India may firm up plans to export Bharat Biotech’s Covaxin

New Delhi: India has received enquiries from other countries for the export of the indigenous Covid 19 vaccine Covaxin jointly developed by Bharat Biotech and ICMR, according to government officials aware of the development

New Delhi: India has received enquiries from other countries for the export of the indigenous Covid 19 vaccine Covaxin jointly developed by Bharat Biotech and the Indian Council of Medical Research (ICMR), according to government officials aware of the development.

A health worker prepares a dose of Covaxin (Arvind Yadav/HT PHOTO)

New Delhi has been approached by at least two countries, Hungary and Paraguay for the commercial export of 1 million doses of Covaxin, with the first holding forth the possibility of access to the EU.

To be sure, decisions on exprts are commercial ones that will have to be taken by Bharat Biotech. In February Bharat Biotech announced that it has signed a pact with Ocugen Inc, allowing the US-based biopharmaceutical firm to co-develop, supply, and commercialize the Indian vaccine maker’s Covid-19 vaccine Covaxin in the US market.

According to the Union government’s affidavit in the Supreme Court, in May, Bharat Biotech has increased its capacity from 9 million to 20 million a month now, which will increase to 55 million units by July 2021. according to the government’s latest vaccine policy, half of these will be sold to the Centre and the other half to the states and private hospitals.

“The govt of Hungary approached the government in mid- April for supply of 1 million doses for Covaxin by around May end on priority. It was also informed that they would grant EU Good manufacturing practice (GMP) certification to Bharat Biotech facilities that would also open India’s vaccine exports to the wider EU markets if the government would consider supplying the 1 million doses. This would not only open up India vaccine exports to the wider EU market (as certification granted by Hungary would be recognized in EU) in future but may also facilitate BBT’s negotiations with Brazil and other markets that they may be exploring as well…,” one of the officials said on condition of anonymity.

“The Covaxin samples received from Bharat Biotech had already been approved by the National Institute of Pharmacy and Nutrition and the Hungarian National Drug Authority. We were informed that the expert team that visited India last month to audit BBT facilities had also returned and given its report. They were ready to grant emergency use authorization for Covaxin. It was also noted that certain issues were found during the expert team’s visit to BBT facilities. The Brazilian team that had visited BBT around the same time had also flagged these issues... ,” the official added.

In March Brazilian health regulator Anvisa denied permission to import Bharat Biotech’s COVID-19 vaccine Covaxin into the country after its authorities found that the plant in which the vaccine is being made did not meet the Current Good Manufacturing Practice (CGMP) requirements. Bharat Biotech in February said it had signed an agreement with the Brazilian government for supply of 20 million doses of Covaxin during the second and third quarters of the current year. The vaccine maker then said: “the requirements pointed out during inspection will be fulfilled,” and that the timelines for fulfilment were under discussion with the Brazil NRA and will be resolved soon.’’

Bharat Biotech did not respond to a detailed questionnaire sent on May 12.

The government has also been approached for commercial contracts for Covaxin by Paraguay, according to a second official. According to the external affair ministry’s Vaccine Maitri portal. Paraguay has thus far received 2 lakh doses of vaccines as a gift.

“ They (Paraguay) have thanked Prime Minister Modi for gifting the vaccines under its vaccine Maitri initiative. We were informed last month that negotiations were on between Paraguay, which is looking to sign a contract with Bharat Biotech for procurement million doses of Covaxin,” the second official added. A third official from the external affairs ministry confirmed this.

On May 1 HT reported that Centre is also exploring the possibility of offering the locally developed coronavirus vaccine, Covaxin for production abroad through a technology transfer between commercial entities, according to government officials aware of the development.

India’s indigenous vaccine, Covaxin is developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high containment facility.

In a statement issued on April 20, Bharat Biotech said it was exploring manufacturing partnerships with partners in other countries, who have prior expertise with commercial scale manufacture of inactivated viral vaccines under biosafety containment.

The company also said Covaxin has received Emergency Use Authorisation in several countries across the globe with another 60 in process. It has been granted EUAs in Mexico, Philippines, Iran, Paraguay, Guatemala, Nicaragua, Guyana, Venezuela, Botswana, Zimbabwe, among several other countries. It is in the process of getting EUAs in the US and Europe, according to Bharat Biotech.

Earlier this month, a joint statement on the India- EU leaders’ meeting said: “Recognising the role of extensive immunisation as a global public good and concurring that the vaccination process is not a race amongst countries but a race against time, we welcomed the EU’s and its Member States’ contribution to vaccines’ production and their substantial support to the COVAX Facility, as well as India’s efforts to produce and distribute COVID-19 vaccines to over 90 countries through its ‘Vaccine Maitri’...We are committed to working together to better prepare for and respond to global health emergencies. We agreed to cooperate on resilient medical supply chains, vaccines and the Active Pharmaceutical Ingredients (APIs), and on the application of international good manufacturing standards to ensure high quality and safety of products.”