Emergency Approval in India to Help Supply Covid-19 Vaccine Across the Globe: AstraZeneca
07-January-2021

Terming approval of its COVID-19 vaccine in India as an important milestone, drug major AstraZeneca on Wednesday said the development would also help in supplying the medication to countries around the world. The company has partnered with the Serum Institute of India (SII), the world's largest vaccine manufacturer, for the supply of the vaccine to the Indian government and also to a large number of low and middle-income countries.

The drug maker also stated that the vaccine has so far been granted emergency use authorisation in six countries � India, Argentina, Dominican Republic, El Salvador, Mexico and Morocco for active immunisation of adults.

The vaccine has shown in clinical trials to be safe and effective at preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose, it added. The drug firm further stated that it is working with its global partners to continue building manufacturing capacity of up to three billion doses of the vaccine globally in 2021 on a rolling basis, pending regulatory approvals.

"These emergency use authorisations will soon bring the vaccine to many millions of people and are proof of our long-held commitment to broad and equitable access around the world," AstraZeneca CEO Pascal Soriot said. The company expects that this effective, well-tolerated and simple-to-administer vaccine will now begin to have a real impact on the deadly virus, he added.

"We would like to thank the regulators for their swift and decisive actions and our partner, Serum Institute of India, for its substantial contribution to this global effort," Soriot said.

SII CEO Adar Poonawalla said the emergency licensure in India marks an important milestone. "The regulatory decisions are welcoming and encouraging towards ensuring equitable access to a safe, immunogenic, and affordable vaccine for millions of people worldwide," he added.

The pandemic of 2020, however devastating, brought public and private institutions, health authorities, governments of various countries, and most importantly the global communities together to pose a resilient front against the virus, Poonawalla noted.

AstraZeneca said it has already submitted a substantial data package to support a conditional marketing authorisation for its COVID-19 vaccine to the European Medicines Agency (EMA), as part of an ongoing rolling review process. It will continue to work closely with the EMA to seek approval in the coming weeks. The drug firm added that it is also seeking Emergency Use Listing from the World Health Organisation (WHO) for an accelerated pathway to vaccine availability in low-income countries during this health crisis and has ongoing rolling reviews with many other regulatory authorities around the world.

In addition to the University of Oxford-led trials, the company is conducting a trial in the US as part of a global programme. In total, the University of Oxford and AstraZeneca expect to enrol more than 60,000 participants worldwide. Additional safety and efficacy data will continue to accumulate from ongoing clinical trials, it said.

The vaccine can be stored, transported and handled at normal refrigerated conditions (two-eight degrees Celsius/ 36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings, it added. Based in Cambridge, UK, AstraZeneca operates in over 100 countries.