Ease of international travel for Indians and export of the vaccine will be some of the benefits of a WHO approval to Bharat Biotech’s Covid-19 vaccine dubbed Covaxin. According to reports, the international health body is likely to give its approval to the jab this week.
Covaxin, and Covishield – the AstraZeneca Covid-19 vaccine manufactured by the Serum Institute of India – had been the two jabs India had started its vaccine drive with in January 16 this year. While Covishield has WHO’s nod, Covaxin is yet to receive the same, making international travel a difficulty for many who have received the homegrown jab.
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Why Hasn’t Covaxin Been Approved Yet?
The WHO approval procedure for a vaccine consists of four steps: acceptance of the manufacturer’s expression of interest (EOI), a pre-submission meeting between WHO and the manufacturer, acceptance of the dossier for evaluation by WHO, decision on status of assessment, and final approval decision.
Bharat Biotech submitted an emergency use listing (EUL) application to the World Health Organization (WHO)-Geneva in May. On June 23, WHO held a pre-submission meeting with Bharat Biotech. A senior official at the Hyderabad-based pharma company was quoted as saying by Times of India that once Bharat Biotech submits the entire Covaxin Phase-3 clinical trials data, the dossier will be complete and taken up for review by the health body. The official had said the company expects the review process for the EUL application of Covaxin to be taken up in July post submission of the efficacy study data.
Business Today in a report on September 1 had said a WHO panel would convene in the week to assess Covaxin’s application for emergency use listing, which will allow persons immunised with Bharat Biotech’s vaccine to travel freely. The WHO panel will evaluate Covaxin’s immunogenicity, vaccine safety, and vaccine effectiveness, the report had said. The homegrown company had submitted its Phase 3 clinical trials data that demonstrated 77.8 per cent efficacy to the subject expert committee of the Central Drugs Standard Control Organisation (CDSCO).
“All documents required for emergency use listing (EUL) of Covaxin have been submitted to WHO as of July 9. The review process has now commenced with the expectation that we will receive EUL from the WHO at the earliest,” Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech had earlier said.
‘Insufficient Information’: The US Food and Drug Administration had also earlier declined to approve Covaxin. The FDA has stated that there is “insufficient information” on Covaxin to issue its emergency use authorization request for this vaccine.
Ocugen, Bharat Biotech’s US partner, has stated that the company will now pursue complete approval for Covaxin. The FDA has urged the company to conduct an additional trial so that it can file for a Biologics Licence Application (BLA), which is a full approval.
International Travel Ease
World travel restrictions have gradually lifted according to Covid case loads in various countries. Recently, the UAE lifted its restrictions on entry for fully vaccinated residents from a number of countries including India.
While some countries – Guyana, Iran, Mauritius, Mexico, Nepal, Paraguay, Philippines, Zimbabwe, Estonia (which has approved the jab for its vaccine passport) – have approved Covaxin, WHO’s nod would help ease restrictions in the rest of the world and ease travel for those Indians who wish to travel due to education, work, or other personal purposes.
Export Facilitation, Vaccines to Developing Nations
An emergency use approval is likely to encourage countries to import Covaxin, facilitate its manufacturing abroad and ease travel for those vaccinated with it. The emergency listing will also mean that Covaxin can be used to Covax, the global vaccine alliance, later to vaccinate people in many developing countries.
Hungary and Paraguay had earlier approached New Delhi about exporting 1 million doses of Covaxin, with the first offering access to the EU.
Decisions on exports are commercial in nature and must be made by Bharat Biotech. Bharat Biotech stated in February that it has reached a deal with Ocugen Inc, allowing the US-based biopharmaceutical company to co-develop, supply, and commercialise the Indian vaccine maker’s Covid-19 vaccine Covaxin in the US market.
A Hindustan Times report had quoted an official as saying that the government 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,” they said.
“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 report quoted them as saying.
In the most latest development on the matter, Covaxin received Good Manufacturing Practices (GMP) compliance certificate from Hungary in August.
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