Context: World Health Organization (WHO) confirmed that it has suspended the supply of Covaxin through UN procurement agencies.
It also recommended to countries that received the vaccine to take actions as “appropriate”.
Why has the WHO taken this step now?
Covaxin, India’s first indigenous vaccine for Covid-19, had got emergency use listing (EUL) from the WHO in November 2021.
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.
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, 2022 based on which the WHO has announced that suspension of supply of Covaxin through UN procurement agencies.
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.
In some cases, an inspection was conducted even before the EUL was granted. For some manufacturers, inspections have been conducted on multiple occasions.
What did the WHO inspection of COVAXIN facility 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?
Company 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, 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. 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.
Can the company shut down and upgrade the facilities now?
Yes, that is what it will do.
The company announced a temporary slowing down of production of Covaxin across its manufacturing facilities, having completed its supply obligations.
The decision was taken because the procurement of Covid-19 vaccines has come down.
The company will now begin maintenance and upgrade activities.
Once the upgrade is complete, the company has to receive fresh regulatory approval for commercial use of the facility.
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. Also 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, the company in February took a call to slow down production of Covaxin.
However, the company has already built an antigen bank. If the country needs vaccines, it can convert them into vials in a 30-40-day timeline and supply the product.
