The US drug agency told labs working on a potential coronavirus vaccine on Tuesday it was asking for at least two months of reliable data to grant emergency clearance, a measure that could push back availability vaccine after the US presidential election on November 3.
A senior administration official confirmed that the White House had approved the Food and Drug Administration (FDA) plan, whose stricter-than-prior recommendations dampen Donald Trump’s hopes of guaranteeing voters a vaccine beforehand. voting.
The Republican president, who is running for a second term, expressed his dissatisfaction on Tuesday evening. “The new FDA rules make it more difficult to speed up (development) of vaccines for approval before election day. Another political attack! ”He wrote on Twitter .
The New York Times reported on Monday that the White House had vetoed the new guidelines but the senior administration official denied any delay in the review process for the guidelines as U.S. officials work to minimize the political character of the issue and to ensure public health security.
There is still a possibility that the White House will force a vaccine to be authorized without additional medical data. Such a move would expose a conflict with the FDA and scientists, and could add to the perception that the political aspect plays a role in the availability of a vaccine.
Pfizer and its partner BioNTech are expected to be the first laboratories to announce the results of the last phase of their clinical trials in the United States . About half of some 44,000 volunteers taking part in these trials received the second of two doses of the potential vaccine at the end of September.
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