Trump humiliation as coronavirus vaccine developer IGNORES pressure to fast-track trials

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Trump humiliation as coronavirus vaccine developer IGNORES pressure to fast-track trials

The White House is said to have considered disregarding regulatory channels in a bid to have the jab authorised before the US presidential election

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The White House is said to have considered disregarding regulatory channels in a bid to have the jab authorised before the US presidential election on November 3. British drugmaker Astrazeneca currently holds the licence for the coronavirus vaccine.

The company will also oversee manufacturing and distribution.

On Monday, it said it was too early to begin discussions with US regulators about an emergency use authorisation.

A spokesman for the firm said: “Astrazeneca has not discussed emergency use authorisation with the US government and it would be premature to speculate on that possibility.”

The US Food and Drug Administration’s emergency authorisation rules do not include a situation were a treatment is fast-tracked against its developer’s will.

This month, the emergency use authorisation has been given to 21 products.

They had all been in response to drug developer demands.

For goods to be granted an emergency use authorisation there must be “evidence of effectiveness”.

The FDA’s rules indicate it would “assess the potential effectiveness” of a vaccine “on a case-by-case basis using a risk-benefit analysis”.

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Danny Altmann, a professor of immunology at Imperial College London, said: “It should be incredibly disturbing to the global medical community to see any potential attempts by any politicians, whether in Russia, the USA or elsewhere, to seek to manipulate, short-circuit or exert influence in any way over the agreed scientific protocols that are in place to carefully evaluate comparative safety, immunogenicity and efficacy of vaccines.

“In decades to come, we won’t remember which politician polled a few more or less votes, but we really won’t forget any failed opportunities to put in place the safest, most effective possible global programmes to eradicate this pandemic.”

Prof Angus Dalgleish FMedSci, Principal of the Institute for Cancer Vaccines and Immunotherapy, and Professor of Oncology, St Georges, University of London, said: “This is clearly an election ploy and perhaps a response to Mr Putin’s sputnik.

“Many vaccines may induce a good immune response and perhaps few side effects.

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“However, the concern is what happens upon challenge.

“The SARS 1 vaccine induced antibody enhancement which appears to have been ignored and it must be proven that any COVID vaccine does not do the same before approval.

“The great Maurice Hillman (Head of Merck & Co/MSD’s vaccine programme) once said he couldn’t sleep well until the 3 millionth person had received one of his vaccines without significant side effects!”

The Oxford vaccine is now in final stage trials in Britain, South Africa and Brazil.



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