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Moderna’s chief exec expects to have COVID-19 vaccine data in November

If data is promising, company could seek emergency use authorisation in the US in December

Moderna’s chief executive officer Stéphane Bancel (pictured above) said he expects interim results from the company’s COVID-19 vaccine trial in November, according to the Wall Street Journal.

Bancel also added that the vaccine candidate could be granted an emergency use authorisation (EUA) by the US Food and Drug Administration (FDA) in December, assuming that the data from its phase 3 trial is positive.

Previously, Bancel told the Financial Times that Moderna's vaccine candidate would be ready for EUA submission on 25 November.

Speaking at the WSJ’s annual Tech Live conference, Bancel said: “That first analysis is likely to occur in November, but it’s hard to predict exactly which week because it depends on the cases, the number of people getting sick.”

Depending on if there are sufficient interim results demonstrating efficacy from the study, Moderna may have to push back its regulatory submission to next year.

Moderna’s mRNA-based candidate, mRNA-1273, entered the 30,000-participant phase 3 trial in July. The study, which is being conducted in collaboration with the US National Institutes of Health (NIH), is investigating two shots of the candidate at a dosage of 100 µg.

The primary endpoint of the study is the prevention of symptomatic COVID-19 disease, with key secondary endpoints including the prevention of severe COVID-19 disease and prevention of infections with SARS-CoV-2, which causes COVID-19, regardless of symptoms.

Also this week, Pfizer’s CEO Albert Bourla revealed a similar timeline for its BioNTech-partnered COVID-19 vaccine, saying that the company could seek an EUA in the US in the third week of November.

Pfizer is awaiting a key data readout later this month, with Bourla adding that the company may know whether or not its candidate, BNT162b2, is effective by the end of October.

However, like Moderna, this depends on the number of COVID-19 cases in the phase 2/3 trial, which need to reach a certain number in order to compare the effectiveness of the vaccine to placebo.

For Moderna to apply for an EUA, 53 subjects in its phase 3 study need to be infected with the novel coronavirus, and the cases in the placebo arm need to be significantly higher than those in the vaccinated arm.

If the trial does not show sufficient efficacy at this point, Moderna will aim to evaluate the success of the vaccine when 106 trial participants contract symptomatic COVID-19.

Interim analysis from the phase 1 study of mRNA-1273 that was published in July showed that the vaccine produced rapid and strong immune responses against SARS-CoV-2 in all participants tested.

Following two doses with the vaccine, neutralising antibody levels among participants were similar to those seen in individuals who had tested positive and recovered from COVID-19.

Although high levels of neutralising antibodies are not definitive proof that a vaccine is effective against a virus, it is still considered an important indicator of efficacy in early clinical trials.

Article by
Lucy Parsons

20th October 2020

From: Research

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