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US pharma giants Johnson & Johnson, Novavax seek govt nod for use of their vaccines in India

US pharma giants Johnson and Johnson (JandJ) and Novavax are seeking India’s drugs regulator for emergency use approval of their Covid vaccines

US pharma giants Johnson & Johnson (J&J) and Novavax have approached India’s drugs regulator for emergency use approval of their Covid vaccines with plans to produce the doses in partnerships with Indian companies.

While Pune-based Serum Institute of India is producing and carrying out trials for Novavax, Hyderabad-based Biological E is producing vaccines for J&J.

The J&J vaccine has been approved in the US and Europe, while the Novavax shots has shown successful results in clinical trials.

The approval is being sought under the new fast track mechanism that the government has put in place to accelerate the production of vaccines in the country. 

Johnson & Johnson Pvt Ltd said it had “On 5th August 2021, applied for emergency use authorisation (EUA) of its single-dose Covid-19 vaccine to the government of India. This 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 a collaboration with Biological E Limited,” the company said in a statement.

Also read: US sees big role for India as vaccine supplier in Covid war as China-made shots flop

J&J said it looked forward to concluding its discussions with the government of India to accelerate availability of its Covid-19 vaccine to help end the pandemic.

Novavax said in a statement that it had “with its partner, Serum Institute of India Pvt Ltd (SII), filed regulatory submissions for emergency use authorisation of recombinant nanoparticle protein-based Covid-19 vaccine candidate. The submissions were made to the Drugs Controller General of India (DCGI) and regulatory agencies in Indonesia and the Philippines”.

“Today’s submission of our recombinant nanoparticle COVID-19 vaccine, the first protein-based option filed with any regulatory agency, represents a major milestone in Novavax transformation into a commercial global vaccine company,” said Stanley C Erck, president and chief executive officer, Novavax

The Novavax vaccine showed an efficacy rate of 90% in clinical trials but is yet to be approved for emergency use in any country.

The J&J vaccine, which has shown 66-72% efficacy in different trials, has been approved by regulators in the US, UK, Europe and the World Health Organization.

Representatives of both the vaccine makers’ Indian partners also met top Indian officials on Friday.

Union health minister, Mansukh Mandaviya, on Friday met the managing director of Biological E, Mahima Datla, to discuss Corbevax, the other coronavirus vaccine Biological E is developing in collaboration with the Baylor College of Medicine in Texas.

“Met Ms Mahima Datla, MD of @Biological_E, who briefed me on the progress of their upcoming #COVID19 vaccine, Corbevax. I assured all the Government support for the vaccine,” the health minister tweeted.

SII chief executive Adar Poonawalla also met Mandaviya as well as Union home minister on Friday. Poonawalla, news agency PTI reported, later said that he expects Covavax (the Novavax dose made by it) to become available for adults by October and for children by the first quarter of next year if all regulatory processes proceed as planned.