Moderna is seeking FDA emergency approval for its coronavirus vaccine


The pharmaceutical company Moderna said it would turn to the Food and Drug Administration on Monday to authorize its coronavirus vaccine for emergency use.

The first injections can be given as early as December 21 if the process runs smoothly and is approved, said Stéphane Bancel, the company’s CEO, in an interview.

The use of Moderna is based on data also announced on Monday showing that the vaccine is 94.1 percent effective and that its study in 30,000 people met the scientific criteria needed to make the vaccine work. The determination of the full data set is consistent with an analysis of previous data published on November 16 that the vaccine is 94.5 percent effective.

The new data also showed that the vaccine was 100% effective in preventing serious diseases of the coronavirus. The product was developed in collaboration with government researchers at the Vaccine Research Center of the National Institute of Allergic and Infectious Diseases.

Mr Bancel said the company was “on track” to produce 20 million batches by the end of December and 500 million and one billion batches by 2021. 10 million people.

Moderna is the second vaccine manufacturer to apply for an emergency license; Pfizer filed its application on November 20th. Pfizer says it could produce up to 50 million doses this year, with about half going to the United States. Your vaccine also requires two doses per person.

The first enrollment of the two vaccines is likely to target certain groups, including health care workers, key workers such as police officers, people in other critical industries, and employees and residents working in nursing homes. On Tuesday, the Advisory Board of the Center for Disease Control and Prevention will meet to determine how the initial set of vaccines will be distributed.

The encouraging news comes at a particularly grim moment in the U.S. health crisis. Coronavirus cases have rushed and repressed hospitals in some regions, and health officials have warned that the number could rise even worse in the coming weeks due to Thanksgiving trips and gatherings. In November alone, more than four million new cases and 25,500 deaths occurred in the United States.

In all, about 13.3 million Americans became infected with the virus and more than 265,900 died. There were nearly 62 million cases and nearly 1.5 million deaths worldwide.

More than 70 coronavirus vaccines are being developed worldwide, including 11, which, like Pfizer and Moderna, are in large-scale trials to measure efficacy.

One was made by AstraZeneca, which announced positive but thought-provoking preliminary results on November 23: its vaccination was 90 percent effective in people who received half a dose and then a full dose, but 62 percent effective in those who received two full doses. . Researchers are waiting for more data.

Moderna’s application for an emergency license will include data from a Phase 3 study of 30,000 people. The hundreds-page application also contains thousands of pages of additional data.

FDA scientists will review the information and the application is likely to be subject to a final review on December 17 by the agency’s expert advisory board, Mr Bancel said, adding that he expects the advisors to make a decision within 24-72. hours. The FDA generally follows the recommendations of its advisory bodies.

Warp Speed, a government program to accelerate vaccine development, said vaccinations could begin within 24 hours of FDA approval.

Mr Bancel said Moderna has not yet started delivering vaccines across the country and will not do so until an emergency permit is granted.

The government has decided to buy vaccines from both Moderna and Pfizer and provide them to the public for free. Moderna has received a $ 955 million commitment from the U.S. government’s Biomedical Advanced Research and Development Authority for vaccine research and development, and the U.S. has committed up to $ 1.525 billion to purchase 100 million doses.

Moderna and Pfizer vaccines use a synthetic form of genetic material from the coronavirus, called messenger RNA or mRNA, to program human cells to make many copies of a portion of the virus. This fragment of the virus triggers alerts in the immune system and detects and attacks it when the real virus tries to break in.

No mRNA vaccine has previously hit the market, and Pfizer and Moderna candidates have faced significant skepticism from scientists and the cautious public.

But the powerful results of both vaccinations began to dispel doubts.

So far, none of the vaccines have had serious side effects, but many recipients have suffered from headaches, mild fever, fatigue, joint and muscle pain, and arm pain for a day or two.

Half of the 30,000 people in the Moderna study were vaccinated and half received a placebo from salt water; neither the participants nor their physicians knew who received what. The researchers then monitored the participants to find out who was infected with the coronavirus and watched for side effects.

A total of 151 cases of Covid-19 were required to statistically determine vaccine efficacy.

Because the coronavirus is growing rapidly in the United States, Moderna caused 196 cases – 185 in the placebo group and 11 in the vaccinated group, meaning the vaccine was 94.1 percent effective in preventing Covid-19.

Thirty participants had severe cases, both in the placebo group. One is dead.

Mr Bancel said he considered statistics on the prevention of major diseases to be the most important data in the study.

“That’s why I think this vaccination is going to be a game changer,” he said. The vaccine reduces hospitalizations and deaths, he added. “I hope this country returns to its pre-pandemic state.”

Moderna said it is also seeking marketing authorization for its vaccine in Europe, Canada, Britain, Israel and Singapore.