PremiumNEW DELHI : Johnson & Johnson said on Tuesday that it has applied with the Drugs Controller General of India (DCGI) V.G. Somani for an approval to conduct a local bridging study of the company's single-dose Janssen covid-19 vaccine in the country.
A spokesperson for the company said, the study was aimed to comply with local regulations and added that the application was in line with its commitment to provide safety and efficacy data necessary to support worldwide emergency use of the Janssen covid-19 vaccine candidate.
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Premium However, the American company has as of now not applied seeking emergency authorization for import of its vaccine under revised regulations which expedited licensing to foreign covid-19 vaccine manufacturers that have an emergency use authorization from regulators in the US, UK, European Union, Japan or the World Health Organization.
In case it has an authorization from these top regulators, the company can get an authorization within a week under the norms that were revised last week.
Globally, J&J is also facing regulatory scrutiny, especially in the US where it has been rolled out, for rare cases of blood clots.
Last week, the US Food and Drug Administration and Centre for Disease Control paused the rollout of J&J’s vaccine as they conducted a review of safety reports from six cases where people who took the vaccine had issues of severe type of blood clot along with low levels of blood platelets. So far, around 7 million people in the US have received the single-shot covid-19 vaccine.
Similar cases of blood clots with low platelet count post inoculation were also observed with the vaccine developed by University of Oxford and AstraZeneca. Both vaccines work on the adenovirus vector-based vaccine platform. The European Medicines Agency, WHO and the UK regulator said there were possible side-effects upon taking the vaccines, although they advised further studies on it.
While the vaccine roll-out in the US was halted by the government, J&J voluntarily delayed the roll-out of its vaccine in Europe and paused vaccinations in all its clinical trials while it updated its guidance for investigators and participants.
Premium Premium Anthony Fauci, director of US’ National Institute of Allergy and Infectious Diseases, on Saturday said that the vaccine roll-out could resume by the end of this week with some additional limitations warnings. The CDC’s vaccine advisory committee is expected to meet 23 April to review the vaccine’s path forward.
In India, J&J has partnered with Biological E, a Hyderabad-based company that will contract manufacture the vaccine for global supply. However, the company has not yet started manufacturing the doses.
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