Hyderabad: Pharma company Biological E Ltd’s Covid-19 vaccine, Corbevax, which is being administered in the 12-18 years age group, is the “lowest priced in the country”, saving about Rs 1,500 crore to the exchequer, the firm’s Managing Director Mahima Datla said Wednesday.
According to Datla, the company has priced its vaccine at Rs 990 in the private market inclusive of all taxes and administration charges. For the government, however, the vaccine is priced at just Rs 145, making it very affordable.
The Hyderabad-based manufacturer, which also sought an emergency use authorisation (EUA) in children in the 5-12 age group, said all the necessary interim reports have already been sent to the regulatory bodies, and is “confident” of obtaining the EUA for the particular age group.
The company is eventually planning to develop the vaccine on infants as young as 6 months of age, Narender Dev Mantena, head, global strategy and CEO of specialty generic injectables and synthetic biology, said, adding that as there is evolution of the disease, the firm is confident of a safety profile.
“For the government programmes our vaccine is priced at just Rs 145 which is the lowest in the country and this saves the exchequer Rs 1,500 crore just by our supply alone. For the private market, it is priced at Rs 800 and that would be Rs 990 with taxes and other charges. This would also be one of the most affordable vaccines globally. The vaccine is available for both children and adults,” Datla said at a press meet.
“Our trials on the 5-12 age group are almost completed and we have sent the interim reports. We’re expecting a meeting with the SEC (subject expert committee) soon for a review,” Datla told ThePrint.
According to the firm, it has manufactured 30 crore doses of the Covid vaccine already and has supplied about 5 crore doses to the Government of India.
The company has achieved the capacity to produce 1 billion doses annually, said Dr. Vikram Paradkar, executive vice-president (technical operations), Biological E.
Corbevax is India’s first indigenously developed Receptor Binding Domain (RBD) Protein sub-unit vaccine against Covid and has a shelf life of 12 months. The vaccine received its first EUA for adults in December last year and the same was approved for usage among children between 12-18 years in February.
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‘Our vaccine offers excellent safety profile’
Speaking at the press meet, Paradkar said trials were conducted on over 3,500 people in the respective age groups and there were no ‘grade 3’ or serious AE (adverse events) in any of the subjects. Neither was there any AESI (adverse events of special interest) reported when subjects were monitored for long term.
“Our vaccine offers an excellent safety profile and immune response and minimum reactogenicity. We have also seen strong antibody response in subjects administered with Corbevax even after six months. We are also not seeing any symptomatic infection in any of our vaccinated subjects,” Paradkar said.
Asked about the ‘efficacy’ data or study for the vaccine, Datla told ThePrint that efficacy study is usually done by an ‘innovator,’ especially when there is no existing vaccine in the market adding that the company received a formal advice from the United Kingdom’s MHRA (Medicines and Healthcare products Regulatory Agency) and upon their advice followed a protocol to conduct an immuno-bridging study (comparative study).
“When we approached our country’s drug regulators with protocol based on the UK’s MHRA’s advice, they were quite comfortable with the idea. Our country’s drug controller asked us to demonstrate a higher bar/superiority than an existing vaccine. So, we used Covishield as a comparator to show the same. The data we see from 3,500 subjects is based on head-to-head immuno-bridging study establishing superiority against Covishield,” Datla said in response to a query from ThePrint at the meet.
The study compared the vaccine against Covishield on parameters such as IgG (antibodies) and capacity to neutralise antibodies.
“An efficacy study is done when you do not have an existing vaccine and you are testing something on a naive population and that will give us a chance to do the placebo studies. So, a cohort of people are immunised and another cohort have to be unimmunised and that would be unethical given the current circumstances and wide spread of infection,” Datla told ThePrint.
Reacting to reports that the Centre approved Corbevax for children without National Technical Advisory Group on Immunisation’s clearance, she said the company has sent all relevant data at every stage to NTAGI and has been having regular meetings with them.
Eyeing Australian, African markets, seeking WHO prequalification
The company has applied for a World Health Organisation (WHO) prequalification — process to determine the capacity of a manufacturer to produce a product of consistent quality in accordance with international standards and WHO/UNFPA specifications — and is expecting a visit from the WHO team soon.
Biological E is eyeing Australia and African markets, said Datla, adding that they are receiving several queries for bilateral supplies to countries.
“We have been in talks with the US FDA too but we are not eyeing that market now because we believe our vaccine will not make any significant difference in that market given other manufacturers. We are looking at Australia and Africa,” said Mantena.
They are in talks with a few players for the vaccine supply in the Indian private market but expect the demand to be less than 10 per cent of the total demand given the accessibility and far spread of government vaccine programmes and percentage of population already vaccinated, the company said.
Biological E is also conducting clinical trials to test Corbevax as a booster shot (third dose) after two doses of Covaxin and Covishield. The company also plans to do trials as a booster dose of Corbevax eventually.
Corbevax is generating neutralising antibodies against Delta, Beta and Omicron variants and will continue to test the vaccine against any such upcoming variants in the future, the company claimed.
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