21-05-2020 by Mirai
"Younger people are unlikely to get vaccinated next year, or even in 2022," Moderna CEO Frenchman Stéphane Bancel said Tuesday.
Among the 169 coronavirus vaccine projects launched worldwide, 12 of which are in clinical trials, one of them is currently shining: that of the American biotechnology company Moderna. It even stands out in the world stock markets, which fly with the company's good news announcement and decline when doubts arise. Here we bring everything that is known about this vaccine.
What are the first results of clinical tests?
After being among the first in the world, starting March 16, to begin testing its candidate vaccine in humans, developed in 63 days, Moderna announced on Monday May 18 the preliminary results of its tests, called phase I. According to American biotechnology, founded nine years ago and in which the American government has invested $ 483 million, they are encouraging. In fact, in eight people, the experimental vaccine, called mRNA-1273, triggered an immune response similar to that seen in people who have been naturally contaminated with the virus that causes Covid-19.
"I saw the results, they are amazing," he immediately welcomed the President of the United States, Donald Trump, who wants 300 million doses to be ready by January 2021 to vaccinate the American population. "I am very happy and the markets have risen," he added, the New York Stock Exchange ended on Monday, Moderna's stock soared nearly 20%.
Why should we be careful?
The enthusiasm of the markets was quickly tempered by the publication on Tuesday of an article on STAT, an American news website specializing in health and medicine. In it, journalist Helen Branswell points out several limits to the results disclosed by Moderna, aided by the analysis of two vaccine experts. First, the silence of the National Institute of Infectious Diseases (NIAID), led by the famous doctor Anthony Fauci, adviser to Donald Trump in this health crisis, partner of Moderna in the development of this vaccine and, generally, very quick to brag about his successes.
The data revealed by Moderna are also very fragmented, since they only concern eight volunteers of the 45 patients studied: what about the other 37? Another element that bothers specialists: the fact that Moderna does not publish its results in scientific journals, but only discloses them in press releases. According to Helen Branswell, a way of doing things that is not enough to attract the graces of the scientific community, which requires numbers instead of words.
How does this vaccine work?
The candidate vaccine developed by Moderna is based on a technology called messenger RNA, which aims to provide the body with the genetic information necessary to preventively protect itself against the coronavirus. A technique also used by twenty other research teams around the world, but has not yet proven effective. "No licensed vaccine in humans today is based on RNA," says Judith Mueller, an epidemiologist at the Institut Pasteur and the School of Advanced Studies in Public Health (EHESP).
So why did Moderna choose this technology? Because it allows "to be able to produce quickly in large quantities," says Judith Mueller. Exactly what is needed for Covid-19, a global virus that attacks almost every country on the planet (almost 5 million infections and more than 320,000 dead). Therefore, several billion people may be interested in a potential vaccine.
What steps do they follow?
Moderna's candidate vaccine is still in phase I of the health protocol, which has three phases. Therefore, it is behind the project led by the Chinese biotechnology CanSino, in collaboration with the Chinese Academy of Military Medical Sciences, the only one that has already entered phase II. The results revealed Monday by the US company only refer to "provisional" data. A date for the publication of the full results of the first stage has not yet been announced. Regardless, Moderna has already received the green light from the US Food and Drug Administration (FDA) to enter Phase II testing. With 600 patient coverage, it should start at least in June. As for Phase III, which usually takes place in thousands of people, it should start in July, said Stephen Hoge, president of Moderna.
"In the most optimistic scenario, if everything goes well, and there are 50 reasons for delays, it is not entirely impossible that during the October-November period," the company has enough data to judge theeffectiveness of this vaccine and thus provide a file to regulatory agencies in Europe and the United States, Moderna CEO French Stéphane Bancel said Tuesday. But a problem can still be detected, even at the end of the process, emphasizes Judith Mueller. And he cites the example of a candidate vaccine against dengue, a viral disease transmitted to humans by mosquitoes. "We had to wait for phase III to realize that if we injected the vaccine into people who were never infected with the virus, they would be at greater risk than without a vaccine," said the specialist.
When can it be available?
Once the dossier is submitted to global health authorities, approval of the Modern vaccine could take, in the United States, "a few weeks instead of six months," under an expedited procedure, CEO Stéphane said. Bancel To see if Europe also chooses to shorten the regulatory process. the old continent to which Stéphane Bancel sent a message on Tuesday, asking them to place an order quickly, with delivery times ranging from "6 to 9 months". To make them as small as possible, the company has already announced, like some large laboratories, that it would start producing millions of doses without waiting for the results of clinical trials.
There are currently around a hundred coronavirus vaccine projects in progress, ten of which are in clinical trials.
But the question of production capacity will quickly arise. In fact, "it is difficult to imagine a laboratory that, by itself, has sufficient production capacity for this vaccine," says health economist Nathalie Coutinet, a professor and researcher at the Sorbonne Paris Nord University. Hence the agreement recently signed by Moderna with the Swiss pharmaceutical and chemical giant Lonza, with the aim of being able to manufacture up to a billion doses per year. Despite this, biotechnology, which until now has never received a drug or vaccine license, may not be able to serve everyone right away. "We will have to work with different governments to find out who are the people who need it most," said Stéphane Bancel, citing the hospital, the elderly and people at risk. Rather, "younger people are unlikely to get vaccinated next year, or even in 2022."
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