Serum Institute of India CEO Adar Poonawalla on Friday said he is hopeful that Covovax, another COVID-19 vaccine being manufactured by his company in India, will be launched in October for adults and for children by the first quarter of 2022.
He also thanked the government for all the support provided to Serum Institute and said the company is always trying to expand its Covishield production capacity to meet the demand. Poonawalla met Home Minister Amit Shah in Parliament and the meeting between the two lasted for 30 minutes. “The government is helping us and we are facing no financial crunch. We are thankful to Prime Minister Narendra Modi for all the cooperation and support,” Poonawala told PTI after his meeting. When asked about vaccines for kids, he said, “The Covovax vaccine for kids will be launched in the first quarter of the next year most likely in January-February.”
Poonawala said he is hopeful that for adults Covovax will be launched in October, depending on DCGI approvals. It will be a two-dose vaccine and the price will be decided at the time of launch, he added. On production capacity of Covishield, the vaccine being manufactured and supplied by Serum in India under a licensing agreement with Oxford and AstraZeneca, he said the present capacity is 130 million doses per month and always try to increase it further.
Earlier in the day, Poonawalla also met Health Minister Mansukh Mandaviya. The minister tweeted that he had a productive discussion on the supply of the Covishield vaccine with Poonawalla. “I appreciated their role in mitigating #COVID19 & assured continued Government support in ramping up vaccine production,” Mandaviya said.
Last month, an expert panel of India’s Central Drug Authority recommended granting permission to Serum Institute of India (SII) for conducting phase 2/3 trials of Covovax on children aged 2 to 17 years with certain conditions, official sources had earlier said. The trials would cover 920 children, 460 each in the age group of 12-17 and 2-11 across 10 sites.
The Pune-based pharmaceutical company had submitted a revised protocol for inclusion of pediatric cohort in the ongoing Covovax phase 2 and 3 observer-blind, randomised, controlled study in Indian adults aged 18 years and above to determine the safety and immunogenicity of the jab.
In the revised application, SII director (government and regulatory affairs) Prakash Kumar Singh and director Dr Prasad Kulkarni had stated that globally, all adults aged 18 and above are being vaccinated and after this population is protected against COVID-l9, children will remain the most susceptible group.
Currently, only those who are 18 or above are eligible for vaccination against the coronavirus. The SII is learnt to have informed that their collaborator, Novavax, Inc, US has already generated a large amount of data in adults in different countries and that the safety, efficacy and immunogenicity data on the Novavax COVID-I9 vaccine are very robust which includes a safety database of more than 50000 adults with data from Australia, South Africa, UK and USA and preliminary safety data in 2248 children. “Further in the ongoing Phase 2/3 study in India, more than 1400 participants have received at least first dose of the vaccine with no safety concerns reported so far,” the application stated.
“This will ensure that a life-saving vaccine can be brought at the earliest for our pediatric population also in addition to the adult population immediately after the grant of Emergency Use Authorisation. The SEC on June 30 had recommended against granting permission to SII for conducting phase 2 and 3 trials of Covovax on children aged 2 to 17 years following which the company had submitted a revised study protocol last week.
In August 2020, US-based vaccine maker Novavax, Inc had announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in low and middle-income countries and India.