India’s drug regulator has granted emergency use approval for Zydus Cadila’s Covid-19 vaccine, the world’s first DNA shot against the coronavirus, in adults and children aged 12 years and above.
The approval gives a boost to India’s vaccination programme, which aims to inoculate all eligible adults by December, and will provide the first shot for those under 18, as the country still struggles to contain the virus spread in some states.
The vaccine, ZyCoV-D, uses a section of genetic material from the virus that gives instructions as either DNA or RNA to make the specific protein that the immune system recognises and responds to. Unlike most Covid-19 vaccines, which need two doses or even a single dose, ZyCoV-D is administered in three doses.
The generic drugmaker, listed as Cadila Healthcare, aims to make 100-120mn doses of ZyCoV-D annually and has already begun stockpiling the vaccine. Zydus Cadila’s vaccine, developed in partnership with the department of biotechnology, is the second home-grown shot to get emergency authorisation in India after Bharat Biotech’s Covaxin. The drugmaker said in July its Covid-19 vaccine was effective against the new coronavirus mutants, especially the Delta variant, and that the shot is administered using a needle-free applicator as opposed to traditional syringes.
The regulatory nod makes ZyCoV-D the sixth vaccine authorised for use in the country where only about 9.18% of the entire population has been fully vaccinated so far, according to Johns Hopkins data.
Zydus Cadila had also submitted data evaluating a two-dose regimen for the shot in July and plans to seek regulatory approval for the same.
The firm had applied for the authorisation of ZyCoV-D on July 1, based on an efficacy rate of 66.6% in a late-stage trial of over 28,000 volunteers nationwide.
Meanwhile, Johnson & Johnson has sought approval from Indian drug regulators to conduct a study of its Covid-19 vaccine among 12- to 17-year-olds, the company said yesterday.
Conducting vaccine clinical trials among adolescents is imperative to achieve herd immunity against the coronavirus, J&J said in an e-mailed statement.
The US pharma giant had received emergency use approval for its single-dose vaccine in India earlier this month, making it the fifth authorised vaccine in the country. While J&J has a supply agreement with Indian vaccine maker Biological E Ltd to bring its shot to the country, the company had said that it was too early to give a delivery timeline.
Earlier data showed that the reproduction rate of Covid infection in India has dropped below 1 implying that 100 infected people are spreading the infection to less than 100 people, to 89 people as the R-value at present stands at 0.89.
The Covid-19 situation in the country is improving with active cases falling to around 3.6 lakh, the lowest in 150 days. However, the country is witnessing a considerable number of breakthrough infections and a very high proportion of the Delta variant is responsible for breakthrough infection after either one of two doses of vaccination, the Indian Sars-CoV-2 Genomics Consortium (INSACOG) said. However, the present vaccination drive continues to be effective in reducing severe disease and death, the INSACOG said.