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Debate over vaccine approval intensifies, Paul says have faith in regulator
Covaxin is one of two manufactured-in-India coronavirus vaccines cleared by regulators for emergency use on January 3.
The controversy around the use of Bharat Biotech’s coronavirus vaccine candidate Covaxin continued on Wednesday as the inoculation began shipping for the first time, with leaders from the Congress questioning the government’s decision to roll it out even though it had not progressed far enough in its human trials – concerns that officials attempted to allay afresh later in the day.
Covaxin is one of two manufactured-in-India coronavirus vaccines cleared by regulators for emergency use on January 3. Bharat Biotech, the Hyderabad-based manufacturer, began phase III clinical trials in mid-November and is expected to require several months more before it can determine how effective the vaccine is.
The first vaccinations will be carried out on January 16.
“Covaxin was licensed by government for emergency use. Now government is saying that the recipient won’t be able to pick and choose the vaccine which is administered to them. When phase 3 trial of Covaxin is not complete, it raises various concerns on its efficacy,” Tewari told news agency ANI on Wednesday.
His reference was to comments by government representatives on Tuesday that recipients selected for vaccination in the first phase will not have a say in which shot they will get.
“You can’t use rollout as phase 3 trial, Indians are not guinea pigs,” he added.
“Deeply disturbing report. It is imperative that the Covaxin trials meet the highest standards and that no one is pressed into participation without their informed consent,” Congress MP Shashi Tharoor said in a tweet, while linking to a news report that said trial volunteers had been misled.
The Union ministry of health and family welfare announced on Wednesday it had allocated all procured doses of Covaxin to States and Union Territories in proportion of health care workers database, and concerns regarding its safety were baseless.
Officials in non-BJP ruled states too have expressed concerns over the vaccine. Bengal chief minister Mamata Banerjee took up the matter in a meeting with the Prime Minister on Monday and Chattisgarh health minister TS Singh Deo on Saturday said the shot should not be used until its complete results are out.
“People should have faith in India’s drugs regulator; the product has been approved after due diligence. Having said that we are still in the process of learning; we are adapting based on the evidence before us and it is an accepted norm. The research is going on and we are keeping a close watch,” said VK Paul, member (health), Niti Aayog.
“No government currently is offering a Covid vaccine choice to its people; not even US and UK. There simply aren’t enough supplies in market. It is a public health emergency and the government’s are regulating the vaccination drive so that all those who need the vaccine are not left out,” he added.
