Emergency approval of the corona vaccine in India may have to wait longer. In this connection, the Subject Expert Committee (SEC) of the Drug Regulator Central Drugs Standard Control Organization (CDSCO) met on Wednesday. It discussed the vaccine data of all three companies, who have asked for emergency approval. The committee has raised some questions on the application of emergency approval of all three vaccine candidates, to which companies have been asked to answer.
Wednesday's meeting was extremely important, as it could be called the formal beginning of the emergency approval process for the vaccine in India. CDSCO takes decisions based on the recommendations of the subject expert committee.
What are the recommendations of the SEC on which application?
1. Serum Institute of India (SII) had sought emergency approval for the vaccine covishield of Oxford University and AstraZeneca. On this, the subject expert committee has said three things.
Safety data of phase-2/3 clinical trials going on in India should be updated.
Immunogenicity data of clinical trials in the UK and India should be presented.
What has been the decision on the Emergency Use Application of Drug Regulators in Britain? Emergency Approval in India will be considered when the Serum Institute provides this information.
2. American company Pfizer and its German partner Bioentech have sought emergency approval for their mRNA vaccine. The vaccine has received emergency approval in the UK, Bahrain, and Canada. Pfizer has asked for more time to appear before the committee. In fact, on Wednesday, the Health Authority in the UK issued an alert to four people allergic to the vaccine. Pfizer sought time from the committee about this and it has been given. She has been told that she can approach whenever she is ready.
3. Bharat Biotech has sought emergency approval for its vaccine - covaxin and introduced phase-1/2 data together. The committee has asked him to present safety and affixation data for Phase-3 trials. Phase-3 trials of the company's vaccine have started on November 11. Its safety and efficiency data will be available only after 42 days.
Why is Emergency Approval Important?
Approval of any medicine or vaccine takes a long time. Only then is it known whether a drug or vaccine is safe and effective. If we look at the history of the vaccine, then the vaccine of mumps was the fastest approved. Its approval took four and a half years in the 1960s.
The situation today is such that the corona vaccine cannot be waited for so long. Because of this, drug regulators worldwide are giving emergency approval to medicines, vaccines, and other medical products. This requires adequate evidence that the vaccine is safe and effective.
According to the US Drug Regulator - Food and Drug Regulator (FDA), emergency approval can be granted only if the benefits outweigh the potential dangers of a vaccine or drug. Practically, this means that emergency approval can be considered only after the Phase-3 trials have received the FICC data.
Emergency approval cannot be given based on phase-1 and phase-2 data.
The FDA has determined for COVID-19 that emergency approval will be granted only if the vaccine remains more than 50% effective in phase-3 EfC data. This data should be of more than 3,000 volunteers. There should be no serious side effects for at least one month until one month after giving all doses of the vaccine.
What is the rule regarding emergency approval in India?
According to Dr. Gagandeep Kang, India's Top Vaccine Scientist and Professor at Christian Medical College, Vellore, the rules of India's new clinical trials have been made last year. In this, the regulator has been given the authority to approve medicines or vaccines for emergency use even in emergencies without trial.
According to Dr. Kang, monitoring of emergency use is similar to clinical trials even after being granted permission. Details of every patient are necessary. They are monitored. The company that has got the license for its product elsewhere, has to submit the complete data of pre-clinical and clinical trials to the regulator.
When the company asks for permission for Emergency Restricted Use, it is processed in two stages at the regulator level. The Subject Expert Committee considers that application. After its approval, the matter goes to the Apex Committee. This committee also has secretaries of departments associated with the Ministry of Health.
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