The WHO directed the Hyderabad-based company to upgrade its facilities to address deficiencies in good manufacturing practices. Bharat Biotech will temporarily slow down Covaxin’s production to focus on the job at hand
The World Health Organisation Saturday suspended the supply of Covaxin, Bharat Biotech’s COVID-19 vaccine through United Nations’ procurement agencies and has recommended nations who have received the vaccine to take “appropriate” action.
The vaccine was granted an emergency use licence in November 2021, ending months of suspense over its fate. But now why has India’s first indigenous vaccine been suspended? And what is Bharat Biotech doing in wake of the move?
The WHO’s new directive
WHO called for a suspension after a post-EUL (emergency use authorisation) inspection held between March 14 and March 22. It asked the Hyderabad-based company to upgrade facilities to address the good manufacturing practice (GMP) deficiencies that it recently identified.
While there will be an interruption in the supply of Covaxin, the risk assessment to date does not indicate a change in the risk-benefit ratio, the WHO said, adding that available data indicate the vaccine is effective and no safety concern exists.
A team of three representatives had inspected a Bharat Biotech plant in Hyderabad for five days last month.
Bharat Biotech’s response
In a statement issued on April 1, Bharat Biotech said it was fully committed to implementing facility improvements and upgrades to ensure that the production of Covaxin meets all global regulatory requirements.
“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,” said the company. It added that as a vaccine manufacturer safety is the primary consideration for any vaccine, and hence safety and efficacy will continue to be of paramount importance.
The upgrade that Bharat Biotech needs
Bharat Biotech will temporarily slow down the production of Covaxin to “focus on pending facility maintenance, process, and facility optimisation activities”, the company said in a statement.
It said upgrades were due as all existing facilities were repurposed for the manufacture of Covaxin, with continuous production during the past year, to meet the public health emergency of COVID-19.
“A lot of the facilities that we manufacture Covaxin and for that matter, any company that’s making COVID vaccines are not designed facilities for COVID vaccines. So these are repurposed facilities. Some facilities were designed for saving Injectable Polio Vaccine, some were for rabies, some were present for Japanese encephalitis – different types of facilities,» top officials from the firm told moneycontrol.
In such cases, he said, some facilities may not be 100 per cent perfect for COVID vaccines manufacturers. However, the company has stressed that the quality of the vaccine was never compromised.
“Certain highly sophisticated equipment which was required to enhance the process stringency were unavailable during the COVID-19 pandemic,” the company statement said.
Bharat Biotech has started shutting down the two facilities at Gujarat’s Ankleshwar; one at the Indian Immunologicals Limited; and, except for one all facilities at Hyderabad have been closed down, reports The Indian Express.
The process to maintain and upgrade will begin as soon as it receives a detailed report from the WHO.
According to The Indian Express report, Bharat Biotech will need to source some equipment from domestic suppliers while some will have to be imported. Once the upgrade is complete, it will need fresh regulatory approvals for commercial use of the facility.
The impact on the supply of Covaxin
Covaxin was granted emergency use authorisation in 25 countries, but the orders at the moment are very limited because of the slowdown in the COVID-19 pandemic. The company has a stock of 20 crore vaccine doses. However, the demand has dropped over the last few months, reports moneycontrol.
Bharat Biotech sources said on Monday that the pharma company has not supplied the COVID-19 vaccine to any UN agency and no impact of the suspension would be felt. Gavi Covax, the international vaccine alliance, has also not placed any orders for Covaxin.
So far, the firm has supplied vaccines to the Indian government and nine countries under the Centre’s Vaccine Maitri programme and has made direct commercial supply under emergency use authorisation.
Bharat Biotech’s past troubles
Bharat Biotech started developing the COVID-19 vaccine soon after the pandemic started in India in 2020. It was selected by the Indian Council of Medical Research for a partnership in the development of this vaccine.
The vaccine came under scrutiny after ICMR directed hospitals chosen for vaccine trials to “fast-track all approvals related to clinical trials” because it wanted to launch the “vaccine for public health use latest by August 15, 2020”.
Vaccine approvals take years and the ICMR seemed to imply that it was ready to clear the vaccine in a month and a half, which raised questions about its safety.
The directive was withdrawn, but when Covaxin was given emergency use authorisation in January 2021 without interim results from phase III trials it raised eyebrows again. Congress leader Shashi Tharoor had called the approval premature.
The Covaxin has not yet had Phase 3 trials. Approval was premature and could be dangerous. @drharshvardhan should please clarify. Its use should be avoided till full trials are over. India can start with the AstraZeneca vaccine in the meantime. https://t.co/H7Gis9UTQb
— Shashi Tharoor (@ShashiTharoor) January 3, 2021
At the time, former health minister Dr Harsh Vardhan had backed the decision. “…COVAXIN based on whole inactivated virus has other antigenic epitopes in addition to spike protein So, it’s likely to have similar protective efficacy reported for others (sic),” he had tweeted.
Vaccines approved globally based on gene encoding spike proteins have protective efficacy of over 90%
However, COVAXIN based on whole inactivated virus has other antigenic epitopes in addition to spike protein
So,it’s likely to have similar protective efficacy reported for others pic.twitter.com/AOIONrxZcd
— Dr Harsh Vardhan (@drharshvardhan) January 3, 2021
However, when the vaccine was finally made available it did well. Its safety and efficacy are at par with other vaccines available in India.
According to government data published in September 2021, when 65.28 crore doses were administered across the country, Covaxin accounted for 12.1 per cent. Nearly 88 per cent were Covishield shots, data from the CoWIN portal revealed.
With inputs from agencies