India’s approval of personal COVID vaccine criticised for lack of information | Coronavirus pandemic Information
Opposition politicians and former ministers warn that approval could be premature and risky after the government accelerated Covaxin.
India granted emergency clearance to Covatin from Bharat Biotech on Sunday but faced questions after taking the move without releasing efficacy data for the coronavirus vaccine it has drawn itself.
The news, announced by the Indian Drug Control Officer (DCGI) who asked no questions, was welcomed by Prime Minister Narendra Modi and his ministers as a success in India’s ownership.
The government also approved the use of a vaccine developed by AstraZeneca and Oxford University, which will be the main vaccine in India’s vaccination program pending approval of other vaccinations.
Co-developed with a government institute, Covaxin means India is joining a small list of countries to approve its own coronavirus shot.
Bharat has teamed up with drug developer Ocugen Inc to jointly develop it for the US market, and Brazil has signed non-binding letters of intent to purchase the shot.
The company has announced that it will be discussing Covaxin with more than 10 countries.
“While this vaccine addresses an unmet medical need during this pandemic, our goal is to provide global access to populations in need of it most,” said Krishna Ella, chairman of Bharat Biotech, in a statement.
“Covaxin has generated excellent safety data with robust immune responses to several persistent viral proteins.”
Neither the company nor the Indian Central Drugs Standards Control Organization would disclose their efficacy results.
A source well aware of the matter told Reuters that their effectiveness could be greater than 60 percent with two doses.
China hasn’t released detailed efficacy data for a vaccine approved on Thursday either, but its developer has released preliminary data.
“On what basis was this approval granted if Bharat Biotech has NOT provided enough data to demonstrate safety and efficacy?” Transparency activist Saket Gokhale asked on Twitter.
Gokhale has filed a petition under India’s right to information asking the government for safety and other dates for the two vaccines approved on Sunday.
Covaxin was accelerated like no other vaccine in India. The company said in November it was expected to hit the market in the second quarter of 2021, while a government scientist suggested it could be February or March.
Opposition politicians and former ministers questioned the lack of transparency in the approval on Sunday.
“The approval was premature and could be dangerous,” said former minister Shashi Tharoor, asking Health Minister Harsh Vardhan for an explanation.
“Use should be avoided until full trials are complete. India can start the AstraZeneca vaccine in the meantime. “
Vardhan urged the Indians to trust that “strict protocols” were followed to ensure the safety and effectiveness of the two approved vaccines.
In the largest such study in India, Bharat Biotech said it had recruited 23,000 volunteers out of a target of 26,000 for an ongoing Phase III study of Covaxin that began in November.