NEW DELHI (AP) – As director of a large hospital in the Indian state that has seen most cases of coronavirus in the country, Dr. SP Kalantri was waiting for the day when a vaccine would be approved and would bring protection not only to his community , but also himself.
But he now has his doubts about vaccines after India took a regulatory shortcut to approve a vaccine by Indian pharmaceutical company Bharat Biotech, before the latest clinical tests showed it was effective in preventing diseases caused by coronavirus infections.
“I prefer to wait and watch,” said Kalantri, who runs a hospital in the district of Wardha in the state of Maharashtra.
He is not alone. Several groups and unions representing scientists and doctors have also expressed concerns about the scant evidence of the vaccine’s effectiveness.
Many scientists said that approving a vaccine without evidence of final testing is risky and the lack of transparency in the approval process could increase the vaccine’s hesitation in the second most populous country in the world, where more than 10.4 million cases of coronavirus have been reported among the almost 1.4 billion people.
The home vaccine was one of two that India authorized for emergency use on January 3. The approval of 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 suggested that it was about 70% effective in preventing coronavirus infection disease.
Initially, a member of India’s COVID-19 task force said the Bharat Biotech vaccine would be a “backup”. But on January 5, health officials said it would be given to people after obtaining their consent and ensuring more frequent follow-ups, suggesting that the two vaccines will be distributed. It is not yet clear which states will receive which vaccines and on what basis.
Prime Minister Narendra Modi praised vaccines as evidence of India’s growing self-reliance due to its protectionist policies.
On January 16, India will begin the massive endeavor to inoculate some 30 million doctors, nurses and other frontline workers, before the attention turns to about 270 million people over 50 or with comorbidities .
China and Russia also administered vaccines while the latest clinical trials were still in progress. But India, which is the world’s largest vaccine manufacturer, has been criticized for using two different standards – needing efficacy data for one and not the other – to give the green light to the use of the two vaccines, as well as the lack of transparency in the process.
The panel of experts who ended up approving the vaccines met three times. In the first two meetings, on December 30 and January 1, they were dissatisfied with the Bharat Biotech app and asked for more data on their ability to prevent COVID-19 illnesses, minutes of the meeting. The AstraZeneca vaccine, on the other hand, had the green light on January 1st.
But on January 2, experts allowed restricted use of the Bharat Biotech vaccine as an “abundant precaution” after the company claimed that the vaccine had the potential to target a more contagious variant of the virus found in Britain.
Since its approval, Bharat Biotech’s president and managing director, Krishna Ella, has recognized that the vaccine’s effectiveness against the UK variant is “just a hypothesis”.
Although the minutes of the January 2 meeting state that the company presented “updated data,” there is no clarity as to what new evidence has led experts to change their minds, resulting in the need for “assumptions,” said Dr. Anant Bhan, who studies medical ethics and was not on the panel.
Dr. Vineeta Bal, who studies the immune system at India’s National Institute of Immunology, agrees with the need for transparent approvals that include data that confirm its effectiveness.
“This is a process that Indian government officials themselves are sabotaging,” she said.
The main opposition party of the Congress of India said the premature release was “unprecedented, inadvisable and risking lives”. This concern was echoed by Chattisgarh state health minister TS Singh Deo, who said that the Bharat Biotech vaccine should not be used in the state.
“Rushing general use before tests are completed will set a precedent in which other companies will seek authorization for emergency use before completing mandatory testing. It can also put our citizens’ valuable lives and health at risk, ”said Deo.
Some suggested that the vaccine’s approval was based on nationalism. After the AstraZeneca vaccine was approved and before the release for the Bharat Biotech vaccine was issued, a Modi party leader 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 India’s drug regulator declined to comment on the controversy, while the identity of the experts on the panel that approved the vaccines was not disclosed.
Balram Bhargava, who heads the Indian Medical Research Council, the country’s top medical research body, said that “restricted use” of a vaccine based on data from initial clinical trials is legally possible in a pandemic. The body is a co-sponsor of the tests.
Also muddying the waters was a public feud between the top executives at the Serum Institute of India and Bharat Biotech, in which each questioned the effectiveness of the other’s vaccine. Subsequently, the executives issued a joint statement saying that the events were a “miscommunication and misunderstanding” and that they were focused on launching the vaccine.
“These actions raise doubts in people’s minds and can promote vaccine hesitation,” said Dr. Shahid Jameel, who studies viruses at Ashoka University in India.
He said that while Bharat Biotech’s homemade vaccine was promising, the approval process needs to be based on hard data and evidence.
“Belief has no value in science,” said Jameel.
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