FDA Considering Rules On Vaccine Timeline
FDA CONSIDERING AUTHORIZATION RULES THAT COULD PUSH CORONAVIRUS VACCINE PAST ELECTION DAY
(CNN) – President Trump has repeatedly said the COVID-19 vaccine could be ready by Election Day.
But new authorizations by the U.S. Food and Drug administration could delay that.
Sources familiar with the situation say the FDA is assessing scenarios before giving an emergency use authorization for a vaccine.
One scenario could tell vaccine makers that they need to wait two months after giving all their study participants second doses of the vaccine.
Another scenario would have companies wait 60 days after giving half their trial participants a second dose.
Pfizer and Moderna began phase three clinical trials in July.
Both companies have given second doses to less than half their participants.
An FDA spokeswoman says the agency intends to issue additional guidance shortly on what information it needs to issue an emergency use authorization.