Experts have raised concerns over India’s emergency approval of a locally-produced coronavirus vaccine before the completion of trials.
On Sunday, Delhi approved the vaccine – known as Covaxin – as well as the global AstraZeneca Oxford jab, which is also being manufactured in India.
PM Narendra Modi touted the approval as a “game changer” but health experts warn it was rushed.
It said that there were “intense concerns arising from the absence of the efficacy data” as well a lack of transparency that would “raise more questions than answers and likely will not reinforce faith in our scientific decision making bodies”.
The statement came after India’s Drugs Controller General, VG Somani, insisted Covaxin was “safe and provides a robust immune response”.
He added the vaccines had been approved for restricted use in the “public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains”.
“The vaccines are 100% safe,” he said, adding that side effects such as “mild fever, pain and allergy are common for every vaccine”.
The All India Drug Action Network however, said it was “baffled to understand the scientific logic” to approve “an incompletely studied vaccine”. It also says the hypothesis that it might be useful against mutations of the virus was not being supported by data from the trials.
There has also been a lot of scepticism on social media, including by opposition politicians.
There was a fierce debate on Indian twitter on Sunday night, with ministers and supporters of the government pitted against those who were worried about the lack of data.
Some pointed out that the decision contradicted the government’s own earlier guidelines on the requirements for vaccine approval.
Bharat Biotechs Covaxin might turn out to be best Vaccine in world. Thats not the Point. Concern is that it has been approved without Peer Reviewed Phase 1-2 results and incomplete Phase 3 Trial. Govt saying it is 110% safe is not Data and Give it a Chance is not strategy
— Joy (@Joydas) January 3, 2021
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Mixed feelings on the approval of two vaccines in India. Happy to see India finally get going on vaccines, but serious doubt over the process & evidence used. There’s a complete lack of transparency and accountability (no questions taken during the press briefing). Thread 1/n
— Fahad Hasin (@fahadmh) January 3, 2021
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Whole world is cheering India for granting emergency approval to @SerumInstIndia , @BharatBiotech vaccines ensuring safety, efficacy & immunogenicity showcasing our scientific capability & innovation ecosystem. India celebrates the win but Opposition fails to applaud our prowess.
— Dr Harsh Vardhan (@drharshvardhan) January 3, 2021
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Hope someone is keeping a list of Indias hall of (in)fame of anti-vaxers . They should be refused medical treatment if, god forbid, they do get Covid. Hospital admins please note.
— Smita Prakash (@smitaprakash) January 3, 2021
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India plans to vaccinate some 300 million people on a priority list by August.
It has recorded the second-highest number of infections in the world, with more than 10.3 million confirmed cases to date. Nearly 150,000 people have died.
Both vaccines approved on Sunday can be transported and stored at normal refrigeration temperatures.
media captionCoronavirus: November was Delhi’s deadliest month