In what Prime Minister Narendra Modi called a “decisive turning point” in India’s fight against the Covid-19 pandemic, the Drugs Controller General of India (DCGI) on Sunday formally authorised the emergency use of two coronavirus vaccines developed by AstraZeneca-Oxford University and Hyderabad-based pharmaceutical firm Bharat Biotech.
“A decisive turning point to strengthen a spirited fight! DCGI granting approval to vaccines of Serum Institute of India and Bharat Biotech accelerates the road to a healthier and COVID-free nation. Congratulations India. Congratulations to our hardworking scientists and innovators,” the PM tweeted.
The momentous occasion in India’s Covid-19 battle, however, was disrupted by the Opposition, which indulged in politics over the approval that is expected to kick-off one of the world’s biggest vaccination drives. India, the world’s second most-infected nation with more than 10.3 million Covid-19 cases and almost 150,000 deaths, is set to inoculate 1.3 billion people.
DCGI VG Somani, in a virtual briefing on Sunday, said, “The vaccines of Serum Institute (AstraZeneca/Oxford vaccine) and Bharat Biotech are being approved for restricted use in emergency situations.”
Somani said the drug regulator would “never approve anything if there is the slightest safety concern”. “The vaccines are 100 per cent safe,” he said, adding that side effects such as “mild fever, pain and allergy are common for every vaccine”.
The medical fraternity, too, hailed the achievement. “It’s a great day for our country and it’s a very good way to start the New Year. Both the vaccines are made in India. They are cost-effective and easy to administer. We should, in a very short period, start rolling out vaccine,” said Dr Randeep Guleria, Director, All India Institute of Medical Sciences (AIIMS), Delhi.
Despite experts allaying fears, Congress leaders Shashi Tharoor, Anand Sharma and Jairam Ramesh questioned the vaccine approval. While Tharoor said the approval was “premature” since Bharat Biotech is yet to conduct Phase III trials and advised that its use be put off till trials are completed, Ramesh asked health minister Harsh Vardhan to clarify why internationally accepted protocols on Phase III trials are being modified.
On Saturday, Samajwadi Party (SP) president Akhilesh Yadav had said he would not take the “BJP’s vaccine”. “I am not going to get vaccinated for now. How can I trust BJP’s vaccine, when our government will be formed everyone will get free vaccine…” he had said.
BJP and other parties’ leaders slammed the Opposition for indulging in politics rather than hailing the achievements of Indian scientists.
“India’s opposition is indulging in worst kind of fear mongering with regard to the Covid vaccine. But this isn’t the first time. We have seen similar vicious campaigns during the anti-polio drive too. But Covid, unlike polio, is fatal. Does the opposition want more people dead?” tweeted Amit Malviya, national in-charge of Bharatiya Janata Party’s (BJP) information and technology department.
Uttar Pradesh deputy chief minister Keshav Prasad Maurya said Akhilesh Yadav by refusing to get vaccinated has “not just disrespected the country’s government, but also the country’s scientists and doctors who have worked day and night to prepare the vaccine…”
Former Congress leader Sanjay Jha, tweeted, “I find the campaign against Bharat Biotech’s Covaxin quite ridiculous. Mr Modi’s government is not crazy to endanger lives of its own people through rash experimentation. Can we please trust our bureaucracy, doctors, scientists, R&D, more please if not our politicians?”
Civil aviation minister Hardeep Singh Puri called out the “cynics”. “Our in-house cynics M/s Jairam, Tharoor & Akhilesh are behaving true to form. They first questioned the valour of our soldiers & are now unhappy that the two vaccines to get DCGI nod are made in India. Clearly they are on a quest for permanent political marginalization,” he tweeted.
Former Jammu and Kashmir (J&K) chief minister and National Conference leader Omar Abdullah, who is the BJP’s political opponent, too, supported the vaccine. “I don’t know about anyone else but when my turn comes I’ll happily roll up my sleeve & get a COVID vaccine. This damn virus has been far too disruptive & if a vaccine helps bring about a semblance of normalcy after all the chaos then sign me up,” he tweeted on Saturday.
Meanwhile, the AstraZeneca-Oxford shot (Covishield), already approved in Britain, Argentina and El Salvador, will take the lead and Bharat Biotech’s Covaxin will be administered under stricter conditions given no efficacy data has been released for it. Somani said the overall efficacy of the AstraZeneca-Oxford vaccine was 70.42%, while Bharat Biotech’s Covaxin was “safe and provides a robust immune response”.
Somani said the Bharat Biotech vaccine had been approved “in 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 government has already been holding nationwide drills ahead of the mass inoculation drive and 96,000 health workers have been trained to administer the shots.
Both vaccines will be administered in two doses and stored at 2-8 degree Celsius (36 to 48°F), he said, without clarifying the intervals between the shots. A Reuters report quoted sources as saying that the doses would have to be given four weeks apart.
Adar Poonawalla, CEO of Serum Institute of India, which will manufacture The AstraZeneca-Oxford vaccine, had tweeted, “Happy new year, everyone! All the risks @SerumInstIndia took with stockpiling the vaccine, have finally paid off. COVISHIELD, India’s first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks.”
DCGI on Sunday also gave permission to Cadila Healthcare Ltd to conduct Phase-III clinical trials on 26,000 Indian participants for its DNA-platform vaccine candidate, whose interim trial data showed was “safe and immunogenic with three doses when administered intradermally”.
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