India to clear jabs okayed in US, UK, Europe & Japan

India will grant emergency use authorisation to Covid-19 vaccines that have received similar approval in the US, UK, Europe and Japan, opening up the prospect of a dramatic increase in availability as the country struggles with burgeoning infections amid reports of shortages. Johnson & Johnson, Pfizer and Moderna were specifically invited to seek immediate approval for such use in India. The country has administered more than 110 million doses in the three months since India’s public immunisation programme began.

“The decision would compress the timelines considerably — it is a very liberal regulatory step which will increase the access to vaccines,” VK Paul, Niti Aayog member, health, told reporters. “We hope and we invite the vaccine makers such as Pfizer, Moderna, Johnson & Johnson and others... to be ready to come to India as early as possible.” J&J’s single-shot vaccine is of special interest as it already has a local manufacturing partner, Biological E, although the US has sought to suspend its use pending inquiries into reports of blood clots in some recipients.

As such emergency approvals are given, bridging trials would also be run and data reviewed by the regulator. India had earlier insisted on such approvals being given to vaccines approved abroad only after bridging trials were completed in the country. The first 100 beneficiaries of such vaccines will be assessed for seven days on safety outcomes before the jabs are rolled out further within the country.

No Chinese Vaccines
These follow-ups will be different from bridging or clinical trials, which would be separate, the health ministry said.

Vaccines will be “granted emergency use approval in India, mandating the requirement of post-approval parallel bridging clinical trial in place of conduct of local clinical trial as per the provisions prescribed under Second Schedule of the New Drugs & Clinical Trials Rules 2019”, the health ministry said. “This decision will facilitate quicker access to such foreign vaccines by India and would encourage imports including import of bulk drug material, optimal utilisation of domestic fill and finish capacity etc., which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic (use).”

The supply of fresh vaccines will be subject to pricing negotiations between the government and the companies and will also depend on the availability of excess capacity. As of now, Pfizer and Moderna have not been able to meet their supply obligations to many countries.

Chinese vaccines won’t find a place in India’s public immunisation drive as they haven’t been approved by the regulators listed.

These include the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the UK Medicines and Healthcare Products Regulatory Agency (UK MHRA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) besides vaccines on the WHO Emergency Use Listing.

India has two vaccines in use — Serum Institute of India’s Covishield, based on AstraZeneca-Oxford University technology, and Bharat Biotech’s indigenously developed Covaxin.

Approval was given to a third — the Russian Sputnik V vaccine — on Monday. The bulk of India’s jabs have been Covishield.

The issue of limited supplies and increasing the pace of vaccination was discussed at a meeting of the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC), chaired by Paul, on Sunday. NEGVAC recommended that India allow vaccines developed and manufactured in other countries and given emergency use approval for restricted use by the aforementioned regulators. That recommendation was accepted by the government.

When asked about Chinese vaccines, health secretary Rajesh Bhushan said, “This is a hypothetical question but the answer lies in the wording of our approval shared with you.” Chinese vaccine Sinopharm has been approved by the United Arab Emirates (UAE) and Bahrain. Countries that have ordered Sinopharm and the other Chinese vaccine Sinovac include Pakistan, Singapore, Malaysia and Indonesia.