January 16th marked the world’s largest vaccination drive against COVID-19 as heathcare workers were the first to get the shot which will be followed by frontline workers. At present India has approved Covidshield, the Serum Institute of India, Pune vaccine in association with Oxford university and marketed along with AstraZeneca, while the second vaccine Covaxin is developed by Bharat Biotech with Indian Council of Medical Research(ICMR) in India for emergency use in one of the largest hit countries in the world. Drug Controller General of India(DCGI) has approved both the Serum Institute and Bharat Biotech Covid vaccines for restricted emergency use authorisation.
The DGCI on January 3rd said that the vaccines are 110% safe. “We’ll never approve anything if there is slightest of safety concern. The vaccines are 100 per cent safe. Some side effects like mild fever, pain and allergy are common for every vaccine. It is absolute rubbish that people may become impotent.” said VG Somani, Drug Controller General Of India.
Let us understand what emergency use authorization means
In the United States(US), emergency use authorization is an authority granted to the Food and Drug Administration to give clearance on drugs or vaccines that can be rolled out in an emergency, like a pandemic. The FDA can make a judgement to authorize something within a shorter span of time in case of a declared emergency, without all evidence to fully establish it’s effectiveness and safety. Why this is done is because it may not be possible to have all the evidence within a short span that the FDA would have before approving a drug, device or a test.
Doctors say while the US has seen a pandemic situation in the past and is equipped with laws to handle an emergency situation, in India there is still no law as the country has not faced with such a situation in recent decades. The Drug Controller General of India(DCGI) is the ultimate authority in India which controls the research segment and authorizations of any drafts which can be used clinically for therapeutic purpose.
Before a drug or vaccine comes into the market and is made available for the public at large which takes a few months. This period is cut short due to an emergency situation like a pandemic and the vaccine or drug made available for immediate use is called emergency authorization.
Doctors’ take
“This pandemic situation has not come in India before. We have one of the 4-5 countries that have been able to produce vaccines. With the limited resources, we still have managed to produce 3 different vaccines from 3 different companies. The DCGI is s very strong body which consists of all scientists and regulatory authorities like administrators. They have certain guidelines. Until and unless they are sure it is effective and will not produce any harm to the human body, they will not give any permissions to use it.” Said Dr.Amitabha Saha, Specialist in Critical Care Medicine and Co-Director in Medica Institute Of Critical Care and Coordinator of Internal Medicine.
Dr.Saha has also participated in trials related to phase 2 and 3 and says all researchers should have DGCI permission to use for clinical trial on the human body. “They only give permissions after they are very sure based on phase 1 or 2 of trials that this will not harm the body. For clinical trial, local ethical committee has to approve studies as well. The ethical bodies have doctors, legal experts, society and a novice to medical science to ask questions which helps researches see things from a different angle. It is not only about patient safety but also about cost and effect on society. All these are considered by the ethical committee after the DCGI gives permissions.” Added Dr.Saha.
DGCI asks for all raw data from companies producing vaccines to understand whether there are any serious side effects, whether there are any local reactions and what type of antibodies have developed after how many days of administering the vaccine. There were adverse impacts of vaccines in Brazil and other parts of the world, which have been considered by DGCI before giving a necessary permissions. Hence DCGI has a fool proof procedure for any vaccine to rollout. “If DCGI is satisfied, we should be sure they have checked everything before giving necessary permissions.” Explained Dr.Saha.
Since the country is going through an exigency phase and there is no time to make rules, the Central government has allowed DCGI to give permissions.
Vaccine trial phases
Phase 1- Testing on animals
Phase 2- Seeing safety of human body
Phase 3- Effectiveness of molecule on human body
Phase 4- Post rollout and marketing, study to check for long term side effects
Data will be collected on an everyday basis and after a few months when thorough study is done, the emergency use authorization tag is expected to be removed.