Have enough data for first interim analysis of Covid-19 vaccine: Moderna

Moderna said it has enough data for a first interim analysis of the late-stage trial of its experimental Covid-19 vaccine, which should help determine the vaccine's efficacy

By Manas Mishra and Dania Nadeem

(Reuters) - Moderna Inc said on Wednesday it has enough data for a first interim analysis of the late-stage trial of its experimental COVID-19 vaccine, which should help determine the vaccine's efficacy.

Moderna said the information is being prepared for submission to the trial's independent data safety monitoring board, which will look at the results and make a recommendation. It did not say when it plans to release the efficacy data.

The company said in a news release that it has seen a significant increase in the number of COVID-19 cases among trial participants as infection rates have surged around the United States.

Due to the spike in cases, the analysis will cover substantially more than 53 infections, which had been the targeted trigger point for the first analysis.

The company said the trial remains blinded, so neither it nor study investigators know which participants received the vaccine or a placebo. The vaccine will be deemed a success if the overwhelming majority of those infected had received a placebo, once the monitoring board looks at the early results.

Earlier in the day, Dr. Anthony Fauci, the top U.S. infectious disease expert, said Moderna could have the data from anywhere between "a couple of days" to "a little more than a week."

A high degree of effectiveness would make sense as it is "almost identical" to Pfizer Inc's experimental vaccine, Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, said at a conference organized by the Financial Times.

"It may not be 95%, it might be 90%, or 96%, or 89%, but it is going to be up there," he said.

Pfizer on Monday said its COVID-19 vaccine was more than 90% effective based on interim trial results, significantly higher than the at least 50% efficacy regulators are looking for.

Moderna, which uses a similar messenger RNA technology as Pfizer, said earlier on Wednesday that its November timeline for initial data was on track.

It did not respond to a Reuters request for comment on when it would disclose the data.

The company would still have to wait for two-month follow-up safety data required by the U.S. Food and Drug Administration, which it expects to have in the second half of this month, before applying for U.S. emergency use authorization.

There are no vaccines that have gained global approval yet, although a handful, including Moderna's, are in late-stage studies.

Moderna's shares closed up 8.4% at $82.44 and rose to $83.85 in extended trading.

 

(Reporting by Manojna Maddipatla, Manas Mishra and Dania Nadeem in Bengaluru and Michael Erman in Maplewood, N.J.; Editing by Sriraj Kalluvila, Cynthia Osterman and Bill Berkrot)