The American biotechnology company Moderna, one of nine companies in the late stages of clinical trials for a Covid-19 vaccine, was the first to publish the full blueprints of its study following calls for greater transparency.
Phase 3 is the final step before approval, where a vaccine and 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 ahead of the presidential election in November, when President Donald Trump shows a quick vaccine in response to criticism of his handling of the pandemic.
Trump reiterated on Wednesday that the first vaccine would be approved in October, raising concerns that the White House will put pressure on the Food and Drug Administration (FDA).
“I do not trust Donald Trump,” said his rival from the Democratic Party Joe Biden on Wednesday.
Experts and officials in the Republican president’s administration agree that it is not possible to predict the results of the ongoing trials, and it is highly unlikely to have strong data before the end of 2020.
Vaccine doses will initially be very limited, according to health authorities.
The mother’s CEO Stephane Bancel said on Thursday that his company would know if their vaccine works in November.
October is possible but unlikely, he told CNBC.
The experimental protocol, which was published on Thursday, which runs to 135 pages and is marked “confidential”, fixes the parameters of the experiment.
The most important of these is how it will assess whether the results are decisive.
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 in the placebo group with the group receiving the vaccine.
So the decline in the rate of infection in the United States could theoretically 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 takes a few more weeks to recruit the entire quota of 30,000 participants and for them to receive their second doses.
Only Covid-19 infections registered two weeks or more after the second dose are counted to give the vaccine enough time to take effect.
Interim analyzes by a committee of independent experts are planned during the trial to verify whether a high statistical efficiency threshold has been reached and to monitor for serious adverse reactions.
The FDA has stated that a vaccine that is approved is a vaccine that reduces the risk of becoming ill with Covid-19 by 50 percent.
The modern trial protocol “has the key information (to) stop rules, interim analyzes and efficiency assumptions. Applauds their transparency,” Eric Topol, head of the Scripps Research Institute and one of the critics leading the accusation of possible political interference, told AFP.
Moderna also said that 28 percent of the participants were from racial groups.
Having enough participants among particularly black and Hispanic people is crucial to achieving statistically representative results for those communities that have been disproportionately affected by the pandemic.
The decision by Moderna, which has received $ 2.5 billion in US government money, left a spotlight on Pfizer, whose CEO has repeatedly said the company will have its results by the end of October, which is in line with Trump’s wishes.
A spokeswoman told AFP that 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 of its self-funded Covid-19 vaccine pivotal study available to strengthen Pfizer’s long-standing commitment to scientific and regulatory rigor that benefits patients.”
The other leader is AstraZeneca, which has developed a vaccine with the University of Oxford.
The global trials of the drug were suspended last week after a participant had an unexplained disease, but were later restarted in the UK, Brazil and South Africa. The United States is still excluded for reasons not yet known.