Biological E to prepare up to 100 million doses of Corbevax vaccine per month, calls for green light for studies in children
Call it the story of two major vaccine makers in the same city. Biological E, another Hyderabad company after Bharat Biotech, is now preparing to start its Covid vaccine supplies. Bharat Biotech’s Covaxin was developed in collaboration with the Indian Council for Medical Research (ICMR) and the National Institute of Virology (NIV). However, Biological E’s Corbevax is the result of clinical trials conducted by Biological E on the vaccine candidate, which includes an antigen licensed from BCM Ventures – the integrated business team at the US Baylor College of Medicine, in the United States. Except for an adjuvant (an ingredient added in some vaccines to boost the immune response) from Dynavax Technologies, a US-based company. Corbevax is a protein subunit vaccine, a technology known and deployed in other vaccines such as hepatitis B and HPV vaccines.
On June 3, the Indian government finalized an agreement with Biological E. The agreement was to provide the Indian government with 300 million doses of their vaccines between August and December 2021.
Narendra Modi’s government also announced an advance payment of Rs 1,500 crore to be made to reserve these doses. Mansukh Mandaviya, the new Union Health Minister, even visited the BE facility, among others, on June 27 and tweeted his review of support for increased vaccine production in the country.
Taking time out of her busy schedule, the CEO of Biological E Mahima datla answered some of Financial Express Online’s questions about the status of the company’s vaccine development, timelines in terms of supplies committed, exports, inclusion of children in studies, and vaccine pricing.
Datla, who has spent many years in the vaccine industry, wears several hats. In addition to overseeing BE’s strategic operations, she is also a member of the board of directors of GAVI (Global Alliance for Vaccines and Immunization), member of the FICCI (Federation of Indian Chambers of Commerce and Industry) committee, a GHIT (Global Health Innovative Technology) board member of the fund, which is a Japanese government health innovation fund aimed at improving global access to health care.
And more locally, in her home state of Telangana, the vice-chair of the life sciences advisory committee set up by the state government. Here are the edited excerpts:
What is the current status and the expected timeline for the availability of your vaccine and the one from Johnson and Johnson, which you are going to produce?
Phase III trials for the Corbevax vaccine are underway and we plan to apply for the Emergency Use License (EUL) towards the end of August 2021 and secure the EUL by September 2021. We will provide a minimum of 300 million doses to the Indian government by December. 2021 following obtaining the EUL. While in 2021, the supply would be mainly for domestic purposes, in 2022 we will export part of the production in accordance with the commitments of the Quad (countries of the vaccine partnership – America, India, Australia and Japan – to strengthen and help the countries of the Indo-Pacific region) and COVAX (a global vaccine sharing alliance co-led by the World Health Organization).
Regarding the J&J vaccine, we are not free to disclose information on this subject. The Janssen candidate’s production, testing and supply plan will be finalized by J&J.
What is the production capacity of your vaccine?
For Corbevax, while we plan to fill at a rate of 75 million doses / month at the time of launch, we expect more than 100 million doses / month from February 2022.
Are there any export commitments for your vaccine?
We currently have no export commitments, but we will likely have visibility / commitments closer to WHO prequalification, which is expected in Q1 2022.
So, do you plan to reach a monthly production of more than 100 million doses by February 2022?
Our vaccine production until December 2021 would be limited to the fill rate of 75 million doses / month. But we are forecasting over 100 million doses / month from February 2022.
What about the price of your vaccine?
Biological E (BE) has a long and rich history of supporting public health programs for more than five decades. BE manufactures over 2 million doses of vaccine every day, resulting in enormous economies of scale. The same has enabled us to reduce the cost of fully immunizing a child with the pentavalent from $ 10.50 in 2001 to about $ 2 now. Lower prices have saved UNICEF and GAVI around $ 500 million over 5 years. The reduced cost combined with the increased availability has helped to effectively immunize many LICs (low income countries) and LMICs (low and middle income countries), including India. While it is too early to comment on pricing, we can assure that the efficiency we gain in large-scale manufacturing, i.e. the contribution of all overhead (labor, CAPEX, utilities, maintenance, testing) to more vaccine doses allows us to offer the vaccines at possibly the most affordable price for a comparable vaccine supply commitment.
In addition to this, the pricing mechanism was designed to pass on the benefits derived from funding by BIRAC, CEPI and COVID Suraksha.
Since India does not yet have an approved vaccine for children – So in your clinical trials are children included or are these trials only for adults?
Yes, we will seek authorization from the DCGI (Drug Controller General of India) to initiate studies in children for safety and immunogenicity. The trials would initially be aimed at adolescents (age group 12-18) followed by the recruitment of children (5-12 years), thus expanding the age group to 5-18.
Does your capacity (75 million doses per month to 100 million) also depend on a manufacturing contract or is it just your own capacity?
It is completely BE manufacturing capability.
Many large vaccine suppliers will see oversupply in 2022, so do you think that once your capacity hits 100 million per month, you will remain competitive and be able to deliver even if vaccine prices are forced to fall further? more due to oversupply?
We do not envision an oversupply in 2022 as there are many countries outside of India, whether in low income or lower middle income groups that have very low immunization coverage.