Coronavirus Vaccine Tracker, August 22: A top official of the Food and Drug Administration, which acts as the drug regulator in the United States, has said he would resign if there was any attempt to push through an unsafe or ineffective novel Coronavirus vaccine for political reasons, Reuters has reported.
Peter Marks, director of FDA’s Centre for Biologics Evaluation and Research, told Reuters that he had not come across any political pressure to fast-track the approval of any vaccine, but if this did happen, he would prefer to resign.
“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 feel obligated (to resign) because in doing so, I would indicate to the American public that there is something wrong,” Marks was quoted as saying.
The speed with which the vaccines are being developed, with very specific timelines determining the entire process, has led to some amount of unease among scientists and experts. A Russian vaccine that was approved for public use earlier this month, without undergoing the mandatory third phase of human trials, has come under intense criticism.
There is also apprehension that US President Donald Trump might want to use the development of a vaccine as his achievement during the Presidential campaign. Trump has already said that it was possible that a vaccine might be developed before the November 3 Presidential election. Most scientists and experts believe it would not be before early next year that a vaccine would become ready.
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Vaccine will not end pandemic on its own, or restore old normal: WHO
World Health Organisation director general Tedros Ghebreyesus has said that while a vaccine would be a “vital tool” in containing the spread of Covid-19 disease, it would not end the pandemic on its own.
“A vaccine will be a vital tool, and we hope that we will have one as soon as possible. But there is no guarantee that we will, and even if we do have a vaccine, it won’t end the pandemic on its own,” Tedros said a press conference on Friday.
“We must all lean to control and manage this virus using the tools we have now, and to make the adjustments to our daily lives that are needed to keep ourselves and each other safe. So called lockdowns enabled many countries to supress transmission and take the pressure off their health systems. But lockdowns are not a long-term solution for any country,” he said.
Urging governments and people to pay more attention on individual and societal health, Tedros said some things will need to change permanently.
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“We do not need to choose between lives and livelihoods, or between health and the economy. That’s a false choice. On the contrary, the pandemic is a reminder that health and economy are inseparable. WHO is committed to working with all countries to move into a new stage of opening their economies, societies, schools and businesses safely. To do that, every single person must be involved, every single person can make a difference. Every person, family, community, and nation must make their own decisions, based on the level of risk where they live,” Tedros said.
“That means every person and family has a responsibility to know the level of transmission locally, and to understand what they can do to protect themselves and others. At the same time, we will not – we cannot – go back to the way things were. Throughout history, outbreaks and pandemics have changed economies and societies. This one will be no different,” he said.
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 of August 20, 2020)
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