NEW DELHI (AP) – As director of a major hospital in the Indian state that has experienced the most cases of coronavirus in the country, Dr. SP Kalantri waited for the day when a vaccine would be approved and protect not only his community, but also himself.
But now he has doubts about getting the photos after India took a regulatory shortcut to approve a vaccine by Indian drug manufacturer Bharat Biotech before late clinical trials showed it was effective in preventing disease from coronavirus infections.
“I’d rather wait,” said Kalantri, who runs a hospital in the Wardha district of Maharashtra state.
He’s not alone. Various groups and unions representing scientists and doctors have also expressed concern about the scant evidence of the vaccine’s effectiveness.
Many scientists have said that approving a vaccine without evidence of late trials is risky and that a lack of transparency in the approval process can increase hesitation about vaccines in the world’s second-most populous country, where more than 10.4 million coronavirus cases have been reported among nearly 1.4 billion people.
The homegrown vaccine was one of two that India approved for emergency use on Jan. 3. The approval for the other – a version of the AstraZeneca vaccine made by the world’s largest vaccine manufacturer Serum Institute of India – was given based on partial results from studies in Britain and Brazil that suggested it was about 70% effective in preventing diseases from coronavirus infection.
Initially, a member of India’s COVID-19 task force said the Bharat Biotech vaccine would be a “back-up”. But on Jan. 5, health officials said it would be given to people after they got their consent and for more frequent follow-ups, suggesting both vaccines will be deployed. It remains unclear which states will receive which vaccine and on what basis.
Prime Minister Narendra Modi has touted the vaccines as evidence of India’s growing self-reliance due to its protectionist policies.
On January 16, India kicks off the massive venture of vaccinating an estimated 30 million doctors, nurses and other frontline workers, before focusing on about 270 million people over 50 or having co-morbidities.
China and Russia also administered vaccines while clinical trials were still ongoing. But India, the largest vaccine manufacturer in the world, has criticized the use of two different standards – requiring efficacy data for one and not the other – for giving the green light to the use of the two vaccines. , as well as a lack of transparency in the process.
The panel of experts that ultimately gave the nod to the vaccines met three times. During the first two meetings, on December 30 and January 1, they were dissatisfied with Bharat Biotech’s application and asked for more data on the ability to prevent disease from COVID-19 minutes after the meeting. The AstraZeneca vaccine, meanwhile, got the green light on January 1.
But on Jan. 2, experts allowed limited use of the Bharat Biotech vaccine as an “abundant precaution,” after the company claimed the vaccine had the potential to fight a more contagious variant of the virus found in Britain. .
Since approval, Bharat Biotech’s Chairman and Chief Executive Officer, Krishna Ella, has acknowledged that the vaccine’s effectiveness against the UK variant is “just a hypothesis”.
While the minutes of the January 2 meeting claim that the company presented “updated data,” there is no clarity as to what new evidence prompted the experts to change their minds, resulting in the need for “guesswork,” said Dr. . Anant Bhan, who studies medical ethics and is not part of the panel.
Dr. Vineeta Bal, who studies immune systems at India’s National Institute of Immunology, reiterated the need for transparent approvals containing data confirming efficacy.
“This is a process that Indian government officials themselves are sabotaging,” she said.
India’s main opposition congress party has said the premature approval was “unprecedented and inadvisable and risked lives”. Those concerns were echoed by Chattisgarh State Minister of Health, TS Singh Deo, who said the Bharat Biotech vaccine should not be used in the state.
“Rushing widespread use before the trials are complete will set a precedent where other companies will seek emergency use approval before completing the mandatory trials. This can also endanger the valuable life and health of our citizens, ”said Deo.
Some have suggested that the vaccine’s approval was based on nationalism. After the AstraZeneca vaccine was approved and before approval for the Bharat Biotech vaccine was issued, a leader from Modi’s party tweeted that he was shocked to learn that a foreign vaccine had been approved while an Indian vaccine was “in the ditch” .
The head of the Indian drug regulator has declined to comment on the controversy, while the identity of the experts on the panel that approved the vaccines has not been made public.
Balram Bhargava, who heads the Indian Medical Research Council, the country’s leading medical research agency, said the “limited use” of a vaccine based on data from early clinical trials is legally possible in a pandemic. The body is a co-sponsor of the trials.
Also, the cloudiness of the waters was a public row between the top executives of Serum Institute of India and Bharat Biotech, each questioning the effectiveness of the other’s vaccine. The executives later issued a joint statement saying the events were a “miscommunication and misunderstanding” and that they focused on the introduction of the vaccine.
“Such actions raise doubts in people and can lead to vaccine hesitation,” says Dr. Shahid Jameel, who studies viruses at Ashoka University in India.
He said that while Bharat Biotech’s homegrown vaccine showed promise, the approval process must be based on hard data and evidence.
“Faith has no value in science,” said Jameel.
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The Associated Press Department of Health and Science is supported by the Science Education Department of the Howard Hughes Medical Institute. The AP is solely responsible for all content.