As India reeled from a devastating second wave of coronavirus infections, the US rapidly deployed six planeloads of life-saving supplies in support of the country's fight against the pandemic.
Agency inspectors said a batch of the bulk drug substance for J&J's single-shot vaccine was contaminated with material used to make COVID-19 vaccines for another Emergent client, AstraZeneca.
Johnson & Johnson seeks permission for phase-III trial of its COVID vaccine in India, import licence
They said the company has sought an early meeting of the subject expert committee on COVID-19 of the Central Drugs Standard Control Organisation to take a decision on its application.
Nearly 7 million J&J doses have been administered in the U.S., almost all without serious side effects.
Hundreds of thousands of doses of the vaccine were due to be shipped to Europe in the coming weeks.
The European Medicines Agency (EMA) said four "serious cases" of unusual blood clots had been reported with the Johnson & Johnson vaccine.
The single-shot vaccine -- the third type to be authorized -- is highly effective in preventing severe Covid-19, including against newer variants, US FDA said, before giving it the green light.
The EUA allows the Janssen COVID-19 vaccine to be distributed in the US for use in individuals of 18 years of age or older.
The country of almost 59 million people, which has seen nearly 50,000 succumb to the virus, has been widely criticised for a slow procurement of vaccines and lack of strategy.
Kluge reiterated the WHO's call for rich countries to help poorer parts of the world, urging them to donate spare doses after inoculating the most vulnerable parts of their populations.
A St Louis jury has awarded a California woman more than USD 70 million in her lawsuit alleging that years of using Johnson & Johnson's baby powder caused her cancer.