StockMarketWire.com - Drugmakers GSK and Sanofi announced they would begin a phase 1/2 clinical trial for their potential COVID-19 vaccine and expected first results from the study in early December 2020.

Positive data from the trial, which would include 400 participants, would pave the way for the companies to start the phase 3 trial by the end of this year.

'If these data were sufficient for licensure application, it is planned to request regulatory approval in the first half of 2021,' the companies said.

'Pre-clinical data showed an acceptable reactogenicity profile and data based on two injections of the adjuvanted recombinant vaccine showed high levels of neutralising antibodies that are comparable to levels in humans who recovered from the COVID-19 infection. '

Sanofi and GSK also said they were scaling up manufacturing of the antigen and adjuvant with the target of producing up to 1 billion doses in 2021.





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