Moderna Vaccine Gets OK from FDA; EU to Receive 160 Million Doses

The coronavirus vaccine developed by the American pharmaceutical firm Moderna, based in Cambridge, Massachusetts, along with the National Institute of Allergy and Infectious Diseases (NIAID) was cleared by the FDA on Friday after receiving the all-important thumbs-up from its independent panel of experts on Thursday.

This is the second highly-effective vaccine to be cleared for emergency use in the United States. An FDA analysis found the Moderna vaccine is more than 94% effective at preventing Covid-19 in a trial involving more than 30,000 participants.

“I want to thank the thousands of participants in our clinical trials and the staff at our clinical trial sites who have been on the front lines of the fight against the virus,” said Moderna CEO Stéphane Bancel in a statement on Friday evening.

“I want to thank the NIH and NIAID for their scientific leadership and our partners at BARDA and Operation Warp Speed who have been instrumental to accelerating our progress to this point.

“I am proud of what the Moderna team has achieved in collaboration with our partners. We were able to create and manufacture the Moderna COVID-19 Vaccine in 11 months … I am thankful to all those who have helped us get here today. We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease.”

The second vaccine to be approved in the last two weeks, after a year in which the globe was ravaged by the effects of the coronavirus, the Moderna product resembles the first, produced by Pfizer and BioNTech, which also uses mRNA technology.

One important difference in this vaccine, however, is that it does not need to be stored at the arctic temperatures (-92 Celsius) required by the first serum to be cleared for emergency use. It can be refrigerated safely for up to 30 days.

Experts say that Moderna will be able to provide 60 million doses by the end of next week and 20 million by the end of the year. The Pharma giant, headquartered in Cambridge, Massachusetts, had stated on November 16 that its vaccine 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.

In even more encouraging news, Dr. Zeynep Tufekci and Dr. Michael Mina, who have written extensively about the pandemic, shared extremely positive results of the findings presented to the FDA in a new Op-Ed column for the New York Times today.

As is already known, each person receiving both the Pfizer or the Moderna coronavirus vaccine must be inoculated twice, with shots coming approximately one month apart; this means that 20 million doses will provide protection to 10 million people.

In the trials, involving many tens of thousands of subjects, the writers say that “both vaccines demonstrated a stunning 95 percent efficacy in preventing Covid-19 — a number exceeding our best hopes.”

The doses, involving a first “prime,” followed by a second, “booster” shot, are to be administered 21 days apart for the Pfizer vaccine and 28 days for the Moderna serum. However, the physicians state, it appears in data that was provided by the firms to the FDA that even one single dose “may provide significant levels of protection against the disease.”

If this unusual and welcome development proves to be true in widespread practice, “it would be a game changer,” according to the physicians, meaning that twice the number of individuals could possibly receive the vaccine than had been previously thought.

This may be hugely important in countries where chronic medical care issues and vaccine shortages pose problems even in the best of times.

However, Tukekci and Mina state that much more data is needed — and quickly — to determine if this is the way to go.

It was reported that for both vaccines, a sharp drop in infection rates in the vaccinated group began approximately 10 to 14 days after subjects had received the first inoculation. Moderna reported that their initial inoculation was 92.1 percent efficacious in preventing Covid-19 beginning as soon as two weeks after the initial shot.

We just announced that the FDA has authorized the Moderna COVID-19 Vaccine in the U.S. for emergency use to prevent COVID-19 in individuals 18 and over. The Moderna COVID-19 Vaccine has not been approved or licensed by the FDA. https://t.co/zyd6dfJr53 pic.twitter.com/oNeB3DXazu

— Moderna (@moderna_tx) December 19, 2020

Another bit of positive news emerged on Thursday when the American Pharma giant Johnson & Johnson announced that it had completed the enrollment for its Phase 3 clinical trials for its own vaccine, capping the study at 45,000 participants. The company added that it intends to release the interim data it gathers from the trials by the end of January, 2021.

We just announced that the European Commission has exercised its option to purchase an additional 80 million doses of mRNA-1273, our COVID-19 vaccine candidate, bringing its confirmed order commitment to 160 million doses. Read more: https://t.co/ZmV6IpbBP9 pic.twitter.com/pEDF1kIqFC

— Moderna (@moderna_tx) December 18, 2020