Serum produces 30 million Covishield vaccine vials; awaits emergency licensing for vaccination
The Serum Institute of India (SII) which is a front-runner for providing coronavirus (Covid-19) vaccine to India has produced as many as 30 million Covishield vaccine vials, said, SB Patil, joint commissioner (drugs), Pune division, Food and Drugs Administration (FDA).
Abhimanyu Kale, commissioner, Food and Drugs Administration (FDA), Pune division, along with Kale and other officials visited the institute on Friday to inspect the safety measures and production quality.
SII is awaiting the emergency license from the central government on the lines of World Health Organisation’s (WHO) guidelines. This will expedite the process of vaccinating people who are at the direct risk of being exposed to the Sars-Cov-2-virus which causes the Covid-19 infection, based on the promising response that Covishield has got following the third phase trials in the UK.
A statement issued by FDA said, “Adar Poonawalla said that India is likely to have a ‘safe and effective’ coronavirus vaccine by January 2021. The authorities of SII requested that on the lines of WHO guidelines the government should grant an emergency license to the institute.”
Kale said, “The visit was intended to find out how prepared the institute is in case we have a government-approved vaccine. We also want to make sure that there is no miscommunication or lack of coordination between the government and the institute with regards to permissions and licensing.”
“We told them that we are ready to provide them the regular licenses, but for emergency licenses, we will need to get more information,” he said.
Patil said, “Over 30 million doses of Covishield are ready and the quality levels are satisfactory. The company has asked to grant permission for an emergency license for which there is currently no provision in our law. However, the institute has asked us for permission under the WHO guidelines, which provides for such licenses under exceptional situations like earlier in case of Ebola.”
“The institute will send us an official letter and then we will send it to Drugs Controller General of India who will take the final call. The institute has got such licenses from other countries based on which they have made a similar request for Indian population like healthcare workers,” he said.
Currently, the phase three trials are undergoing in India too in several cities and the results of which are expected to come by the end of the year which will prove its efficacy against Covid-19. The institute, meanwhile, has begun the production of the vaccine parallelly to meet up the demands once the vaccine gets final approval from the WHO and Indian government for mass vaccination.
A request for comment on the same from the SII went unanswered at the time of going to press.