India is one of the countries most affected by the COVID-19 virus, with more than 690,000 confirmed cases to date. There are 11.7 million cases worldwide, including over 5 lakh deaths with 5.4 million recoveries.
Worldwide, dozens of candidate vaccines are in various stages of development in response to the coronavirus pandemic. India is a leading manufacturer of vaccines and generic drugs worldwide.
The endorsement for human clinical trials of two Indian indigenous COVID-19 vaccine candidates, COVAXIN and ZyCov-D, considered the “commencement of the end” of this pandemic. But many experts have raised questions on ICMR move.
Although India’s autochthonous vaccine drug trials are often conducted quickly, it will be unprecedented to complete all three stages (and roll them out to the public) within the timeline set by ICMR.
Is ICMR’s move for fast track COVID vaccine an unrealistic approach in India??
The letter sent by ICMR to Bharat Biotec stated that: “It is expected the vaccine will be launched for public health use by August 15, 2020, after the trials are completed.”
It also remarked that Bharat Biotech is strictly urged to quickly track all necessary approvals to ensure that subject enrollment is initiated no later than July 7th, and “the non- compliance will be taken very seriously.”
Since this letter came out, experts have raised ethical and safety concerns on this move to quickly develop a vaccine for a disease that is still being tested in the world.
Six Indian companies are developing the COVID-19 vaccine. Earlier press reports said that together with the two Indian vaccines COVAXIN and ZyCov-D, 11 out of the 140 candidate vaccines worldwide are undergoing human trials.
None of these will be ready for large-scale commercial use of COVID-19 Vaccines before 2021, the ministry said.
The Ministry of Science’s statement came amid a row in a letter from ICMR, which set August 15 (Independence Day) as the target for the release of coronavirus vaccine.
On Sunday, the Ministry of Science and Technology modified a press release before the moment it was published on the PIB website, removing the statement that “a vaccine is unlikely to be put into mass use before 2021.”
Shortly thereafter, the statement was updated, and the line that stated that “the vaccine is unlikely to be ready before 2021” was erased. The fresh release does not mention the statement in the same paragraph before it.
Usually, the first two stages of drug trial testing are for safety reasons, and the third test is the effectiveness of the drug. Each stage may take months or even years to complete.
The first phase of the COVAXIN trial jointly developed with ICMR is scheduled to be completed within 28 days, which will enable the vaccine candidate to be released on August 15. However, it is unclear how to launch it without completing the second and third phase trials.
Public health experts in India raised safety concerns about ICMR’s sudden push to rapidly develop a coronavirus vaccine, which will be made available to the public by August 15th, an Independence day.
Balram Bhargava, the Director-General of the ICMR, said in a letter that Bharat Biotech and ICMR who developed a coronavirus vaccine (Covaxin) for Human trials, should be carried out “rapidly”.
What are the risks of performing this process in a rush?
History shows that hastily developing or distributing vaccines can have unintended consequences.
Professor Ramana Laxminarayan, director of CDDEP, said that India must develop its vaccine because even if other people develop the vaccine, it is possible to provide it to India at a later stage.
When asked about ICMR’s efforts to push rapid vaccine development, he said: “Vaccines do not work on our timelines. This is a scientific process. Most vaccines fail, not because of lack of talent, hard work, and funds, or intent. It is because the development of vaccines is a very technical process.”
“The vaccine should be unharmed for children, adults, etc. The bar for the Covid-19 vaccine is much higher. After all, it must be tested at different age groups, because young people and adults will use it. All this requires 2 or 2.5 years, we should adjust our expectations accordingly.” Professor Laxminarayan stated.
He also outlined the dangers of fast-tracking this process. He said that if we introduce a vaccine that can even hurt thousands of people, it will still have a terrible impact on public confidence in any Covid-19 vaccine. “This will shake people’s confidence in science and in any other vaccines developed to combat Covid-19”, he said.
At the same time, a look at the clinical trial registration for human trials of a vaccine being developed by Bharat Biotech in India revealed that the trial was registered as a Phase 1 and Phase 2 study on July 1.
Detailed information indicates that it plans to test 1,125 people in these trials and plans to enroll personnel on July 13.
According to the registration, the company may take one year and three months. Among this, only the Phase 1 trial requires at least one month. This means that there is a very short time to study the safety and effectiveness of these trials.
