Two drug companies, Moderna and Pfizer, who are among the nine leading the race to develop coronavirus vaccines, released the blueprints of their study on Thursday after repeated calls for transparency, AFP reported.
Moderna’s trial protocol, which is 135 pages long, fixes the parameters of the experiment. As of Thursday, 25,296 volunteers were recruited for the trial from a target of 30,000. Among them, 10,025 had received their second dose, 28 days after the first. It said it will take a few more weeks to recruit the total number of participants and for them to receive their second doses.
Meanwhile, 28% of its participants were from racial minority groups, which is necessary as members of the Black and Hispanic communities have been among those disproportionately affected by the pandemic.
Moderna Chief Executive Officer Stephane Bancel said his company will know by November whether the vaccine is effective. The United States biotech firm’s statement is contrary to President Donald Trump’s suggestion that a coronavirus vaccine may be only weeks away. The president has reiterated that a vaccine could be ready for distribution before the November 3 election.
“We have been working nine months to try to stop this virus by getting a vaccine to market,” Bancel said, according to Bloomberg. “We want to make sure the general public has trust in vaccines by being transparent.”
The company said a panel, called a data-safety monitoring board will analyse the effectiveness of the vaccine and monitor it for serious side effects. The board could recommend stopping Moderna’s trial after 53 cases, if it was found to be 74% or more effective. If the vaccine turns out to be 60% effective, the trial might have to proceed to the final efficacy readout in order to generate clear results, according to the protocol.
Eric Topol, director of the Scripps Research Institute in San Diego and one of the critics leading the charge against possible political interference in the run-up to the presidential election, praised Moderna’s trial protocol. “It has the key information [for] stopping rules, interim analyses and efficacy assumptions,” he said.
Meanwhile, Pfizer, the other American company currently carrying out Phase three trials in the US, said conclusive efficacy results of their vaccine is likely by October-end.
A spokesperson of the company said they have not shared the full in-depth study protocol, but emphasised the need for transparency. “As a result, the company is making the full protocol for its self-funded Covid-19 vaccine pivotal study available to reinforce Pfizer’s longstanding commitment to scientific and regulatory rigor that benefits patients,” the spokesperson added.
Pfizer’s protocol calls for a first assessment of the vaccine’s performance by the monitoring board after 32 participants have contracted the coronavirus, Reuters reported. The company said over 29,000 people have enrolled in the trial so far and the vaccine needs to be at least 76.9% effective to show its efficacy. In case the drugmaker fails to meet this target, it would face tougher statistical significance thresholds in the subsequent interim assessments, biostatisticians said.
Globally, the coronavirus has affected 3,00,65,728 people and toll reached 9,44,604, according to the Johns Hopkins University. The number of worldwide recoveries crossed 2.04 crore.
Moderna, Pfizer and pharmaceutical company AstraZeneca, collaborating with the German company BioNTech, are among the front-runners in the global race to produce a vaccine to fight the infection. AstraZeneca’s US trial is currently on hold after a patient fell ill in the United Kingdom.