Emergency Use List for Covid-19 Vaccines

News: Faced with concern that Indians receiving the Covaxin vaccine may not get relaxation in travel restrictions, the government has decided to help ensure that Hyderabad-based Bharat Biotech receives clearances from both the World Health Organisation (WHO) and subsequently, the EU’s European Medicines Agency (EMA). The Ministry of External Affairs (MEA) has been tasked with studying the matter and help get Covaxin a place in WHO’s Emergency Use List (EUL).

What is the need for such move?

  • EU member countries recently approved a proposal to allow “fully vaccinated” tourists from countries outside Europe under certain criteria. While the travellers getting AstraZeneca’s Covishield would be included on the WHO and EU’s listings, if travel from India is accepted, those who have taken Covaxin would not.
  • Covaxin on the WHO’s EUL would be a big boost, and a first for an Indian-developed and produced vaccine.

WHO’s Emergency Use List (EUL):

  • The WHO Emergency Use Listing Procedure (EUL) is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency.
  • This will assist interested UN procurement agencies and Member States in determining the acceptability of using specific products, based on an essential set of available quality, safety, and efficacy and performance data.
  • The EUL concerns three product streams (vaccines, therapeutics and in vitro diagnostics), each of which has specific requirements for products to be eligible for evaluation under the EUL procedure.

The following criteria must be met:

  • The disease for which the product is intended is serious or immediately life threatening, has the potential of causing an outbreak, epidemic or pandemic and it is reasonable to consider the product for an EUL assessment, e.g., there are no licensed products for the indication or for a critical subpopulation (e.g., children).
  • Existing products have not been successful in eradicating the disease or preventing outbreaks (in the case of vaccines and medicines).
  • The product is manufactured in compliance with current Good Manufacturing Practices (GMP) in the case of medicines and vaccines and under a functional Quality Management System (QMS) in the case of IVDs.
  • The applicant undertakes to complete the development of the product (validation and verification of the product in the case of IVDs) and apply for WHO prequalification once the product is licensed.