Two US Covid-19 vaccines seek India nod: Novavax and J&J said they had sought emergency use authorisations

Novavax and J&J said they had sought emergency use authorisations from India’s Central Drugs Standard Control Organisation

The Novavax vaccine will be produced by the Pune-based vaccine maker Serum Institute and the J&J vaccine by the Hyderabad-based Biological E.: Shutterstock

G.S. Mudur   |   TT  |  New Delhi   |   07.08.21: India’s drug regulatory agency has received applications for emergency use authorisation for the Covid-19 vaccines from Novavax and Johnson & Johnson that are both licensed for domestic production and could bolster India’s chances of inoculating all adults by December 2021.

Novavax and J&J, in independent announcements on Thursday and Friday, said they had sought emergency use authorisations (EUA) from India’s Central Drugs Standard Control Organisation (CDSCO). The Novavax vaccine will be produced by the Pune-based vaccine maker Serum Institute and the J&J vaccine by the Hyderabad-based Biological E.

The single-dose J&J vaccine had earlier this year received EUAs from regulatory authorities in the US and the European Union and other countries, which would make it eligible for a rapid and near-automatic approval in India. The Novavax application is expected to be scrutinizsd in greater detail by a CDSCO expert panel.

The Union health ministry had not included the J&J and Novavax vaccines among Covid-19 jabs it had listed in an affidavit to the Supreme Court earlier this year, outlining its expected inventory of 1,350 million doses between August and December.

The list had included Covishield, Covaxin and Sputnik V, and two other candidate vaccines — one from Zydus Cadila and another from Biological E — that are yet to be approved by the CDSCO.

Health experts who had expressed doubts over whether India could access the expected 1,350 million doses needed to vaccinate an estimated 943 million adults across India by December say the Novavax and J&J applications promise additional sources. “But how many doses of these vaccines will actually be available for domestic use remains unclear,” a public health expert said.

J&J’s application to the CDSCO made on Thursday is “an important milestone that paves the way to bringing our single-dose Covid-19 vaccine to the people of India and the rest of the world” through the collaboration with Biological E, J&J said on Friday.

The EUA submission is based on data from a clinical trial that demonstrated the single-shot vaccine as 85 percent effective in preventing severe disease and showed protection against Covid-19-linked hospitalisation and death beginning 28 days after vaccination.

J&J declined to specify timelines for production in India or the number of doses that would be available for use for the country up to December 2021. Biological E would need to apply for a manufacturing licence after the CDSCO approves the EUA.

The Novavax statement said the Serum Institute was manufacturing and developing the vaccine in India and the two companies had cumulative commitments to provide more than 1.1 billion doses to Covax, an international facility to make available vaccines to low- and middle-income countries.

Clinical trials of the Novavax vaccine have shown around 90 percent efficacy against Covid-19 infection and 100 percent efficacy against moderate and severe disease, the company had said in mid-June.

The Serum Institute and Novavax have submitted all modules required by regulatory agencies in India, Indonesia and the Philippines for the review of the vaccine, including pre-clinical, clinical and chemistry, manufacturing and controls data, Novavax said.

The CDSCO had successfully completed a good manufacturing practice site inspection of Serum Institute this May.

India had by Friday administered over 500 million doses of Covid-19 vaccines, with about 110 million people (11 percent of the estimated 943 million eligible adults) having received the two doses required for full vaccination.

The CDSCO had last month approved the Covid-19 vaccine from the US-based Moderna, but the company has not yet announced supplies in India yet.