In a significant shift in its policy on regulatory approvals for foreign manufacturers to commercially market their Covid-19 vaccines in the country, the government Tuesday announced it would not enforce the pre-condition of conducting phase 2 and 3 clinical trials in India for those vaccines that have been granted emergency approvals by the US, EU, UK and Japanese regulators, including those listed by the WHO.
Tuesday’s decision effectively fast-tracks approval for foreign vaccines, which can apply for emergency use authorisation. “It will also open up, eventually, door for import of bulk or import of finished foreign vaccines in vials or import leading to fill and finish (of the vaccine) in the country,” Union Health Secretary Rajesh Bhushan said.
The Union Ministry of Health and Family Welfare said the foreign manufactures have to comply with one condition: the first 100 beneficiaries would be assessed for seven days for safety outcomes before the vaccines are rolled out for the immunisation programme. Companies will also have to conduct a “post-approval parallel bridging clinical trial”, but India can have access to these shots even while local data is being collected.
The Centre said that the decision to ease regulatory approvals was taken on the recommendation of the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC). “Essentially, if these regulators have approved the vaccine, they are ready to be brought into India for use, manufacturing, and fill & finish. Very significant development and we hope and we invite the vaccine manufacturers such as Pfizer, Moderna, and Johnson & Johnson, and others to be ready to come to India at the earliest possible,” Dr. V K Paul, Chair of NEGVAC said.
However, the timeline for access to these vaccines remains unclear. A majority of the foreign manufacturers have signed advance commercial deals with different countries. Plus, the national immunisation cold storage infrastructure being used by India for the Covid-19 vaccine drive is geared towards maintaining temperatures of 2-8 degrees Celsius, while the mRNA vaccines of Moderna and Pfizer need to be kept at much lower temperatures.
Paul said the regulatory changes were “significant”. “This is a liberal regulatory step to increase access to vaccines.”
The Centre also informed that it was in touch with as many as five manufacturers for the Russian Sputnik V vaccine which was cleared by Indian regulators on Tuesday. “There is one major company that has an agreement with Russian counterparts. There are five other companies that have signed technology transfer with their Russian counterparts,” Bhushan said.
Speaking to reporters virtually, the CEO of the Russian Direct Investment Fund (RDIF), Kirill Dmitriev, said India would have main production hubs of Sputnik V vaccine followed by Korea and China. “By the end of summer we expect to manufacture 50 million doses or more in India… We are looking at partnerships with large pharmaceutical firms… not just for production but for fill and finish capability as well.” Earlier, the RDIF had said over 850 million doses of Sputnik V would be produced in India annually.
The regulatory changes come as India witnesses a second wave of Covid-19, with several states demanding more stocks of vaccines.
Tuesday’s decision may also see Pfizer reapply for emergency use authorisation for its mRNA Covid-19 vaccine, which it had earlier withdrawn after the regulator sought more data. A Pfizer spokperson told The Indian Express, “We have noted the recent announcement. We remain committed to continuing our engagement with the government towards making the Pfizer and BioNTech vaccine available for use in the government’s immunisation programme.”
Queries to Johnson & Johnson and Moderna about whether they would approach the Central Drugs Standard Control Organisation (CSDCO) for EUA now remained unanswered by press time Tuesday.
The decision is set to also make it easier for the Serum Institute of India (SII) to seek speedier approval for Covovax — its version of the Covid vaccine developed by Novavax. The American vaccine maker had said in March that it could file for authorisation for this vaccine in the UK, and for EUA nod in the US, by the early second quarter of 2021.
Earlier, despite provisions allowing companies to seek waivers on local studies in India if they had received approvals from specific foreign regulators such as the US’s Food and Drugs Administration (FDA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), the country’s top drug regulator had insisted on local clinical trials here.
Pfizer had been the first company to approach the CDSCO for emergency licensure, for the mRNA vaccine it developed with Germany’s BioNTech. The vaccine already had EUA in the UK. However, the application in December, including a request to do away with the need for studies demonstrating the vaccine’s safety and ability to prompt an immune response in the Indian population, had not been successful.
The other foreign Covid-19 vaccines approved in India for emergency use so far have conducted local phase 2/3 clinical trials in the country. The SII began testing Covishield, its version of the vaccine developed by the University of Oxford and AstraZeneca, towards the end of July 2020. Sputnik V, which received the CDSCO’s restricted use permission late on Monday, was tested on around 1,500 participants in the country by Hyderabad-based Dr Reddy’s Laboratories (DRL).
In fact, DRL’s application for emergency approval had been on hold since February 19, and the SEC gave its approval after updated data on the vaccine’s safety and immunogenicity.
Johnson & Johnson, which has a tie-up with Hyderabad-based Biological E to make around 600 million doses of its single-dose Covid vaccine, confirmed last week that it would be approaching the CDSCO for permission to conduct bridging studies for emergency approval. —Inputs from ENS, Pune
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