“As far as I know, there has never been such an accelerated development path for any vaccine, even the vaccines being tried in other countries. Even if the timeline is accelerated, this does seem to be done in a hurry, thus with potential risk, insufficient attention to the process,” Anant Bhan said.
Track the stage of the vaccine:
According to the global average, drug candidates in the laboratory usually take 12 years to hit the market, while vaccines take 8-10 Years. They are at different phases of clinical trials.
1. The first phase is for 1,000-3,000 patients, and it takes at least 2 years.
2. The second stage is for 1,000-3,000 patients, and it takes at least 2 years.
3. The third stage conducted on 15,000 to 30,000 patients and takes at least 3-5 years.
However, in situations such as the ongoing pandemic, accelerated trials are seen to move rapidly in the direction of vaccine development.
Under the accelerated test:
- The first phase is for safety research, involving 50 to 500 people. It mostly takes four months.
- The second stage is for the dose of the vaccine. It takes place on 500 to 1,000 people and takes another four months.
However, as far as Covaxin is concerned, these two phases will now occur simultaneously, making the vaccine development process faster, just like the rest of the world.
According to the sources, ICMR officials stated that the letter is authentic and had requested a rapid vaccine trial. Bharat Biotech, a company involved in vaccine development, has not issued any remark on this.
“For vaccines that are still under preclinical development, how do you start recruiting clinical trials on July 7 and launch the vaccine on August 15? How do you complete the vaccine trial in little more than a month and determine the efficacy in advance?” Researcher Anant Bhan at the Global Health, Bioethics and Health Policy, stated in a series of tweets about this development.
Dr. Krishna Ella said in one of his statements that the vaccine will definitely be there by the end of this year.
In fact, the candidate vaccine is expected to enter clinical trials in the second half of 2020 and, if triumphant, it would be available in the second half of 2021, the two companies also stated in a statement.
A former member of the Prime Minister’s Economic Advisory Committee, Professor Shamika Ravi stated: “The timeframe for this vaccine seems to be aspirational. Let us wait for further details.”
The WHO Director-General also said that the COVID-19 vaccine may take 2.5 years!
Dr. David Nabarro said that the world will have to wait at least 2.5 years to produce a vaccine that is effective against Covid-19 and is mass-produced.
Dr. David Nabarro also stated that there is currently no treatment for Covid-19, and if someone makes such claims, they must be asked to provide complete evidence.
Commenting on vaccines’ development around the world (some of which have entered human trials), Dr. Nabarro stated that the first thing to understand is that we really don’t know that a person who has been infected with Covid-19 will gets fully immune and not be infected with it again.
He further said: “Even if the vaccine comes, it will take some time to determine whether a person who is vaccinated is fully protected from the virus. There are still many things to prove.”
The second question is whether these recommended vaccines are safe so that they will not trigger adverse reactions when they are injected into humans. When you are using the vaccine, you must pay careful attention to an adverse reaction, Dr. David Nabarro said.
How long will it take to ensure everyone in the world to get a dose of vaccine?
I think we will spend at least 2.5 years on it. That’s why I tell everyone to plan accordingly and be prepared to change their living habit for at least 2.5 years, Dr. David said.
On Thursday, the total number of Indian Covid-19 test positives exceeded 6.2 lakh. In terms of the highest number of coronavirus cases, India is already the third most affected country in the world.
Last week, as the country entered Unlock 2.0, more than 15,000 cases were reported every day.
When talking about the speed and scale of India’s transmission spread, Dr. Nabaro said that the transmission is assuredly accelerating, but “this is nothing compared to the situation we would have where no measures have been taken to check”.
“Overall, the Indian’s health capacities are strong. But capabilities vary from region to region. The expansion of the number of tests conducted in India, even to the current level, is an extraordinary achievement. I would like to say it again, it is a remarkable achievement given the country’s size” Dr.Nabaro said.
LIVING WITH THE VIRUS
“Learning to live with Covid-19” term has been repeatedly used by medical experts, news reports, and governments in recent periods to recommend that since there is no early cure seen, people should learn to do behavioral adjustments to restrict the transmission of the virus.
“Living with coronavirus does not mean giving up or taking the virus for granted. In fact, it means taking a robust approach to containing its spread,” said Dr. Nabarro, adding that the virus is here to stay.
When will the Covid-19 vaccine be available to the public?
The vaccines being developed worldwide are in different stages of testing. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he is confident that by the first quarter of 2021, one of the candidate vaccines will prove to be safe and effective. But it is not clear which candidate showed the greatest hope.