Recently, WHO denied the approval for Covaxin again based on insufficient additional details that are required by the expert panel before approving any vaccine or drug for public use at mass.
The ongoing pandemic situation has necessitade speedy approval of new vaccinations on urgent basis. If we see in the normal situation, it takes years for a vaccine to get approval by the WHO and pass through the different parameters set up by the WHO, but considering the need for the hour, WHO has approved many drugs and vaccines for emergencies.
Coming back to Covaxin, it is the indigenously made vaccine for COVID-19 by Bharat biotech in Association with ICMR.
Problem with covaxin
Covaxin is the first vaccine to be made from an inactivated version of coronavirus; that means, the vaccine has a coronavirus but dead, or more precisely, inactivated form. As soon as the immune system recognizes this viru,s it starts building up antibodies against the virus. This is the basic model on which any vaccine works. The problem with the Covaxin is the use of inactivated virus. The vaccines which got the WHO approval like Johnson and Johnson, Oxford-AstraZeneca, etc. use other methods, which are mostly gene based, without using the inactivated form of the virus.
The problem with the inactivated form of the virus is if by chance the virus didn’t get killed or inactivated or gets semi-activated as soon as it enters the body, it will start multiplying itself and will attack the immune system thereby causing the individual to test positive for the virus.
To prove the fact that the virus is dead or inactivated and there is even a slight chance that the virus is alive, is a very hard and complex task.
This is what WHO has asked Biotech to do before approval. Also, SAGE, that is the strategic advisory group of experts, considers good manufacturing and quality management as one of the parameters that they assess any vaccine or drug during the approval process on.
Issues with Covaxin
Use of inactivated viruses, and no proper documentation regarding the inactivated virus, many experts have raised issues about the vaccine not being safe. Issues related to the efficacy rate of the vaccine make this vaccine less desirable according to the experts. There were also some sayings that the clinical trials were not done properly or have not been done yet. There are several doubts regarding the effects and after-effects of this vaccine on the human body. No report related to efficacy rate so far has been published.
Why there is a criterion for proving inactivated viruses?
Around 1955, there were companies in the US who were preparing vaccines for polio from the inactivated virus of polio. By mistake, the vaccine had few activated and semi-activated viruses. When they were injected into children, it multiplied itself in the body thereby causing polio in the children.
According to the sources, around forty thousand children were affected out of which many got paralyzed. After this incident, it became necessary for the manufacturing companies to prove the stated fact that the virus is inactive so that in the future this won’t happen.
Brief about Bharat bio-tech
It is a Hyderabad-based multi-national company that is involved in drug recovery, drug manufacturing, manufacturing vaccines, pharmaceuticals, and health care products. Founded by Krishna Ella in 1999, it has successfully established its presence all over the world. Bharat biotech has level 3 safety-based laboratories. It successfully made ROTAVIRUS VACCINE called ROTAVAC. They have also made vaccines for viral diseases like Zika and chikungunya.
WHO’s stand on delays
WHO has asked for detailed data and documents related to manufacturing and clinical trials from Bharat-biotech, as they consider it to be an essential criterion for the approval, and then they will match the information with their set parameters. The delays happened because the insufficient data and information provided by the company to WHO did not match with the parameters set by the WHO.
The process of approving is opaque. The proceedings of WHO is not at all transparent in terms of parameters set, elements required, what should be ideal efficacy rate, etc. Also, the report they publish regarding the approval is not clear that is on what grounds the vaccines get the approval, how many parameters the vaccines have passed so far, etc.
On 19th April an EOI an expression of interest was submitted to WHO for the emergency use of Covaxin by Bharat biotech. EOI is the a process by which new or unlicensed products can be approved during health emergencies.
No doubt the parameters are very important for approving any vaccine or unlicensed drug but the catch in this, which is very important even for the companies applying for approval and published for whom the approval is given, is that the transparency of the entire approval process does matter a lot. There is a need to at least bring if not more but at least some transparency when it comes to the proceedings.
People should know details about the vaccine or drug which are to be given to them in future and also about the company and the WHO parameters. Transparency is something that will clear some doubts of the people regarding the vaccine, and it will encourage more people to have a positive outlook whenever it comes to vaccination drives.
When covid was on a peak, it was really hard for the front liners to make people believe that the vaccine is safe, and it is a very general problem that the front liners and medical officials face. Whenever it comes to giving vaccination or any kind of drug, hesitation and fear is evident whether if it’s a developing country or under developing country or even for a developed country.
Edited by Anupama Roy