Vaccine Politics in India: Politicians Questions Efficacy of Homegrown Covaxin
News Desk
The emergency-use approval for Bharat Biotech’s Covaxin vaccine against Covid-19 from the country’s drug regulator on January 3 has kicked up a political storm. After a section of opposition leaders questioned the efficacy of the India-made Covaxin, calling the approval “premature” and “dangerous”, many Bharatiya Janata Party (BJP) leaders, including union ministers, urged opposition leaders to not cause panic in the minds of the people through their ‘wild’ theories.
“Time and again we have seen whenever India achieves something commendable — that will further public good — Congress comes up with wild theories to oppose and ridicule the accomplishments. The more they oppose, the more they are exposed. Latest example is the Covid vaccine,” said BJP President JP Nadda.
The Drug Controller General of India (DCGI), the national drug regulator, announced on January 3 that the Central Drugs Standard Control Organization (CDSCO) has decided to approve the Covid-19 vaccines of both Serum Institute of India (Covishield) and Bharat Biotech (Covaxin) for restricted use in the country.
The Covishield vaccine, developed by the University of Oxford and pharmaceutical giant AstraZeneca, is being produced in the country by Pune-based Serum Institute. Bharat Biotech’s Covaxin vaccine — the country’s first indigenous vaccine against Covid-19 has been developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
Soon after the approval, many Congress leaders, including Shashi Tharoor, Jairam Ramesh and Anand Sharma, raised concerns over the permission for the restricted use of Covaxin.
‘No Phase-3 trials on Covaxin yet’
“Covaxin has not yet had Phase-3 trials. Approval was premature and could be dangerous,” said Tharoor, Member of Parliament from Thiruvananthapuram, urging Health Minister Harsh Vardhan to avoid Covaxin till full trials are over.
Bharat Biotech said in a statement that Phase-III human clinical trials of Covaxin began mid-November, targeted at 26,000 volunteers across India. This is India’s first and only Phase-III efficacy study for a Covid-19 vaccine, and the largest Phase-III efficacy trial ever conducted for any vaccine in India, it said.
The nationwide vaccination drive is scheduled to begin with the Covishield shot. Though experts said that Covaxin is a back-up in clinical trial conditions if a spike in cases triggers the need for doses, critics argued that even in emergency situations, approval must be granted only after safety and efficacy are established.
Minister Vardhan backed the Covaxin approval terming the opposition leaders’ criticism “disgraceful”. In a series of tweets on January 3, Vardhan tagged opposition leaders, including Congress’ Tharoor and Ramesh and the Samajwadi Party’s Akhilesh Yadav. The former UP chief minister had on January 2 asked people not to get vaccinated.
Among the leaders who hit out at Congress leaders after the criticism were Civil Aviation Minister Hardeep Singh Puri and Petroleum Minister Dharmendra Pradhan.
On January 3, the Central licensing authority issued permission to Bharat Biotech to manufacture the pharmaceutical formulation of a new drug, Covaxin, for sale or distribution.
The firm will have to submit safety data with due analysis every 15 days for two months and monthly thereafter. It will also have to submit a risk management plan and provide a protocol for restricted use of the vaccine in an emergency situation.
Many Congress leaders, including chief spokesperson Randeep Surjewala and former union minister Ashwani Kumar, welcomed the approval given to the vaccines.
Reference: Moneycontrol News