Moderna Applies for Emergency F.D.A. Approval for Its Coronavirus Vaccine – The New York Times
The drugmaker Moderna said it would apply on Monday to the Food and Drug Administration to authorize its coronavirus vaccine for emergency use.
Mr. Bancel said the company was “on track” to produce 20 million doses by the end of December, and 500 million to a billion in 2021. Each person requires two doses, administered a month apart, so 20 million doses will be enough for 10 million people.
Over all, about 13.3 million Americans have contracted the virus, and more than 265,900 have died. Worldwide, there have been nearly 62 million cases and almost 1.5 million deaths.
One of those is made by AstraZeneca, which announced positive but puzzling preliminary results on Nov. 23: Its vaccine was 90 percent effective in people who received a half dose and then a full one, but 62 percent effective in those who received two full doses. Researchers are waiting for more data.
The government has arranged to buy vaccines from both Moderna and Pfizer and to provide it to the public free of charge. Moderna has received a commitment of $955 million from the U.S. government’s Biomedical Advanced Research and Development Authority for research and development of its vaccine, and the United States has committed up to $1.525 billion to buy 100 million doses.
The Road to a Coronavirus Vaccine
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Both Moderna’s and Pfizer’s vaccines use a synthetic form of genetic material from the coronavirus called messenger RNA, or mRNA, to program a person’s cells to make many copies of a part of the virus. That viral fragment sets off alarms in the immune system and trains it to recognize and attack if the real virus tries to invade.
No mRNA vaccine has reached the market before, and the candidates from Pfizer and Moderna have faced considerable skepticism from scientists and a wary public.
But the strong results from both vaccines have begun to quash the doubts.
So far, neither vaccine has had serious side effects, but many recipients have had headaches, mild fevers, fatigue, joint and muscle aches and sore arms for a day or two.
Of the 30,000 people in the Moderna study, half were vaccinated and half received placebo shots of salt water; neither the participants nor their doctors knew who got what. Then, researchers monitored the participants to see who contracted the coronavirus, and watched for side effects.
To determine statistically whether the vaccine was effective, a total of 151 cases of Covid-19 were needed.
Because the coronavirus has been surging in the United States, Moderna wound up with 196 cases — 185 in the placebo group, and 11 in the vaccinated group, meaning that the vaccine was 94.1 percent effective at preventing Covid-19.
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