Fissures have emerged in medical and scientific circles with many supporting the rollout of two vaccines but others questioning the use of one without efficacy data, two days before the start of India’s Covid-19 inoculation campaign.
A group of 49 scientists and doctors on Thursday released a statement that cited the safety and capacity of the AstraZeneca-Oxford vaccine, called Covishield, and the home-grown vaccine from Bharat Biotech, named Covaxin, |to generate immune |responses.
Two signatories told The Telegraph that the statement’s objective was to |affirm the signatories’ |support for the government’s plan to launch |the vaccination campaign with both jabs.
“We’re in an extraordinary situation — a pandemic. The safety and immunogenicity have already been proven for both vaccines; both should be used,” said Narinder Mehra, a medical immunologist and former professor at the All India Institute of Medical Sciences, New Delhi.
Health officials defending the government plan have cautioned that waiting for efficacy data amid a pandemic would be tantamount to disregarding the loss of lives. “You have to put faces on the numbers of the dead,” said Samiran Panda, head of the epidemiology division at the Indian Council of Medical Research.
But 13 others, including six fellows of the Indian Academy of Sciences, have in an independent statement suggested that the government should have waited for efficacy data |before introducing |Covaxin into the |vaccination campaign.
Prime Minister Narendra Modi will launch via videoconference at 10.30am on Saturday the nationwide campaign that will roll out with 3,006 vaccination sites across the country, each tasked with providing |vaccines to an average 100 people a day.
A senior expert guiding the national vaccination strategy told this newspaper that Covishield and Covaxin should be and were being viewed as “equal” and would be treated thus as they get administered across the country.
But health officials |have declined to explain |the criteria adopted to |determine which vaccine goes where amid the |constraint that the two-dose vaccines cannot |be interchanged.
A public health expert advising a state government said on the condition of anonymity that the state had not received instructions on how to distribute the two vaccines.
Amid the uncertainty, the Indian Medical Association has urged its 350,000 members to accept whatever vaccine they are offered. “Both vaccines have been evaluated by a subject expert panel — safety and immunogenicity are assured,” Johnrose Austin Jayalal, the IMA’s national president, told this newspaper.
The statement by the 13 scientists has underscored the need for transparency before starting a vaccination programme. While acknowledging the safety and promising immunogenicity data for Covaxin, they said: “It is imperative that relevant data from the larger phase-3 (efficacy) trial become available before administering the vaccine to large numbers of people.”
Among the signatories are Partha Majumder, president of the Indian Academy of Sciences; academy fellows Dipankar Chatterjee and V. Nagaraja from the Indian Institute of Science, Bangalore; Jyotsna Dhawan from the Centre for Cellular and Molecular Biology, Hyderabad; and Vidyanand Nanjundiah and H.A. Ranganath from the Centre for Human Genetics, Bangalore.
Health officials have said the vaccine recipients would not have the option of choosing between the two vaccines, but some doctors have told this newspaper they are hoping to receive Covishield, which has demonstrated efficacy in studies outside India.
Some doctors have questioned the timetable for the simultaneous release. The Serum Institute of India, which is manufacturing Covishield, has said it has already stockpiled 50 million doses. The government needs 60 million doses to vaccinate the estimated 30 million healthcare and frontline workers.
“We need a 28-day gap between the first and second doses — the government could have vaccinated all 30 million with Covishield and waited for at least interim efficacy data to emerge for Covaxin by mid-March,” said a senior doctor in a Delhi hospital. “The decision is baffling.”
Majumder and his co-signatories said providing a vaccine without adequate efficacy data could lead to “a false sense of security” among the recipients. “We are not being pessimistic; our concern is only the necessity of following essential safeguards in a transparent manner before releasing a vaccine for public use.”
The following is the statement issued by the scientists in their personal capacities:
We are scientists working in various institutions in India and are writing in our personal capacities.
From press reports we have learnt that the administration of Covaxin and Covishield vaccines is starting in India. We express our concern about the inadequacy of publicly-available information on which the approvals to initiate the vaccine campaign have been issued by the national regulatory authorities. A greater degree of transparency prior to the start of the vaccination programme is essential. This is especially true for Covaxin, for which Phase-3 safety and efficacy data are not yet available. We appreciate the efforts that Bharat Biotech and ICMR have put in to develop a vaccine formulation which is said to have promising results in Phase 1/2 human trials on a small number of people. It is imperative that relevant data from the larger Phase-3 trial become available before administering the vaccine to large numbers of people. Providing a vaccine without adequate efficacy data can lead to a false sense of security among vaccine recipients. In addition, articulation of a clear and consistent policy of making publicly available relevant data, and the approval pathway adopted by the Government of India, is required for other vaccines in development to ensure rapid access to safe and efficacious vaccines both for our citizens and for the rest of the world. We are not being pessimistic; our concern is only with the necessity of following essential safeguards in a transparent manner before releasing a vaccine for public use.
Partha P. Majumder, National Institute of Biomedical Genomics, Kalyani &
Indian Statistical Institute, Kolkata
VidyanandNanjundiah, Centre for Human Genetics, Bengaluru
H.A. Ranganath, Centre for Human Genetics, Bengaluru
Jyotsna Dhawan, Centre for Cellular and Molecular Biology, Hyderabad
Dipankar Chatterji, Indian Institute of Science, Bengaluru
Deepak Kumar Saini, Indian Institute of Science, Bengaluru
Upendra Nongthomba, Indian institute of Science, Bengaluru
Sohan Prabhakar Modak, Deccan Gymkhana, Pune
Rahul Siddharthan, Institute for Mathematical Sciences, Chennai
Ramray Bhat, Indian Institute of Science, Bengaluru
Gopal Pande, 107 Kakatiya Apartments, Habsiguda, Hyderabad
Analabha Basu, National Institute of Biomedical Genomics, Kalyani.