NEW DELHI (AP) – As director of a major hospital in the Indian state that has seen the most cases of coronavirus in the country, dr. SP Kalantri waited for the day that a vaccine would be approved, and would not only protect its community but also itself.
But now he has his doubts about the shots after India took a shortcut for the approval of a vaccine by Indian drugmaker Bharat Biotech before late clinical trials showed it was effective in preventing coronavirus infections.
“I would rather wait and see,” said Kalantri, who runs a hospital in Maharashtra’s Wardha district.
He is not alone. Several groups and unions representing scientists and doctors have also expressed concern about the lack of evidence of the vaccine’s effectiveness.
Many scientists have said that the approval of a vaccine without evidence from late trials is risky and a lack of transparency in the approval process could increase the hesitation of vaccines in the world’s most populous country, where more than 10.4 million cases of coronavirus has been reported. 1.4 billion people.
The homemade vaccine was one of two that India approved for emergency use on January 3rd. 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 which suggested that it was approximately 70% effective was to prevent diseases due to coronavirus infection.
Initially, a member of India’s task force COVID-19 said the Bharat Biotech vaccine would be a “backup”. But on January 5, health officials said it would be given to people after they got permission and were followed up more frequently, indicating that both vaccines would be deployed. It remains unclear which states will receive which vaccine and on what basis.
Prime Minister Narendra Modi saw the vaccines as proof of India’s growing independence as a result of its protectionist policies.
On January 16, India begins the massive undertaking to vaccinate an estimated 30 million doctors, nurses and other frontline workers before paying attention to about 270 million people over the age of 50 or due to illness.
China and Russia also administered vaccines while late clinical trials were still ongoing. But India, which is the world’s largest manufacturer of vaccines, has drawn criticism over the use of two different standards – which require efficacy data for one and not the other – for the use of the two vaccines, as well as the lack of transparency in the process.
The panel of experts who finally gave the nod to the vaccines met three times. In the first two meetings, on December 30 and January 1, they were dissatisfied with Bharat Biotech’s application and asked for more information on the ability to prevent COVID-19 diseases, minutes from the meeting. The AstraZeneca vaccine, meanwhile, went green on 1 January.
But on January 2, experts allowed the limited use of the Bharat Biotech vaccine as an “abundant precaution” after the company claimed the vaccine had the potential to be a more contagious variant of the virus found in Britain, to rig.
Bharat Biotech’s chairman and managing director, Krishna Ella, has acknowledged since his approval that the effectiveness of the vaccine against the British variant is ‘only a hypothesis’.
Although the minutes of the January 2 meeting claim that the company presented ‘updated data’, there is no clarity about the new evidence that prompted the experts to change their minds, which had the need for ‘guesswork’, the dr. Anant Bhan, who is studying medical ethics and was not on the panel.
Dr. Vineeta Bal, who is studying the immune system at the Indian Institute of Immunology of India, acknowledged the need for transparent approvals containing data confirming its effectiveness.
“This is a process that Indian government officials are sabotaging themselves,” she said.
India’s largest opposition party in Congress has said the early approval was “unprecedented, unacceptable and life threatening”. The concern was reiterated by Chattisgarh State Health Minister TS Singh Deo, who said the Bharat Biotech vaccine should not be used in the state.
‘If you take general use before the trials are completed, it will be a precedent where other companies will get permission for emergency use before completing the trials. It can also endanger the valuable lives and health of our citizens, ”said Deo.
Some have implied that the approval of the vaccine is based on nationalism. After the AstraZeneca vaccine was approved and before the approval for the Bharat Biotech vaccine was issued, a leader of Modi’s party tweeted that he was shocked to learn that a foreign vaccine had been approved, while an Indian vaccine ‘lay in the ditch’.
The head of India’s drug regulator declined to comment on the controversy, while experts from the panel approving the vaccines were not released.
Balram Bhargava, who heads the Indian Medical Research Council, the country’s top medical research institute, said the ‘limited use’ of a vaccine based on data from early clinical trials was legal in a pandemic is possible. The body is a co-sponsor of the trials.
A public outcry between the top executives of Serum Institute of India and Bharat Biotech, in which they questioned the effectiveness of the other’s vaccine, also made the water muddy. Management later issued a joint statement saying the events were a ‘miscommunication and misunderstanding’ and that they were focused on the explosion of vaccines.
“Such actions do arouse people’s minds and can promote the hesitation of vaccines,” said Dr. Shahid Jameel, who studies viruses at Ashoka University in India, said.
He said that Bharat Biotech’s indigenous vaccine is promising, but that the approval process should be based on hard data and evidence.
“Faith has no value in science,” Jameel said.
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The Associated Press Health and Science Division receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.