The World Health Organization (WHO) announced on Saturday that it has halted the distribution of the COVID-19 vaccine Covaxin, manufactured by India’s Bharat Biotech, through United Nations agencies to allow the manufacturer to upgrade facilities and address deficiencies discovered during an inspection.
According to the statement, the WHO asked countries that had received the vaccine to take appropriate actions, but did not specify what those actions should be.
Moreover, the WHO is “confirming the suspension of supply of Covaxin produced by Bharat Biotech, through UN procurement agencies, and recommending to countries that received the vaccine take appropriate actions,” according to the organisation.
However, the vaccine is effective, and there are no safety concerns, according to the WHO, but the suspension of export production will cause the Covaxin supply to be disrupted.
Further, it said the suspension is in response to the findings of a WHO post-emergency use listing (EUL) inspection that took place from March 14 to 22, and that the vaccine maker has committed to suspending the Covaxin export production.
Meanwhile, in a statement released Bharat Biotech said there is “no impact on the efficacy and safety of the COVID-19 vaccine Covaxin.” “For the millions who have received Covaxin, the vaccine certificates issued still stand valid as there is no impact on efficacy and safety of the vaccine,” Bharat Biotech said in the statement.
“Notwithstanding this excellent safety and efficacy record, Bharat Biotech is diligently working to further improvements and upgrades to ensure that the production of Covaxin continues to meet ever-increasing global regulatory requirements. Since patient safety is the primary consideration for any new vaccine, there can be no compromises in meeting operational excellence objectives,” Bharat Biotech said.
Bharat Biotech has announced that it is slowing down Covaxin production in order to improve facility efficiency. “For the coming period, the company will focus on pending facility maintenance, process and facility optimization activities,”
Moreover, the company has “committed to complying by addressing GMP (good manufacturing practise) deficiencies and is developing a corrective and preventive action plan for submission to the Drugs Controller General of India (DCGI) and WHO,” according to the WHO.
In the meantime, Bharat Biotech has stated that it will stop producing Covaxin for export as a precautionary measure. The WHO also stated that the risk assessment shows no change in the risk-benefit ratio.
WHO’s risk assessment is based on the global distribution of hundreds of millions of doses of Covaxin, during which time the product has demonstrated an excellent safety and efficacy profile in extensive post-marketing surveillance.
“The data indicate the vaccine is effective and no safety concern exists,” WHO stated. Bharat Biotech said in a statement on April 1 that it is fully committed to implementing facility improvements and upgrades to ensure that Covaxin production meets global regulatory requirements.
Covaxin, India’s Indigenous COVID 19 vaccine
Bharat Biotech developed COVAXIN®, India’s indigenous COVID-19 vaccine, in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).
Moreover, Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high containment facility develops and manufactures the indigenous, inactivated vaccine.
However, the vaccine is being developed on a platform derived from Whole-Virion Inactivated Vero Cells. Because inactivated vaccines do not replicate, they are unlikely to revert and cause disease. They contain dead viruses that are unable to infect humans but can still instruct the immune system to mount a defensive response in the face of infection.
Why are inactivated vaccines being developed?
Inactivated vaccines have been around for decades in the traditional sense. Seasonal influenza vaccines, polio vaccines, pertussis vaccines, rabies vaccines, and Japanese encephalitis vaccines all use the same technology to develop inactivated vaccines with a safe track record of over 300 million doses of supplies to date. In the world of vaccine technology, it is the most well-known and time-tested platform.