WASHINGTON/LONDON • Moderna, the US biotech firm, said on Tuesday that it would enter the final stage of human trials for its Covid-19 vaccine on July 27, to test how well it protects people in the real world.
The announcement came as the results from an earlier trial, intended to prove the vaccine was safe and triggered antibody production, were published.
The upcoming phase three trial will recruit 30,000 participants in the United States, with half to receive the vaccine at 100 microgram dose levels, and the other half to receive a placebo.
Researchers will then track the participants over two years to determine whether they are protected against infection by the virus.
Or, if they do get infected, whether the vaccine prevents symptoms from developing.
If they do get symptoms, the vaccine can still be considered a success if it stops severe cases of Covid-19.
The study should run until Oct 27, 2022, but preliminary results should be available long before that date.
The announcement came shortly after the New England Journal of Medicine published results from the first stage of Moderna’s vaccine trial, which showed that the first 45 participants all developed antibodies to the virus.
Moderna is considered to be in a leading position in the global race to find a vaccine against the coronavirus.
But scientists caution that the first vaccines to come on the market may not be the most effective or the safest.
Number of participants who will be recruited in the US for phase three of Moderna’s vaccine trial.
Number of years that researchers will track participants of the trial.
Number of participants in the first phase of the trial. All were found to develop antibodies to the virus.
The “interim results” that Moderna published in May from the first stages of its trial were hailed to be “encouraging” by Dr Anthony Fauci, the director of the US National Institute of Allergy and Infectious Diseases, a co-developer of the vaccine.
But some in the scientific community said they would reserve judgment until they saw the full results in peer-reviewed form.
Meanwhile, in the UK, positive news on initial trials of the University of Oxford’s potential Covid-19 vaccine that has been licensed to AstraZeneca could be announced as soon as today, according to British news channel ITV’s political editor Robert Peston, citing a source.
The project has started phase three of the human trials to assess how the vaccine works in a large number of people over the age of 18, but has yet to report phase one trial results.
The developers of the vaccine earlier this month said they were encouraged by the immune response they had seen in trials so far.
AGENCE FRANCE-PRESSE, REUTERS