Moderna closes in on release of COVID-19 vaccine data

BENGALURU/NEW JERSEY - 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 percent, it might be 90 percent, or 96 percent, or 89 percent, but it is going to be up there," he said.

Pfizer on Monday said its COVID-19 vaccine was more than 90 percent 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 percent at $82.44 and rose to $83.85 in extended trading.

-reuters-

COVID-19 vaccine frontrunner pauses trial after unexplained illness

WASHINGTON -- Pharmaceutical company AstraZeneca said Tuesday it had "voluntarily paused" a randomized clinical trial of its coronavirus vaccine in what it called a routine action after a volunteer developed an unexplained illness.

The company, which is developing the drug alongside the University of Oxford, is a frontrunner in the global race for a COVID-19 vaccine. 

"As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee," a spokesperson said.

"This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials."

It added that in large trials, illnesses will sometimes happen by chance but must be reviewed independently.

"We are working to expedite the review of the single event to minimize any potential impact on the trial timeline," the spokesperson added.

It was not immediately clear where the patient was, or the nature and severity of their illness.

Holds during clinical trials are not uncommon, but this is thought to be the first time it has happened for a COVID-19 vaccine trial.

AstraZeneca is one of 9 companies currently in late-stage Phase 3 trials for their vaccine candidates.

In the US, the company began enrolling 30,000 volunteers across dozens of sites on August 31. 

The vaccine, called AZD1222, uses a weakened version of a common cold causing adenovirus that has been engineered to code for the spike protein that the novel coronavirus uses to invade cells.

After vaccination, this protein is produced inside the human body, which primes the immune system to attack the coronavirus if the person is later infected.

Agence France-Presse