Eyebrows raised over India’s COVID-19 shot approval

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[NEW DELHI] India’s endorsement for crisis utilization of a privately created COVID-19 antibody that is as yet going through clinical preliminaries has raised a tempest of analysis by clinical specialists and associations engaged with general wellbeing.

On Sunday (3 January), the Drugs Controller General of India (DCGI), the fundamental administrative body, reported endorsement for Covaxin. The immunization was grown natively by Bharat Biotech in association with the state’s Indian Council of Medical Research despite the fact that it is as yet going through stage 3 human preliminaries but then to distribute information on immunogenicity and viability.

DCGI explicitly restricted Covaxin sending to ‘clinical preliminary mode’, a class numerous specialists had issues with. “Never knew about such a classification,” Manu Raj, research methodologist and general wellbeing scientist connected to the Amrita Institute of Medical Sciences and Research Center in Kochi, Kerala, tells SciDev.Net.

“It may be a good vaccine but this way of approval casts a shadow on its image”

Formal solicitations for explanations sent by SciDev.Net to India’s Department of Biotechnology, the public authority organization supporting the native creation of COVID-19 immunizations, were declined.

Likewise affirmed for crisis use was the Oxford University-AstraZeneca’s Covishield that utilizes a debilitated adenovirus as a vector to convey the COVID-19 spike protein. The Indian form of Covishield is being made in India by the exclusive Serum Institute of India.*

Following the DCGI declaration, Prime Minister Narendra Modi said in a tweet: “It would make each Indian glad that the two antibodies that have been given crisis use endorsement are made in India! This shows the enthusiasm of our academic local area to satisfy the fantasy of an Aatmanirbhar Bharat (confident India), at the base of which is care and sympathy.”

In a separate tweet, Modi wrote: “A decisive turning point to strengthen a spirited fight! DCGI granting approval to vaccines of Serum Institute of India and Bharat Biotech accelerates the road to a healthier and COVID-free nation. Congratulations India. Congratulations to our hardworking scientists and innovators.”

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Poonam Khetrapal Singh, regional director for WHO South-East Asia, said in a tweet that the organization welcomed India’s decision to give “emergency use authorization” for COVID-19 vaccines.

“The use of vaccine in prioritized populations, along with the continued implementation of other public health measures and community participation, will be important in reducing the impact of COVID-19,” she tweeted.

But medical scientists and voluntary agencies involved in public health and the rational use of drugs are alarmed at the bypassing of clinical trial protocols and the release of the indigenously developed Covaxin without publishing or publicizing trial results.

T. Sundararaman, the global coordinator for the People’s Health Movement, an international network of grassroots health organizations, says: “The hasty approval for Covaxin was very unnecessary — they could easily have waited another two months for the completion of phase 3 trials when data and information may have been available. What was the tearing hurry when case incidence in the country was very low?”

A country of 1.3 billion people, India has so far reported 10.3 million COVID-19 cases, the second-highest in the world, with 150,000 of them fatal. But infection rates have been on the decline after peaking in mid-September.

“It might have been better to take scientists and the public into confidence before releasing it in this manner,” Sundararaman, a former executive director of the National Health Systems Resource Centre of India’s central Ministry of Health and Family Welfare, tells SciDev.Net. He says releasing the vaccine minus data would undermine its credibility and relegate it to a “poor man’s alternative,” even if its efficacy is as good as that of other vaccines.

Raj says: “It may be a good vaccine but this way of approval casts a shadow on its image.” He adds, however, that with the availability of two different vaccines India may be better able to achieve its target of immunizing a third of its population over the next six months.

The All India Drug Action Network (AIDAN), an influential drug activists’ group issued a statement asking the DCGI to release all data and analyses on which the decision to launch COVID-19 vaccines was based.

“In the interest of transparency and public welfare, we ask that the regulator [DCGI] share the detailed rationale for the decision along with disclosure of the data, evidence, and information that was reviewed by the SEC [subject experts committee] and the data and analysis on the basis of which the REU [restricted emergency use] approval is granted,” the AIDAN statement said.

Mira Shiva, a physician and leader of AIDAN, tells SciDev.Net that the group was “shocked over the decision to grant approval to Bharat Biotech’s Covaxin, while still in clinical trial mode, especially in the context of reports of infection by mutant strains”.

“In contrast, the Oxford University-AstraZeneca vaccine that is being manufactured here by the Serum Institute was approved in the UK and other countries on the basis of data from rigorous clinical trials,” she says.

According to Shiva, what is at stake is India’s reputation as a major source of reliable and cheap vaccines for the developing world and one controlled by regulatory institutions known for strict conformance to protocols and for carrying out science-based assessments before granting approvals.

Krishna Ella, Bharat Biotech’s managing director, defended his product at a virtual press conference on Monday. “Many people are just gossiping. It is just a backlash against Indian companies. That is not right for us. We don’t deserve that. Covaxin has shown less than 10 percent adverse reactions.”

Covaxin is produced using a whole inactivated virus, the oldest vaccine technique, by which the live virus is killed so that it can no longer replicate but is still capable of stimulating an immune response in the recipient. Partial phase 1 and 2 trial results for the vaccine are available on the company’s website.

Meanwhile, Adar Poonawalla, chief executive officer of Serum Institute of India said in a tweet: “All the risks @SerumInstIndia took with stockpiling the vaccine, have finally paid off. Covishield, India’s first COVID-19 vaccine is approved, safe, effective, and ready to roll-out in the coming weeks.”

Poonawalla had earlier announced that his firm, among the world’s largest vaccine manufacturers, had stockpiled close to 50 million doses of Covishield, ahead of clinical trials, and was prepared to make 300 million doses by July 2021.

India has in the pipeline another indigenous COVID-19 vaccine candidate, approved by DCGI for phase 3 clinical trials — a plasmid DNA vaccine called ZyCoV-D developed by Zydus Cadila. DNA vaccines rely on a genetically engineered plasmid (DNA molecule separate from chromosomal DNA and capable of copying itself) that contains the DNA sequence encoding the antigen(s) against which immune response is sought.

“Zydus Cadila completed Phase-I/II clinical trials of this DNA vaccine candidate, in India, in more than 1,000 participants and interim data indicated that the vaccine is safe and immunogenic when three doses were administered intradermally,” a Department of Biotechnology media release said on Sunday.

Student of English literature, Treatise Versifier, Content Writer. Passionate about writing my own ideas and to share it with the public.

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