New Delhi, December 1: Moderna Inc, which has reported its vaccine against coronavirus (COVID-19) is 94 percent effective, has sought emergency use authorisation from the US Food and Drug Administration (USFDA). Moderna will also file with European regulators for emergency use authorisation for its COVID-19 vaccine, named mRNA-1273. A few days ago, Pfizer sought approval from the US FDA for emergency use authorisation for a vaccine it has developed in collaboration with BioNTech of Germany. COVID-19 Vaccine Before Christmas 2020? US Likely to Approve Moderna, Pfizer Candidates in December

In India, Adar Poonawalla's Serum Institute of India (SII), which will manufacture and produce COVID-19 vaccine Covishield, developed by Oxford University and AstraZeneca, has said it is expected to apply for emergency use authorisation within the next two weeks. PM Narendra Modi Visits Serum Institute of India, Reviews COVID-19 Vaccine Manufacturing Facility.

What is Emergency Use Authorisation?

Before launching vaccines for public use, vaccine-makers require the approval of regulatory authority such as the US FDA in America and Central Drugs Standard Control Organisation (CDSCO) in India. Besides vaccines, medicines and medical devices also need approval before they are used. In case of a vaccine, regulatory bodies analyse its safety and effectiveness before giving approval.

The process to check if a vaccine is completely safe and effective is long. In fact, the fastest approval for any vaccine till now came about four and a half years after it was developed. However, in case of an emergency like the one world is facing today due to the coronavirus outbreak, regulatory authorities around the world have a mechanism to grant interim approvals.

If there is sufficient evidence to suggest that a vaccine is safe and effective, and would help in stopping an outbreak, regulatory authorities issue an emergency use authorisation, which permits the use of the vaccine for the public. In simple words, an emergency use authorisation allows vaccine-makers to roll out their vaccine for the general public prior to the final approval which takes years to get.

(The above story first appeared on LatestLY on Dec 01, 2020 12:07 PM IST. For more news and updates on politics, world, sports, entertainment and lifestyle, log on to our website latestly.com).