A local newspaper ran a piece of news on January 2 with the following title: 'India's drug regulator's expert body recommends two Covid-19 vaccines for emergency use.'
The news noted CDSCO "met for two days…and recommended that the Drugs Controller General of India (DCGI) 'grant permission for restricted emergency use' of the Oxford-AstraZeneca vaccine, subject to multiple regulatory conditions to the Serum Institute of India based in Pune city".
It added, "The emergency use approval of a drug -- which is what has been recommended by the panel -- is usually granted if there is sufficient evidence to suggest that the drug is safe and effective."
After reading the news, I was puzzled. In search of a coherent understanding, I approached several knowledgeable persons in Bangladesh and abroad. My primary question was: "What does the statement, 'regulatory body recommends two Covid-19 vaccines for emergency use', mean?"
I understand that this sort of immunization is meant to be preventive and applies to normal (non-emergency) states as well. What is then meant by "recommended...for emergency use"?
Within a short span of time, I got responses from four persons with revealed expertise in various fields.
The first is a distinguished senior citizen, the second had a long career in the global pharmaceutical industry, third was a reputed senior civil administrator (CA) and the fourth is a Professor in medicine (M). I have reproduced their responses with minor and non-distorting edits.
The senior citizen, who is keenly awaiting the arrival of a drug, said the following, "The drug approval authorities in respective countries have cleared the vaccines for 'emergency use', but the health authorities are apparently permitted to roll out mass vaccination according to priority categories...and the governments are going along with that without raising the fine point!"
The person with prior knowledge of the drug approval procedure in the pharmaceutical industry wrote to me in some detail. "In certain cases where there is no alternative available, the vehicle ("emergency use") allows usage of the medication while additional data is being collected or the final registration process is being completed.
Though it is not a perfect analogy, the person gave the following illustration. "At times, requests are received, before a drug is formally approved and launched, for patients who are likely to die before the anticipated date of final approval. For the vaccine referred to, under normal circumstances, the agencies would likely require more long-term data (e.g., six to 12 months safety and stability data), plus more review time. They have decided that the potential benefit outweighs the risk of waiting."
The seasoned bureaucrat said, "All the vaccines so far approved added the sentence 'approved for emergency use'. It is probably to safeguard them from possible litigation, in case. Although it doesn't make much sense as all vaccines are for preventive purposes, therefore, purportedly to be applied under the normal healthy condition to avert an emergency for the person or the society. My guess is the pandemic itself is an emergency (menace) causing thousands of deaths, so they use the phrase 'for emergency use.' Otherwise, in normal conditions, vaccines would be administered for 'non-emergency use', without having the need to mention emergency."
The second commentator had the following to add hearing the response of the third person, "You may be correct on the litigation angle. However, I think there may be more to it than that. These agencies have long and rigid procedures. If they are bypassing those - which they are - they need to be able to explicitly note the qualifiers. Whether this is for legal defence or even ex-post-facto analysis purposes, the reality is that it should be treated differently from regular or full approval."
The final response, while I was retiring for the day, came from the Professor (in medicine), "The present Covid-19 situation is considered an emergency state and hence these two vaccines are recommended to for use in this situation, which would not normally be recommended considering the inadequate trial status."
I sincerely hope that the media continues to enlighten us with deeper insights and critical engagement, and help us avoid disasters in our collective existence.
This article has been compiled by Sajjad Zohir, a researcher by profession with a background in Economics.