Moderna and Pfizer have released their study protocol, making public details on how their COVID-19 vaccine will be evaluated.
The two drug companies have abandoned their traditional secrecy and released comprehensive road maps of coronavirus vaccine evaluation due to “public pressure”, said a report by The New York Times.
According to the report, both the companies have revealed details including the process of selecting participants for trials of vaccine and monitoring them.
The conditions under which the trials could be stopped early if there were problems and the evidence researchers will use to determine whether people who got the vaccines were protected from COVID-19 have also been revealed, said the report.
The sharing of these details while the trials are still underway is a “rare move” as companies typically do this after their studies are complete, as per the report.
However, in case of the COVID-19 vaccine, it has been done to address the growing suspicion among Americans that President Donald Trump’s drive to produce a vaccine before the November 3 election could result in a product that was unsafe.
Trump, who is seeking a re-election, has said a vaccine to fight the coronavirus pandemic is possible before the polls, raising concerns over political interference. Following his remarks, scientists have questioned whether drugmakers will have enough evidence to achieve success by that time.
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Moderna and Pfizer are on the human clinical trial stage of their respective COVID-19 vaccine candidates.
Moderna's vaccine candidate - mRNA-1273 - is nearing the finish line in its push to enroll 30,000 individuals in a late-stage trial of a novel coronavirus vaccine.
For Pfizer’s vaccine, developed together with Germany's BioNTech SE, more than 29,000 people have enrolled in the trial that started in July, some receiving the vaccine and the others receiving a placebo.
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