Two promising vaccines that could have hit the market have suffered setbacks in the final-stage trials and now probably won’t be available until at least the spring.
Moderna CEO Stéphane Bancel, whose vaccine was one of seven candidates that have entered final-stage trials, says that it will be November before Moderna will be able to offer its vaccine to front-line medical workers. The company also announced that it would not seek emergency FDA approval.
“I think a late [first quarter], early [second quarter] approval is a reasonable timeline, based on what we know from our vaccine,” Bancel said, according to the Financial Times.
A spokesperson for Moderna confirmed Bancel’s comment at the conference noting that the company expects to have enough vaccine testing data to apply with the FDA for emergency use authorization by November 25.
The timeline is a setback for Moderna, which saidthat it could seek emergency authorization for a vaccine as soon as November 1. It also deals a blow to claims by President Donald Trump, which he repeated on Tuesday in his debate with Joe Biden, that a vaccine could be ready in a matter of weeks, or before the November 3 presidential election.
Since the timeline for vaccine development is measured in years, this will still be a truly remarkable scientific achievement. Bringing a vaccine to market in less than a year from the outbreak of the coronavirus pandemic will be the result of unprecedented cooperation between private companies and the government.
More bad news from AstraZeneca’s final-stage trials as the FDA is broadening its safety inquiry into the vaccine. In September, one of the participants in the trial became ill with a spinal disease, forcing the company to halt the trials. Now the FDA wants more data from not only this trial but other trials the scientists have been involved in.
The widened scope of the FDA probe raises the likelihood of additional delays for what has been one of the most advanced COVID-19 vaccine candidates in development. The requested data was expected to arrive this week, after which the FDA would need time to analyze it, two of the sources said.
Effective vaccines are seen as essential to help end a pandemic that has killed more than one million people worldwide.
The administration of President Donald Trump has pledged $1.2 billion to support development of the AstraZeneca vaccine and secure 300 million doses for the United States. Other leading companies in the U.S. vaccine race include Pfizer Inc, Moderna Inc and Johnson & Johnson.
As for the other companies, Johnson and Johnson just began final-stage trials earlier this month as did Novavax’s vaccine. And Inovio’s DNA vaccine has yet to reach the final stage of testing. The FDA has placed Inovio’s vaccine on a partial clinical hold while they study the data.
Inovio insists the delay isn’t related to any concerns about the safety of INO-4800, which is thought to be the furthest ahead among four DNA-based vaccines that have started human testing for COVID-19. An expanded phase 1 trial of the shot is still ongoing and unaffected by the partial hold.
Even with virtually unlimited amounts of money, making a vaccine is hard. I don’t think Trump oversold the idea of a vaccine by Election Day. He was just going by what the industry was telling him. But his own public health people were telling him it would be late spring or summer before a vaccine would be widely available.
That looks more realistic now in light of these delays.