NEW DELHI (AP) – As director of a large Indian hospital that has seen more coronavirus cases in the country, Dr SP Kalantri was waiting for the day the vaccine would be approved and would provide protection not only to his community, but also himself.
But he now has his doubts about how to get the shots after India took a regulatory shortcut to approving a vaccine by Indian pharmacist Bharat Biotech before late clinical trials proved it was effective in preventing coronary heart disease.
“I prefer to wait and watch,” said Kalantri, who runs a hospital in Wardha district in the state of Maharashtra.
He is not alone. Several groups and unions representing scientists and doctors have also expressed concern about the lack of evidence for the vaccine’s effectiveness.
Many scientists have said that approving a vaccine without testing from late trials is risky and that a lack of transparency in the approval process could increase hesitation in the world’s second most populous country, where more has been reported. of 10.4 million cases of coronavirus 1.4 billion people.
The self-produced vaccine was one of two that India authorized for emergency use on 3 January. The approval of the other, a version of the AstraZeneca vaccine developed by the Serum Institute of India, the world’s largest manufacturer, was given on the basis of partial results from studies conducted in Britain and Brazil which suggested that it was about 70% effective in preventing diseases from coronavirus infection.
Initially, a member of India’s COVID-19 working group said the Bharat Biotech vaccine would be a “backup”. But on Jan. 5, health officials said people would be given after obtaining their consent and ensure more frequent follow-up, suggesting the two vaccines be deployed. It is not yet clear which states will receive which vaccine and on what basis.
Prime Minister Narendra Modi has announced vaccines as proof of India’s growing self-sufficiency due to its protectionist policies.
On January 16, India will launch the massive initiative to inoculate some 30 million doctors, nurses and other front-line workers, before the care targets about 270 million people over the age of 50 or with comorbidities. .
China and Russia have also administered vaccines while late clinical trials were still being conducted. But India, the world’s largest vaccine maker, has criticized the use of two different standards, which need efficacy data for one and not the other, to give the green light to use. of the two vaccines, as well as the lack of transparency in the process.
The group of experts who finally headed for the vaccines met three times. At the first two meetings, on 30 December and 1 January, they were dissatisfied with Bharat Biotech’s request and asked for more information on its ability to prevent disease from COVID-19, minutes from the meeting schedule. The AstraZeneca vaccine, meanwhile, was lit in green on 1 January.
But on January 2, experts allowed the restricted use of the Bharat Biotech vaccine as an “abundant precaution” after the company claimed the vaccine had the potential to target a more contagious variant of the virus found. in Britain.
Since its approval, Bharat Biotech President and CEO Krishna Ella has acknowledged that the vaccine’s effectiveness against the UK variant is “just a hypothesis”.
Although minutes from the Jan. 2 meeting it is argued that the company presented “updated data,” there is no clarity on what new evidence motivated the experts to change their minds, which resulted in the need of a “work of supposition,” said Dr. Anant Bhan, who studies medical ethics and did not participate.
Dr. Vineeta Bal, who studies immune systems at the National Institute of Immunology of India, echoed the need for transparent approvals that include data confirming efficacy.
“This is a process that Indian government officials themselves are sabotaging,” he said.
India’s main opposition party in Congress has said the premature clearance was “unprecedented, inadvisable and life-threatening”. This concern was echoed by Chattisgarh State Health Minister TS Singh Deo, who said the Bharat Biotech vaccine should not be used in the state.
“Accessing general use before the trials are completed will set a precedent in which other companies will apply for emergency use authorization before completing the mandatory trials. This can also endanger the valuable lives and health of our citizens, ”Deo said.
Some have hinted that vaccine approval was based on nationalism. After the AstraZeneca vaccine was approved and before the authorization of the Bharat Biotech vaccine was granted, a Modi party leader tweeted that he was surprised to learn that a foreign vaccine had been approved, while an Indian vaccine he was “in the gutter.”
The head of India’s drug regulator has declined to comment on the controversy, while the identity of experts from the group that approved the vaccines has not been made public.
Balram Bhargava, who heads the Indian Council for Medical Research, the country’s medical research body, said “restricted use” of a vaccine based on data from early clinical trials is legally possible in a pandemic. The body is a sponsor of the tests.
A public dispute between the top executives of the Serum Institute of India and Bharat Biotech in which each questioned the effectiveness of the other’s vaccine also got muddy. Executives later issued a joint statement saying the facts were “poor communication and misunderstanding” and that they were focused on the deployment of vaccines.
“These actions raise doubts in people’s minds and may encourage vaccination of the vaccine,” said Dr. Shahid Jameel, who studies viruses at Ashoka University in India.
He said that while Bharat Biotech’s own production vaccine was promising, the approval process should be based on data and evidence.
“Belief has no value in science,” Jameel said.
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The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.