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Process and Issues linked to Emergency Use Authorisation (EUA) of COVID Vaccines in India

Central Drug Standard Control Organisation (CDSCO) has received applications from 3 vaccine developers seeking Emergency Use Authorisation/Approval (EUA) for their candidate Covid-19 vaccines which are still under trial. These Vaccines are COVISHIELD, COVAXIN, and BNT162b2.

None of the Vaccine developers has yet generated data about the effectiveness of their vaccine from phase-III trials conducted in India.

What is the normal process of Vaccine Development?

In normal circumstances, a Vaccines has to go through several phases, with each phase taking many months to get completed, but in the case of COVID, it is expected that vaccines would be in the market within a year from its start, after seeking Emergency Use Approval (EUA) from their respective governments.

After Pre-clinical testing of Vaccines, it is tested on the human under clinical trials before its mass production.

Clinical trials: It involves testing on humans. There are 3 phases of clinical trials;

  • Phase I of a clinical trial is conducted on a small group of healthy individuals. It only indicates what is the ideal dose required to administer in the next stage, it provides evidence of the vaccine’s ability to generate an immune response and its safety.

  1. The vaccine is not considered safe if it develops any major complication, however little headache and fevers are expected.

  • In phase II, the range of participants is expanded to a few hundred healthy participants to check the immune response system in the body and it also assesses the time period for which antibodies last to provide immunity against the virus.

  • Phase-III involves a very large group of people (Thousands of individuals) to investigate its efficiency among large population groups. Half of the population is administered the actual Vaccine and the other half are administered dummy vaccines.

  1. Individuals administered Vaccines are checked on fixed intervals which can be months in normal conditions to see whether their immune system is responding to the virus or not.

After the Vaccine is successfully tested, it would require regulatory approval before it can be produced in bulk quantity.

Emergency Use Authorisation (EUA)

The term “Emergency Use Authorisation (EUA)” has been used mainly by the regulatory agencies like FDA in the US and some other countries with the following guidelines;

FDA has specified that it would consider an application for EUA only if phase 3 data showed

  • it was at least 50% effective in preventing the disease.

  • This data needed to be generated from “well over” 3,000 trial participants, “representing a high proportion of participants” enrolled.

  • These participants needed to be followed up for any serious adverse effects for at least one month after all dosages had been given.

  • EUA can be granted only in a declared public health emergency.

Accelerated Approval Process in India

In India, New Drugs and Clinical Trials Rules, 2019 governs Clinical trials of new drugs and vaccines and their approvals.

But the term Emergency Use Authorisation (EUA) has not been used anywhere in rules in India. However, 2019 rules provide for an “Accelerated Approval Process” for granting approval to a drug that is still in clinical trials. The definition of a new drug in the 2019 Rules includes a vaccine.

Conditions for Accelerated Approval Process

  • There should be a prima facia case that the drug is of Therapeutic benefits.

  • “Accelerated approval may also be granted to a new drug if it is intended for the treatment of a serious, or life-threatening condition, or disease of special relevance to the country, and addresses unmet medical needs,”.

  • Approval can be granted even if “remarkable” effectiveness is reported even from phase-II trials.

Approval granted to drugs or vaccines that are still in clinical trials is temporary, and valid only for one year.

Examples of granting EUA

  • FDA granted its first EUA for use of Tamiflu drug for infants and young children for the treatment of H1N1 infection for the civilian population in 2009.

  • Remdesivir or faviparir, are existing drugs approved for other ailments received EUA for treatment of Covid-19, including in India.

Issues in EUA of Vaccines

  • Due to tolls or public sentiments, Governments are putting pressure on regulatory bodies to fast-track the entire process of Vaccine development.

  • Lack of transparency about vaccine safety and efficacy may negatively impact people’s confidence and willingness to get vaccinated.

  • Some surveys have shown that there is vaccine hesitancy among a certain section of people due to the hastening of the vaccine development process.

  • Whereas FDA has formulated its guidelines 50% effectiveness and no. of participants, the Indian regulator has not formulated any such guidelines.

  • Another issue with EUA-approved drugs and treatments is that they can reflect and exacerbate already existing inequities in the health system if the vaccine administered is found out to be ineffective. It might create a huge burden on the pocket of poor people.

  • There are examples of granting EUA to certain drugs like hydroxychloroquine, a malaria drug in haste, which later proved to be ineffective treatment, and the risks of taking it outweighed any benefits.

  • If a drug proved to be ineffective later on, after its administration to a huge population, it would be very harmful to the people’s confidence, economy, and health system of the country.

Way forward

Concerns regarding use of Vaccines can be addressed when all stakeholders are transparent at every stage of development and not by merely sharing guidelines regarding vaccine safety with the States. It is important that those seeking emergency-use authorisation share the safety and efficacy data with the authorities and public immediately.

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