NEW DELHI (AP) – As director of a major Indian state hospital that has seen the most coronavirus cases in the country, Dr. SP Kalantri has been waiting for the day a vaccine will be approved and will provide protection not only to his community. , but also himself.
But he now has doubts about taking the photos after India took a quick regulatory order to approve a vaccine by Indian doctor Bharat Biotech before late clinical trials show it is effective in preventing coronavirus infections.
“I would rather wait and watch,” said Kalantri, who runs a hospital in Wardha district 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 the approval of a vaccine without evidence from late studies is risky and the lack of transparency in the approval process could increase the hesitation of the vaccine in the second most populous country in the world, where more than 10.4 million have been reported. of coronavirus cases among 1.4 billion people.
The homemade vaccine was one of two authorized by India for emergency use on January 3rd. The approval of the other – a version of the AstraZeneca vaccine by the world’s largest vaccine manufacturer Serum Institute in India – was given based on partial results from studies in the UK and Brazil which suggested it was about 70% effective in prevention of coronavirus infection.
Initially, a member of the COVID-19 working group in India said that the Bharat Biotech vaccine would be a “reserve”. But on January 5, health officials said it would be given to people after obtaining consent and ensuring more frequent action, suggesting that both vaccines would be used. It remains unclear as to which states will receive which vaccine and on what basis.
Prime Minister Narendra Modi backed vaccines as evidence of India’s growing independence over protectionist policies.
On January 16, India will start the massive inoculation enterprise of about 30 million doctors, nurses and other front-line workers, before the focus shifts to about 270 million people over the age of 50. , or have comorbidities.
China and Russia also administered vaccines, while late clinical trials were still ongoing. 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 clarify the use of the two vaccines, as well as the lack of transparency. of the process.
The group of experts who eventually nodded at the vaccines met three times. In 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 COVID-19 diseases, a few minutes after the meeting. Meanwhile, the AstraZeneca vaccine was lit in green on January 1.
But on January 2, experts allowed the restricted use of the Bharat Biotech vaccine as an “abundant precaution” after the company claimed that the vaccine has the potential to target a more contagious variant of the virus found in the UK.
Since the approval, Bharat Biotech President and CEO Krishna Ella has acknowledged that the effectiveness of the vaccine against the British version is “just a hypothesis”.
Although in a few minutes of the January 2 meeting it was alleged that the company had submitted “updated data”, there is no clarity as to what new evidence led the experts to change their minds, which led to the need for a “work of guess, ”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 in India, recalled the need for transparent approvals that include data confirming efficacy.
“This is a process that Indian government officials are sabotaging themselves,” she said.
India’s main opposition party, Congress, said the premature clearance was “unprecedented, unadvised and life-threatening”. This concern was reiterated by Chattisgarh State Health Minister TS Singh Deo, who said the Bharat Biotech vaccine should not be used in the state.
“The launch in general use before the completion of studies will set a precedent in which other companies will apply for emergency use permits before the completion of compulsory studies. This can also endanger the valuable lives and health of our citizens, ”said Deo.
Some have suggested that vaccine approval was based on nationalism. After the approval of the AstraZeneca vaccine and before the release of the Bharat Biotech vaccine, a Modi party leader wrote on Twitter 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 identities of experts in the group that approved the vaccines have not been made public.
Balram Bhargava, who heads the Indian Medical Research Council, the country’s apex medical research body, said the “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 trials.
The clouding of the waters was also a public spit between the top directors of the Indian Serum Institute and Bharat Biotech, in which each questioned the effectiveness of the other’s vaccine. Executives later issued a joint statement saying the events were “misrepresentation and misunderstanding” and focused on launching the vaccine.
“Such actions raise doubts in people’s minds and can promote the hesitation of the vaccine,” said Dr. Shahid Jameel, who studies viruses at Ashoka University in India.
He said that while the local Bharat Biotech vaccine was promising, the approval process must be based on data and evidence.
“Faith has no value in science,” Jameel said.
___
The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.