August 7, 2020 7:46:49 am
Covid-19 vaccine tracker: Amidst an unprecedented race to develop a vaccine by a pre-determined deadline, nearly 400 medical experts in the United States have written to the Food and Drug Administration asking it to ensure that a novel Coronavirus vaccine was approved only after a transparent and rigorous process that was “devoid of political considerations”.
The letter came on a day the US President Donald Trump said that it was possible that a Coronavirus vaccine was made available even before November 3, the date Americans will vote to elect their new President. Trump is seeking a re-election.
Asked whether he thought a vaccine would boost his chances of re-election, Trump said, “It wouldn’t hurt”, before adding that he was not pushing for an early vaccine for that reason, but because he wanted to “save a lot of lives”.
There was no indication that the letter to the FDA by the medical experts — virologists, epidemiologists, vaccinologists, infectious diseases specialists, and others — was prompted by Trump’s remarks. But it did express concerns that the regulatory review on a Coronavirus vaccine might not be as rigorous as on previous vaccines.
“The need (for a Coronavirus vaccine) is urgent but all vaccines must be rigorously studied to determine whether their benefits exceeded their risks. For this reason, we urge that Covid-19 vaccines are made widely available only after the Food and Drug Administration (the drug regulator in the United States) has been able to evaluate safety and efficacy data from completed phase-3 clinical trials. The FDA’s review must be as thorough as has been the case for previous vaccine candidates,” the letter said.
The signatories to the letter, among them a former surgeon general of the US, and a former head of FDA, also demanded more information on the vaccines being developed under the oversight of FDA.
“We must be able to explain to the public what we know and what we don’t know about these vaccines. For that to happen, we must be able to witness a transparent and rigorous FDA approval process that is devoid of political considerations. We ask that company executives and government officials take due note of these key points,” the experts said in the letter.
By all current indications, a novel Coronavirus vaccine is likely to become available by early next year. If that happens, it would be the fastest vaccine to be ever developed. Usually, it takes several years, sometimes over a decade, to produce a vaccine. The speed at which the efforts to find a Coronavirus vaccine has progressed, sometimes by cutting corners of regulatory processes, has led to unease about the safety of the vaccine candidates.
Some, like Microsoft founder Bill Gates, who has been supporting the development of several vaccine candidates, have been candid enough to suggest that the first vaccines might not be best, most effective, or affordable, and a better vaccine might just take a little more time to appear on the horizon.
The rush to push the development of a vaccine had created an uproar in India as well, when it had become known last month that the Indian Council of Medical Research (ICMR) had set a deadline of August 15 to “launch” a vaccine that was yet to get into human trials at that point. That particular vaccine, being developed by Hyderabad-based Bharat Biotech, has just now completed phase-1 human trials and begun phase-2. Another Indian vaccine, this one being developed by Ahmedabad-based Zydus Cadilla, has also moved into phase-2 trials.
Meanwhile, Anthony Fauci, the top infectious diseases expert in the United States, has said that he had discussed the issue of political pressure with the regulatory authorities and had been assured that safety and efficacy of the vaccine would be the “prime consideration” while approving any vaccine. Fauci made these remarks in an interview with Reuters. He also reiterated that he was “cautiously optimistic” that a vaccine would become available early next year.
“I am cautiously optimistic, though you can never guarantee things with a vaccine. I am cautiously optimistic that we will have a vaccine that is effective enough to get approved, because the early studies of phase-1 study showed that it induced the kind of neutralising antibodies that were at least comparable, if not better than what you see in convalescent serum. And that is a whole mark of a predictive quality that a vaccine might work,” he said.
Serum Institute would produce Novavax vaccine as well
Pune-based Serum Institute of India, the world’s largest manufacturer of vaccines by volume, has entered into an agreement with American biotech company Novavax for the supply of a Coronavirus vaccine that the American firm is developing.
Serum would have exclusive rights to supply the Novavax vaccine in India, and non-exclusive rights, “during the pandemic period”, in all countries not designated by the World Bank as “upper middle or high income countries”.
This is Serum’s second such arrangement with a leading developer of novel Coronavirus vaccine. The company already has an agreement with AstraZeneca, a British-Swedish pharmaceutical major that is developing a vaccine in collaboration with Oxford University. Serum is also carrying out late stage human trials, phase-2 and phase-3, of that vaccine in India. The trials, on about 1,600 volunteers, is expected to begin next week. The vaccine is already in phase-3 trials in some other countries.
The Novavax agreement happened on July 30, but the announcement has come just a day after the company released results its phase-1 human trials. The company said its vaccine candidate had “elicited robust antibody responses in the 50 volunteers between 18 and 59 years of age who were injected at two hospitals in Australia. The company had also reported findings of its tests on monkeys, claiming that the vaccine had strongly protected the monkeys from Coronavirus infections.
Novavax also happens to be one of the several pharmaceutical companies with whom the US government has entered into billion-dollar advance agreements for securing their vaccines. The US government has said it would pay US$ 1.6 billion to the company to expedite its vaccine development, and secure 100 million doses of the vaccine. The Maryland-based company has never produced a successful vaccine earlier.
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HUNT FOR CORONAVIRUS VACCINE: THE STORY SO FAR
- More than 160 vaccine candidates in pre-clinical or clinical trials
- 23 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-I human trials.
(Source: WHO Coronavirus vaccine landscape of July 31, 2020)
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