Dec 08 WATCH: FDA advisers endorse Pfizer COVID-19 vaccine for emergency authorization By Lauran Neergaard, Matthew Perrone, Associated Press A U.S. government advisory panel has endorsed Pfizer's coronavirus vaccine, in a major step toward an epic vaccination campaign that could finally conquer the outbreak. Continue reading
Dec 08 U.S. is taking final steps to review the first COVID-19 vaccine. Here’s what’s next By Associated Press The Food and Drug Administration posted a positive review of the Pfizer vaccine on Tuesday and will hold a public hearing on Thursday. The Associated Press has a look at the process. Continue reading
Dec 06 Watch 5:27 A whistleblower says the FDA isn’t properly regulating vaccine facilities While much attention has been given to approving a COVID-19 vaccine, there's been little paid to the facilities where many vaccines are manufactured. A recent investigation in Vanity Fair features a former FDA inspector turned whistleblower who says that the… Continue watching
Nov 30 Risk of COVID-19 scams as vaccine approaches FDA approval By Colleen Long, Associated Press The coronavirus vaccine inching toward approval in the U.S. is desperately anticipated by Americans longing for a path back to normal life. But criminals are waiting, too. They're ready to use that desperation to their advantage. Continue reading
Oct 23 AstraZeneca, Johnson & Johnson resume U.S. tests of COVID-19 vaccines By Linda A. Johnson, Associated Press Two drugmakers say they have the go-ahead to resuming U.S. testing of their COVID-19 vaccine candidates. Both are in the final stage of testing before the companies can seek regulatory approval. Continue reading
Oct 22 U.S. regulators, experts take up thorny vaccine study issues By Lauran Neergaard, Matthew Perrone, Associated Press With vaccines against COVID-19 inching closer, U.S. regulators took an unusual step Thursday in asking outside scientists: Are the government's standards high enough to adequately judge the shots?… Continue reading
Oct 22 WATCH: FDA advisory committee assesses COVID-19 vaccine development By Helen Branswell, STAT This week's meeting, while likely dry and technical, "shows the public that this is how FDA is going about its decisions," one expert said. Continue reading
Oct 06 FDA discloses vaccine guidelines previously blocked by White House By Zeke Miller, Matthew Perrone, Associated Press In briefing documents posted on its website, the FDA said vaccine makers should follow trial participants for at least two months to rule out safety issues before seeking emergency approval. Continue reading
Sep 23 U.S. health officials say they would get FDA-approved COVID-19 vaccine By Associated Press Dr. Brett Giroir, an assistant secretary at the Department of Health and Human Services, told a Senate hearing he’d “have no hesitancy” to take that vaccine. Continue reading
Aug 28 Health agencies’ credibility at risk after week of blunders By Matthew Perrone, Ricardo Alonso-Zaldivar, Associated Press First, the head of the Food and Drug Administration had to walk back exaggerated statements about the benefits of a new plasma therapy for coronavirus. Then the Centers for Disease Control and Prevention triggered a backlash from the medical community… Continue reading