Why the WHO suspended Covaxin

The World Health Organization (WHO) has recently suspended the supply of Covaxin through UN procurement agencies and has recommended to countries that have received the vaccine to take appropriate actions.

Status so far

• Covaxin, India’s first indigenous vaccine for Covid-19, had got emergency use listing (EUL) from the WHO last year.
• This means that Covaxin had met the standards set by the WHO for protection against the coronavirus disease.
• The WHO’s EUL is a prerequisite for a vaccine to be part of supply under COVAX initiative and thus the licence paved the way for Bharat Biotech to supply Covaxin to UN agencies including through COVAX.
• However, at the time the EUL for Covaxin was granted, the WHO had not done any inspection.

Observation by WHO

• Covaxin is effective and there is no safety concern.
• However, WHO has asked the company to address deficiencies in good manufacturing practice (GMP) which is basically upgradation and making specific changes in its manufacturing facilities for Covaxin.
• The necessary upgrades: When the company received emergency use authorisation from India’s drug regulator, it repurposed its existing facilities, some of which were used for producing vaccines for a polio, rabies and Japanese encephalitis vaccine.
• This indicates the absence of a specifically designed facility for Covid-19 vaccine production.

Issues with Upgradation

• Requirement of complete shutdown: When a facility needs to be upgraded for a specific vaccine, it has to completely shut down and given that the company is engaged in active production, it cannot undertake extensive maintenance and upgrade.
• Procurement of new equipment: During the peak of the pandemic, procurement and supply of new equipment required for an upgrade would have been both time consuming and not economical.
• 120 day manufacturing time: Since the manufacture of a batch of Covaxin takes 120 days from start to finish, shutting down and upgradation of the facility could have resulted in the loss of almost 6 months.
• Urgency to vaccinate the population: There was acute urgency to vaccinate the population, weighing the risk of which the company had chosen to start manufacturing Covaxin in a repurposed facility in a manner where the vaccine is safe.

Process of Upgradation

• The process of upgrading is complex.
• Some of the equipment has to be sourced from domestic suppliers and some to be imported.
• Once the upgrade is complete, the company has to receive fresh regulatory approval for commercial use of the facility.
• The Company/firm has to undergo the process of corrective and preventive action (CAPA) which 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.

How it impacts global Covaxin supply

• In around 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.
• 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

Exam Track

Prelims Take Away

• WHO
• EUA
• CAPA
• Covaxin