The WHO has not given Emergency Use Listing (EUL) status to India's homegrown Covaxin, manufactured by Bharat Biotech, or Russia's Sputnik V, which are both permitted for use in the country.
Bharat Biotech started the process of EUL in April and has completed all of the necessary paperwork. The data must still be analyzed by WHO. The makers of both have submitted their expression of interest documentation to the WHO for approval. Sputnik V has progressed farther in the process, with data and WHO clinical inspections scheduled for June. As for Bharat Biotech, WHO has tagged its request with a note for "more information required."
It's worth noting that the COVAXIN vaccine's Phase 3 clinical trial results have yet to be made public. Phase 3 interim data has been released. Interim data is scientific information that is studied part way through a medical research project to see whether there are hazards associated with the study or clear benefits from one treatment or another. The vaccination is 78 percent effective against the coronavirus, according to the company. Bharat Biotech has already started testing the coronavirus vaccine on children aged two through eighteen.
Why is EUL important?
One of the reasons Bharat Biotech is racing to start this procedure is that the WHO's emergency listing will offer them international prominence. COVAXIN is not on the list of vaccinations approved by the European Union (EU), the United Kingdom (UK), or Canada.
While few nations have implemented a "vaccine passport," they will develop these guidelines based on suggestions from their local health authorities or vaccinations recognized by the World Health Organization.
Approval from WHO
The four steps in the WHO approval procedure for a vaccine are- 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, the decision on the status of assessment, and final approval decision.
On April 19, the Hyderabad-based biotech firm submitted its expression of interest. The pre-submission meeting, the second phase, is slated for this month (June 2021).
Meanwhile, the WHO certified the Pune-based Serum Institute of India (SII), which manufactures Astrazeneca's Covishield vaccine, on February 15 after passing the same four procedures.
Phase 3 Trials for Covaxin
Bharat Biotech's position is further complicated because the data for the phase III trial for Covaxin has yet to be published. The company has yet to publish its efficacy findings in a peer-reviewed scientific journal.
The results of Bharat Biotech's phase III study are reportedly to be released in July 2021. The company plans to apply for a complete license(it has only been approved for emergency use) for Covaxin. The vaccine will also undergo additional testing "for real-world effectiveness," according to the company. "It's critical to understand the phase III data will first be submitted to CDSCO," Bharat Biotech told ANI, referring to the Central Drugs Standard Control Organization. Then there will be peer-reviewed journals, with a three-month turnaround time for publication. "As communicated earlier, Covaxin phase III results in full trial data will be made public during July."
A recent comparative analysis based on a preliminary study that showed Covishield, the COVID vaccine made by Serum Institute of India, created more antibodies than Covaxin was labeled "flawed" by the business. "It's neither a peer-reviewed publication nor a statistically and scientifically designed study. The study design and conduct reflect an ad hoc analysis...further, the study was not...approved by CDSCO," said Bharat Biotech.
"Bharat Biotech is also doing phase 4 trials to check on the real-world effectiveness of the vaccines, and to ensure its vaccine met every rigorous scientific standard for safety, effectiveness, and manufacturing quality needed to support emergency use authorization," ANI reported it as saying.
Any vaccine that wants to be a part of Covax, the worldwide vaccine sharing effort, must meet the WHO's EUL. Covishield and the Pfizer and Moderna vaccines are among the seven vaccines on the list so far.
Interest from South American Countries for Covaxin
Covaxin has been used to vaccinate around 2 crore individuals thus far. With the WHO's clearance, other nations in need of COVID-19 vaccination will be able to import the vaccine from India. A number of countries have indicated an interest in Covaxin, according to the government.
Several South American regulatory organizations have expressed interest in using the indigenous Covaxin vaccine to vaccinate their populations.
Last Friday, Buenos Aires Province Governor Axel Kicillof announced a provisional agreement. This was to acquire 10 million doses of the Indian-made Covaxin vaccine, according to sources.
Argentina's municipal government signed the contract with Bharat Biotech. The license was contingent on the first shot receiving permission from Argentina's drug authority.
The Brazilian health regulator, Anvisa, finally approved the import of Bharat Biotech's Covaxin vaccine last week.
"After obtaining regulatory approvals the other biggest challenge remains for developing countries are in nationalizing the production of the active ingredient of these vaccines to be more independent which has been the very critical part of manufacturing these COVID vaccines in large scale to accelerate immunization in their respective countries," according to Mr. Subramaniam, an experienced professional from the pharmaceutical industry in Brazil. To put it in simpler words, the biggest hurdle, second to approval, for developing countries in terms of their vaccines is to produce the active ingredients used in them domestically. Most countries, like India, import the raw materials used in their vaccines which can slow down the vaccine drive.
Students and Travel
There is rising worry among Indians who have received the Covaxin vaccine. This is about whether it will be accepted for international travel. There is even more fear among Indian students heading to the United States. They may be forced to re-vaccinate on their campus due to the lack of WHO approval for Bharat Biotech’s COVID-19 vaccine.
People acquainted with the situation indicated that problems faced by Indian students who received the Covaxin vaccine in planning a return to US educational institutions were discussed in a meeting between foreign secretary Harsh Shringla and US chargé d'affaires Daniel Smith on Wednesday.
Many US institutions are opening their doors to international students and planning in-person classes starting in the autumn, so students must be properly vaccinated.
Even those who have already had the Covaxin shots are concerned that it would jeopardize their overseas travel plans. "Vaccine passports are not a reality right now, but if they were to be implemented and Covaxin doesn't make it to the WHO list, I will not be able to visit my daughter in the UK," says Shama Gupta, a 56-year-old resident of New Delhi.
"Those who have taken Covaxin are considered unvaccinated as per government rules. They have to undergo mandatory institutional quarantine and testing," said the head of the transformation at Aster Sanad Hospital, Srivatsan Sridhar.
If Covaxin was not to be approved by the WHO soon could hamper the plans and education of international students.