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House Speaker Nancy Pelosi took aim at the British vaccine testing safety regime, as she warned that UK approval of a vaccine would not automatically mean that it was safe under the US’s own procedures. .
Amid a race to produce an effective Covid-19 vaccine that meets wide international acceptance for its safety, Pelosi’s comments appear in part motivated by concerns that Donald Trump will adopt any swift and unilateral British approval of a vaccine for political gain, perhaps even earlier. of the November 3 elections.
Currently, one of the leading candidates globally is the vaccine developed by AstraZeneca / Oxford University which is now in phase III trials, which stopped briefly to examine whether a disease in one participant was related to the vaccine.
The trial remains on hold in the US, despite restarting elsewhere where it was taking place.
“We have very strict Food and Drug Administration rules here about clinical trials, timing, number of people, etc., so when the FDA approves a drug that is safe and effective, then you have the trust of the people. American. Pelosi commented.
“My concern is that the UK system for that type of trial is not on par with ours. So if Boris Johnson decides that he is going to approve a drug and this president accepts it, that’s the concern I have. “
Pelosi’s intervention raises questions for a number of reasons, including the widely held assumption that the AstraZeneca vaccine is unlikely to be approved, under any circumstances, before the end of the year.
Trump suggested in August that he might seek an emergency authorization in the United States for a British vaccine, but there is no evidence that the British vaccine is close to being approved.
The UK government has consulted on changing the legislation so that the Medicines and Healthcare Products Regulatory Agency can approve a vaccine by December, if the trial data is ready at that time and satisfactory, but it is likely that any MHRA approval is in line with it. strict approach like other European agencies.
Even then, the US FDA would still have to examine the vaccine itself.
