On April 02, the World Health Organisation (WHO) officially announced the suspension of the supply of Covaxin through the United Nations procurement agencies. Hailed as India’s first indigenous vaccine against COVID-19, Covaxin is produced by Bharat Biotech India Limited (BBIL) in collaboration with the apex research institute – the Indian Council of Medical Research.
The WHO has stated that “The suspension is in response to the outcome of a WHO inspection on 14 – 22 March 2022, and the need to conduct process and facility upgrade to address recently identified deficiencies in good manufacturing practices (GMP)”.
This development, however, might have dampened the spirits, especially when a few days ago, on March 28, the founders of BBIL were conferred with India’s third Highest Civilian Award, Padma Bhushan.
A day earlier, BBIL had announced that “having completed its supply obligations to procurement agencies and foreseeing the decrease in demand”, it is temporarily slowing down the production of Covaxin.
GMP is the quality assurance aspect that ensures that medicinal products are consistently produced and controlled to appropriate quality standards. As per WHO, GMP defines quality measures for both production and quality control and defines general measures to ensure that processes necessary for production and testing are clearly defined, validated, reviewed, and documented, and that the personnel, premises and materials are suitable for the production of pharmaceuticals and biologicals including vaccines. It also has legal components, covering responsibilities for distribution, contract manufacturing and testing, and responses to product defects and complaints.
In the case of Covaxin, although the WHO has stated that the risk assessment does not indicate change in the risk-benefit ratio and that the data shows the vaccine is effective and no safety concerns exist, it recommended that countries using the vaccine take action as appropriate.
In its response letter on Twitter, BBIL has stated that “facility maintenance, process and facility optimisation activities” were pending as all its facilities were repurposed towards COVID-19 emergency. It said that it will focus on these upgrades now and execute the planned improvement activities “as soon as practical”.
After clearing the WHO EUL/PQ evaluation process and getting approval from the WHO on November 3, 2021, the Indian government reportedly used diplomatic channels to get more country approvals for Covaxin. As per data from the UNICEF Market Dashboard, to date, there are about 15 countries that have approved the use of Covaxin. These include Comoros, Central African Republic, Ethiopia, Mauritius, Paraguay, Philippines, Botswana, Iran, Bahrain, Nepal, Zimbabwe, Mexico, Vietnam, and Malaysia and Oman being the latest ones to give approval in March 2022.
Responding to the issue, Leena Menghaney, South Asia Head for Médecins Sans Frontières (MSF) Access Campaign, explains that “The WHO pre-qualification system is like a regulatory body for developing countries, particularly low-income countries, which do not have the capacity to evaluate vaccines and medicines produced in other jurisdictions. To do a GMP inspection and ask for corrections is routine. There are GMP issues arising regularly in the pharma and bio-pharma sector. In fact, if a regulatory body is doing a GMP audit it should automatically be used by other regulatory bodies, including the Indian CDCSO. Quality assurance is partly technical but also people’s perception towards a product. Hence, BBIL should address this immediately in the domestic context and for exports."
NewsClick has sent an email to BBIL seeking answers to a few questions on the issue, but there was no response till the publication of this article.
Covaxin Controversy More Than Once
Earlier in March 2021, much before the WHO grant of EUL, BBIL’s Covaxin had hit a rough patch when Brazil rejected the lot and accused BBIL of irregularities in the contract and lobbying. The scandal became known as “Covaxingate” in Brazil, and the contract was eventually terminated. Nothing much has come out from official sources regarding the entire controversy.
“There were some issues earlier also regarding Covaxin, but now the WHO has told us that Bharat Biotech was not following the "Good Manufacturing Practices". This observation by the WHO can have implications for India’s vaccine programme in the future unless the government takes urgent steps to ensure that Bharat Biotech conforms to all the GMP requirements at the earliest. Several commentators have argued that India can not only export Covaxin, but can also forge joint ventures with manufacturers in other countries," opines Prof. Biswajit Dhar, Faculty, Jawaharlal Nehru University.
He further points out, “There is still a substantial proportion of the population, both in India and other developing countries, who are yet to be fully vaccinated. The Indian government will now have the task of convincing all concerned about the safety and efficacy of Covaxin. The government needs to instil confidence in people. And to assure them that Bharat Biotech needs to address only procedural issues and that the product is absolutely safe.”
In India, the safety concerns are all the more important because, as per the guidelines, only Covaxin is being administered to persons aged 15-18 years. In addition, the adults who have been administered with 2-doses of Covaxin are also being administered with Covaxin as the booster dose.
As of April 07, of nearly 99 million people in the age group of 15-18 years, about 39 million are fully vaccinated, and 18 million have got only the first dose. There is a substantial proportion that still needs to be vaccinated. The question is, given the WHO suspension, will further vaccination of this age group using Covaxin be stopped in India?
Several questions still remain unanswered. To ward off any doubts or fears that might crop up among people regarding the safety of the vaccine, both domestically and in the countries where Covaxin is being used, the Indian government and BBIL need to be transparent. They need to keep things in the public domain and regularly communicate the developments, and correct the deficiencies pointed out by the WHO at the earliest.
