For vaccines developed abroad, the Indian drug regulator insists on having safety and immunogenicity data from the local population to give emergency approval. To generate this data, companies are required to do a bridge trial on 1,500-1,600 participants. This requirement can be waived-off, if the global trial conducted by the vaccine maker has included enough Indians. Serum Institute of India has done a bridge trial for the AstraZeneca-Oxford vaccine while Dr. Reddy’s is conducting a bridge study for the Sputnik V vaccine. But we hear this condition of local trial has become a bone of contention in the approval of Pfizer’s COVID-19 vaccine. The CDSCO expert panel has turned down Pfizer’s application for emergency use authorisation for its vaccine candidate in the absence of any plan on the firm’s part to generate safety and immunogenicity data in the local population. The Pfizer vaccine has been approved by the US, UK, EU and WHO and dozens of other countries. Many Indians living in the US, Europe and Gulf region have already got this vaccine. Pfizer hasn’t shown much inclination to conduct the bridge trial in India. Meanwhile Johnson & Johnson hasn’t sought permission to conduct bridge trials in India for its single-dose vaccine, which was approved by US and WHO. The Indian regulator has put itself in a situation where it can’t favour one particular vaccine maker by waiving off local trial requirements. On the flip side, this limits COVID-19 vaccine options for the public at large.
