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American biotechnology company Moderna, one of nine companies in the final phase of clinical trials of a Covid-19 vaccine, is the first to publish its comprehensive plans for analysis, following calls for greater transparency.
The initiative is putting pressure on other corporations to meet their needs, Pfizer, the other U. S. corporation that is currently conducting Phase 3 testing in the United States.
This is the last step before approval, in which a vaccine and placebo are tested on thousands of participants to ensure that the drug is safe and effective.
The vaccine race has become deeply politicized in the United States in the run-up to november’s presidential election, while President Donald Trump complains about his pandemic management.
Trump reiterated Wednesday that the first vaccine would be until October, sparking fears that the White House would put pressure on the approval agency, the Food and Drug Administration (FDA).
“I don’t accept Donald Trump as true,” Democratic rival Joe Biden said Wednesday.
Experts and officials in the management of the Republican president agree that it is not imaginable to expect the effects of existing trials and that it is highly unlikely that falsified knowledge will be available before the end of 2020.
First, vaccine doses will be very limited, according to fitness authorities.
Moderna CEO Stéphane Bancel said Thursday that his company would know if his vaccine will work until November.
October is imaginable but unlikely, he told CNBC.
The 135-page test protocol, which is marked as “confidential”, are the parameters of the experiment.
The most important thing is how you will judge whether the effects are conclusive.
– Wait for that –
The truth of an immunization trial is that it is mandatory to wait until a certain number of volunteers become naturally infected, to compare the effects on the placebo organization with the organization receiving the vaccine.
Therefore, the decrease in the rate of infection in the United States could, in theory, maintain the effects until December, Bancel said.
By Thursday, Moderna had recruited 25,296 volunteers. Of these, 10,025 had won their doses, 28 days after the first.
It will take a few more weeks to recruit the full quotient of 30,000 participants and get their dose.
Only Covid-19 infections recorded two weeks or more after the dose count, so that the vaccine has enough time to take effect.
Intermediate analyses are planned through an independent panel of test experts to determine whether a higher statistical threshold for effectiveness has been reached and to monitor serious side effects.
The FDA has said its approval bar is a vaccine that reduces the threat of health problems with Covid-19 by 50%.
“This includes key data (for) prevention rules, intermediate analyses and power assumptions. He applauds his transparency,” Eric Topol, director of the Scripps Research Institute and one of the critics who leads the rate opposed to imaginable political interference, told AFP.
– Below –
Moderna said 28% of its participants belonged to racial minorities.
To have enough participants between blacks and Hispanics in specific is to achieve statistically representative effects of communities that have been disproportionately affected by the pandemic.
Moderna’s decision, which earned $2. 5 billion in U. S. government cash, has won $2. 5 billion in cash from the US government. USA, it now leaves the highlight of Pfizer, the company that is vying for america’s first approval. But it’s not the first time
Its CEO has said the company will have its effects until the end of October, in accordance with Trump’s wishes.
The favorite is AstraZeneca, who co-developed a vaccine with the University of Oxford.
Global trials of the drug were suspended last week after a player suffered from an unexplained disease, but then restarted in the UK, Brazil and South Africa. The United States remains the exception for reasons that are still known.
“Transparency is key to overcoming reluctance to vaccines. Other vaccine manufacturers follow the example of moderna_tx,” tweeted Angela Rasmussen, a virologist at Columbia University.
ico / ia / st