So far, the company has supplied COVID-19 vaccines to the Government of India and around nine countries under the Vaccine Friendship Program of the Central Government, and direct commercial supplies under emergency use authorization, according to one. PTI report good.
The WHO suspension of India Biotech Supplies of Covaxin is not related to safety or efficacy issues, but only to UN agencies to supply.
The WHO suspension of Covaxin supply is for UN agencies only.
Bharat Biotech’s Covaxin has received emergency use approvals from more than 25 countries.
“After we got an emergency license in India, we applied for the EUL with the WHO and we got that too. The EUL was intended to supply vaccines to UN agencies like UNICEF, PAHO and the GAVI Covax facility.
“But we have not received any order from any UN agency till date. So we haven’t made any supplies yet. We have supplied vaccines only to the Indian government and a few other countries, but all these supplies were based on the EU received from those countries,” a company source told PTI.
The international vaccine alliance, Gavi Kovax, has also not placed any orders for Covaxin, the source reiterated.
“Our vaccine certificates are valid and there will be no disruption of supply in India,” a source said, emphasizing that “the WHO itself has already said that there is no impact on quality and safety”.
The World Health Organization (WHO) on April 2 confirmed the suspension of the supply of Covaxin through UN procurement agencies, citing deficiencies in good manufacturing practices (GMP) and recommending countries that have taken appropriate action. received the vaccine for
In a statement, WHO had said that this suspension is in response to the outcome of the WHO Post Emergency Use Listing (EUL) inspection and the need for process and facility upgrades to address the recently identified GMP deficiencies.
On facility upgrades, company sources said on Monday that many of these facilities where Covaxin is being made were not specifically designed to manufacture the COVID-19 vaccine.
These are renovated facilities that already existed for the manufacture of other vaccines. “Facility designs are not 100 percent perfect for manufacturing COVID vaccines.
“We have made a commitment to WHO that any facility we manufacture covaxin in the future will be designed entirely to manufacture covaxin. These are facility upgrades that we are bringing in.” In some places it will be facility upgradation while in some places it will be purchase of equipment.
“Our vaccine certificates are valid and there will be no interruption in supply in India. They (WHO) have just given a global advice, countries have to decide what to do.”
WHO officials inspected the BB facility during 14-22 March.
It was not a surprise visit, sources said, adding that no inspection was conducted before the EUL was approved and the WHO audit focused on Covaxin.
Responding to a question, the source said that once all the facilities are upgraded “we will apply to the WHO for a full license for Covaxin”.
Responding to a question, sources said any regulatory audit and approvals in the pharma world or in the vaccine sector are part of the process.
“We have received some feedback. We will continue to require facility modifications and maintenance and upgrades. These are minor issues and we do not see them as final or punitive issues,” the source said.
“The feedback or observations we have received are not harmful to future products. WHO itself has already stated that there is no impact on quality and safety,” the source said.
When asked about the possible cost escalation, the source said it would be in the tens of crores of rupees.
Bharat Biotech issued a statement on April 1 announcing the temporary slowing down of Covaxin production at its manufacturing facilities, the source said, adding that the facilities did not have a 15-month break due to production pressures.
“We had decided that depending on the orders we have received, we will decline sometime in the month of January or February.
“If we produce at the same rate that we are doing at the high rate of 80 million, we will have so much stock and product available that no one else is going to take it from us,” the source said.
“Plus, once we turn it into a vial, the shelf life starts over. We’ve already started turning those features off or on.”
Sources said the firm has enough pharmaceutical substances (available in bulk) and has also created an antigen bank.
“If the country requires it, we can convert it in 30-45 days’ time and we can supply the product.”
“We had two facilities in Ankleshwar and we have gradually closed them. We were manufacturing at Indian Immunologicals and that too has stopped. Here on campus, right now there’s only one facility that’s really making coxwins. The rest have been closed.”
“Due to all the production pressure, we were not able to operate these activities in the frequency that we want to do it and now it is time, there is a reduction in procurement. We can take those breaks now,” the source said.
Responding to a question on the nasal vaccine, the company source said that the Phase-III trial is underway and it will have data in four months as it is a very complex trial.
“After analyzing the data, we will decide whether we should go for additional tests or apply for a licence,” the source said.
WHO had said that India Biotech is committed to address the shortcomings of GMP and is developing a corrective and preventive action plan to be submitted to the DCGI of India and the Drugs Controller General of WHO.
As an interim and precautionary measure, India has indicated its commitment to suspend its production of Covaxin for export, the WHO had said.
The WHO said that the risk assessment so far does not indicate a change in the risk-benefit ratio. The data available with WHO suggests that the vaccine is effective and that no safety concerns exist.
Bharat Biotech also said that the WHO announcement will not affect the OcuGen trials. Ocugen had entered into an agreement with Bharat Biotech to develop, supply and commercialize Covaxin for the US market.
“We just got approval for a clinical trial. So we’re going to do clinical trials in adults and then in children in the US. It’s a long process.
“We are not looking to sell accelerated EUA and some products in the US for a short time. That is not our strategy. Our strategy is long term. We want to get Covaxin approved as a licensed vaccine in the US, EUL No,” said the source.
The FDA has approved Covaxin’s application for phase 2-3 adult clinical trials.
Bharat Biotech touched its annual maximum capacity of 1 billion for Covaxin last month.
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