Recently the United Kingdom became the first country in the west to approve the use of a fully tested COVID-19 vaccine. The regulatory body of the UK has given Emergency Use Approval (EUA) to the vaccine developed by Pfizer and BioNTech, and the general public started getting the vaccine this week. Pfizer has now approached the Indian and the U.S government for the same. It is also the first company to apply for a EUA in India.
What is emergency use authorization or approval?
Any medical product, including medicines and vaccines, need approval from a regulatory authority before they can be given to the public. The regulator evaluates the vaccine for its safety and efficacy based on the data from human trials before approving.
The approval process may take as long as 10 years as the regulator evaluates every stage of the trials to make sure that the vaccine is effective and safe. But in times of crisis like the current one when COVID-19 has claimed more than 1 million lives worldwide, regulators can allow vaccines to be used on the public under the ‘Emergency Use Authorisation (EUA)’ provision.
An EUA is an interim measure till the vaccine is finally approved after the end of the trials and the analysis of the complete data. It is granted only when the potential benefits of the vaccine outweigh the potential risks.
Which vaccines have applied for emergency use in India?
- Pfizer’s COVID-19 vaccine candidate, developed in collaboration with BioNtech, and whose interim analysis of phase 3 trials revealed a 95% efficacy, has sought EUA from the Indian government.
- Serum Institute of India for ‘Covishield’, the vaccine being manufactured jointly with Oxford/AstraZeneca in India, has sought for EAU in India. Early analysis of phase 3 trials of the vaccine demonstrated a 70% efficacy.
- Bharat Biotech for ‘Covaxin’, India’s first indigenously developed COVID-19 vaccine, has applied for EUA. The National Institute of Virology-ICMR is collaborating with Bharat Biotech to develop this vaccine.
Who approves the emergency use of vaccines?
In India, the regulatory body that approves the emergency use of vaccines is the Central Drugs Standard Control Organisation (CDSCO). For other countries, the regulatory bodies which approve the EUA are:
- United States – U.S Food and Drug Administration (FDA)
- Britain – Medicines and Healthcare products Regulatory Agency (MHRA)
- China – National Medical Products Administration
- Russia – European Medicines Agency (EMA)
How long does the approval process take?
The emergency approval process for Pfizer’s COVID-19 vaccine in the UK was accelerated and done through a ‘rolling review’ regulatory process. This process is generally used during a public health crisis when the complete evaluation of a promising vaccine is done in the shortest time possible.
In India, the CDSCO usually takes up to 90 days to grant EUA but health experts and authorities are positive about the approval coming sooner than that, possibly within weeks.