Printed in January 2021 Issue
India’s drug regulator approved two COVID-19 vaccines on 3 January, a decision Prime Minister Narendra Modi hailed on Twitter as “a decisive turning point to strengthen a spirited fight!” against the pandemic and a testament to the Indian scientific community’s self reliance.
But some scientists and patient advocates are sharply critical of the move—in particular, the decision to greenlight Covaxin, a vaccine developed in India by Bharat Biotech, without awaiting the results of a phase III trial to determine efficacy and safety.
The approval of a vaccine without phase III data is “unconscionable,” says Vineeta Bal, an immunologist at India’s National Institute of Immunology.
It also seems to ignore guidelines from the Central Drugs Standard Control Organisation (CDSCO), the authority helmed by Somani, which stipulate that vaccinemakers must show a minimum efficacy of 50% in a phase III trial for their vaccines to be approved, says Gagandeep Kang, a microbiologist at Christian Medical College, Vellore, and a board member of the Coalition for Epidemic Preparedness Innovations. “They provided the guidance and then went again their own guidance,” Kang says. “I don’t know what made them do this.”
The AstraZeneca-Oxford vaccine, produced by the Serum Institute of India (SII) under the name Covishield, is backed by phase III data from studies in Brazil and the United Kingdom. But its approval was rushed as well, says the All India Drug Action Network, a patient rights group.
CDSCO guidelines required SII to carry out a “bridging study” showing its vaccine can elicit an immune response comparable with the original AstraZeneca vaccine in the Indian population; a panel of experts advising CDSCO recommended that Covishield’s approval be conditioned on its results.
Experts say such a trial is necessary because certain vaccines, such as those against polio and typhoid, have proved less immunogenic in Indians than in Western populations. But the data from SII’s study have yet to be analyzed fully, and the company did not respond to queries from Science.