WASHINGTON | The u.s. biotechnology company Moderna announced on Tuesday that it would enter the 27 July in the final phase of its clinical trials for a vaccine against the COVID-19, in order to test the effectiveness of the latter in real-world conditions.
This announcement came at a time where were published the results of the first phase of the trial of Moderna, which was intended to verify that the vaccine was safe and that it triggered the production of antibodies.
Pivotal phase 3 trial, which will therefore be launched at the end of the month, will appeal to 30,000 people in the United States: half of them will receive a dose of 100 micrograms, the other a placebo.
The researchers will then follow for two years to determine if they are protected against infection by SARS-CoV-2. Or, if they are still infected, if the vaccine can prevent the progression to symptoms.
Even if symptoms are recognized, the vaccine can be considered a success if it prevents serious cases of Covid-19.
The study is expected to last until 27 October 2022, but the preliminary results should be communicated before that date.
This announcement puts Moderna is in the forefront of the global race for a vaccine against the disease, which has infected more than 13 million people in the world, and more than 570 000 people dead.
It comes after the publication Tuesday in the New England Journal of Medicine the results of the first phase of the trial of Moderna, after which the experimental vaccine triggered antibodies against the coronavirus among all participants, the number of 45.
The announcement was made shortly after the publication in the New England Journal of Medicine the results of the first phase of the trial of Moderna, after which the experimental vaccine triggered antibodies against the coronavirus among all participants, the number of 45.
Moderna had made public the “interim results” of this Phase 1 in may, according to which the vaccine had induced an immune response in eight patients.
These results were called” encouraging ” by the immunologist Anthony Fauci, and the full study was eagerly awaited by the scientific community.
According to the article published on Tuesday, the 45 participants in Phase 1 were divided into three groups of 15, to which doses of 25 micrograms, 100 micrograms, and 250 micrograms were administered.
They have received a second dose, in the same amounts, 28 days later.
After the first administration, it was found that the antibody levels were higher with the higher doses; after the second, the participants had higher levels of antibodies that most of the patients having had the Covid-19, and having generated their own antibodies.
More than half of the participants experienced any side effects mild or moderate, this is considered normal.
Among these side effects include fatigue, chills, headaches and pain where the vaccine was injected.
Three participants did not receive a second dose. One has developed a rash on both legs, and the other two have missed the window of opportunity because they have developed symptoms of Covid-19. Their tests, however, proved to be negative.
Amesh Adalja, infectious disease specialist at the Johns Hopkins university, found it encouraging that the participants have developed high levels of antibodies.
But ” we really need to limit the extrapolations from a clinical trial of phase 1, because we want to see how it works when a person is exposed to the true virus “, he added.
And the technology of Moderna, based on the messenger RNA, has never been shown to be effective against other viruses. It aims to give the body the genetic information needed to trigger preventive protection against the coronavirus.
Previous work using this technology have had the opposite effect to that desired, making recipients more likely to be infected, explained David Lo, professor at the University of California Riverside.
“One of the things that we need to monitor, this is if there is an effect on the long-term where the immune response (…) is developing a potential immunological tolerance, which would in fact be deleterious to protection “, he said.