Pharmaceutical company Moderna announced that it would submit its coronavirus vaccine for emergency FDA approval on Monday, following clinical trial data showing its vaccines to be highly effective in preventing cases of COVID. 19.
Once submitted, Moderna will be the second coronavirus vaccine undergoing emergency approval by the U.S. Health Agency. Pfizer submitted its vaccine for approval earlier this month.
Moderna’s request to the FDA will be based on 196 cases of COVID-19 reported in its clinical trial of 30,000 people. One hundred and eighty-five of the people who became ill had received a placebo vaccine, indicating that the vaccine was 94.1% effective. The 30 cases of severe COVID-19 were in the placebo group and one person in the group died of the disease.
These promising results are in line with preliminary data the drug company announced earlier this month. No serious side effects have been reported.
If approved, the Pfizer and Moderna vaccines could begin delivery in the United States as early as December. The FDA emergency approval meeting for Pfizer’s vaccine is scheduled for December 10, while Moderna said it is scheduled to take place on December 17. How long it will take the health agency to approve a vaccine is unclear: Peter Marks, head of The Center for Biologics Evaluation and Research at the FDA, said it could take days or even weeks. Once approved, Operation Warp Speed chief operating officer General Gus Perna said last week he would be able to start shipping vaccines across the country within 24 hours.
The CDC presented a three-phase vaccine distribution plan that recommends that each state give the vaccines to health workers first. The elderly, essential workers and people with underlying health problems are as follows. Mass vaccination is expected to begin in the United States by April.
The encouraging news comes as the US health crisis continues to rapidly escalate. The United States has recorded more than 4 million COVID-19 cases and more than 25,000 deaths in November alone, hospitals across the country are overwhelmed, and public health officials warn there will be an even larger spike important after the Thanksgiving holidays. More than 266,000 Americans have died from COVID-19 to date, some of the nearly 1.5 million people around the world who have died from the disease.
By the end of 2020, Moderna said it expects to have 20 million doses of its vaccine available in the United States and hopes to manufacture between 500 million and 1 billion doses globally by 2021.
The Moderna and Pfizer vaccines are both part of a new class of gene messenger RNA (mRNA) vaccines that have not yet been approved for use in humans. They carry genes that instruct human cells to make viral proteins, triggering the body’s immune response.