Moderna shares Covid-19 vaccine trial blueprints, Pfizer follows
US biotech firm Moderna, one of nine companies in the late stages of clinical trials for a Covid-19 vaccine, became the first to publish the complete blueprints of its study following calls for greater transparency.
Pfizer, the other American company currently carrying out Phase 3 trials in the US, followed suit a short time later and there is now added pressure for the remainder 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 the medicine is safe and effective.
The vaccine race has become deeply politicized in the US in the run-up to the presidential election in November, as President Donald Trump touts a quick vaccine in response to criticism of his handling of the pandemic.
Trump repeated on Wednesday that the first vaccine would be approved by October, increasing concerns that the White House will place pressure on the approval body, the Food and Drug Administration (FDA).
“I don’t trust Donald Trump,” his rival from the Democratic party Joe Biden said Wednesday.
Experts and officials in the Republican president’s administration agree that it’s not possible to predict the results of the trials that are underway, and it’s highly unlikely to have strong data before the end of 2020.
Vaccine doses will be initially very limited, according to health authorities.
Moderna’s CEO Stephane Bancel said on Thursday his company would know whether their vaccine works by November.
October is possible but unlikely, he told CNBC.
The trial protocol published 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 judge whether results are conclusive. (AFP | Ivan Couronne)