Corporate hostility between vaccine makers!

Putting an end to India’s desperate wait for a vaccine against the Coronavirus, the Drugs Controller General of India (DCGI) on Sunday gave approval to Covishield by Oxford-AstraZeneca which is manufactured by Serum Institute of India (SII), and indigenous Covaxin by ICMR-Bharat Biotech for emergency use. The approvals came at breakneck speed after the Subject Expert Committee (SEC) of Central Drugs Standards Control Organisation (CDSCO) recommended the two vaccines for the accelerated approval process on Saturday. However, the vaccination schedule is likely to be announced by the Centre next week.  According to Health Minister Dr Harsh Vardhan, the vaccination will be in three phases.
Sadly, simmering undercurrents of business rivalry seems to have erupted into vocal corporate hostility between India’s two Covid-19 vaccine makers that medical experts say could leave the public confused about their vaccines.
The heads of the Pune-based Serum Institute, manufacturing the AstraZeneca-Oxford vaccine in India, and the Hyderabad-based Bharat Biotech, producing a home-grown vaccine, have questioned the credentials of each other’s vaccine. India’s drug regulatory authority on Sunday approved restricted emergency use of both vaccines, clearing the decks for the government to launch its planned campaign to vaccinate over 300 million people in the coming six months. Some medical researchers have questioned both the approvals, underlining what they say is the absence of adequate efficacy data on the AstraZeneca-Oxford vaccine and the lack of any efficacy data on the Bharat Biotech vaccine. Covid-19 vaccines from Pfizer, Moderna, Sputnik V and a Chinese manufacturer are already in emergency use in several countries.
The UK and Argentina have also approved the AstraZeneca-Oxford vaccine. The vaccine makers give thousands of volunteers in phase III trials the dose or a placebo and wait to see who develops infections. If, for instance, infections are lower by 50% in the vaccinated group, the efficacy rate comes to 50% -- the globally accepted benchmark for success. Oxford-AstraZeneca took nearly six months to determine this; Pfizer-BioNTech and Moderna for almost four months. In contrast, Covaxin’s late-stage trials began only one-and-a-half month ago, its efficacy rate is unknown, and the period may be too short to map all possible side-effects. Authorities indicated that Covaxin will be used only if there is a shortage and if the new mutation takes hold. But Bharat Biotech and the regulators must now speed up the disclosures around the vaccine – people who receive it have the right to know how effective and safe it is.
 

- Prabhakar Purandare

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