India’s Bharat Biotech intends to provide additional documentation needed for WHO’s emergency use listing of the Covaxin vaccine by June and is in final negotiations with American authorities for conducting small-scale phase III clinical trials in the US.
The status of the application for emergency use listing of Covaxin by the World Health Organization (WHO) was assessed at a virtual meeting on Monday that was joined by foreign secretary Harsh Shringla, senior officials of the health ministry and Bharat Biotech managing director V Krishna Mohan.
WHO’s latest update on emergency use listing (EUL) of Covid-19 vaccines, issued on May 18, shows Bharat Biotech submitted an expression of interest for EUL on April 19. The UN’s health agency sought more information from Bharat Biotech following the submission.
“On the issue of WHO’s authorisation of EUL for Covaxin, Bharat Biotech officials noted that the company had submitted 90% of documentation required to WHO. The remaining is expected to be submitted in June,” a person familiar with developments said on condition of anonymity.
Bharat Biotech is “confident about obtaining EUL, given its experience of getting its other vaccines pre-qualified by WHO,” the person added.
{{/usCountry}}Bharat Biotech is “confident about obtaining EUL, given its experience of getting its other vaccines pre-qualified by WHO,” the person added.
{{/usCountry}}The Hyderabad-based biotechnology company is in the final stages of negotiations with the US Food and Drug Administration (FDA) to conduct small-scale phase III clinical trials of Covaxin in the US, people familiar with developments said.
Covaxin, billed as the first indigenous Covid-19 vaccine, was developed by Bharat Biotech in collaboration with the National Institute of Virology (NIV) under the Indian Council of Medical Research (ICMR).
WHO’s emergency use listing will allow countries to expedite regulatory approvals for Covaxin and also make the vaccine eligible for supply to the WHO-backed COVAX facility, which was set up to distribute vaccines to low and middle-income nations.
The external affairs and health ministries are playing key roles in facilitating the EUL of Covaxin. A total of 19 firms from around the world have sought EUL for their vaccines from WHO, and the listing has been finalised for seven applicants, including the Serum Institute of India (SII) which manufactures the AstraZeneca vaccine with the brand name Covishield.
The matter has gained urgency after several countries, especially the 27 members of the European Union, announced they would allow the entry of fully vaccinated travellers. While the AstraZeneca vaccine is among those approved by these countries, Covaxin doesn’t figure on their list.
“It is important to note that no country has instituted a vaccine passport. Countries have their own requirements for approval, which in most cases involves travel by carrying a negative RT-PCR report,” a second person said.
Monday’s meeting was also informed that Covaxin has received regulatory approval in 11 countries. Eleven companies from seven countries have shown interest in technology transfers for the production of Covaxin, the people cited above said.
India has so far supplied Covaxin under its Vaccine Maitri initiative, either as grants or commercial sales, to Myanmar (200,000 doses), Mauritius (200,000 doses), Iran (125,000 doses), Paraguay (200,000 doses), and Zimbabwe (35,000 doses). However, there have been no exports of Covaxin since March and the people said supplies to foreign countries were unlikely in the immediate future.
Bharat Biotech is currently in the final stages of submitting documents for Covaxin’s regulatory approval in Brazil and Hungary, and the firm has held extensive consultations with both countries. The firm has also said that all regulatory approvals have “retrospective and prospective effect”, the people said.
“Bharat Biotech is in regular touch with regulatory authorities in several countries, and it is confident about the robustness of its dossier as it has data for anti-body persistence after six months as well as eight months,” the second person said.