J&J seeks Indian approval to conduct bridging study for single-shot vaccine
However, as of now, the company has not sought emergency authorisation for import of its vaccine. Revised government regulations expedite licensing to foreign manufacturers that have an emergency use authorisation from regulators in the US, UK, European Union, Japan or the World Health Organization
US multinational company Johnson & Johnson is seeking India’s approval to conduct a bridging study of its single-dose Janssen COVID-19 vaccine in the country, according to reports.
The company said on Tuesday that the study was aimed at complying with Indian regulations. The application is with the Drugs Controller General of India (DCGI) VG Somani, a spokesperson said.
However, as of now, the company has not sought emergency authorisation for import of its vaccine. Revised government regulations expedite licensing to foreign manufacturers that have an emergency use authorisation from regulators in the US, UK, European Union, Japan or the World Health Organization.
The J&J vaccine is facing regulatory scrutiny in Europe and America for rare cases of blood clots.
Last week the US Food and Drug Administration and the Centers for Disease Control and Prevention paused the rollout of the vaccine after finding that six women between the ages of 18 and 48 years who got the jab had developed blood clots and one died.
So far, around seven million people in the US have received the single-shot vaccine.
J&J also voluntarily delayed the rollout of the vaccine in Europe and paused vaccinations in all its clinical trials while it updated its guidance for investigators and participants.
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.