MUMBAI – India’s need for speed in providing a Covid-19 vaccine and attempts to push a locally-produced version through for use before a required phase 3 trial was finished has raised doubts and protests from politicians, scientists and academicians.
The country has 244,000 active cases from a total of 10.34 million recorded infections, the second-highest in the world behind the 21 million in the United States.
The Drugs Controller General of India (DCGI) approved the Oxford-AstraZeneca vaccine that’s being produced locally by the Serum Institute of India as Covishield.
The world’s largest vaccine manufacturer based in Pune said it can readily provide 50 million vaccines to the government for immediate use and can roll out full production to start supplying the population by March.
The DCGI also approved a vaccine produced by Bharat Biotech Ltd along with the Indian Council for Medical Research and the National Institute of Virology named Covaxin for emergency use on a trial basis.
Now here’s the catch.
Bharat Biotech has successfully conducted phase 1 and 2 trials, but has yet to complete the third phase of trials. Of the planned 25,800 volunteers, as many as 22,500 of them have been vaccinated and the vaccine has been found to be safe, the government said.
“Vaccines approved globally based on gene encoding spike proteins have protective efficacy of over 90%,” said Health Minister Dr Harsh Vardhan. “However, Covaxin is based on the whole inactivated virus has other antigenic epitopes in addition to spike proteins, so it’s likely to have similar a protective efficacy reported for the others.’’
Vinod Paul, the head of the national Covid task force, said on Sunday the use of the Bharat vaccine would be like a clinical trial and would only be given to those who opt for it, and its after-effects would be monitored.
Some experts said it was a desperate move to contain the spread of any new strain of the virus. With a population of 1.38 billion, India is highly vulnerable to catching and spreading the virus.
Following tough lockdowns and restrictions, India has been able to contain the number of active cases and is ranked 10th globally. Yet authorities remain skeptical considering the spurt in the number of cases across Europe and the United States.
Still, not many are prepared to buy the government’s reasoning.
Gagandeep Kang, a clinical scientist and a professor at the Christian Medical College in Vellore, said there can’t be a halfway with a vaccine – either you do clinical trials or you do not.
Covaxin, she said, has no clinical efficacy data and therefore can’t be considered to be an efficacious vaccine.
“We are extremely alarmed and shocked because it signifies the grant of regulatory approval without any efficacy data. The phase 3 trials are currently ongoing and it is too early for data to meet the criterion for an interim analysis,” said Malini Aisola, co-convenor of the All India Drug Action Network (AIDAN).
“This would amount to rolling out an untested and unproven vaccine to the public, which raises concerns.’’
AIDAN is an independent network of several non-government organizations working to increase access and improve the rational use of essential medicine in India.
Some leaders of political parties also raised objections, inviting the government’s wrath and being called cynics.
“The Covaxin has not yet had phase 3 trials,” said Shashi Tharoor, a former junior foreign minister and undersecretary-general at the United Nations. “Approval was premature and could be dangerous. Its use should be avoided till full trials are over. India can start with the AstraZeneca vaccine in the meantime.”
“Offering the Bharat Biotech vaccine before phase 3 clinical trials have proven efficacy is a violation of every scientific protocol and unheard of in the world,” said Tharoor. “Jingoism is no substitute for common sense.”
India plans to inoculate 300 million people in the first phase. Frontline workers, medical professionals on Covid duty, other government employees who face a high risk of being exposed, police and others in security forces, senior citizens and those suffering from co-morbidities are likely to be among the first to get the vaccine.
On January 2, India conducted an all-India mock drill to test its systems of logistics and mechanisms that will be required for providing vaccinations on a huge scale. India is also using its vast database from the Election Commission to identify people and provide vaccines.
The Serum Institute is expected to ensure an adequate number of vaccines to cater to local requirements before the government permits exports. Scores of low-income countries depend on companies such as the Serum Institute, which can roll out the vaccine at a cheaper price.
Compared with others, the Oxford-AstraZeneca vaccine is cheaper and can be stored in a normal refrigerator, making it useful for tropical and other warmer and less affluent countries, say medical experts.