Eric Topol, director of the Scripps Research Institute and one of the critics leading the charge against possible political interference. AFP.
Pressure on
Moderna also said that 28% of its participants were from racial minority groups.
Having enough participants among black and Hispanic people in particular is crucial to obtain statistically representative results for these communities that have been disproportionately affected by the pandemic.
Moderna’s decision, which has received $ 2.5 billion in money from the US government, has put Pfizer in the spotlight, whose chief executive officer has repeatedly said the company will have its results by the end of October, which is in line with Trump’s wishes.
A spokeswoman said AFP Pfizer has traditionally not shared the full in-depth study protocol, but “the Covid-19 pandemic is a unique circumstance and the need for transparency is clear.”
“As a result, the company is making the full protocol for its self-funded Covid-19 vaccine pivotal study available to reinforce Pfizer’s commitment to scientific and regulatory rigor that benefits patients.”
The other pioneer is AstraZeneca, which has jointly developed a vaccine with the University of Oxford.
Global trials of the drug were suspended last week after a participant had an unexplained illness, but were later restarted in the UK, Brazil and South Africa. The United States remains the exception for reasons that are not yet known. – AFP
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