The Food and Drug Administration has ‘recommended’ Ocugen Inc, US partner of the Indian vaccine maker, to go for BLA route with addl data
A sign advertises a free vaccination site set up inside Union Station in an effort to target commuters, in Los Angeles, California. Pic/AFP
In a setback that could potentially delay the launch of Bharat Biotech’s Covid-19 vaccine Covaxin in USA, the Food and Drug Administration there has “recommended” Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixing hopes of Emergency Use Authorisation (EUA).
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Ocugen in a statement on Thursday announced that as recommended by the FDA, it will pursue submission of a biologics licence application (BLA) for Covaxin. The BLA is a “full approval” mechanism by the FDA for drugs and vaccines. The development may delay the Covaxin launch in the US, Ocugen said. “The company will no longer pursue an EUA for Covaxin. The FDA provided feedback to Ocugen regarding the Master File. The company had previously submitted and recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data,” Ocugen said.
Ocugen is in discussions with the FDA to understand the additional information required to support a BLA submission. The company anticipates that data from an additional clinical trial will be required to support the submission. “Although we were close to finalising our EUA application for submission, we received a recommendation from the FDA to pursue a BLA path. While this will extend our timelines, we are committed to bringing Covaxin to the US,” Dr. Shankar Musunuri, chairman of the Board, chief executive officer and co-founder of Ocugen said. “This differentiated vaccine is a critical tool to include in our national arsenal given its potential to address the SARS-CoV-2 variants, including the delta variant,” he added.
Germany officially launches vaccine certificate CovPass
A delegate listens during the opening of the online party congress of Germany’s Alliance 90/The Greens in Berlin. Pic/AFP
After a two-week test phase, the new digital Covid-19 vaccination certificate ‘CovPass’ was officially launched in Germany, Minister of Health Jens Spahn announced. Implementing a programme by the European Union (EU), the modifications of the certificate would make it possible to prove vaccinations, tests and previous Covid-19 illnesses when travelling in Europe, Xinhua news agency quoted Spahn as saying in a press briefing on Thursday.
SL records highest daily Covid-19 deaths
The Covid-19 death toll in Sri Lanka has crossed the 2,000-mark as the country on Thursday recorded its highest single-day fatalities with 101 deaths since the onset of the pandemic. The death toll from Covid-19 has now reached 2,011 in Lanka, which is facing a third wave, health officials said on Friday. The 101 deaths reported on Thursday was the highest number of deaths confirmed in a day since the onset of the pandemic in the country in March 2020.
J&J vaccine’s shelf life extended
Johnson & Johnson said the US Food and Drug Administration has extended the shelf life of its single-shot Covid-19 vaccine from three months to 4.5 months, as millions of unused doses are set to expire this month. The decision is based on data from ongoing stability assessment studies, which have demonstrated that the vaccine is stable at 4.5 months when refrigerated at temperatures of 36 to 46 degrees Fahrenheit, according to the drugmaker, Xinhua reported.
‘90% of African nations not on track with vax’
Nine out of 10 African countries could miss the target of vaccinating 10 per cent of their population against Covid-19 by September, dimming hopes of containing the pandemic in the continent, a World Health Organization (WHO) official said on Thursday. Matshidiso Moeti, WHO regional director for Africa, said that nearly 90 per cent or 47 out of 54 African countries are off-track in terms of inoculating 10 per cent of their population against the virus in the next three months even as they grapple with surging infections, Xinhua reported.
37,59,71
No. of new cases reported globally in the past 24 hours
17,49,72,721
Total no. of cases worldwide
37,75,556
Total no. of deaths worldwide
Source: WHO/Johns Hopkins
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