J&J withdraws vaccine approval request in India, CDSCO says
What's the story
Johnson & Johnson has withdrawn its proposal seeking an accelerated approval of its COVID-19 vaccine, Janssen, in India, the country's drug regulator said.
"The firm has informed that they are withdrawing their proposal," the Central Drugs Standard Control Organisation (CDSCO) announced in a note.
J&J, however, maintains it is still in talks with the Indian government for its vaccine's delivery in India.
Quote
'We're in discussions with the Indian government'
"We are in ongoing discussions with the government of India and are exploring how best to accelerate our ability to deliver our COVID-19 vaccine to India," J&J said in a statement emailed to news agency Reuters.
Details
J&J had sought approval for trial in April
J&J had, in April, sought approval to carry out a bridging clinical trial of its vaccine in India.
Reports also said a limited supply of the vaccine could arrive in India in July.
Janssen is a single-shot COVID-19 vaccine, currently approved in several countries.
The company recently claimed the jab is effective against the highly-contagious Delta variant and other strains of the coronavirus.
Controversies
J&J vaccine has been mired in controversies
J&J's vaccine was authorized for emergency use in the US this February.
However, weeks after that, the jab was linked to a rare but serious blood clotting disorder, leading to a brief pause in its use.
Besides that, in July, the European medicines regulator added a rare nerve-degenerating disorder, Guillain-Barré syndrome, as a possible side effect of the vaccine.
Vaccines
Which vaccines are approved in India?
India had approved Covishield, developed by Oxford-AstraZeneca, and the indigenous jab COVAXIN, in January.
In April, Russian vaccine Sputnik V was approved by the Indian authorities, however, its supplies remain limited.
Most recently, American firm Moderna's COVID-19 vaccine became the fourth shot to get the nod in India. But its doses have not arrived in the country yet.
Vaccination
How is India's vaccination drive going?
India has administered more than 47 crore vaccine doses so far.
Even though nearly 27% of the population have received at least one shot, just around 7.5% have been fully vaccinated.
India has set a goal of inoculating nearly a billion people by the end of this year.
However, several states continue to report a shortage of vaccines.