The Food And Drug Administration (FDA) Decision to hold Vaccine Developers to the Stricter Criteria will likely Push any Vaccine Authorization beyond Election Day.

Four Vaccines in the United States are in the Final Stage of Testing, but the Agency’s New Regulations Advise Vaccine Makers to:

- Follow Test Patients, half of Clinical Trial Participants, for a At-Least Two Months after their Final Dose.

- Vaccine Makers to Document Five Cases of Severe Infection in People who Received the Placebo instead of the Vaccine.

The Agency's Requirements are Designed to Ensure that there is Adequate Safety Data on any Vaccine before it is Authorized for Emergency use, FDA said.

The White House Blocked the Release of the Standards after Officials told Trump that the Pharmaceutical Industry Objected to FDA's Stance. A Spokesperson for FDA, on Tuesday Oct. 6th, Confirmed that the White House Budget Office Approved Release of the Guidelines.

In a Letter Tuesday, more than 60 Top Doctors and Public Health Researchers, from Universities including: Harvard; Johns Hopkins; and Yale, said the FDA should take an even Tougher Line.

The Group told FDA Commissioner, Stephen Hahn, that the Agency should Require a Minimum of Two Months of Monitoring of All Trial Participants before Considering a Vaccine Maker's Application for Emergency Authorization. "Premature authorization would prolong the pandemic, with disastrous consequences," they wrote.

Hours after FDA Released the Guidelines, Trump called them "just another political hit job!" in a Tweet addressed to FDA Commissioner, Stephen Hahn.










NYC Wins When Everyone Can Vote! Michael H. Drucker