American companies Johnson & Johnson and Novavax have applied to the Indian regulator for an emergency use authorisation (EUA) of their respective Covid-19 vaccines.
Stating that it had approached the Central Drugs Standard Control Organisation (CDSCO) for an EUA on its Covid-19 vaccine on Thursday, J&J said, “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.” Further it added, Biological E would be part of its global supply chain supporting J&J’s partnerships with governments, health authorities and organisations such as Gavi, the vaccine alliance and the World Health Organization (WHO)-supported Covax facility.
J&J’s announcement comes days after it clarified that it had withdrawn an earlier application for conducting bridging trials in the country, after India revised its rules and fast-tracked approvals on vaccines that already had regulatory approvals from other countries.
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The EUA submission is based on safety and efficacy data from the Phase 3 ENSEMBLE clinical trial, which demonstrated J&J’s vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against Covid-19 related hospitalization and death, beginning 28 days after vaccination, the spokesperson said.
Novavax-Serum
Hours earlier, vaccine makers Novavax Inc and Serum Institute of India also said they had filed regulatory submissions for emergency approvals of the Novavax recombinant nanoparticle protein-based Covid-19 vaccine candidate with Matrix-M™ adjuvant.
The submissions were made to the Drugs Controller General of India (DCGI) and regulatory agencies in Indonesia and the Philippines, Novavax said. A submission to the WHO for an emergency use listing (EUL) based on the DCGI submission was also expected in August, it added.
Recently, SII had got the go-ahead for vaccine trials on children and industry-insiders indicated that too starts this month. Serum had projected, the locally-produced Novavax vaccine would be ready for launch in September, and this is believed to be on track, insiders told BusinessLine . A joint site inspection of SII was successfully completed by DCGI in May 2021, it added.
No details were available on Novavax production targets. Serum also makes and markets the AstraZeneca-OxfordUniversity vaccine locally, with production pegged at 110 million doses a month.
SII is manufacturing, and developing, and is responsible for commercializing the vaccine in India. Novavax and SII have cumulative commitments to provide more than 1.1 billion doses to COVAX.
Min meets vaccine-makers
In a separate development, Health Minister Mansukh Mandaviya met the heads of Serum Institute, Biological E and Dr Reddy’s Laboratories (that markets Russian vaccine Sputnik V), over the last two days. They discussed vaccine supplies and the Government has assured its support, the Minister tweeted.