August 24, 2020 8:55:06 am
Coronavirus vaccine tracker: US President Donald Trump has unleashed a political storm by suggesting that the development of a novel Coronavirus vaccine was being deliberately delayed to ensure that it was not made available until the US Presidential election was over, in a possible attempt to sabotage his re-election bid.
In a tweet on Saturday, Trump said blamed a “deep state” within the Food and Drug Administration (FDA), the US drug regulator, for the delay.
“The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives,” Trump said.
The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives! @SteveFDA
— Donald J. Trump (@realDonaldTrump) August 22, 2020
The US Presidential elections are slated for November 3. Trump is seeking re-election. His tweet suggested that a novel Coronavirus vaccine could be one of the most prominent issues to decide the fate of the Presidential candidates.
While most experts believe that a novel Coronavirus vaccine was unlikely to be ready until next year, Trump has, earlier this month, suggested that the possibility that the vaccine could be made available before the Presidential election could not be ruled out. Asked whether he thought a vaccine would boost his chances of re-election, he had replied, “It wouldn’t hurt”, before adding that he was not pushing for an early vaccine for political reasons, but because he wanted to “save a lot of lives”.
FDA has said in the past that it would not “cut corners” to approve a vaccine. Just a day earlier, Reuters had quoted a top FDA official as saying that he would resign if there was any attempt to push through an unsafe or ineffective novel Coronavirus vaccine for political reasons.
“I could not stand by and see something that was unsafe or ineffective that was being put through. You have to decide where your red line is, and that’s my red line. I would indicate to the American public that there is something wrong,” Peter Marks, director of FDA’s Centre for Biologics Evaluation and Research, was quoted as saying.
More than 400 medical experts in the United States have written to the FDA asking it to ensure that a novel Coronavirus vaccine was approved only after a transparent and rigorous process that was “devoid of political considerations”.
Meanwhile, a report in The Financial Times newspaper suggested that the Trump administration had already decided to grant emergency use authorisation to the vaccine being developed by Oxford University for use in the United States before the Presidential elections.
The Oxford University vaccine, being developed in collaboration with pharma major AstraZeneca, is considered to be one of the most promising to become successful. More than three billion doses of that vaccine have already been pre-booked by countries, even though it is still undergoing phase-3 human trials. The vaccine is currently being tested on 10,000 volunteers. The FDA rules require testing on at least 30,000 individuals before it can be considered for approval.
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India trial of Oxford University vaccine to start this week
Phase-2 clinical trials of the vaccine being developed by Oxford University and AstraZeneca would begin this week. The trials are being conducted by the Pune-based Serum Institute of India, which has an agreement with AstraZeneca to manufacture and market this vaccine for low and middle income countries, including India.
Earlier this month, India’s drug regulator had given its go-ahead to conduct phase-2 and phase-3 human trials of the vaccine in India, a mandatory requirement before a vaccine can be used on Indian population.
Top officials at the Indian Council of Medical Research said three to four trial sites were ready to go begin the testing, and the first doses could be administered to volunteers from Monday. The tests are to be conducted at 14 sites, four of which are in Pune, and two in Mumbai.
Hunt for Coronavirus vaccine: The story so far
- More than 160 vaccine candidates in pre-clinical or clinical trials
- 30 of them in clinical trials
- Six in final stages, phase-III of human trials
- At least eight candidate vaccines being developed in India. Two of these have entered phase -II trials after completing phase-I.
(As on August 20; Source: WHO Coronavirus vaccine landscape)
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