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A committee of American experts meeting on Thursday decided to recommend the approval of the COVID-19 vaccine from the American company Moderna, which may pave the way for the Food and Drug Administration (FDA, for its acronym), in a matter of hours in English) authorizes its use in that country next week.
If that happens, Moderna’s will be the second vaccine approved in the United States and in the world to combat the ravages of the new coronavirus, after last week the Pfizer-BioNTech drug received the same authorization for emergency use from the US authorities .
Thanks to that, This week the first three million vaccines were distributed throughout the country, the most affected in the world by the pandemic.
This Thursday’s meeting was broadcast live to the public and ended with a favorable vote by a score of independent scientists and representatives of the pharmaceutical industry. The objective of the so-called FDA Vaccine and Biological Products Advisory Committee was to vote on whether or not to recommend approving this vaccine against covid-19.
(Also read: The FDA considers the Moderna vaccine to be safe and effective)
A vote in favor of the committee, however, is not binding and does not mean that the vaccine was automatically given the green light, as it is up to the FDA to make the final decision.
Scientists analyzed the results of a clinical trial with 30,400 volunteers that established that Moderna’s vaccine is 94.1 percent effective in preventing COVID-19 compared to a placebo, with slightly better performance in young adults. compared to the elderly.
The FDA had already endorsed the results of the submitted clinical trials, in which no “specific safety concerns” were found.
The most common side effects associated with this vaccine, called mRNA-1273, were fatigue (70%), headache (60%), muscle pain (60%), joint pain (45%), and chills (45%). ). The rare “serious” side effects tend to occur in younger participants more than older ones. Cases of lymphadenopathy, or swelling of the lymph nodes, appeared in 1.1% of the participants who received the vaccine, compared with 0.6% of those who received the placebo.
(You may be interested: Colombia, close to confirming its first vaccines against covid-19)
The vaccinated group also showed more allergic or inflammatory reactions (1.5% versus 1.1% for the placebo group), but none were classified as severe.
The clinical trial also recorded three cases of Bell’s palsy (generally temporary and not severe), one among the vaccinated participants and two among those who received the placebo. The Pfizer-BioNTech vaccine trial, on its side, counted four cases of this paralysis, all in the vaccinated group, for which the FDA recommended specific surveillance.
About the vaccine
Moderna, a small Massachusetts-based biotech company partnered with scientists from the US National Institutes of Health to develop the vaccine. Work began in January, shortly after China shared the Sars-CoV-2 virus genome.
His project has received more than 2.5 billion dollars from the United States government and has promised to deliver six million doses in a first phase.
Both the Pfizer and Moderna vaccines use mRNA (messenger ribonucleic acid) molecules to cause human cells to generate the coronavirus spike and thus prevent the coronavirus from sticking. Both companies used a slightly different formulation that resulted in different cold storage requirements: -70 degrees Celsius for Pfizer; -20 degrees Celsius for Moderna.
(See: The year science advanced like never before in history)
If approval is confirmed, the United States will have two vaccines available starting next week and accelerate the immunization campaign that began on Monday with the Pfizer / BioNTech product. The government’s goal is to vaccinate 20 million people in December. Health workers and residents of nursing homes will be the first.
HEALTH UNIT
