Govt fast-tracks emergency approval for foreign vaccines: What it means for manufacturers and India

Coronavirus vaccination in India: The worsening situation of the coronavirus pandemic in India has led to the Centre deciding to fast track approvals for foreign manufacturers of vaccines. The country is currently undertaking a massive coronavirus vaccination programme in which over 11 crore doses of vaccines have been administered. So far, India has approved three vaccines, of which two were approved back in January, days before the vaccination drive started. These were Serum Institute of India’s Covishield, and Covaxin, indigenously developed by Bharat Biotech. The latest approval was given to Russia’s Sputnik V on Monday. However, there are reports of shortage of vaccines from several parts of the country. Now, the government has decided that vaccines having emergency use approvals by the US, the UK, the Japanese regulators, as well as those having been listed by the WHO might be granted emergency use approvals in India as well.

The development was announced on Tuesday, and the move is expected to accelerate India’s access to foreign vaccines. This would mark the first time that India would begin importing COVID-19 vaccine, as at the moment, all vaccines, including Covishield and Sputnik V, are being developed indigenously as part of partnerships of developers with manufacturers in India.

Rules for emergency approvals to foreign vaccines

As per the New Drugs and Clinical Trials Rules, 2019, any foreign manufacturer, when applying for emergency use authorisation, is required to submit the results of local clinical trials, called bridging trials. In these, the manufacturer of the vaccine holds phase 2/3 trials to test the safety and efficacy among the local population. However, since for such vaccines, the foreign trials are already conducted, the local trials are conducted using limited participants.

This rule is the reason why Serum Institute of India conducted a bridging study for a version of Oxford-AstraZeneca’s vaccine, named Covishield in India, and why Dr Reddy’s Lab conducted bridging study for Russian vaccine Sputnik V.

These rules have also allowed the Indian drug regulator to relax these conditions in cases of vaccines which have received approval from a national regulator of another country, where no major unexpected seriousness has been reported and the vaccine is meant for a serious or a life-threatening disease. The vaccine must also be required for an unmet need in India.

This is the clause that the Centre has now invoked, eliminating the need for foreign manufacturers to conduct a bridging study here.

Implication of this rule for foreign manufacturers

This means that vaccine manufacturers who have received approval from USFDA, UK MHRA, PMDA Japan or the EMA, or are enlisted in WHO’s Emergency Use listing would be able to directly apply for emergency-use approval in India, effectively fast-tracking the process.

Assessment of vaccine safety in such situations

Indian regulator has come with a solution as per which the manufacturers would have to monitor for seven days the first 100 beneficiaries receiving the dose in order to assess the safety outcomes. Only after this would the vaccine of that particular manufacturer be allowed to be rolled out for further vaccination drive in the country.

Moreover, once the approval has been received, a parallel bridging study would need to be conducted, the safety data of which would have to be sent to the regulator.

Beneficiaries

Johnson and Johnson, which is the only manufacturer to provide a single-dose vaccine, Pfizer and Moderna could all benefit from this new route. As per the ministry’s speculated prizing, a single dose of Pfizer could cost Rs 1,431, not taking into account the overhead cost and taxes, while Moderna vaccine’s single dose is expected to cost between Rs 2,348 and Rs 2,715. A single dose of Sputnik V and J&J vaccine is expected to cost Rs 734 each.

Notably, in India, Covaxin and Covishield are being administered in private hospitals at Rs 250 per dose, currently.