Explainer | Covid-19 vaccine: What is Emergency Use Authorisation?

Pfizer-BioNTech's vaccine candidate received the FDA approval for emergency use authorisation on Friday

In a landmark step against the Covid-19 pandemic, the US Food and Drug Administration (FDA) on Friday issued the first emergency use authorisation (EUA) for the Pfizer-BioNTech vaccine candidate.

Earlier this week, Indian regulators also reviewed proposals from pharma major Bharat Biotech and the Serum Institute of India (SII) for emergency use approval.

Vaccines usually take 10 years or more to be developed and distributed, contrary to the EUA which pharma companies are asking for within a year of developing their candidates. This process has been accelerated as a result of the Covid-19 pandemic, which has already claimed over 1.5 million lives globally. So, what is this emergency approval and under what criteria is it issued?

India

India does not have a term like the EUA as in the US or UK in its regulatory processes. But in the New Drugs and Clinical Trials Rules, 2019, there are provisions for pharmaceutical companies to get approvals for clinical trials for new drugs or vaccines in India.

Regulatory bodies in India can provide for an ‘accelerated approval process’ for certain drugs in special circumstances, like the Covid-19 pandemic. In this situation, the vaccine has to have a “meaningful therapeutic benefit”. The law also states that if a vaccine or a drug is needed to treat a fatal disease like the one caused by novel coronavirus, a new drug can be given the green light if it shows “remarkable efficiency” during its second phase of human trials conducted in the country.

However, Indian Express reported that this approval is only valid for up to a year.

The Central Drugs Standard Control Organisation (CDSCO) has asked for more safety data from Indian vaccine makers Bharat Biotech and SII, from their clinical trials in India, before giving them the emergency approval.

USA

In the US, the FDA allows the use of unapproved medical products or unapproved uses of approved drugs in case of an emergency under section 564 of the Federal Food, Drug and Cosmetic Act (FD&C Act).

To get the EUA, it needs to be established that there is a life-threatening disease in the country that poses a risk to the public and needs to be diagnosed, treated, or prevented, much like the coronavirus.

It must be noted that a EUA is different from an FDA approval of a vaccine. To issue an EUA, the FDA has to study available data and evidence and gauge the potential risks and benefits of a vaccine candidate. It needs to ensure that the benefit-risk assessment is favourable before making the product available to the public.

Now, for a particular company to get the EUA, it must submit its proposal to the FDA, which then determines if all criteria are met and studies the scientific evidence about the vaccine. Pharma companies also have to include dosage information and instructions in their proposal. The regulatory body also expects companies to continue clinical trials on drugs or vaccines that have received the EUA, to get additional data.

It is required for Pfizer and BioNTech to report back the Vaccine Adverse Event Reporting System (VAERS) for their vaccine, administration errors, serious adverse cases and deaths from Covid-19.

“The FDA’s authorization for emergency use of the first Covid-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” FDA Commissioner Stephen M. Hahn, MD, said in a statement on Friday.