Bharat Biotech, which is scrambling to raise production of COVID-19 vaccine Covaxin, is possibly lagging behind the anticipated pace of scale up, as testing, quality control and upgradation of facilities that were used for other products takes time, sources told Moneycontrol.
Bharat Biotech is currently manufacturing Covaxin at four facilities in India, including repurposed sites at Malur, Karnataka and Ankileshwar, Gujarat. The company has earlier said further expansion is in process to reach the capacity of 1 billion doses a year by the end of 2021.
Bharat Biotech had indicated that it would continue to produce 25 million doses of Covaxin until August-September, and subsequently raise it to 60-70 million doses per month .
Bharat Biotech had not respond to queries on its current capacity and delays at the time of publishing this story.
The government has so far bought 85 million doses of Covaxin and placed advance orders for another 190 million doses to be supplied between August and December.
The Centre’s affidavit in the Supreme Court on June 26 said the company supplied 28 million doses to the government until June 12, a fraction of the total purchase order of 85 million. In the same affidavit, the Centre, which was projecting availability of 2.16 billion COVID-19 vaccine doses from August to December, has tapered down its estimates by 38 percent to 1.35 billion doses. It is now expecting only 400 million doses of Covaxin in August-December, lower than its earlier estimate of 550 million doses
States and private hospitals are seeing erratic supply of COVID-19 vaccines, which is impacting their planned vaccination drives.
"Production isn't as much as it should have been. there is depletion at the source, complicated at distribution level," said Dr Alok Roy, Chairman of Kolkata-based Medica Superspecialty Hospital. Roy is also the chair of the FICCI Health Services Committee.
Scaling up issues
Currently, Covaxin is produced mainly from Bharat Biotech’s Genome Valley facilities on the outskirts of Hyderabad, which has a capacity to produce about 10-12 million doses per month. The Malur facility in Karnataka, which was repurposed to produce 30 million doses in July and 50 million by August, is yet to see significant ramp up.
The Malur site has a capacity to manufacture about 10,000 kilolitres (KL) of Covaxin drug substance annually, and will be the biggest production site for the company.
The Malur facility, owned by Bharat Biotech's sister concern Biovet, was originally meant to make animal vaccines -- more specifically, Foot & Mouth Disease vaccine. The site was repurposed for manufacturing Covaxin, with multiple production lines. Ankileshwar on other hand manufactures Rabies vaccine and is being used to produce Covaxin. This site can make about 200 million doses of Covaxin.
A person who didn't want to be named told Moneycontrol that the delay could be due to the manufacturing complexity and testing requirements.
"The first batch will take about 3-4 months to release, but thereafter the production gathers pace, as more batches will go into production. Vaccine manufacturing may take two weeks, but testing requires about two months. One month internal testing and another month for the clearance of Central Drugs Laboratory (CDL), Kasauli in Himachal Pradesh.
The testing is done to ensure quality checks, to see whether the vaccine has the desired quantity of inactivated virus, and whether it is producing antibodies.
Every batch of vaccine produced in India will have to be cleared by CDL Kasauli. There could be some relaxations for old and well established vaccines, but for the new ones and those produced at new or repurposed facilities - the testing will be stringent, the executive said.
"Repurposing FMD vaccine facility isn't the same as repurposing a Rabies vaccine. While both the vaccines are based on inactivated platform, Rabies vaccine is just one stage lower compared to producing Covaxin. FMD vaccine on other hand is several notches down in terms of purification stages required," the executive said, explaining the possible reasons for the delay.
The three PSUs contracted to manufacture Covaxin drug substance - Haffkine Biopharmaceutical Corporation Ltd, Indian Immunologicals Ltd (IIL), Hyderabad, and Bharat Immunologicals & Biologicals Ltd, Bulandshahar, Uttar Pradesh.
Sources told Moneycontrol that IIL is expected to rollout Covaxin drug substance by July, the others may take beyond October-November.