Pfizer and BioNTech initiate trials of Covid-19 vaccine in Japan

Henrietta Strickland
November 21, 2020

The CEO of Cambridge-based biotech company Moderna said their vaccine could be given emergency authorization as early as December.

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 USA government authorisation might arrive by the following month.

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

Last week saw Moderna's rolling submission accepted under the Canadian Minister of Health's Interim Order, which permits companies to present safety and efficacy data and information as they become available, without waiting for studies to end. The US Food and Drug Administration could decide whether to gr ant an emergency use authorization for the shot in December if Moderna submits an application soon after reaching that safety milestone, according to the Journal.

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.

However, it's possible that the vaccine won't be deemed effective enough when the initial data is analyzed next month, the paper reported.

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", the report quoted Bancel as saying.

Moderna has one of the leading COVID-19 vaccines in development, along with a vaccine co-developed by Pfizer Inc.

Pfizer Inc and BioNTech SE announced on Tuesday the start in Japan of combined Phase I and Phase II clinical trials of their mRNA vaccine candidate against the coronavirus.

Other reports by Click Lancashire

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