Biological E to make up to 100m Corbevax vaccine doses a month, seeks nod for studies on children

Call it a tale of two leading vaccine makers from the same city. Biological E, yet another company from Hyderabad after Bharat Biotech, is now gearing up to begin its Covid vaccine supplies. Bharat Biotech’s Covaxin was developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). Biological E’s Corbevax however, is the result of clinical trials conducted by Biological E on the vaccine candidate, which includes an antigen in-licensed from BCM Ventures – Baylor College of Medicine’s integrated commercial team from the US apart from an adjuvant (an ingredient added in some vaccines to boost immune response) from Dynavax Technologies, a US-based company. Corbevax is a protein subunit vaccine, a known technology and deployed in other vaccines like Hepatitis B and HPV vaccines.

On June 3rd, the Indian government finalised an arrangement with Biological E. The agreement was to supply the Indian government with 300 million doses of their vaccines between August and December 2021.

The Narendra Modi government had also announced an advance payment of Rs 1,500 crore to be made to reserve these doses. Mansukh Mandaviya, the newly-appointed Union Health Minister, even visited the BE facility among others on June 27th and tweeted about his review of the support for boosting vaccine production in the country.

Taking time out from her busy schedule, Biological E Managing Director Mahima Datla responded to some of the questions from Financial Express Online on the status of the company’s vaccine development, the timelines in terms of supplies committed, exports, inclusion of children in the studies and the vaccine pricing.

Datla, who has spent long years in the vaccine industry, wears several hats. Other than overseeing the strategic operations at BE, she is also a board member of GAVI (Global alliance for vaccines and immunization), a member of FICCI (Federation of Indian Chambers of Commerce and Industry) committee, a GHIT (Global Health Innovative Technology) fund board member, which is a Japanese government innovation healthcare fund for improving global access to healthcare.

And more locally, in her home state of Telangana, the Vice-Chairman of the Life Sciences Advisory Committee put in place by the state government. Here are the edited excerpts:

What is the current status and the projected timelines on the availability of your vaccine and that of Johnson and Johnson, which you will be producing?

Phase-III trials for Corbevax vaccine are underway and we expect to apply for EUL (Emergency Use License) towards end of August 2021 and secure the EUL by September 2021. We will supply a minimum of 300 million doses to the government of India by December 2021 following the obtainment of the EUL. While in 2021, the supply would be primarily for domestic purposes, in 2022 we will be exporting a portion of the production as per commitments to the Quad (vaccine partnership countries – America, India, Australia and Japan- to strengthen and assist countries in the Indo-Pacific region) and COVAX (a global vaccine-sharing alliance co-led by the World Health Organisation).

On the J&J vaccine, we are not at liberty to disclose information on this. The production, trials & supply plan of the Janssen candidate will be finalized by J&J.

What is the production capacity for your vaccine?

For Corbevax, while we expect to fill at a rate of 75 Million doses/month at the time of launch, we anticipate over 100 million doses/month starting February 2022.

Are there any export commitments for your vaccine?

We currently have no export commitments but are likely to have visibility/commitments closer to receiving pre-qualification from the WHO, which is anticipated in Q1 2022.

So, you are intending to touch a monthly production of over 100 million doses by February 2022?

Our vaccine production till December 2021 would be limited to the fill rate of 75 million doses/month. But we anticipate over 100 million doses/month starting February 2022.

What about the pricing of your vaccine?

Biological E (BE) has a long and richly textured history of supporting public health programs for over five decades. BE manufactures more than 2 million doses of vaccine every day and this allows for huge economies of scale. The same has allowed us to bring down the cost to fully immunize a child with pentavalent from $10.50 in 2001 to about $2 now. The lower prices have saved UNICEF and GAVI about $500 million over 5 years. The reduced cost combined with the increased availability has helped effectively immunize a lot of LICs (Low Income Countries) and LMICs (Low and Middle Income Countries) including India. While it is too early to comment on the pricing, we can assure that the efficiencies that we gain in large scale manufacturing i.e. contribution of all the overhead costs (manpower, CAPEX, utilities, maintenance, testing) to larger number of vaccine doses enables us to offer the vaccines at probably the most affordable price for comparable vaccine supply commitment.

Besides this, the mechanism of pricing was built to pass-on the benefit gained out of the funding by BIRAC , CEPI, and COVID Suraksha.

Given that India does not have, as yet, an approved vaccine for children – So as part of your clinical trials, are children included or are these trials only for adults?

Yes, we are going to request the DCGI (Drug Controller General of India) permission for initiation of study in children for safety and immunogenicity. The trials would be initially for the adolescents (age group 12-18) followed by enrolling of children (age 5-12), thus expanding the age group to 5-18.

Does your capacity (75 million doses a month to 100 million) depend also on any contract manufacturing or is it all your own capacity?

It is completely BE manufacturing capacity.

Many major vaccine suppliers will see oversupplies in 2022, so do you think once your capacity gets to 100 million a month you will stay competitive and be able to supply even if vaccine prices are forced to soften even more due to oversupply?

We don’t envision an oversupply in 2022 as there are many countries outside India be it in low income or lower-middle income groups who have very poor vaccine coverage.