The statement was made by Dr. Stephen Hahn, senior commissioner of the FDA, on December 12, one day after the approval of the Pfizer vaccine.
The FDA is forced to make quick decisions under pressure from the White House and the public – who are desperately waiting for the pandemic to end.
Dr. Hahn said scientists remain calm in the face of external factors when evaluating vaccines.
`The FDA’s decision is based entirely on science and data,` Hahn said.
The agency referred to recommendations from the Vaccines and Biological Products Advisory Committee (VRBPAC).
Hahn insists the FDA is completely transparent about the data.
Emergency use approvals typically occur more quickly than regular authorizations.
Dr. Stephen Hahn, Senior Commissioner of the FDA, spoke at the White House during the Covid-19 vaccine approval meeting on December 11.
`The FDA not only reviewed Pfizer and BioNTech’s reports on the clinical trial in 40,000 volunteers, the agency also evaluated the preliminary data. These data showed that the vaccine was safe and protected,` Hahn said.
Hahn understands that many Americans are hesitant to get vaccinated.
To address this issue, the FDA has released information about Pfizer and BioNTech’s vaccine production process as well as the approval process.
`We believe that transparency and a rigorous evaluation process will give the American people confidence in the FDA and this vaccine,` he said.
After the case of a vaccine recipient in the UK suffering anaphylactic shock, the agency added a warning to Americans.
`While this has been a year of tragedy, sadness and sacrifice, this year also recognizes remarkable scientific achievements to pass on to future generations,` said Mr. Hahn.