Current DateSeptember 17, 2021

Covid-19: Moderna’s vaccine to enter phase-3 trials

The American biotechnology company Moderna, one of the most advanced in the race to find a vaccine against the new coronavirus, announced very preliminary but encouraging results for its experimental vaccine in eight volunteers. It will launch phase 3 of its trial on July 27, on 30,000 people in the United States.

The young company, in which the US government has invested $483 million, has announced “positive interim data” from the initial phase of clinical trials: in eight people, the vaccine project called mRNA-1273 has triggered a similar immune response to what we see in people who have been naturally infected with the virus that causes Covid-19.

Moderna was one of the first two to inject humans with its vaccine project on March 16.

The administration of President Donald Trump, who wants 300 million doses by January to vaccinate the American population, invested early in the Moderna project as well as in those, less advanced, of the American group Johnson & Johnson and the French laboratory Sanofi, which has production sites in the United States.

The full results of the Phase 1 trial, involving 45 participants aged 18 to 55, were published in the New England Journal of Medicine and reveal that the vaccine has triggered the production of antibodies in all participants. Phase 2 had already received the green light from the United States Medicines Agency (FDA), which granted an accelerated development procedure.

The vaccine was developed in partnership with the National Institute of Infectious Diseases (NIAID), led by Dr. Anthony Fauci. The institute is also conducting the clinical trial.

The first data “suggest that mRNA-1273 has a high probability of creating protection” against the coronavirus, said Stéphane Bancel, director general of Moderna, during a conference call.

The company, founded nine years ago and based in Cambridge near Boston, has so far never received a drug or vaccine license. “We are overwhelmed by these interim data,” he said.

The second phase of the trial started in June on 600 people, said Stephen Hoge, president of Moderna, and the most important, phase 3, should start in July; the protocol is being finalized with the FDA.

Billions of doses needed

It usually takes years to develop a vaccine, but many governments and labs want one or more vaccines by next year, or even before the end of 2020, for emergency vaccinations.

China — where the pandemic started — reports that five experimental vaccines are being tested on humans.

The problem is not only to identify an effective and safe vaccine, it will then be necessary to manufacture billions of doses.

The major laboratories, as well as Moderna, have therefore announced that they would start producing millions of doses without waiting for the results of their clinical trials, an unprecedented risk-taking and largely funded by states and large non-governmental organizations.

Regarding Moderna, in the first trial phase, three groups of 15 volunteers received three different doses (25 micrograms, 100 micrograms and 250 micrograms), with a booster 28 days later.

In view of the first results, the scientists decided to eliminate the highest dose from the rest of the tests, since the lower doses seemed to have an effect. “The lower the dose, the more people you can protect,” said the president of Moderna.

The company recently announced a partnership with the giant Lonza to increase its production capacity and manufacture up to a billion doses per year, if the lowest dose is chosen.

Tests in mice have separately shown that the vaccine stops the virus from replicating in their lungs, the company said.

Phase 3 to start on July 27

Moderna is now on its way to the final phase of its trials, which will begin on July 27. It consists in measuring the effectiveness of the vaccine in real conditions. 30,000 people will participate in this trial, half will receive a dose of 100 micrograms, the other a placebo.

The researchers will then monitor patients for two years to see if they are protected from SARS-Cov2 infection or if the vaccine can stop the infection from progressing if infected, including whether the vaccine prevents a serious course .

The study is expected to last until October 27, 2022.