Politicians apart experts concerns should also be considered.
It is heartening the scientists have finally succeeded in preparing a vaccine to control the Covid 19 virus.In India the Central drugs and standard committee formally approved the covid 19 vaccine by Bharat biotech and the Serum Institute of India. The vaccines Covishield by Serum Institute of India and based on the Oxford Astra Zaneca vaccine and Covaxin by Bharat Biotech to be offered to health care workers and frontline workers in India. According to the union health ministry about 3 crore such persons considered to be at highest risk for Covid 19 would be given the vaccine for free. It had however, not been clarified by the health ministry which vaccine will be given to these targeted workers.
Immediately after this announcement former UP Chief Minister and national President of Samajwadi party Mr. Akhilesh Yadav said that he would not the shot for Covid 19 as he did not trust the “BJP Vaccine”. He later clarified that he trust the Indian scientist and doctors but had no faith in the medical system under BJP government.” We will not get the BJP’s political vaccine but when we will come to power we will provide free vaccines to our people.
Though Mr. Akhilesh Yadav has issued a political statement the fact remains that neither the Covishield of Serum Institute of India nor the Covaxin of Bharat Biotech has completed the crucial phase 3 trial. Under this trial a vaccine is administered to volunteers at multiple locations of the country. The Central Drugs and Standard Committee’s approval is based on the recommendations by a subject expert committee which deliberated for two days and about 12 hours in total. Minutes of the meetings of this committee are also not available. A press statement issued by union health ministry said the vaccine efficacy in Indian volunteers was comparable to that tested in overseas trial. This does’nt satisfy the concerns of many experts saying that there is great difference in immunity and other physiological systems of Indians and foreigners so trial of vaccine on them do not naturally fit for Indians. Both approvals accorded are for restricted use in emergency situation. It may be noted here that phase 1 and 2 trials were conducted on 800 volunteers to determine the safety and immunology of Covaxin but the efficacy data of on going phase 3 trials with about 22500 volunteers have not been made public yet. The Covishield vaccine efficacy is reported to be 70.4% based on the phase 3 trials conducted in the UK and Brazil. But on 1700 Indian volunteers the efficacy data has not been made public.
Prime Minister Narendra Modi has congratulated the scientists and innovators immediately after announcement of approval by Drugs controller general of India. Calling the development an acceleration on the road to a Covid free nation Prime Minister termed it as a decisive turning point to strengthen a spirited fight. Union health minister Dr. Harsh Vardhan said that the vaccine is a fitting tribute to the Corona warriors. He expressed his gratitude to health care professionals and front line workers for their exemplary efforts during the unprecedented times.
Congress on the other hand expressed concern over the Drugs Controller General of India (DGCI) granting permission for restricted use of Bharat Biotech Covid 19 vaccine by dispensing with mandatory protocols and verification of data. Mr. Anand Sharma Congress deputy leader in Rajya Sabha who also heads parliamentary panel of home affairs that extensively dealt with the issue said no country had dispensed mandatory phase 3 trials and verification of data and issue of granting authorization needs to be taken carefully. ”The DGCI statement is puzzling and the government must reveal the final data on global efficacy trials and the final trial in UK” he said.
Not only political opponents but several experts have also raised concern over the hasty approval granted to these vaccines despite the lack of adequate efficacy data. Professor Gagandeep Kang of Christian Medical College Vellore said that she is completely unaware of any data that suggests that Covaxin has any efficacy against any SARS-CoV2 strain let alone the UK strain. A doctor cum research head of a lab affiliated to a government research lab also expressed reservation. At the condition of anonymity he said “at this point I would’nt advise Covaxin. All we seem to know is that it is safe and so many not harmful but efficacy is different matter and needs to be proved.”Ms. Malini Aisola of All India Drug Action Network said “In the interest of transparency we ask the regulator to share the detailed rationale or the decision along with disclosure of data –we are baffled to understand what scientific logic has motivated top experts of the Subject Expert Committee to approve this vaccine post haste.
However the emergency use approval is conditional on the vaccine developers submitting details of any adverse effect to the drug regulator every 15 days. A factsheet with safety details will also be provided to those receiving first lot of vaccines. The regulator has pointed out that these are crucial steps and the approval were expedited in view of the public health emergency and the vaccination will be conducted in a “clinical trial mode”. Union health ministry has also acknowledged that these are initial steps. Protecting the country against a notoriously unpredictable virus could throw up unforeseen challenges. Health care authorities will have to remain alert to any eventuality.