C.D.C. Panel Endorses Moderna Vaccine for Americans

The Four Percent


As the coronavirus continued to surge across the United States, an independent panel of experts advising the Centers for Disease Control and Prevention voted on Saturday to endorse a second coronavirus vaccine for use in the United States.

The committee’s recommendation follows an emergency authorization granted by the Food and Drug Administration on Friday. The committee’s endorsement now awaits final approval by Dr. Robert R. Redfield, director of the C.D.C., expected shortly.

Some 5.9 million doses of the Moderna vaccine are slated for distribution starting on Sunday, and the first inoculations are expected to begin sometime on Monday.

Unlike the Pfizer-BioNTech vaccine, which was authorized for use in people 16 and older, Moderna’s vaccine is approved only for people 18 and older. While Pfizer began clinical trials of its vaccine in children as young as 12 in October, Moderna did not begin its pediatric studies until this month and does not expect to have complete data on safety and efficacy until sometime next year.

Some experts have pointed to polyethylene glycol, or PEG, a chemical found in many pharmaceutical products, including laxatives like Miralax, that has very rarely been found to cause allergic reactions. Both the Pfizer-BioNTech and Moderna vaccines contain PEG, though in slightly different formulations.

Dr. Sarah Mbaeyi, a medical officer at the C.D.C., said the agency was recommending that people who know they have severe allergies to any ingredient in the vaccines abstain from getting the shots for now.

People with a history of anaphylaxis to other vaccines or injectable therapies should consult their doctors and linger on site for monitoring for 30 minutes after their inoculation in case they start feeling sick. (Everyone else — including people who react strongly to other substances like food, pollen or pet dander, and people with mild allergies of any sort — may leave after 15 minutes.)

Three severe allergic reactions were reported in Moderna’s clinical trials, which included more than 30,000 adults, half of whom received a placebo instead of the vaccine. None were believed to be linked to the vaccine.

At the meeting, experts also raised concerns about four cases of a temporary facial paralysis called Bell’s palsy, three of which occurred in the vaccine group in the Moderna trial. (Four cases of Bell’s palsy also arose in Pfizer’s trials, all in the vaccine group.)

There’s no evidence yet that directly links the paralysis to either vaccine, and Dr. Jacqueline Miller, a senior vice president at Moderna, said her company was continuing to monitor vaccine recipients for the side effect.

More than half of people who received the Moderna vaccine in clinical trials reported uncomfortable symptoms, including fatigue, headaches and soreness, after their second shot, given about four weeks after the first. Some volunteers also developed a fever or a rash around the injection site.



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