Top sources in Bharat Biotech, the Hyderabad-based maker of COVID-19 vaccine Covaxin, have said that the company did not supply the vaccine to any of the UN health agencies so far.
The sources also said that as its facilities having been used in Covaxin production were repurposed ones, some of them will be upgraded and modified for exclusively making vaccines against coronavirus.
This comes two days after the World Health Organization (WHO) announced to stop procuring the vaccine from the manufacturer citing deficiencies in the good manufacturing processes.
A team of three representatives had inspected the Bharat Biotech plant in Hyderabad for five days last month.
Covaxin has been granted emergency use authorisation in twenty five countries so far but the company says that the orders at the moment are very limited due to the slowdown in the COVID-19 pandemic everywhere.
It also said that 20 crore of the vaccine doses, demand for which has dropped considerably, are in stock as of now.
"After we got India licensure, we applied for WHO authorisation and we got that. The intent for this is to supply to UN agencies, which is UNICEF, Pan American Health Organization (PAHO), and the Global Alliance for Vaccines and Immunization's COVAX facility," said the executive.
"However, we have not received any orders till date from any of the UN agencies. So, we've not made any supplies so far. So we only supplied to the Government of India, and other countries, quite a few other countries. But all these supplies were based on emergency use authorisations that were received from those countries also."
The company sources emphasised that it had committed to upgrading some of its facilities exclusively for Covaxin production.
"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( IPV), some were for rabies, some were present for Japanese encephalitis – different types of facilities," said the top officials.
In such cases, he said, some facilities may not be 100 percent perfect for COVID vaccines manufacturers.
"So we are committing that in facilities where we are going to make COVID19 vaccines, it will be perfectly designed for manufacturing Covaxin. So those are the facility upgrades," he said.
A day before the WHO advisory the company had issued a statement saying it was slowing down Covaxin production for maintenance of facilities and upgradation.
"We have started doing that since the month of February. Because as we have put out statements in the past – our manufacturing takes about 120 days, from start to finish, it's not something that happens overnight," the executive also said.
In some plants where Covaxin is being produced, according to company executives, there will be a facility upgrade while in others there will be the procurement of new equipment.
" The new orders on equipment take 12 months or 15 months or 18 months and if a filling line is to be ordered, it makes up to 34 months," said a senior executive in Bharat Biotech.
The company sources however also stressed that an antigen bank has been built and if the country needs it, it can be converted within a 30 to a 45-day timeline.
"We have covered at least all the basis from our perspective – we have product available, we have bulk available, we have facilities available, but – for the last 15 months or so we have not been able to take shut down in some of these facilities which are required for upgradation or maintenance", the executive said.
Very low supplies of Covaxin have gone out of the country so far and most of the vaccine doses that are being supplied outside are through the Centre's COVID-19 vaccine Maitri programme.
Sources in the vaccine maker said that Other than what it has supplied outside India, it has not received any repeat orders.
The amount of procurement of COVID-19 vaccine has come down internationally, they said adding that mostly it is all donations by the US and European countries that are going into African countries, but there is a massive slump in independent procurement and supplies.
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