FDA expands Pfizer COVID booster, opens extra dose to age 16
There’s one more step: The Centers for Disease Control and Prevention must formally recommend the boosters for this age group and a decision is expected soon.
There are 10 article(s) tagged FDA:
There’s one more step: The Centers for Disease Control and Prevention must formally recommend the boosters for this age group and a decision is expected soon.
The Food and Drug Administration already has OK’d kid-size doses — just a third of the amount given to teens and adults — as safe and effective for the younger age group.
The similarly made Moderna vaccine also is being studied in young children, and both Pfizer and Moderna also are testing shots for babies and preschoolers.
Shelby County Health Department Director Dr. Michelle Taylor said she was “cautiously optimistic as cases and the 7-day average and positivity rate are dropping.”
The first COVID-19 vaccines for U.S. use arrived at FedEx’s Memphis hub about 11:30 a.m. Sunday. By 4 p.m., vaccine shipments had started moving to final destinations. Related article: FedEx flying high into latest earnings report
About face comes after high-ranking experts, including Dr. Anthony Fauci, said early results did not prove the therapy works.
Since 2015, the FDA has sent warning letters to at least 23 companies about claims regarding their products. The FTC co-signed some of the FDA’s letters, including three sent in March, and sent letters to three companies on its own in September.
Active Implants’ president and CEO hopes to shave time off the FDA approval process for the company's synthetic meniscus device.
A procedure to insert the world's first commercially-approved heart device for babies weighing less than two pounds was performed at Memphis' Le Bonheur Children's Hospital.
PharMEDium, a mass-production compounding pharmacy that has had regulatory issues, has filed notice of plans for a layoff at its Memphis facility effective March 12.
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