Johnson & Johnson's single-dose COVID-19 vaccine gets Emergency Use approval in India
New Delhi: Johnson & Johnson's single-dose COVID-19 vaccine has been given Emergency Use approval in India, Union Health minister Mansukh Mandaviya said on Saturday.
He said this will further boost the country's collective fight against the novel coronavirus infection.
"India expands its vaccine basket! Johnson and Johnson's single-dose COVID-19 vaccine is given approval for Emergency Use in India. Now India has five EUA vaccines. This will further boost our nation's collective fight against #COVID19," the minister tweeted.
The US-based pharmaceutical company had applied for Emergency Use Authorisation for its jab on Friday and was granted the approval the same day by the Drugs Controller General of India (DCGI), a senior official said.
The five vaccines granted Emergency Use Authorisation in India are Serum Institute's Covishield, Bharat Biotech's Covaxin, Russia's Sputnik V, Moderna and now Johnson & Johnson (J&J).
J&J earlier had sought approval to conduct phase-3 clinical trial of its vaccine on approximately 600 participants in two age groups---those aged 18 and below 60 years and those aged 60 years and above---to evaluate the safety, reactogenicity and immunogenicity of the jab in healthy Indian adults.
However, on July 29, the firm withdrew its proposal.
A health ministry official at a recent press conference had clarified that J&J earlier applied for conducting phase-3 clinical trial of its vaccine.
"The application was to undertake clinical trial and when we issued relaxed guidelines in which we said if you had approval from other regulatory bodies of other countries, then exemption would be given from clinical trials, and emergency use authorisation would be granted and trial could be continued later on, so now since they did not need it they withdrew that application," the official had said.
In a bid to fast-track emergency approvals for all foreign produced coronavirus jabs, the central government had announced that COVID-19 vaccines which were approved for restricted use by regulators in the US, UK, Europe and Japan, or which were on the World Health Organisation's Emergency Use Listing, would not have to conduct bridging clinical trials in India.
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Another North Goa nightclub sealed; Kejriwal says corruption led to fire tragedy
Panaji (PTI): As part of a crackdown against tourist establishments violating laws and safety norms in the aftermath of the Arpora fire tragedy, Goa authorities on Saturday sealed a renowned club at Vagator and revoked the fire department NOC of another club.
Cafe CO2 Goa, located on a cliff overlooking the Arabian Sea at Vagator beach in North Goa, was sealed. The move came two days after Goya Club, also in Vagator, was shut down for alleged violations of rules.
Elsewhere, campaigning for local body polls, AAP leader Arvind Kejriwal said the fire incident at Birch by Romeo Lane nightclub at Arpora, which claimed 25 lives on December 6, happened because the BJP government in the state was corrupt.
An inspection of Cafe CO2 Goa by a state government-appointed team revealed that the establishment, with a seating capacity of 250, did not possess a no-objection certificate (NOC) of the Fire and Emergency Services Department. The club, which sits atop Ozrant Cliff, also did not have structural stability, the team found.
The Fire and Emergency Services on Saturday also revoked the NOC issued to Diaz Pool Club and Bar at Anjuna as the fire extinguishers installed in the establishment were found to be inadequate, said divisional fire officer Shripad Gawas.
A notice was issued to Nitin Wadhwa, the partner of the club, he said in the order.
Campaigning at Chimbel village near Panaji in support of his party's Zilla Panchayat election candidate, Aam Aadmi Party leader Kejriwal said the nightclub fire at Arpora happened because of the "corruption of the Pramod Sawant-led state government."
"Why this fire incident happened? I read in the newspapers that the nightclub had no occupancy certificate, no building licence, no excise licence, no construction licence or trade licence. The entire club was illegal but still it was going on," he said.
"How could it go on? Couldn't Pramod Sawant or anyone else see it? I was told that hafta (bribe) was being paid," the former Delhi chief minister said.
A person can not work without bribing officials in the coastal state, Kejriwal said, alleging that officers, MLAs and even ministers are accepting bribes.
