White House COVID-19 adviser Anthony Fauci suggested the Johnson & Johnson COVID-19 vaccine should have required two doses after a Food and Drug Administration (FDA) panel recommended booster doses for the vaccine when it becomes available. “This should have been a two-dose vaccine to begin with,” Fauci told ABC News on Sunday morning, adding: “I…
US FDA Declines to Approve Revance’s Frown-Line Treatment
Revance Therapeutics Inc said on Friday the U.S. Food and Drug Administration (FDA) had declined to approve its long-acting injectable drug to treat moderate to severe frown lines, sending its shares plunging 29 percent. The company said the FDA pointed to “deficiencies” related to the regulator’s inspection of Revance’s manufacturing site. No other concerns were…
Second Dose of Johnson & Johnson COVID-19 Vaccine Recommended for All US Adults
Every adult 18 and older in the United States who received the single-shot Johnson & Johnson COVID-19 vaccine will be able to get a booster dose if the Food and Drug Administration (FDA) accepts a recommendation from its advisory panel. The panel unanimously voted Friday to advise the agency to authorize boosters for all adults,…
FDA Panel Unanimously Recommends Authorization of Moderna COVID-19 Vaccine Booster
A Food and Drug Administration (FDA) advisory panel voted unanimously on Thursday to recommend the agency let millions of Americans get a booster of Moderna’s COVID-19 vaccine. The 19–0 vote came after hours of discussions and presentations in an all-virtual meeting. Moderna officials presented data from clinical trials, including a small trial that studied the…
Some Americans May Be Able to Get 4 Doses of COVID-19 Vaccine: FDA
Some Americans may be able to get two additional doses of messenger RNA-based COVID-19 vaccines, with the possibility of the primary series being expanded from two to three doses, Food and Drug Administration (FDA) scientists said Thursday. Moderna has sought authorization for a third dose, or a booster, for its COVID-19 vaccine and the FDA…
FDA Says J&J Booster Could Bolster Protection, but Not Enough Time to Independently Analyze Data
U.S. drug regulators on Wednesday said a second shot of Johnson & Johnson’s COVID-19 vaccine could bolster people’s protection against the disease, but that they did not have enough time to independently analyze the data the company submitted. Both Johnson & Johnson and Moderna are asking regulators to allow boosters for their vaccines following the…
FDA Spells Out Lower Sodium Goals for Food Industry
NEW YORK—Food companies are coming under renewed pressure to use less salt after U.S. regulators spelled out long-awaited guidelines aimed at reducing sodium levels in dozens of foods including condiments, cereals, french fries, and potato chips. The voluntary goals that were finalized on Wednesday for 163 foods are intended to help lower the amount of…
FDA Scientists Decline to Take Stance on Moderna COVID-19 Booster Shots
Scientists at the Food and Drug Administration (FDA) on Tuesday said they were not taking a stance on a proposal to authorize booster shots of Moderna’s COVID-19 vaccine. Moderna has asked the FDA to expand the emergency use authorization for its jab to allow a third dose for millions of Americans, pointing to waning effectiveness…
Merck Seeks Authorization From US Regulators for Antiviral COVID-19 Treatment
Merck and its partner on Monday announced they filed an emergency use authorization application with the U.S. Food and Drug Administration (FDA) for their oral antiviral medicine for the treatment of COVID-19. The pill is meant to combat cases of mild or moderate COVID-19. Merck said last week that an interim analysis of its phase…
Pfizer Board Member: Potential COVID-19 Vaccine Mandate For Young Children ‘A Long Way Off’
October 10, 2021
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AMERICACCP VirusCDCchildrenCOVID-19 vaccine mandateDr. Scott GottliebFDAPfizer BioNTechUSVaccines & Safety
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Dr. Scott Gottlieb, former Food and Drug Administration (FDA) commissioner, said on Sunday that he believes a potential COVID-19 vaccine mandate for young children is likely to be “a long way off.” Gottlieb, now a board member for U.S.-based pharmaceutical company Pfizer, said during an appearance on CBS’s “Face the Nation” that such a mandate…
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