Biological E eyes 1 billion doses of non-Covid vaccines in 5 years

Hyderabad-based Biological E is eyeing a capacity to produce 1 billion non-Covid vaccines per annum in the next five years, and aims to be the largest vaccine maker in India by volume.

At present, the firm has a capacity to make 1.5-2 billion Covid vaccines and 600 million non-Covid vaccines per annum. Currently, Pune’s Serum Institute of India (SII) is not only India’s but the world’s largest vaccine maker by volume.

It has an annual capacity to make 3 billion vaccines (Covid and non-Covid put together).

Speaking to Business Standard, Lakshminarayana Neti, chief operating officer (COO), vaccines division, Biological E, said the company has a Covid vaccine manufacturing capacity of 1.5 to 2 billion doses. This could be scaled up to 2.5 billion doses in case there is a demand.

“We have not stopped supplies of any non-Covid vaccine even during the pandemic. We now have a target to scale this up to 1 billion annual doses, going forward, let’s say in another five years or so,” Neti said.

Several vaccine products are in the pipeline — the pneumococcal conjugate vaccine (PCV), the Inactivated polio vaccine, the Hepatitis A vaccine, measles vaccine — to name a few. Of these, the PCV may be licensed by financial year 2022-23, Neti said.

The privately-held company has a turnover of Rs 1,000 crore (FY22), and draws bulk of the revenue (close to 80 per cent) from vaccines.

As for the Covid vaccine business, there are two important milestones that Biological E is now eyeing — one is a World Health Organisation (WHO) emergency-use listing (EUL). And secondly, approval of 

Corbevax as a heterologous-boosting vaccine after Covishield and Covaxin.

“We are doing studies to check how effective Corbevax is as a heterologous booster after Covishield and Covaxin. The serological tests are on. Once the data is ready, we will present it before the regulator,” Neti said.

The firm may present the data on heterologous boosting before the Drugs Controller General of India (DCGI) this month.

So far as the WHO-EUL goes, Biological E is working closely with the WHO on the process. Typically, WHO EULs are granted based on efficacy studies, but Biological E’s Corbevax did not have the efficacy data as most of the population had developed Covid antibodies.

Efficacy studies are not feasible when other vaccines or interventions are available. Therefore, the firm did an immune-bridging study where Covishield was the comparator vaccine.

Biological E had to prove superiority in generating immune responses compared to Covishield in a head-to-head comparison study on 3,000 people.

Neti said WHO has now made policy modifications to consider such immune-bridging study data for granting EUL. Pre-submission meetings with the WHO team are expected soon, he added.

According to sources, the central government, too, is taking keen interest in the accelerated review of Corbevax by the WHO.

This is because 29.1 million children in India, aged 12-14 years, have taken the vaccine. These kids are facing issues in travelling overseas as the vaccine does not yet have WHO approval.

WHO EULs happen after technical reviews and facility audits, and are a time-consuming process.

Mahima Datla, managing director (MD), Biological E, has been recently quoted as saying the company is well versed with WHO requirements from an infrastructure point of view. Therefore, it is expecting an expedited approval.

Biological E is also in talks with several countries for bilateral supplies.

It has supplied 100 million doses of Corbevax to the Centre and has 200 million doses ready to be supplied to the government as well as the private sector.