Trump Pressures FDA To Speed Up Vaccine Approval Reviews
Despite behind-the-scenes fuming from the White House, FDA chief Stephen Hahn says that agency is working quickly but that it will take the time it needs because “we absolutely have to do this the right way.”
Trump To FDA: Why Is Europe Beating Us On Vaccine?
A president who preached "America First" is demanding to know why the United States could end up third, or worse, in the global vaccine race. President Donald Trump and his deputies are privately admonishing Food and Drug Administration officials for not moving faster to authorize promising coronavirus vaccines — a push partially motivated by Trump’s desire to claim credit for record-fast vaccine development, four officials said. (Diamond, Cancryn and Owermohle, 12/1)
Pushed To Rush, FDA Head Says Feds Will Get Vaccine 'right'
The head of the agency responsible for authorizing COVID-19 vaccines said Tuesday that it would take the time needed to “get this right,” despite increasing pressure from President Donald Trump to speed up the process. “No one at FDA is sitting on his or her hands. Everyone is working really hard to look at these applications and get this done,” Stephen Hahn, the head of the Food and Drug Administration, told ABC in an interview on Instagram Live. “But we absolutely have to do this the right way.” (Lemire, Colvin, Perrone and Miller, 12/2)
Dry Ice Rules For Massive Covid-19 Vaccine Airlift Approved
Rules allowing the rapid shipment of Covid-19 vaccines by cargo aircraft have been approved by U.S. transportation regulators. The Transportation Department established safety requirements for carrying the potentially dangerous dry ice needed to keep some vaccines stable, the agency said in a press release Tuesday. It also set standards for carrying flammable batteries needed in the airlift and eased restrictions on how long flight crews involved in the effort can work. (Levin, 12/1)
In other COVID news from the Trump administration —
White House To Host Covid-19 Vaccine Summit, As Trump Seeks To Burnish Record
The Trump administration has invited leading vaccine manufacturers, drug distributors, and government officials to a “Covid-19 Vaccine Summit” next week, just two days before a Food and Drug Administration advisory committee meeting to consider the first U.S. application for a Covid-19 vaccine. (Facher, 12/1)
Hahn Downplays White House Meeting On Vaccines
Food and Drug Administration (FDA) Commissioner Stephen Hahn downplayed a meeting Tuesday with White House chief of staff Mark Meadows, saying he was merely updating the administration on the COVID-19 vaccine authorization process. Axios reported Monday that Meadows summoned Hahn to the West Wing for a morning meeting to explain why emergency use authorization (EUA) for Pfizer's coronavirus vaccine has not been approved faster. (Deese, 12/1)
GAO Calls For COVID-19 Medical Supplies, Testing Guidance
The US Government Accountability Office (GAO) yesterday published a report calling for actions such as increasing transparency in COVID-19 vaccine and treatment development and meeting states' needs for scarce medical supplies. In its fourth report on the Coronavirus Aid, Relief, and Economic Security (CARES) Act, the GAO also recommended improved COVID-19 testing guidance, more accurate estimates of the number of people relying on unemployment benefits, better oversight of Veterans Affairs nursing homes, and more information on the status of economic impact payments to individuals. (Van Beusekom, 12/1)