What is Emergency Use Authorization?
Recently, several drug makers are seeking Emergency Use Authorisation (EUA) for the COVID-19 vaccine. Pfizer had applied for the EUA in UK and has been approved by the Medicines and Healthcare Products Regulatory Agency of the country. Also, the Serum Institute of India and Moderna have also applied for the Emergency Use Authorisation of COVID-19 vaccine.
What is Emergency Use Authorisation?
Vaccines, medicines, diagnostic tests and medical devices require approval for their usage from a regulatory authority, which is the Central Drugs Standard Control Organisation in India. This approval is granted after assessing its safety and effectiveness. This is generally a prolonged process. The emergency use authorization (EUA) is a mechanism used by the regulatory bodies to grant interim approval in case of emergencies. This is done only when there is sufficient evidence. The final approval, however, is given after completion of trials.
When can Emergency Use Authorisation be granted?
In the United States of America, the Food and Drug administration grant the Emergency Use Authorisation only after it has been proved that the potential benefits of the vaccine outweigh the potential risks. In other words, the Emergency Use Authorisation is provided only after sufficient efficacy data has been generated at the end of Phase III trials. The Emergency Use Authorisation cannot be provided based on the data provided from Phase 1 or phase 2 trials.
For covid-19 vaccine, the Food and Drug administration of United States has specified that it will consider an application for Emergency Use Authorisation only if the Phase 3 data proves at least 50% efficacy in preventing the disease. The data has to be generated from more than 3000 volunteers.
Emergency Use Authorisation in India
The drug regulations in India do not have provisions for Emergency Use Authorisation. However, Central Drugs Standard Control Organisation (CDSCO) has been granting restricted emergency approval to Covid-19 drugs. For instance, the CDSCO granted restricted emergency approval for Favipiravir and Remdesivir in June and Itolizumab in July.