Moderna submits a vaccine for official FDA approval


The coronavirus vaccine candidate, developed by Massachusetts Moderna biotechnology company, will be submitted for official approval on Monday, the company said, the second leading drug to meet the milestone this month.

Moderna said it is seeking emergency approval from the U.S. Food and Drug Administration after completing the Phase 3 study and found the vaccine to be 94.1 percent effective against Covid-19.

Moreover, according to Moderna, vaccination was 100% effective in preventing severe cases of the disease.

These results were the same in all age, race and gender categories, the company said in a statement. So far, there have been no serious safety concerns, he added, with the most common side effects being fatigue, muscle and joint pain, and headaches.

Moderna said it is looking forward to a meeting of the FDA’s Advisory Committee on Vaccines and Related Biological Products on Dec. 17 to discuss its submission. It’s a week after the FDA is expected to discuss another candidate, developed by U.S. pharmaceutical giant Pfizer and its German partner BioNTech, which also observed a similar level of effectiveness for regulatory approval.

Both Moderna and Pfizer-BioNTech drugs involve inserting a special code called mRNA into the body to develop an immune response. Previously, no mRNA-based drug has been approved.

Hajo Zeeb, a professor at the German Leibniz Institute for Preventive Research and Epidemiology, said it was extremely encouraging that two separate studies had similarly high success.

“I would be surprised if something else came to light in the FDA process, and I think they will most likely be approved,” he said.

Although optimistic, Zeeb warned that the exact percentages could change if hundreds of millions of people, rather than tens of thousands, start vaccinating.

“These are still small numbers overall,” he said of the sample size of the trial, “but the reduction in severe cases is exactly what we want to see. If it’s just a mild virus, we can live with it,” he said.

Moderna received more than $ 1 billion in U.S. federal government support to develop and produce its candidate, and received an additional $ 1.5 billion for the U.S. public.

The experiment involved 30,000 people, half of whom received the vaccine candidate and the other half received placebo. From this group, the scientists registered 196 Covid-19 cases, of which only 11 were the group that received the vaccine. There were 30 cases of serious illness – both in the placebo group.

Thus, none of the 15,000 people who received the vaccine became seriously ill with Covid-19 during the trial period, the company said.

Last week, AstraZeneca and the University of Oxford fought their own promising results, only later acknowledging that a technical error had occurred during the trial and that they plan to run further tests. Like the others, there was no suggestion that vaccination was unsafe.

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While recent developments have been widely optimized among scientists and stock exchanges, experts are also cautious until further data is released beyond the triumphant, expert-free press releases of various companies. These vaccination attempts are primarily aimed at preventing symptomatic diseases, but questions remain about how effectively they also stop transmission.

President-elect Joe Biden also warned that vaccines that take time to approve and introduce will do nothing to alleviate the harsh winter in the U.S., Europe and other countries.

Coronavirus cases continue to multiply, with more than 267,000 Americans dying and fears that Thanksgiving could cause even more deaths. Europe was caught up in a similar wave until widespread closures began to turn the tide. More than 1.4. millions were killed worldwide.

Even if these drugs get official approval, delivering the shots to millions of people around the world is a challenge to the Byzantine supply chain, they have never tried.