F.D.A. Panel Endorses Moderna’s Coronavirus Vaccine

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Moderna’s study found that 91.6 percent of recipients had sore arms, 68.5 percent had fatigue, 63 percent headaches, 59.6 percent had muscle pain, 44.8 percent had joint pain and 43.4 percent had chills. Some participants also had swollen lymph nodes in the armpit on the side where they received the injection.

At the meeting on Thursday, company scientists emphasized that the vaccine does not alter a person’s genes or interact with DNA, and that the mRNA is quickly broken down and does not linger long in the body.

Both the Moderna and Pfizer-BioNTech studies reported a small number of cases of a temporary facial paralysis called Bell’s palsy. Moderna found three cases in the vaccine group and one in the placebo group, and Pfizer had four cases, all in the vaccine group. F.D.A. reviewers did not think the disorder was related to the vaccine. On Thursday, Moderna said the company would monitor for the condition.

Shipping of the vaccine will be managed by the Trump administration’s Operation Warp Speed, but each state will decide where its doses should go. Tennessee, for example, plans to disperse most of its anticipated allocation of 115,000 initial doses next week among all 195 of its local health departments, which will inoculate first responders, and to every hospital in the state that did not receive a Pfizer shipment this week.

North Carolina, too, will send doses of the Moderna vaccine next week to its local health departments and many smaller hospitals, though it plans to reserve half its initial shipment for long-term care facilities.

In Kentucky, Gov. Andy Beshear told reporters that he expected close to 80,000 doses of the Moderna vaccine in the state’s initial shipment, adding, “We’re going to ensure we have some allocation for every acute care hospital across the commonwealth.”

And in Massachusetts, Gov. Charlie Baker said Tuesday that 110,000 of the state’s expected 120,000 Moderna doses would go to smaller hospitals and outpatient clinics, including community health centers.



Source : Nytimes