The tug of war between science and politics continues to grow, with Russian President Putin announcing this week that a fast-tracked vaccine for coronavirus disease 2019 (COVID-19) is ready for use, and President Trump indicating days earlier that a vaccine could be ready in the United States before the 3 November presidential election.
There’s been a dangerous rush to get to the vaccine finish line first. In a race of “Sputnik” proportions (as Putin puts it), quick approval by regulatory agencies is needed to “win.” This is dangerous thinking, driven by political goals and instant gratification: Shortcuts in testing for vaccine safety and efficacy endanger millions of lives in the short term and will damage public confidence in vaccines and in science for a long time to come.
The Russian vaccine remains shrouded in mystery—there is no published information about it, and what has been touted comes from the mouths of politicians. In the United States, the pressure applied to government scientists by the administration on any aspect of the pandemic is becoming increasingly palpable, as they have been criticized or quieted in plain sight by the administration and Trump.
The majority of epidemiologists worldwide who work on infectious diseases are firmly committed to randomized controlled trials (“phase 3”) for all interventions, but especially for vaccines to be given to healthy people. This method allows comparison to a control group that receives a placebo. The phase 3 studies now under way on promising COVID-19 vaccine candidates involve approximately 30,000 patients. A randomized controlled trial is particularly important for determining the effectiveness of the vaccine, and the trial must continue until individuals in the control group become infected. It is impossible to predict how long that will take. Physicians who seek to advise healthy patients on taking the vaccine will rightfully require these data.
Read Also– “Million Dollar Placebos”
Almost every resident of India have these question….
When will India have a COVID-19 vaccine available?
COVID-19 cases have crossed the 30 lakh mark in the country. Trials for COVAXIN, ZyCOV-D and Oxford University’s novel vaccine candidate, to be marketed as ‘Covishield’ are in different phases of trials right now, with strong hopes that the country might stand to see a vaccine in the earliest possible timeframe.
Serum Institute’s vaccine to be ready soon?
Just recently, Serum Institute of India found itself surrounded by rumours with a claim that an Indian vaccine shall be made available in as early as 75 days, which was later clarified.
In the past weeks, top-level authorities have conducted several meetings to devise out a strategy for vaccine distribution and marketing in India. But when can we get a vaccine for the Indian masses? As COVID-19 cases continue to surge across, this remains a challenging question to answer.
End of December is the month ?
Union Minister for Health and Family Welfare, Dr Harsh Vardhan recently said that he is confident about leading vaccine trials in the country will be wrapping up by the end of December this year, which will be followed by mass production; he suggested that India might have a vaccine ready super soon.
“I hope that if everything goes well, India will get a coronavirus vaccine by the end of this year.”
The 1st dose who will get?
While authorities sign pacts to secure access to a vaccine and ensure distribution, a lot of thought is also being given to who will get the vaccine first in the country. Some reports suggest that while logistical challenges are being dealt with right now, the government is planning on inoculating the front line workers, army personnel and certain categories first. A similar approach has been adopted by Russian officials as well, with teachers and healthcare workers being the first in line to start getting vaccine jabs.
There is also speculation that the most vulnerable category (high-risk patients) will be administrated the vaccine in the first leg of administration in India. Such a move could further help lower the mortality rate in the country.
Logistics of distribution in India not so easy!!
Dr Gagandeep Kang, Medical Scientist and Former Chair Member of ICMR Panel on COVID drugs and vaccines, said in an interview that the scientist said that logistics and supply still need to be configured at large.
“It takes time to make a vaccine and the reason why vaccine manufacturers are now trying to buy facilities, book time at the manufacturing facilities, is because they want to be able to make the vaccine even before it is proven safe and effective…That is the fastest way to get to the market but the whole process of regulation takes time. It will take time to review the dossiers, it will take time to get the vaccine licensed, and once the vaccine is licensed we have to think about the logistics of distribution… You need something that fits in with your cold chain infrastructure, you need to be able to buy the vaccine, you need to land the vaccine, you need to distribute the vaccine, you need to train staff in how to give the vaccine.”
Russia’s vaccine hit the Indian market?
While praising the safe success rates achieved by the Oxford University candidate, Dr Kang said that there’s a lot of research needed to prove a vaccine’s efficacy and cut out the risks.
She also warned against early hopes supporting the use of Russian or Chinese vaccine, one of the firsts to be registered being used in India:
“Any time you get people who short-cut the system, who don’t follow the process, that plays undue risk, it becomes a problem. So we have the Chinese and the Russian vaccines as examples of where the system has been short-circuited in a way. And what that leads to is people being unsure whether these are really quality effective products or not. I would not advise that one way or the other, you need to prove that a product works before you use it.”
Premature approval of a vaccine in the India (or anywhere) could be a disastrous replay of the hydroxychloroquine fiasco but with much higher stakes. Approval of a vaccine that is harmful or isn’t effective could be leveraged by political forces that already propagate vaccine fears.
Countless lives are at stake—no compromises on the vaccine.