“New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!” Trump tweeted on Tuesday night, tagging FDA Commissioner Stephen Hahn on the post.
New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job! @SteveFDA
— Donald J. Trump (@realDonaldTrump) October 7, 2020
Issued earlier on Tuesday, the non-binding FDA guidelines encourage vaccine manufacturers to monitor volunteers for at least two months after their last immunization to detect any delayed adverse reactions, as well as whether patients retain a strong immune response. While four vaccines are currently in Phase III trials, the final stage of clinical testing, under the new rules emergency approval wouldn’t take place until sometime in December, weeks after the November 3 election.
Trump has repeatedly vowed to ensure a vaccine would be available before voters hit the polls next month, but with the election fast approaching and a viable jab even further out of reach under the new rules, that promise may be impossible to keep.
The FDA can issue emergency use authorization for vaccines, but only if there is “no adequate, approved, and available alternative to the [vaccine] for diagnosing, preventing, or treating” the illness in question. Any inoculation approved on an emergency basis must also be proven effective in preventing disease – a feat no drug manufacturer had accomplished for a human coronavirus prior to 2020. A number of previous attempts failed to pass the animal stage of trials, as the vaccines ended up causing more severe infections in the test subjects, a phenomenon dubbed “vaccine-associated enhanced respiratory disease” in the FDA’s guidelines.
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