[News] FDA: Moderna's COVID-19 Vaccine Shows No Safety Issues

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Moderna's vaccine against covid-19 is safe and effective, estimated on Tuesday the United States Drug Agency (FDA) in an analysis that allows to predict its emergency authorization in the country before the end of the week.

The vaccine made by this young American biotechnology company does not present "specific safety problems" that "prevent the issuance" of an authorization for emergency use, according to the FDA, whose committee of experts will meet this Thursday.

If it finally gets approval, Moderna's immunizer will join Pfizer / BioNTech's one week later, which already received a green light from the FDA last Friday, for the largest vaccination campaign in US history.

The analysis published by the FDA details that of the 30,400 participants in the clinical trial, 196 contracted COVID-19 before November 21: eleven among those who received the vaccine and the other 185 in the placebo group.

The mean efficacy rose to 94.1%. It even went up to 95.6% for those under 65, compared to 86.4% for those over that age.

Among the 196 COVID-19 cases, 30 were serious, the FDA's analysis continues, and all were in the placebo group.

 

Side effects
The most common side effects of Moderna's vaccine, named mRNA-1273, are fatigue (70%), headaches and muscle aches (60%), as well as joint discomfort and chills (45%).

The rare "serious" side effects tend to occur in younger participants rather than older ones.

Cases of lymphadenopathy, or swelling of the lymph nodes, appeared in 1.1% of the participants who received the vaccine, compared to 0.6% of those who received the placebo.

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 (usually 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.

Both in the case of the immunizer from Moderna and that of Pfizer-BioNTech, the FDA judges the information it has insufficient to determine whether the vaccine is at the origin of the paralyzes.

Serious events with the potential to endanger the lives of the participants were rare, around 1% in each group, and there is nothing to say that the vaccine was the cause.

 

Mass vaccination
The US authorities plan to vaccinate about 20 million people before the end of December, 100 million before the end of March and the entire po[CENSORED]tion before the boreal summer.

Experts estimate that more than 70% of inhabitants must be vaccinated to end the epidemic.

The United States purchased 200 million doses of Moderna's vaccine, half of which will not be distributed until the second quarter of 2021. They also purchased 100 million doses of Pfizer / BioNTech's.

Initially, vaccines will be administered as a priority to the most exposed health workers and to inmates in nursing homes.

More than 300,000 people have died of COVID-19 in the United States, according to the Johns Hopkins University tally.

The world's leading economic power, which is also the country most mourned by the virus, continues to set new records, regularly exceeding 200,000 new cases per day and 2,500, and even 3,000 deaths every 24 hours.