Hyderabad based Bharat Biotech is scheduled to meet the World Health Organisation officials on June 23 to ensure that the indigenously produced Covaxin receives Emergency Use Listing approval for it to be universally accepted.
Covaxin received emergency use authorisation in India in January 2021 while its Phase III trials were still underway and only shared its interim Phase III results in March 2021. It has submitted its Phase III trial efficacy data to the Central Drugs Standard Control Organisation which shows that the vaccine has 77.8 per cent efficacy against SARS-CoV-2.
This Emergency Use Listing first pre-data submission meeting comes at a time when several US universities asked students to get re-vaccinated if they had received Covaxin. WHO's emergency use listing is an approval suggesting that the particular vaccine is successful in curbing the effect of the pandemic.
The WHO has, so far, received Expression of Interest from 22 COVID-19 vaccine manufacturers and has approved EUL for eight of them while the others are still in the pipeline. Pfizer-N-Biotech, Oxford- AstraZeneca (EU, Korea, India), Janssen, Moderna, Sinopharm, and Sinovac have received EUL approval so far. Gamaleya Institute, the makers of the Russian Sputnik V vaccine have been asked to submit additional data.
Prior to the WHO providing EUL, it is mandatory that the national regulatory authorities of each of the countries where the vaccine is being manufactured have approved the vaccine for emergency use.
What Is EUL?
Emergency Use Listing is a risk-based procedure for assessing and listing unlicensed vaccine, therapeutics and in-vitro diagnostics to expedite their availability during a Public Health Emergency. The proposals are accepted on the basis of the availability. quality, safety, as well as efficacy performance, along with checking the final data. The WHO can also ask for special requirements to be clarified to ensure that the product is beneficial for everybody.
Products are allowed to apply for an EUL only when the disease is serious, immediately life-threatening, is an outbreak, epidemic, or a pandemic. An EUL is also brought into play when pre-existing vaccines and medicines are unsuccessful in containing the spread of the said disease. There should also be no licensed product already being used on other critical populations. The benefits of using the product should also outweigh the foreseeable risks in the future.
It is also mandatory that the product in question should follow the Good Manufacturing Practices designed by the WHO and that the complete validation and verification of the product will be completed to make it eligible for WHO pre-qualification post licensing.
The EUL, the WHO says is time limited and not an alternative to pre-qualification. In contrast to the pre-qualification, in case of an EUL, the WHO committees may be willing to tolerate less certainty about safety and efficacy due to the nature of the disease, currently, COVID-19.
Steps For Receiving EUL
Manufacturers after receiving approval from the National Regulatory Authorities have to send their expressions of interest to the WHO EUL team. This EOI can be submitted by vaccine manufacturers whose vaccine candidates are in either Phase 2b or Phase 3 trials.
In the EOI, the manufacturers are expected to discuss their manufacturing quality data, non-clinical and clinical data, a plan to monitor quality, safety and efficacy in the field and an undertaking to submit any new data to WHO as soon as the new data are available, and labelling details.
Once the EOI is accepted, the WHO will set up a pre-submission meeting with the manufacturers. In the pre-submission meeting, the manufacturers have to discuss their goals and assure that they will be helping low and middle income countries with their vaccines. Post this meeting, the dossier is accepted for review after all the requisite data is submitted.
The manufacturers have to follow the guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use's Common Technical Document. The dossier includes details on animal study data, bio-immunological markers, clinical trial design, the necessary efficacy, immunogenicity, and safety endpoints. The manufacturers are also expected to submit the detailed statistical criteria followed to achieve the results.
Along with the neutralising antibodies, the dossier must also include data on T-cell responses. Approvals from the Ethics Committees, registration of clinical trials, and certificates of good clinical practices should be a part of the dossier. The manufacturers should also report all kinds of side effects, adverse reactions and a risk management plan for handling any problems.
The WHO committee comprising of members from the WHO as well as some of the national regulators will ask for more data if they need more clarity on the subject. Post this, the data will be screened and assessed, further responses from the applicants will be taken into consideration, and later after studying the risk-benefit ratio, a final decision will be undertaken.
The WHO then shares whether the vaccine has received EUL and can be used across the world. This EUL helps vaccines to be made accessible across the world while regulators of countries importing the vaccine assess its licensing in the country.
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