Corona Vaccine Emergency Approval: What Does Emergency Use Authorisation Means For Pharma Companies?

Globally regulatory authorities are in a position to grant interim approvals to be administered, in case of in emergency situations such as pandemic only if a sufficient evidence is established that the medical product is safe and effective.

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Globally, Pfizer Inc and BioNTech SE has emerged as the first vaccine candidate to get emergency use approval in the UK and Bahrain, and now the company has sought clearance from India regulatory agencies.  Pfizer Inc and BioNTech SE vaccine candidate, BNT162b2, has shown 95 per cent efficacy against coronavirus during a preliminary clinical trial data analysis. Not just Pfizer, the Serum Institute of India, Bharat Biotech has also asked for emergency use authorisation for its Covid vaccine in India. What is emergency use authorisation (EUA)? In India, all vaccines and medicines including diagnostic tests and medical devices have to get approval of a regulatory authority before they can be administered.  It is the Central Drugs Standard Control Organisation (CDSCO), which gives the regulatory approval in India. In case of vaccines and medicines, the approval gets through only after its safety and effectiveness is assessed based on data from trials. The regulator gives the approval at every stage of these trials. It is a complicated and a long process that can take years. For instance in emergency situations, such as the pandemic, regulatory authorities globally are in a position to grant interim approvals once sufficient evidence is established that the medical product is safe and effective. However, the final approval comes only after completion of the trials and analysis of full data. So, emergency use authorisation (EUA) in the case of Covid-19 will allow the medicine or the vaccine to be used on the public. When can EUA be granted? In case of the US, the Food and Drug Administration (FDA) gives an EUA after it has been determined that the “known and potential benefits outweigh the known and potential risks of the vaccine” (or medicine). The regulator considers the application only after sufficient efficacy data from phase 3 trials had been generated. It is to be noted that an EUA cannot be granted solely on the basis of data from phase 1 or phase 2 trials but even these pahse have to exhibit the product is safe. In the case of coronavirus vaccination, the FDA has mandated that EUA will be considered only if phase 3 data exhibits at least 50% effective in preventing the disease. This data has to be generated from “well over” 3,000 trial participants, “representing a high proportion of participants” enrolled. What is the process of getting an emergency use authorisation in India? As per experts the India’s drug regulations do not have provisions for an EUA, and in fact the process to get the approval is not clearly defined or consistent. However, in this pandemic time CDSCO has been giving emergency or restricted emergency approvals to Covid-19 medicines including remdesivir and favipiravir in June, and itolizumab in July. How will a Covid-19 vaccine get an EUA in India, then? There is lack of clarity on this. As per the report in the Indian Express, any company looking to launch a vaccine approved elsewhere would have to conduct local trials to prove its efficacy on the Indian population.