Moderna Inc. unveiled details of its plan to analyze data from its Covid-19 vaccine trial, offering an unusual look under the hood of the study of one of the leading vaccine candidates.
In a statement ahead of an investor meeting the company will hold on Thursday, Moderna said the trial has now enrolled 25,296 of the 30,000 expected volunteers and more than 10,000 have received two doses of the vaccine.
While the outlines of major drug trials are available on a U.S. government website, drug companies often keep details of how and when confidential the data monitoring boards that oversee the plan. trials to analyze the data.
However, the unprecedented push to bring a vaccine to market quickly has increased interest in those details. Analysis of the findings and the rules for stopping a trial if there are encouraging early signs could determine how quickly an injection receives emergency clearance from US regulators.
The shares rose 2% to $ 70.20 in pre-market trading in New York. They have more than tripled since the beginning of the year.
Moderna decided to publish its full trial plan to build public confidence that it is doing everything it can to ensure a vaccine is safe and effective, said CEO Stephane Bancel.
“We have been working for nine months to try to stop this virus by bringing a vaccine to market,” Bancel said in an interview. “We want to make sure vaccines are trusted by the general public by being transparent.”
Under the Moderna plan, a data monitoring board will preliminarily analyze the efficacy results after 53 participants have contracted the coronavirus, and again after 106 cases are reached. The final analysis will occur after 151 cases, according to the investor meeting slides.
Moderna’s plan is more conservative than the benchmark of 32 cases that Pfizer Inc. uses for its first preliminary analysis of its Covid-19 vaccine. Pfizer has said that conclusive efficacy results are likely to be obtained by the end of October.
According to a slide presented at the meeting, Moderna’s trial is likely to only generate clear positive results in the first analysis if it turns out to be very highly effective, reducing Covid-19 cases by 74% or more.
If the vaccine turns out to be more modest than 60% effective, the trial may need to proceed to the final efficacy reading to generate clear results, based on the 135-page trial protocol.
November data
In the interview, Bancel said the most likely scenario was that Moderna’s vaccine could generate preliminary efficacy data in November. It is “technically possible” that Moderna will get results in October, but this is unlikely, she said.
Bancel said it is “extremely unlikely” that everyone in the country will be able to get vaccinated by the end of the first quarter of 2021, as a Trump administration official suggested Wednesday. The three most likely starter vaccines are based on newer technologies, meaning that companies have had to create new manufacturing capacity, he said.
There are likely only enough approved vaccines for every American who wants an injection by the second half of next year, according to Bancel.
Unlike an AstraZeneca Plc trial that was suspended twice to investigate potential neurological adverse events, Moderna’s trial has had no pause to investigate potential safety concerns, Bancel said.
The AstraZeneca vaccine trial in the UK was resumed after a safety review was completed, while another AstraZeneca trial in the US remains on hold. Documents sent to participants in the UK say the symptoms were probably unrelated to the AstraZeneca injection.
In an email, an AstraZeneca spokeswoman said she had “no update at this time” on the design of her US trial, beyond the details that are already available in the US database. , Clinicaltrials.gov.
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