Why WHO suspended Covaxin?

Context:

Recently, 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”.

Relevance:

GS II- Health

Dimensions of the Article

1. Why has the WHO taken this step now?
2. What did the WHO inspection find?
3. Why did the company not upgrade its facility specifically for Covaxin earlier?
4. How does the order impact the supply of Covaxin?

Why has the WHO taken this step now?

• In November of last year, the WHO granted Covaxin, India’s first indigenous vaccine for Covid-19, an emergency use listing (EUL).
• This means it met the World Health Organization’s (WHO) requirements for coronavirus protection.
• The WHO’s EUL is also required for a vaccine to be included in the COVAX supply chain; hence, Bharat Biotech was able to supply Covaxin to UN agencies, including through COVAX.
• The WHO had not conducted an inspection at the time the EUL for Covaxin was granted.
• Following a recent examination of the Bharat Biotech plant, the WHO has announced the suspension of Covaxin supply through UN procurement agencies, as well as advising countries that have received the vaccine “to take actions as appropriate”.

What did the WHO inspection find?

• 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.

What are these upgrades?

• 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.

Why did the company not upgrade its facility specifically for Covaxin earlier?

• 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.
• During the peak of the pandemic, procurement and supply of new equipment required for an upgrade would have taken 15-18 months.
• 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

Can the company shut down and upgrade the facilities now?

• 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.

How does the order impact the supply of Covaxin?

• 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.

-Source: Indian Express