Moderna Sends Coronavirus Vaccine to FDA for Approval

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The US pharmaceutical firm Moderna filed for Food and Drug administration approval for its coronavirus vaccine on Monday, just several days after its rival, Pfizer, sent its own vaccine to the FDA.

If the emergency authorization is granted, vaccinations could begin as early as December 21, 2020, according to Stéphane Bancel, the company’s chief executive officer.

The scientists of Cambridge, Massachuetts-based Moderna, Inc. Credit: Moderna/Facebook

The Pharma giant, headquartered in Cambridge, Massachusetts, had stated on November 16 that its vaccine, which also employs RNA technology like the Pfizer/BioNTech shot, had a 94.5% effectiveness rate according to its patient testing.

On Monday, the company stated that at the time of referral to the FDA, the vaccine’s effectiveness had most recently proven to be 94.1%, and that its trials, including 30,000 subjects, met all the appropriate scientific criteria that are needed for approval.

Even more impressively, the Moderna vaccine has been proven by data to be 100% effective in the prevention of “severe” Covid-19. The Cambridge firm produced the vaccine in collaboration with US government scientists from the Vaccine Research Center at the National Institute for Allergy and Infectious Diseases.

Bancel said in the interview that the company was on track to produce 20 million doses by the end of next month — and “500 million to one billion” in 2021.

Each individual  must receive two doses of the vaccine, administered one month apart; similar to the Pfizer vaccine, this means 20 million doses will cover the vaccination needs of 10 million people.

The news comes as another welcome sigh of relief for a suffering world, after Pfizer/BioNTech submitted their vaccine application to the FDA on Nov. 20. Pfizer has stated that it can produce up to 50 million doses this year, with about half going to the United States.

It has been widely reported that the very first vaccines will go to frontline health care workers as well as as essential workers such as police officers and those who work in other critical industries. Employees and residents in nursing homes will most likely also be some of the first to receive the shots.

The Wall Street Journal reported that a panel of advisers to the Centers for Disease Control and Prevention will meet on Tuesday to determine how to allocate those most precious initial supplies of the vaccine.

This was another piece of very welcome news amidst the second surge of the virus across much of the world, which has proven in some areas to be even more deadly than the first as pandemic fatigue set in.

Officials have warned in the United States that the situation may even worsen in the coming weeks as more than six million Americans traveled by air to celebrate the Thanksgiving holiday last week,

The month of November saw the diagnosis of more than four million new coronavirus cases in the United States — along with and 25,500 deaths in those who had suffered with the virus.

Current figures show that a total of 13.3 million Americans have contracted Covid-19, and more than 265,900 have succumbed with the disease.

Globally, there have been nearly 62 million coronavirus cases and almost 1.5 million deaths in this who had the disease.

The Oxford University/AstraZeneca vaccine has also proven to be highly effective in its trials, up to 90%, according to recent statements by its CEO and it is expected to be placed before regulators for approval soon.

One odd glitch in that vaccine appears to be that it gives 90% protection after the first half dose but only 62% protection after the second half dose. Trials of this vaccine are ongoing.

Moderna CEO Bancal stated that the FDA will examine the results of their vaccine’s trials and there will be a final review on December 17 by expert advisers — who may make a decision within 24 to 72 hours.

Operation Warp Speed officials have stated previously that whatever vaccine is approved first may be given to individuals within 24 hours after the FDA gives the green light.

Unlike Pfizer/BioNTech, which has already begun shipping its vaccine around the nation in anticipation of its approval, Moderna has not done so at this point and will wait for FDA approval, according to Bancel.

The United States government has already arranged for the payment for vaccines from Pfizer and Moderna and President Trump has assured the nation that they will be provided free of charge.