Moderna Submits Covid-19 Vaccine for FDA Regulatory Approval

Today, Moderna announced that its company would submit its coronavirus vaccine for regulatory approval — the second leading drug to pass the milestone this month.

The Massachusetts biotech firm said it will ask the Food and Drug Administration for emergency use authorization after completing its Phase 3 trial, finding the vaccine was 94.1 percent effective against Covid-19. Moderna said the vaccine was 100 percent effective at preventing severe cases of the disease.

The company said that the results were the same across all ages, races, and gender categories. They added that there have been no serious safety concerns so far, with the most common side effects being fatigue, headaches, muscle and joint pain.

Moderna said it expects the FDA’s Vaccines and Related Biological Products Advisory Committee to convene on Dec. 17 to discuss its submission. That is a week after the FDA is expected to discuss another candidate, developed by the U.S. pharma giant Pfizer and its German partner BioNTech, which has also applied for regulatory approval having observed a similar level of efficacy.

Both the Moderna and Pfizer-BioNTech drugs involve inserting a special code called mRNA into the body, tricking it into developing an immune response. No mRNA-based drug has ever won approval before.

Hajo Zeeb, a professor at Germany’s Leibniz Institute for Prevention Research and Epidemiology, said it’s hugely encouraging that two separate studies both found similarly high levels of success.

He said, “I would be surprised if something different came out in the FDA process, and I think these are highly likely to be approved.”

Though optimistic, Zeeb cautioned that the exact percentages may change once hundreds of millions, rather than tens of thousands of people, start taking the vaccine.

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

Moderna received more than $1 billion in U.S. federal government funding to develop and produce its candidate, and another $1.5 billion to supply it to the American public.

The trial involved 30,000 people. Half were given the vaccine candidate, and the other half a placebo. Of this group, the scientist recorded 196 cases of Covid-19, only 11 were from the group that had been given the vaccine, 30 of the cases had serious illnesses — all of them in the placebo group.

The company said out of the 15,000 people given the vaccine; not one became seriously ill with Covid-19 during the trial period.

Last week, AstraZeneca and Oxford University championed their own promising results, only to later admit there had been a technical error during its trial and that it was planning on running some additional tests. Like the others, there has been no suggestion its vaccine is unsafe.

While developments have been met with optimism among scientists and stock markets, experts are urging caution until more data is released beyond the various companies’ triumphant non-peer-reviewed press releases. These vaccine trials are primarily geared toward preventing symptomatic disease, but questions remain about how effective they are at stopping transmission.

President-elect Joe Biden has also warned that vaccines may do nothing to soften the tough winter facing the U.S., Europe, and elsewhere.

As coronavirus cases continue to surge, and more than 267,000 Americans, experts fear that Thanksgiving might bring yet more fatalities. A similar wave gripped Europe until widespread lockdowns began to turn the tide. More than 1.4. million have been killed globally.

Even if these drugs get regulatory approval, rolling out the shots to billions of people worldwide will involve a byzantine supply-chain challenge at a scale never attempted before.

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