Explainer: COVAXIN production ramp up and its challenges

News date: 18 April 2021Source: https://www.livemint.com/news/india/explainer-covaxin-ramp-up-and-its-challenges-11618660650221.html

NEW DELHI: The government on Friday announced that three state-run vaccine makers will support Bharat Biotech International in scaling up the manufacturing capacity of Covaxin by at least 10-fold in about five months. To aid the scale up, the government has even provided ₹130 crore in aid to Bharat Biotech and one of the companies, Haffkine Biopharmaceuticals Corp. Ltd. Mint looks at the challenges that may emerge in scaling up vaccine production and, if it is successful, the impact it could have on the inoculation process.

The department of biotechnology (DBT) announced that it has roped in Haffkine, Indian Immunologicals Ltd, and Bharat Immunologicals and Biologicals Ltd (BIBCOL) to support the indigenous vaccine developer Bharat Biotech in manufacturing Covaxin. It has also provided financial support to all three companies, with Bharat Biotech and Haffkine getting ₹65 crore each, while Indian Immunologicals and BIBCOL will also get an undisclosed amount. The financial grant will help double the total Covaxin manufacturing capacity by June from 10 million a month now. The capacity will then go to around 60-70 million doses per month by August and then around 100 million by September.

Of the 100 million, it is expected that Bharat Biotech will produce almost 60 million per month, while Haffkine will produce around 20 million per month. The remaining will be produced by the other two companies. The DBT is also pushing Panacea Biotec to contract manufacture the vaccine. Talks between the government, Bharat Biotech and Panacea have started.

What impact will improved Covaxin supply have?

Currently, less than a tenth of the covid-19 vaccine doses administered are Covaxin, with the remaining being Covishield, which is manufactured by Serum Institute of India. Bharat Biotech's vaccine, developed in India, has played second fiddle so far. The primary reason behind this has been Covaxin’s low production rate—while only 10 million doses a month of Covaxin are produced, Serum Institute is producing 60-70 million doses of Covishield every month. The latter will scale up capacity to 100 million a month from May.

Initial hesitancy also played its part as Covaxin was given emergency use license in ‘clinical trial mode’ in January even as its efficacy data was awaited. After the company announced an 80.6% interim efficacy, the Indian regulator granted full emergency authorisation to the vaccine and its pick up increased. However, capacity remained a crucial hurdle.

Meanwhile, India is seeing a sharp jump in covid-19 cases, especially in Maharashtra, Uttar Pradesh, Karnataka, Chhattisgarh, and the national capital Delhi. On Friday, India added over 234,000 new cases. Experts believe it is important to vaccinate as many people as soon as possible to avoid severe losses. India has administered over 50 million doses in the first half of this month, more than what was administered in the entire month of March. Currently, the inoculation rate is higher than the production rate. Ramping up Covaxin production will significantly aid India’s covid-19 immunisation drive during the second wave.

Aren’t other vaccines coming?

Yes, Sputnik V vaccine has recently received authorisation in India, but there is no clarity on its supply and pricing yet as Dr Reddy’s Laboratories, the Indian commercialising partner for the vaccine, is still in discussions about it with the government. Initially, limited quantities of Sputnik V are likely to be imported to India, and the production ramp is expected only after July.

Other vaccines that are being developed include Zydus Cadila’s ZyCoV-D, Covovax (Serum Institute’s version of Novavax’s vaccine) and Biological E’s vaccine, but their supply could take time.

The government has also eased regulations for foreign vaccines which have authorisations from the four top foreign drug regulators, including the US Food and Drug Administration and World Health Organization. The norms fast-track entry of vaccines from Pfizer, Moderna and Johnson & Johnson. However, there is no clarity on when these companies will apply for the expedited authorisation. Even if they apply for and get the import license, supplies could be limited as these companies already have supply contracts with the US, European Union and some developed countries.

While J&J has contracted Biological E to manufacture its single-dose vaccine, production is yet to begin.

What are the challenges for Covaxin ramp up?

The government has given ambitious targets for the companies contracted to produce Covaxin, especially when it comes to the three PSUs. For Bharat Biotech, the company is likely to take about two months to start ramping up production, and while production may double to around 20 million a month by June, it may not be enough to meet India’s own increasing demand.

For the three PSUs, the task is challenging because they have to set up or repurpose existing facilities at breakneck speed to start producing Covaxin—a vaccine that comes with far more stringent biosafety requirements compared to Covishield. Covaxin is an inactivated vaccine, meaning it requires cultural large batches of SARS-COV2 and then inactivating it, purifying and processing it before finally bottling it. Since it requires culturing the highly infectious virus, the production facility should meet biosafety level 3 (BSL3) standards.

Currently, only Bharat Biotech and Panacea Biotec have these facilities in India, and according to an official at a vaccine manufacturer, it could take at least four months to just repurpose an existing plant. Building a new plant would take more time. According to DBT, Haffkine had sought a year to set up such a facility but the government has asked the company to do it in half that time.