Saturday, January 09, 2021

Shouldn't we protect the trust in our vaccines?

"The controversy over speedy approval for Covaxin developed by Indian Council for Medical Research (ICMR), National Institute of Virology and Bharat Biotech exemplifies the risk of damage to the nation's vital interests that single-minded criticism of the government entails," thundered an editorial in The Economic Times. "Opposition parties must give up their knee-jerk response of spreading doubt to delegitimise every effort made by the Modi administration." Then it suggests that the government could have communicated better with the public and the regulator could have published all trial data so that experts could give their opinion. "The recommendations of the Indian drugs regulator's subject expert committee (SEC) released on Tuesday  show that the panel asked Bharat Biotech International Ltd to present more efficacy data for its Covid-19 shot before it could consider approving the treatment," reported Reuters. "The very next day, the committee recommended approving Bharat Biotech's vaccine for 'restricted use in emergency situation in public interest as an abundant precaution'." "How can a coronavirus vaccine be cleared for emergency use by millions of vulnerable people in a 'clinical trial' mode?" asked the BBC. Dilip D'Souza explained the trial numbers. "Covaxin's Phase 1 trial was registered on 1 July 2020." It was to run for 15 months on 1,125 volunteers. Phase 2 was registered just over two months later on 8 September to run on 124 volunteers for 8 months. Phase 3 was registered on 9 November to run till 9 November 2021 on 25,800 volunteers. It has been approved for 1.4 billion people when not even Phase 1 has been completed.  "Covaxin is made of an inactivated vaccine, meaning the vaccine is made up of the virus that had been killed and can no longer cause infection," explained The Print. "On 22 December, Bharat Biotech published data from its phase 2 trial with a follow-up on its phase 1 trial, on a non-peer reviewed website." Suspicion is justified by a letter written by Director-General of ICMR Balram Bhargava in July asking for all trials to be completed by 15 August 2020, India's Independence Day, and threatening "non compliance will be viewed very seriously". "Like many things in India nowadays, the science of vaccine approval has also run into the politics of chest-thumping nationalism," wrote Andy Mukherjee. "China and Russia appear more desperate to beat the West in saving the world," but " as Clara Ferreira Marques has noted, both these countries' vaccine candidates face a transparency deficit, which could limit their global acceptance. That's a risk that India, which manufactures more than 60% of the world's vaccines, should avoid at all cost." This is the only thing that we manufacture better than China. Should we sacrifice it on political propaganda?   

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