What Does ‘Emergency Use’ Mean as India Gets Two Vaccines Against COVID-19?

Here we explain the terms 'emergency us authorisation' and 'restricted use authorisation' in the most simplest words for you.

The Drugs Controller General of India (DCGI), today (January 13) announced that the Central Drugs Standard Control Organisation gave approval to India’s 2 vaccines against COVID-19 for emergency and restricted use. This happened after the subject expert committee (SEC) under the CDSCO recommended Covishield, for emergency use and Covaxin for restricted use. For many, the terms emergency and restricted use are confusing. Therefore, here we break and explain them to you in the most simplest words for you.

What does DCGA mean by emergency use authorisation?

Any vaccine or medicine is given an emergency use authorisation keeping its importance in mind. Interim approval is provided after assessing its safety and effectiveness based on the results of the clinical trials only if the vaccine or the medicine is needed immensely on an urgent basis. In the case of COVID-19, CDSCO has approved the emergency use of the Covishield vaccine keeping the increasing spread of the new strain of the coronavirus and its deadly nature in consideration.

In India, we do not have a provision for providing emergency use authorisation and so approvals for public use is given only after the results of the complete clinical trials come out. However, the current situation seems different. Earlier in June, CDSCO had granted emergency or restricted emergency approvals to COVID-19 drugs namely remdesivir and favipiravir. This was done considering the increasing number of deaths owing to the pandemic in mind. And, the drugs found out to be effective in treating extremely sick COVID-19 patients.

What do you mean by restricted use authorisation?

In today’s press conference the DCGA announced that India’s first indigenous vaccine against COVID-19 has been approved for restricted use. This means it should not be given to everyone. Only those in extreme need of it based on his/her medical condition will be given the vaccine.

To give you a clear perspective, we take the example of remdesivir drug that is being used to treat extremely sick patients right now. It is not prescribed to every COVID-19 patient as the drug has some side-effects too. If a patient can be treated with general medicines, he/she will not be given remdesivir. Only those with a greater risk of dying due to the disease are being given the injection.