Moderna reached human testing for its COVID-19 vaccine candidate in record time, and now with its phase 3 trial moving right along, the company is expecting efficacy data in November—likely after Pfizer and BioNTech, but before everyone else.
The biotech believes it'll know in November whether the vaccine works, CEO Stéphane Bancel said on CNBC Thursday. A readout in October is possible but unlikely, he added, while a readout in December would represent a “worst-case scenario.”
As the pandemic gained steam early this year, Moderna and NIH researchers quickly pushed into phase 1 testing in March. After success in that trial, the company started its phase 3 trial in July. Study investigators have already enrolled around 25,000 people, and 10,000 people have received the second dose of either vaccine or placebo.
But Moderna isn’t the only company expecting results this year. Pfizer CEO Albert Bourla has said his company expects to know whether the vaccine works by late October.
AstraZeneca, the other company in a U.S. phase 3 study, had to pause its late-stage trial due to a safety scare, but its partner University of Oxford concluded the illness was “unlikely” to be linked to the vaccine. AstraZeneca is on track to file its data by the end of the year, CEO Pascal Soriot told the Financial Times after the delay.
As the vaccines push forward, the FDA has set an October 22 advisory committee meeting to discuss the progress.
Also on Thursday, Moderna released the trial protocol for the high-profile phase 3 study. With that and the public results to date, analysts with Jefferies wrote to clients that the “probability of success is high for a positive readout in Q4.”
All of the vaccines are advancing as questions swirl about political pressure affecting the FDA's decisionmaking process. President Donald Trump has said a vaccine could be coming “in a matter of weeks," echoing previous comments that he's pushing for a vaccine to be available before the November 3 election.
Previous FDA decisions during the pandemic haven't alleviated concerns that politics will sway the scientific process. When the agency issued its emergency use authorization for convalescent plasma last month, FDA Commissioner Stephen Hahn made misleading comments about the treatment that he later acknowledged were incorrect.
Before that, the agency issued an EUA for hydroxychloroquine—a malaria drug President Trump had been touting as a COVID treatment—but it later revoked the authorization when controlled trials didn't show a benefit for the drug.
In response to the controversies, top vaccine players have pledged not to rush a shot to market, and top FDA officials have pledged to follow the science as the agency works through key decisions during the pandemic.