Emergency use authorisation for Covid-19 vaccines explained

After the Indian arm of US pharmaceutical giant Pfizer Inc, Pune-based Serum Institute of India on Sunday became the first indigenous company to seek emergency use authorisation for the Oxford Covid-19 vaccine in the country.

The Pune-based company has collaborated with Britain’s Oxford University and pharmaceutical company Astra Zeneca for making the vaccine and is conducting trials in India. “As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorisation for the first made-in-India vaccine, Covishield,” SII CEO Adar Poonawala tweeted. “This will save countless lives, and I thank the Government of India and Sri @narendramodi ji for their invaluable support,” he added.

Pfizer India had said last week it has applied to Drugs Controller General of India (DCGI), India’s drug regulator, for emergency use authorisation for its Covid-19 vaccine, after the company’s parent received clearance for the treatment from Britain and Bahrain.

What is Emergency Use Authorisation (EUA)?

Regulatory authorities need to approve vaccines, medicines, diagnostic tests and medical devices before they can be administered to people or used by medical professionals. These authorities give their nod after assessing the safety and effectiveness of these vaccines, medicines, etc, based on data from trials. Each and every phase of the trials has to be approved by the regulator.

The US Food and Drug Administration (FDA) says an emergency use authorisation is a “mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic.” FDA says it may allow the use of unapproved medical products, or unapproved uses of approved medical products in “an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.”

“Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA. Once submitted, FDA will evaluate an EUA request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA,” the agency said on its website.

Exceptions for emergency

FDA has said that the development process may be atypical in public health emergencies, such as a pandemic. However, it said, that efforts to speed vaccine development to address the ongoing Covid-19 pandemic “have not sacrificed scientific standards, integrity of the vaccine review process, or safety.”

“Recognizing the urgent need for safe and effective vaccines, FDA is utilizing its various authorities and expertise to facilitate the expeditious development and availability of vaccines that have met the agency’s rigorous and science-based standards for quality, safety, and effectiveness. Early in a public health crisis, FDA provides clear communication to the pharmaceutical industry pertaining to the scientific data and information needed to ensure development of vaccines and works quickly to provide advice on their proposed development plans and assessment of the data that are generated,” it said.

What is the process in India?

India’s drug regulations do not have provisions for EUA and the process for receiving one is not clearly defined or consistent. However, CDSCO has granted emergency or restricted emergency approvals to Covid-19 drugs - remdesivir and favipiravir in June and itolizumab in July - during the current coronavirus pandemic.

How are volunteers kept in the loop?

FDA says it must ensure that recipients of the vaccine under a EUA are informed “to the extent practicable given the applicable circumstances”, that the agency has authorised the emergency use of the vaccine, “of the known and potential benefits and risks, the extent to which such benefits and risks are unknown, that they have the option to accept or refuse the vaccine, and of any available alternatives to the product.”