Speaking at The Wall Street Journal's annual Tech Live conference, the head of the biotechnology outfit, Stephane Bancel, said that if positive interim results from a large scale trial were available in November, then United States government authorisation might arrive by the following month. That analysis is expected to take place in November, though the exact timing is tough to predict "because it depends on the cases, the number of people getting sick", Bancel said.
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.
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.
It is the third COVID-19 vaccine candidate accepted by Canada for this rolling submission process, with those being developed by BioNTech and Pfizer and AstraZeneca already privy to the same assessment method. However, it also added that it requires safety data from a global trial of 44,000 people and this data will be available next month. Bourla stated that in order to seek approval for public use, it must be proved that the COVID-19 vaccine is effective, safe and can be consistently manufactured at the highest quality standards.
Drugmakers are racing to develop a COVID-19 vaccine, with more than 150 potential therapies being developed and tested globally.
The vaccine's readiness hinges on the interim results of a large clinical trial that is now underway.