TBC Explainer: What if the Covaxin doesn't pass Phase 3 trials

Many questions have been raised at the efficacy of Covaxin. People are concerned whether the vaccine is safe for public use.
TBC Explainer: What if the Covaxin doesn't pass Phase 3 trials
People are concerned whether the vaccine is safe for public use (Representational)TBC

After a long battle against the virus, India has two COVID-19 vaccines approved by the Central Drugs and Standards Committee. Both the vaccines work similarly by producing antibodies in the body and both are storage-friendly as well. Covishield which is a joint effort of Oxford University and AstraZeneca has cleared the three clinical trials and Serum Institute of India will be manufacturing the same vaccine. Whereas, Bharat Biotech which is going to manufacture Covaxin, is still under the Phase 3 trial. What is shocking to know is that Covaxin has already been given a green signal even before completing the Phase 3 trials.

Many questions have been raised at the efficacy of Covaxin. People are concerned whether the vaccine is safe for public use. The concern of people is justified as the vaccine is still under its Phase 3 trials and the actual efficacy of the vaccine can only be known after the Phase 3 trials are done.

Vice reported severe lapses in the Phase 3 trial in Bhopal. People who were given the vaccine were not aware that they are a candidate in the vaccine trial. People were also not given consent forms that they could carry home.

"I can assure our vaccine is 200 per cent safe,” Bharat Biotech MD, Krishna Ella, said in a virtual press conference.

Scientists at Indian school of virology have worked tirelessly to come out with a vaccine and we are not doubting their efforts. But science revolves around trial and error method. So we can't be sure if the vaccine will pass the Phase 3 trials.

The decision of approving Covaxin before the Phase 3 trials faced a major backlash. In reply to the backlash Bharat Biotech CMD, Krishna Ella, said, “India can innovate. It’s not a copycat country. We don’t deserve a backlash; we do everything systematically and yet we get bashing from the news media. A company has branded our vaccine as water. It hurts as a scientist and we don’t deserve that. Why is nobody questioning the UK trials? Because, Indian trials are easy to be bashed.”

Dr Randeep Guleria, Director, All India Institute of Medical Sciences (AIIMS) said Covaxin is a backup vaccine, just in case, there is a sudden increase in cases. But, in a media briefing by Dr VK Paul, Member (Health), NITI Aayog, on January 12th, he said that both the vaccines have established its safety and immunogenicity and are safe to use.

"In an emergency situation when there is a sudden increase in cases and we need to vaccinate, Bharat Biotech vaccine will be used. It can also be used as a backup when we're not sure how efficacious the Serum Institute vaccine is going to be," All India Institute of Medical Sciences (AIIMS) Director, Dr Randeep Guleria, told news agency ANI.

Government has already placed an order of 55 lakh doses of Covaxin from Bharat Biotech and 110 lakh doses of Covishield from the Serum Institute of India which were delivered to various states yesterday.

The irony here is that Dr VK Paul said in the media briefing that India's COVID-19 cases have seen a downward trend after reaching the peak in September and it continues to decrease constantly.

We fail to understand that if the daily COVID-19 cases are decreasing sharply, then what is the need of a vaccine which haven't passed the Phase 3 trials and have been showing adverse effects on the candidates.

On contrary to the price expectation of Covaxin, the predictions were that Covaxin will be priced around $1 per vaccine, making it viable for a common man to get vaccinated. But the GoI has procured one vaccine from Bharat Biotech at Rs 295 per dose, which is roughly $4 per dose and almost 50 per cent more expensive than Serum Institute produced Covishield. The actual cost of the vaccine is 4x the predicted cost. Although, Bharat Biotech has contributed 16.5 lakh vaccines for free to the government, hence taking its cost down to Rs 206 per dose.

Whereas, the government has procured Covishiled from Serum Institute at Rs 200 (excluding taxes) per dose. Adar Poonawalla, CEO of Serum Institute, said that the current price is only for the vaccine procured by the government of India. Whereas, the vaccine will be available in the private market for Rs 1,000 per dose.

But just in case if the vaccine doesn't pass the Phase 3 trials, will we ever come to know about it?

Because this will tell the world about the lapses in the Indian government, which will harm India's reputation in the global market.

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