India’s central drug authority, Drugs Controller General of India (DCGI), on Sunday announced the formal approval for the Covid-19 vaccines of Oxford-AstraZeneca, manufactured by the Serum Institute, and Bharat Biotech, saying they would be administered in two dosages each. Drugs Controller General of India V.G. Somani said that the two firms submitted data on their trial runs of the Covid vaccines and both have been granted permission for “restricted use” in emergency situations.
The approval by the DCGI was given on the basis of recommendations submitted by an expert committee of the Central Drugs Standard Control Organisation (CDSCO).
Announcing approval to Serum Institute’s ‘Covishield’ vaccine, Somani said that the vaccine trial was conducted on 23,745 participants and the overall efficacy of the vaccine was found to be more than 70 per cent. “The Indian data was also found to be comparable with overseas clinical studies,” the DCGI said.
“Bharat Biotech’s coronavirus vaccine ‘Covaxin’ is safe and gives a robust immune response,” the DCGI said adding that Covaxin, too, has been approved for restricted use in emergency situations.
Somani also quelled rumours surrounding the Covid-19 vaccines regarding impotency, rubbishing such speculations as “complete nonsense”.
“We will never approve anything if there is even the slightest safety concern. Vaccines are 110 per cent safe. Some side effects like mild fever, pain and allergy are common for every vaccine. It (rumours of impotency) is complete nonsense,” he said.
Earlier on Saturday, Samajwadi Party chief and former Chief Minister of Uttar Pradesh Akhilesh Yadav had said, “Covid-19 vaccine might contain something, which can cause harm. Tomorrow, people will say the vaccine was given to kill or decrease the population. You can even become impotent, anything can happen.”
On 31 December, Prime Minister Narendra Modi had urged people to be careful regarding rumours about vaccines and as responsible citizens refrain from forwarding messages on social media without checking.
“The number of new cases of Covid-19 is decreasing in the country now. We are preparing to run the world’s largest vaccination programme in the next year. In our country, rumours spread quickly. Different people for their personal gains or due to irresponsible behaviour spread various rumours. Maybe rumours will be spread when vaccination begins, some have already begun,” Prime Minister Modi had said.
All India Institute of Medical Sciences (AIIMS) director Dr Randeep Singh Guleria lauded the work done by Indian laboratories in making indigenous vaccines. “The research has been done here and it’s truly from the scratch and it is Indian vaccine. It’s a great moment, especially because unlike past where we had to rely on importing various products like PPE or N95; now we have vaccines which are being manufactured in India itself. We do not have to rely on vaccines coming from outside. They are cost-effective and easy to administer between 2 to 8 degrees Centigrade,” he said.
He also said that a vaccine has to go through various stages of study to make sure that it is safe for use. “It is important to understand that when we look at any vaccine, safety is paramount and therefore a vaccine goes through various stages of studying to make sure that it is safe,” Dr Guleria stated in an interview with ANI.
On some concerns being raised by the Opposition, the AIIMs director said, “All the data are being critically looked at by the regulatory authorities and experts and then only a vaccine is given approval. At multiple levels, the safety is ensured and I do not think we should be concerned.”
There are questions being raised on Covaxin of Bharat Biotech which is yet to go for Phase III trials. Dr Guleria responded, “Even as far as Bharat Biotech vaccine is a concern, it is on a traditional platform which has been used for other vaccines also. It is shown to be safe and they have robust data from Phase I and Phase II trials to show that it’s a safe vaccine.”