Why WHO suspended Covaxin, and how Bharat Biotech is responding

Why WHO suspended Covaxin, and how Bharat Biotech is responding

Why WHO suspended Covaxin, and how Bharat Biotech is responding

The WHO has suspended Covid-19 vaccine Covaxin's supply through UN agencies, after an inspection flagged issues relating to manufacturing. What are these issues, and how is Bharat Biotech addressing them?

The Hindi version of director SS Rajamouli’s RRR witnessed its first major day-on-day drop at the box office on its second Monday. The film is expected to have made Rs 7 crore, according to Box Office India. RRR’s running total is Rs 190 crore in the Hindi belt, and it will cross the Rs 200 crore mark by Wednesday.

While the film will beat Sooryavanshi’s total on Tuesday, overtaking The Kashmir Files seems difficult at this stage. Starring Jr NTR and Ram Charan, RRR is an epic historical film set in pre-Independence India. While mainly a Telugu language film whose stars are still new to Bollywood audiences, RRR has performed exceedingly well in North India, just like Rajamouli’s Baahubali films. Ram Charan recently made a trip to Mumbai to celebrate the film’s success.

Notably, RRR is now the fifth highest grossing Indian film worldwide, having overtaken PK. The film’s international total stands at Rs 900 crore. The film now trails Secret Superstar (Rs 966 crore), Bajrangi Bhaijaan (Rs 969 crore), Baahubali 2: The Conclusion (Rs 1810 crore) and Dangal, the highest grossing Indian film ever, with Rs 2024 crore. These figures are unadjusted for inflation, of course.

RRR’s success comes at an important time for the Indian box office, particularly in the North. It’s the third hit of the year, following Sanjay Leela Bhansali’s Gangubai Kathiawadi, and the surprise hit The Kashmir Files. Meanwhile, John Abraham-starrer Attack couldn’t make much of an impact at the box office, having been released in the shadow of both RRR and The Kashmir Files. This was also the case with Bachchhan Paandey, starring Akshay Kumar, which was sandwiched between the two blockbusters.

On Saturday, the World Health Organization (WHO) confirmed that it has suspended the supply of Covaxin through UN procurement agencies and recommended to countries that received the vaccine to take actions as “appropriate”.

A look at what the new directive means for this Covid-19 vaccine, developed by the Indian Council of Medical Research (ICMR) and Hyderabad-based Bharat Biotech:

Covaxin, India’s first indigenous vaccine for Covid-19, had got emergency use listing (EUL) from the WHO in November last year. This meant it met the standards set by the WHO for protection against the coronavirus disease. The WHO’s EUL is also a prerequisite for a vaccine to be part of supply under COVAX initiative; the licence thus paved the way for Bharat Biotech to supply Covaxin to UN agencies including through COVAX.

At the time the EUL for Covaxin was granted, however, the WHO had not done an inspection. The inspection of the Bharat Biotech facility was done between March 14 and 22, based on which the WHO has announced that suspension of supply of Covaxin through UN procurement agencies and recommending to countries that received the vaccine “to take actions as appropriate”.

The WHO has said that the data available to it indicate that Covaxin is effective and there is no safety concern. It has, however, asked the company to address deficiencies in good manufacturing practice (GMP). In other words, the WHO has asked Bharat Biotech to upgrade and make specific changes in its manufacturing facilities for Covaxin.

The facilities used to manufacture Covaxin were not specifically designed for a Covid-19 vaccine. When the company received emergency use authorisation from India’s drug regulator, it repurposed its existing facilities, some of which were used for producing a polio virus vaccine, some for a vaccine rabies and some for a Japanese encephalitis vaccine.

Sources said the WHO has asked the company to upgrade facilities specifically for manufacturing a Covid-19 vaccine, in this case Covaxin.

Company sources said that when a facility needs to be upgraded for a specific vaccine, it has to completely shut down. As such, when the company is engaged in active production, it cannot undertake extensive maintenance and upgrade.

Second, the sources said, during the peak of the pandemic, procurement and supply of new equipment required for an upgrade would have taken 15-18 months. “These are not something you can buy off the shelf,” one source said.

Manufacture of a batch of Covaxin takes 120 days from start to finish. Shutdown and upgrade of the facility could have resulted in the loss of almost 6 months. The company could not have shut down its facility only for upgrade because of the urgency to vaccinate the population, the sources said. Therefore, the company, after weighing the risks, chose to start manufacturing Covaxin in a repurposed facility in a manner where the vaccine is safe, they said.

Yes, that is what it will do. On Friday, the company announced a temporary slowing down of production of Covaxin across its manufacturing facilities, having completed its supply obligations to procurement agencies and foreseeing a decrease in demand. The decision was taken because the procurement of Covid-19 vaccines has come down.

S sources said the company has started shutting down the two facilities at Ankleshwar; one facility at the Indian Immunologicals Limited has been closed down; and, except one, all facilities at Hyderabad have been closed down.

The company will now begin maintenance and upgrade activities.

Sources said undertaking an upgrade is a complex process. “Some of the equipment has to be sourced from domestic suppliers and some of it has to be imported. Once you make a change to the facility, it is not as simple as just buying the equipment, installing and starting using it,” a source said.

Once the upgrade is complete, the company has to receive fresh regulatory approval for commercial use of the facility.

Sources said the company is waiting for a detailed report from the WHO, after which the company will start the process of corrective and preventive action (CAPA). These are a set of actions or regulations required in manufacturing, documentation, procedures, or systems to rectify non-conformance. A report on CAPA has to be submitted to both the Indian regulator and the WHO.

“Audits and approvals are part of the regulatory mechanism. Companies do improvement and go back, and undertake and implement CAPA,” a source said.

It does not impact the supply of Covaxin. In the first place, the company has not received any orders from UN agencies, including the GAVI-COVAX facility, to supply Covaxin.

Second, in some 25 countries, Covaxin has been given emergency use authorisation (EUA). In these countries, the company has already fulfilled its supply commitments. Sources said it has not received any fresh orders from these countries.

Again, the company has also stockpiled vaccines required for India’s inoculation drive. Based on that alone, the company in February took a call to slow down production of Covaxin. Sources said, however, that while the company has announced a temporary slowing down of Covaxin production, it has already built an antigen bank. “If the country needs vaccines, we can convert them into vials in a 30-40-day timeline and supply the product,” a source said.

Has the WHO inspected other companies manufacturing Covid-19 vaccines?

Yes, WHO teams have inspected the manufacturing facilities of several companies that have received an EUL. Sources said that in some cases, an inspection was conducted even before the EUL was granted. For some manufacturers, inspections have been conducted on multiple occasions.

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