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Explained: How COVID-19 vaccine made way for political bickering in India

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New Delhi, Jan 05: On January 2, the Drugs Controller General of India (DCGI), announced the approval for COVID vaccines of Oxford-AstraZeneca-manufactured by the Serum Institute in India-and, of Bharat Biotech, saying that both vaccines would be administered in two doses each. The approval by the DCGI was given on the basis of recommendations submitted by a coronavirus subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).

vaccine

Dismissing safety concerns, Somani asserted that no vaccine with even the slightest safety concern would be approved by DCGI. "The vaccines are 110 per cent safe. Some side effects like mild fever, pain and allergy are common for every vaccine," said the DCGI.

Though the officials came up with much assurances, several Opposition leaders have questioned the approval of the vaccines, particularly that of Bharat Biotech. It can be seen that Congress leaders raised concern over the grant of permission for the indigenously developed 'Covaxin' of Bharat Biotech without phase 3 trials.

Explained: What is the process to get COVID-19 vaccine and who will get it first? Explained: What is the process to get COVID-19 vaccine and who will get it first?

Congress leader Anand Sharma said the issue of granting authorisation to Bharat Biotech's vaccine needs to be taken carefully as no country had dispensed with the mandatory phase 3 trials and verification of data.

According to Sharma, the submissions made before the expert panel, phase 3 trials have not been completed and, therefore, the data on safety and efficacy has not been reviewed, which is a mandatory requirement. His colleague and Lok Sabha MP Shashi Tharoor also expressed apprehensions over approval to Covaxin, saying it had not yet had phase 3 trials.

Earlier, former Uttar Pradesh chief minister and Samajwadi Party chief Akhilesh Yadav sought to politicise the issue by saying that he would not take a vaccine distributed by the BJP. "I am not going to get vaccinated for now. How can I trust the BJP's vaccine? When our government is formed, everyone will get free vaccine. We cannot take the BJP's vaccine," Yadav had said.

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With this, it can be seen that the issue has led to a war of words between the BJP and the Opposition parties. In this political game of one-upmanship and the rush to own or discredit the vaccine, what has been forgotten is that the vaccine has been manufactured to combat an unprecedented human crisis that India and the world have been facing for nearly a year.

It is reportedly said that the SEC has recommended Covaxin for conditional approval based on Phase 3 immunogenicity data for 24,000 volunteers after the first dose, and for 10,000 volunteers after the second dose. The phase 3 trial started in November after it recruited 26,000 volunteers. While the data has reportedly been submitted to the drug controller, it is not in the public domain, causing the political furore.

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    While several Opposition leaders believe that this "hasty" permission to Covaxin has been given to promote Prime Minister Narendra Modi's 'atmanirbhar Bharat' campaign, it's unlikely that the designated expert committee would throw caution to the winds for political benefits, particularly in a matter involving the lives of millions.

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