The clinical trials are over for the Moderna vaccine – the company announced their drug was 94.1% effective and then filed for Emergency Use, globally
Today (30 November) Moderna released the end results of their Phase Three clinical trials. Thirteen days ago, they reported an efficiency of 95% for their vaccine – which is the highest confirmed amount in any reported clinical setting so far.
Moderna at Phase Three
Their trial had 30,000 people, with 15,000 of them taking two real doses and the other half being given empty doses. The real vaccine injections were given four weeks apart, same as the placebo. The first 95 people to develop COVID-19 became the key participants for demonstrating how this new drug works – only five people who took the vaccine contracted COVID-19. Overall, 196 people developed COVID-19 and there was only one death. The death was in the group that did not have the vaccine. There were 11 severe cases of the virus among the participants, but this was not in the group that had been given the vaccine.
The trials have been across a spectrum of age, race and ethnicity – with Hispanic, Black, Asian and multiracial participants.
To be clear, no-one who took this vaccine developed severe COVID-19.
Filing for Emergency Use across the globe
The company is the second to file for Emergency Use Authorisation (EUA) with the US Food and Drug Administration, after Pfizer and BioNTech filed last week. Moderna simultaneously filed for their COVID vaccine to be given regulatory approval in Europe, Israel, the UK, Canada, Singapore and the WHO itself.
The expected date of the FDA meeting on the Moderna vaccine, aka MRNA-1273, will be 17 December, 2020. After this point, if the regulatory bodies approve, Moderna appears ready to ship and manufacture the vaccine immediately. Stéphane Bancel, CEO of Moderna, said in an interview that he expects the date of first vaccinations to be 21 December.
Stéphane Bancel, Chief Executive Officer of Moderna, further commented: “I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. I would again like to thank our partners at NIH, NIAID, BARDA and Operation Warp Speed who have helped us advance the clinical development of mRNA-1273.
“Finally, I want to thank the Moderna team and our suppliers and partners for their tireless work on the research, development and manufacturing of our vaccine.”
The European Commission struck a contract with Moderna on 25 November. The contract provides for the initial purchase of 80 million doses on behalf of all EU Member States, plus an option to request up to a further 80 million doses, and in exchange offers resources to help manufacture the vaccine.
President of the European Commission, Ursula von der Leyen, said: This is our sixth contract with a vaccine producer, and we are working on yet another one.”
Moderna say they are on track to manufacture 500 million to 1 billion doses in 2021. There is increasing pressure to make sure that the vaccine is distributed equally, to the poorer and more vulnerable global populations.