About: Emergency use authorisation (EUA) or Emergency License

About: Emergency use authorisation (EUA) or Emergency License

  • Vaccines, like medicines, require the approval of a regulatory authority before they can be administered to people.
  • In India, the Central Drugs Standard Control Organisation (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices.
  • The final approval is granted only after the completion of the trials and evaluation of the results. The overall approval process takes a long time, in order to ensure that the medicine or vaccine is completely safe and efficient.
  • The quickest approval for any vaccine until now happened 4 and a half years after it was developed. This was for a vaccine for mumps, granted in the 1960s.
  • However, in emergency conditions, like the present one, regulatory authorities across the world have developed mechanisms to grant emergency use authorisation (interim approval) to medicines, vaccines etc.
  • According to US Food and Drug Administration (FDA), the drug regulator in the United States, the public must know that the medication/vaccine has only been granted an EUA and not a full approval.

Conditions for granting an EUA:

  • EUAs are granted to medicines, vaccines, or different medical devices only if there is no alternate option available in adequate quantities.
  • According to the US FDA, an EUA can be granted only after it has been decided that potential benefits are more than the potential risks of the vaccine (or medication).
  • Thus, an EUA can be granted only after adequate information on the efficacy of the vaccine/medicine has been generated from phase-three trials and cannot be granted only on the information from phase-1 or phase-2 trials.
  • For Covid-19 vaccines, the FDA has specified that it will grant an EUA only if the Phase 3 trials confirm that the vaccine is at least 50 per cent efficient in stopping the illness.
  • Moreover, this knowledge would have to be generated from over 3,000 individuals who have been a part of the trials.

Examples of EUA:

  • EUA is a comparatively recent phenomenon. The FDA granted its first EUA for the Tamiflu drug for infants and younger kids for the remedy of H1N1 infection.
  • Since then, a number of EUAs have been granted, for medicines, diagnostics, and medical gadgets and tools, like ventilators. However, an EUA has not been given till now for a vaccine.
  • The earlier EUAs were given during emergencies like the Ebola virus, Zika virus and Middle East Respiratory Syndrome (MERS) coronavirus.
  • Several EUAs have been granted throughout the present pandemic as well. Drugs like remdesivir or faviparir have obtained emergency use authorisation for remedy of Covid-19 illness in India.

Importance of vaccination for Covid:

  • Covid-19 is a highly infectious virus which impacts the body in different ways with a wide range of severity.
  • The level of viral load a person is exposed to, the immunity status or pre-existing health conditions may be factors which influence this severity.
  • It has not been easy to predict who can be safe from it, as even young persons have become severely ill or died, after getting infected.
  • Due to this unpredictable nature of the disease, everyone should get vaccinated after a safe and effective vaccine is available.
  • Moreover, a vaccine leads to a good immune response which is likely to last longer than a natural infection. Thus, vaccination will provide stronger protection from the disease.

Criteria for selecting priority groups for vaccination:

  • The two main criteria for selection of the initial groups to be offered the vaccine are essentiality and vulnerability.
  • Healthcare providers who test, treat or counsel persons infected with the Covid-19 are both essential service providers and also very vulnerable to becoming infected. Thus, they will be at the top of the priority list for vaccination everywhere.
  • Other essential services include sanitation, security, transport and those involved in the production of essential goods and supplies.
  • Applying the vulnerability criterion, elderly persons and people with known co-morbidities (like diabetes, heart disease etc.) which enhance the risk of severe illness or death are a high priority.
    • The problem in identifying this group is that several persons who have these conditions may be unaware of them, because of the weak health services in urban slums, small towns or villages.
    • One option in such cases is to apply the age criterion and move steadily down decade by decade from the 60+ age group to the 20+ age group.

Geographic strategy for vaccination:

  • The right strategy would be to start vaccination in cities where the crowd density is higher, co-morbidity levels are more, factors like air pollution are severe and health services are stronger.
  • The experience of vaccination in cities will be helpful as the immunisation programme moves towards small towns and rural areas.
  • However, if there are hotspots of rapidly increasing cases in any part of the country, urgent immunisation of susceptible persons should be done in such places.

Vaccination roadmap in India

  • India’s vaccination strategy will depend on the type of vaccine available. Some of the successful vaccines will probably have to be stored at only 2–8°C or even at room temperatures.
  • If India can get access to these vaccines, the existing supply chain logistics will be adequate in the initial stages, in which groups of essential workers and the elderly will be immunised.
  • The main challenge will be the actual administration of the vaccine, as an intramuscular injection in two doses.
  • Those who are at present authorised to administer such injections are doctors, nurses and auxiliary nurse midwives. Their numbers are inadequate in many parts of the country.
  • Those who are available will also be busy providing other health services, including care of Covid-19 infected persons. Thus, additional personnel (like medical, dental and nursing students) may have to be trained to administer (give) the vaccines.

Future Outlook

  • The future depends on how the virus behaves over the next year and the speed at which immunisation programme can cover the country.
  • Hence over the next year, it is important to observe public health advisories on masks, physical distancing, hand washing and avoiding super spreader events.

 Social Issues