The Drug Controller General of India (DCGI), India's drug regulator, approved the emergency use of CoviShield and Covaxin on January 3, following the recommendations of the Subject Expert Committee (SEC). The results of Covishield's Phase-3 trials have come, but Covaxin's Phase-3 trials are ongoing.
Coveshield is co-created by Oxford University and AstraZeneca. It is being built in India by the Serum Institute of India (SII) of Adar Poonawala, Pune. At the same time, covaxin is an indigenous vaccine, which Bharat Biotech has created in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). Its phase-3 trials are going on.
The way the drug regulator has given emergency approval to both these vaccines, questions are being raised. The biggest question is about Covaxine, whose trial data is not available, that is, no one knows how effective this vaccine is. Experts say transparency was not maintained in the emergency approval process. Let's understand what is the objection of the experts and what does the government have to say on that?
What is the basis of emergency approval?
Drug Controller General of India VG Somani had said that we will not approve any vaccine which will have little safety concern. Both these vaccines are 110% safe. Side effects such as mild fever, pain, and allergies are caused by the vaccine.
Similar claims are also made by the members of the National Taskforce on the Covid-19. He claims that approval given to Covaxin is different from Covishield. AIIMS-Delhi director Dr. Randeep Guleria said that covaxin will be used as a back-up.
According to Dr. Guleria, till the final data of Bharat Biotech comes, the Covishield will be installed. Those who will apply Covaxin will take their consent. Will be monitored. It will be like clinical trials. When the final data of Covaxin arrives, it will also be allowed as Covishield.
Dr. Balaram Bhargava, Head of ICMR, says that we have done a lot of work at NIV, Pune for Covaxin's affixation data. Bronchoscopy was performed on monkeys for 14 days. The symptoms were seen every day and the effect of the vaccine was seen.
He says that Phase-1 trials of Covaxin consisted of 375 volunteers and Phase-2 consisted of 380 volunteers. Neither phase showed any serious side-effects. So far 23 thousand volunteers have been given the first dose under Phase-3 trials. But there are no concerns related to safety.
According to Dr. Bhargava, the entire virus has been targeted through covaxin. Other vaccines target the spike protein of the virus. In such a situation, the ability of covaxin against new strains has been important in its approval. This strain has now arrived in 34 countries. Because of this, it is extremely important to stop it.
What kind of questions are being raised on the vaccine approval process?
There are four main objections to the decision of India's Drug Regulator, DCGI -
1. Reliability: According to Dr. Anant Bhan, former president of the International Association of Bio-Ethics, only China and Russia have approved the vaccine before the results of Phase-3 trials. India has done the same. This puts the reliability of the regulatory process at bay.
2. Rule: Malina Isola of All India Drug Action Network says that under which rule the vaccine has been approved, it has not been given any information. The conditions related to the vaccine are also not mentioned.
3. Transparency: Epidemiologist Giridhar Babu says that if the use of covaxin will still be similar to clinical trials, what will be the process of getting consent? Have not answered any such questions.
4. Security data: Dr. Amar Jessani, editor of the Indian Journal of Medical Ethics, said the SEC has not presented any data on the issue of approving covaxine. How to know if this vaccine is completely safe and effective?
What is the main concern of experts?
Dr. Gagandeep Kang, one of the top vaccine scientists in the country, says that the regulatory process has led to confusion. If emergency approval has been given to covaxin, how will it be used in clinical trial mode? This has never happened before, how will it happen now? It would have known the impact and then giving emergency approval, there would be no problem.
They also say that the SII trials of Coveshield are being called Phase-2/3 trials. But it has everything that happens in phase-2 trials worldwide. That is, safety and immunogenicity are being seen in it, its effect is not being analyzed. If someone has asked how our approval differs from China and Russia, I have no answer.
What is the government's argument on the objections of experts?
Dr. Guleria states that there is no anti-viral drug available against coronavirus. As such, covaxin has been approved in the same way as remdesivir and hydroxychloroquine have been given limited approval.
He says cases have increased rapidly in Britain, the United States, and Europe. If we also have a fast case, then we also have to use covaxin as a back-up. It can be an effective weapon in preventing the spread of corona.
If there is no data regarding the effect of covaxin, Dr. Guleria says that at present, only the SII vaccine will be used more. When interim data from Covaxin's Phase-3 trials are revealed, it too will get approval like Covishield.
He says that caution will be maintained regarding the use of covaxin. It is not permitted to market the vaccine. It will be installed in trial mode only. That means its database will be maintained. Those who are vaccinated will have side-effects monitoring.
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