
FDA Grants EUA for J&J's 1-Dose COVID-19 Vaccine
The FDA granted emergency use authorization (EUA) for the distribution of the nation's third COVID-19 vaccine, and on Sunday, a CDC panel will meet to decide on recommendations to put it into practice.
As expected, the
On Friday, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), a panel of outside infectious disease experts, other doctors, and medical researchers,
On Sunday, the
The last EUA was granted on December 18, 2020, for the
The J&J vaccine, Ad26.COV2.S, is a replication-incompetent adenovirus type 26 (Ad26) vectored vaccine encoding a stabilized variant of the SARS-CoV-2 S protein, meaning it helps prime the immune system to fight coronavirus. The vaccine platform has also been used for the company’s Ebola vaccine and construct its Zika, RSV, and HIV investigational vaccine candidates.
Each vial, which can be stored at normal refrigerator temperatures, has 5 doses per vial.
J&J plans to begin trials of the vaccine in pregnant women as well as adolescents, and a trial looking at a 2-shot version is also underway.
Shortly after the FDA announcement, President Joe Biden called it an "exciting development" but urged Americans not to pretend the fight is over.
"We know that the more people get vaccinated, the faster we will overcome the virus, get back to our friends and loved ones, and get our economy back on track," he said in a statement. Echoing caution that was issued by his top health officials Friday, he said, "As I have said many times, things are still likely to get worse again as new variants spread, and the current improvement could reverse."
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