FDA chief Stephen Hahn is summoned to the White House to explain why he hasn’t yet approved Pfizer’s COVID vaccine
- Hahn was called the the White House Tuesday morning
- White House chief of staff Mark Meadows summoned him there
- FDA has been evaluating Pfizer’s request for emergency use authorization
- Moderna is seeking approval for use of its vaccine
- Hahn says government scientists will ‘take the time that’s needed’
In an extraordinary clash, Hahn, who previously appeared regularly at coronavirus briefings when they occurred, is publicly pushing back on efforts to rush a decision – while anonymous officials have begun badmouthing Hahn in the press.
It all comes amid breakthrough news as Moderna seeks emergency approval for its vaccine just days after Pfizer submitted its own paperwork for approval.
FDA Commissioner Stephen Hahn got called to the White House Tuesday to explain why approval of Pfizer’s coronavirus vaccine has not yet received government approval
White House chief of staff Mark Meadows demanded Hahn come to the White House Tuesday morning to explain why approval has not come more quickly, Axios reported.
Hahn’s response, which he shared with the outlet, was not to be rushed and allow scientists to evaluate the data on vaccine safety and efficacy.
‘Let me be clear — our career scientists have to make the decision and they will take the time that’s needed to make the right call on this important decision,’ Hahn said.
A senior administration then took a swipe at Hahn by complaining that he took a week-long ‘vacation’ in the Outer Banks during a critical time in vaccine approval.
Mark Meadows, White House chief of staff, summoned Hahn to the White House
President Trump has clashed with government scientists, while also championing Operation Warp Speed, which seeks to push out vaccines as soon as possible
Pizer is seeking emergency use approval for its COVID-19 vaccine
‘There are some who are complaining the FDA is not working around the clock to get things approved and because of that, Meadows has asked Dr. Hahn for a briefing,’ an official told Axios.
The FDA pushed back, saying Hahn ‘was recently exposed to COVID while working at the FDA’s White Oak [Maryland] campus. Dr. Hahn chose a remote location to quarantine and he continued working, as he has done throughout the pandemic. Dr. Hahn has worked every single day of this pandemic, including weekends, holidays and more.’
U.S. drug maker Pfizer and German BioNTech on November 20th announced they were seeking FDA authorization for Emergency Use Authorization for their vaccine – the first to be announced.
On November 30th, Moderna announced it was seeking approval from the FDA for emergency use of its vaccine.
Both have shown high efficacy rates of well above 90 per cent, representing potential game-changing breakthroughs in combatting the coronavirus.
President Trump has clashed publicly numerous times with disease expert Dr. Anthony Fauci. But Hahn in his public appearances has repeatedly sought to avoid antagonizing the president while also asserting that the FDA will follow science and data.
Without such assurances, there are concerns members of the public will not take a vaccine if there is not sufficient trust in the process.
Hahn testified in June to Congress that ‘data and science will dictate’ when the FDA approves products, amid pressure that it was too slow to approve testing methods in some cases.