Washington, United States:
US biotech firm Modern, one of nine companies in the final stages of a clinical trial for the Kovid-19 vaccine, became the first to publish the full blueprint of their study after calls for greater transparency.
Pfizer, the second US company currently doing Phase 3 trials in the US, started doing the suit a short time later and now the pressure to do the same for the remainder has increased.
Phase 3 is the final stage before approval, in which the vaccine and placebo are tested on thousands of participants so that the drug is safe and effective.
The vaccine race in the US for the presidential election in November has been deeply politicized, as President Donald Trump takes a quick comment in response to criticism for dealing with the epidemic.
Trump on Wednesday reiterated that the first vaccine would be approved by October, raising concerns that the White House approval body would pressurize the Food and Drug Administration (FDA).
“I don’t trust Donald Trump,” Democratic Party Joe Biden said Wednesday.
Experts and officials in the Republican presidential administration agree that it is not possible to predict the results of the ongoing tests right now, and it is unlikely to have strong figures before the end of 2020.
According to health officials, the vaccine dose will be very limited initially.
Modern CEO Stephen Bansell said on Thursday that his company would know if his vaccine works until November.
October is possible, but unlikely, he told CNBC.
The test protocol was published on Thursday, which runs for 135 pages and is marked “Confidential”, fixing the parameters of the experiment.
The most important of these is how it will determine whether the results are conclusive.
wait for it
The reality of an immunization test is that it is necessary to wait until a certain number of volunteers are naturally infected to compare the results in the placebo group against the group given the vaccine.
So a decline in the rate of infection in the US could theoretically delay the results – possibly until December, Bansell said.
As of Thursday, Modern had recruited 25,296 volunteers. Of those, 10,025 received their second dose, 28 days after the first.
It would take a few more weeks to recruit a full run of 30,000 participants and receive a second dose.
Only Kovid-19 infection was recorded two weeks or more after the second dose count to allow sufficient time for the vaccine to take effect.
Interim analysis by a committee of independent experts has been planned during testing to confirm whether a higher statistical threshold of effectiveness has been reached, and to monitor for serious side effects.
The FDA stated that its strip for approval is a vaccine that reduces the risk of falling ill with Kovid-19 by 50 percent.
The Modern Trial Protocol “contains important information (for) preventing rules, interim analyzes, and efficacy assumptions, appreciate their transparency,” Eric Topol, director of the Scripps Research Institute and critics leading the charge against political interference One of them told AFP. .
Modern also said that 28 percent of its participants were from racial minority groups.
Having adequate participants, particularly among blacks and Hispanic people, is important in achieving statistically representative results for these communities, which have been badly affected by the epidemic.
The decision by Morden, which has received $ 2.5 billion in US government money, left a spotlight on Pfizer, whose CEO has repeatedly said the company would have its results by the end of October, consistent with Trump’s wishes .
A spokesman said that AFP Pfizer has not traditionally shared the full in-depth study protocol, but “the Kovid-19 epidemic is a unique circumstance and the need for transparency is clear.”
“As a result, the company is creating complete protocols for its self-funded Covid-19 vaccine pivotal study that is available to reinforce Pfizer’s long-term commitment to scientific and regulatory rigor that benefits patients.”
The other precursor is AstraZeneca, which has co-developed a vaccine with the University of Oxford.
Global trials of the drug were suspended last week when a participant had an unexplained illness, but was later resumed in the UK, Brazil and South Africa. The US remains an exception for reasons that are not yet known.
(This story has not been edited by NDTV staff and auto-generated from a syndicated feed.)