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, after the publication of the preliminary results are promising.
Pivotal, phase 3 trial will involve 30,000 people in the United States; half of them will receive a dose of 100 micrograms, the other a placebo.
The primary goal of this trial will be whether the vaccine is safe and prevents the infection by the SARS-CoV-2. If a person is still infected, it will also know 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.
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 chinese company SinoVac is also at an advanced stage of the research, and the Russian agency TASS announced that Russian scientists had completed clinical trials for a vaccine, but these have not made the data public.
Scientists warn, however, that the first vaccines arriving on the market are not necessarily the most effective or the safest.
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.
Moderna had made public the “interim results” of its Phase 1 in the form of a press release on its website 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.
The company has since gone on to the next step of his trial, with 600 people.
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 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, without these latter reach the level at which it would have had to cancel the test.
Among these side effects include fatigue, chills, headaches and pain where the vaccine was injected.
Three participants did not receive a second dose. One of them has developed redness 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.
Moderna is among the first in the global race to the vaccine, receiving 483 million dollars from the u.s. government.
If the dose chosen for testing (100 micrograms) should prove effective, Moderna is expected to be able to produce 500 million doses per year, and ” possibly up to $ 1 billion “.