Updated: December 9, 2020 10:02:09 am
Vials of Covishield, the Indian version of the AstraZeneca-Oxford vaccine, at the Serum Institute of India in Pune, India. (Reuters photo)
Three vaccine developers have submitted applications to the Central Drug Standards Control Organization (CDSCO), India’s drug regulator, seeking emergency use approval for their Covid-19 candidate vaccines that are still in testing. . None of them have yet generated data on the efficacy of their vaccine from phase III trials conducted in India, which is a mandatory requirement in the normal approval process.
And each of the three presents a slightly different case, which the CDSCO will need to evaluate and decide.
What are these vaccine candidates?
COVISHIELD: Pune-based Serum Institute of India has applied for approval for its version of the vaccine developed by the University of Oxford and AstraZeneca, which it has been testing in India for the past few months. The candidate is currently in phase III trials in India. In its application, Serum has submitted safety data from phase I and phase II trials, while efficacy data has been obtained from phase III trials of the same vaccine in the UK and Brazil.
COVAXIN: Bharat Biotech, a Hyderabad-based company that is developing a vaccine, Covaxin, in collaboration with the National Institute of Virology, an ICMR institute in Pune, has started phase III trials only recently, and has not yet enrolled all of the participants according to your design. Its application is based primarily on safety data from phase I and phase II trials.
BNT162b2: Major US drugmaker Pfizer has not conducted clinical trials in India of its vaccine, developed in collaboration with BioNTech, but has yet applied for approval for use here based on the results of trials conducted in the US. The Pfizer-BioNTech vaccine is the first to receive regulatory approval anywhere in the world, as it was granted emergency use authorization in the UK last week. 📣 Follow Express explained on Telegram
What are the regulatory provisions for approval of vaccines in India?
New drug and vaccine clinical trials and approvals are governed by the 2019 New Drugs and Clinical Trials Rules. These Rules do not use the term “emergency use authorization”. This term is used primarily by regulatory agencies in the United States and some other countries, and has become popular in the context of the current epidemic. However, that does not mean that India’s regulatory system does not have provisions for “special situations” like the current one.
The 2019 rules provide for an “expedited approval process” in several situations that would include one such as the current pandemic. In such situations, there is a provision to grant approval to a drug that is still in clinical trials, “provided there is a prima facie case that the product has a significant therapeutic benefit.”
“Accelerated approval can also be granted to a new drug if it is intended to treat a serious or life-threatening condition, or disease of particular relevance to the country, and addresses unmet medical needs,” one of the relevant provisions of the say Rules. The definition of a new drug in the 2019 Rules includes a vaccine.
Additionally, it makes clear that approval of a new drug, or vaccine, can be considered if “remarkable” effectiveness is reported even in phase II trials.
“If you see the remarkable efficacy with a defined dose in the phase II clinical trials of the new investigational drug for the unmet medical needs of serious and life-threatening diseases in the country, you can consider granting marketing approval by from the central licensing authority based on data from phase II clinical trials. In such cases, additional post-licensing studies may be required after approval to generate the data on a larger population… ”the Rules say.
Consequently, the approval given to drugs or vaccines that are still in clinical trials is temporary and valid for only one year. Thus, such an arrangement makes even Bharat Biotech eligible to apply for approval, although it is still in the early stages of phase III clinical trials.
How different are Indian regulations from elsewhere?
Some provisions of the 2019 Rules, such as those mentioned above, are different compared to what is prescribed by the US Food and Drug Administration (FDA), which had issued very specific guidelines for the approval of vaccines for Covid. -19. The FDA has made it clear that an emergency use authorization can only be considered after sufficient data is generated from phase 3 trials, and an application cannot be made based on data from phase 1 trials alone or 2. You have also said that preliminary data from phase 3 must show at least 50% effectiveness in preventing the disease, and that this data must be generated from “more” than 3,000 trial participants.
What about vaccines that have worked well in trials outside the country?
The 2019 Rules do not say anything specific about whether data from a trial conducted in another country can be considered when evaluating an application for expedited approval of a drug or vaccine to be used in India. But the Indian health authorities have said that they are keeping an open mind and that it will all depend on what scientists and experts do with the data presented to them.
They emphasized that when evaluating vaccine applications, expert committees in the field will carefully weigh the risks against the potential benefits to assess whether the vaccine is likely to provide a significant advance in containing the current epidemic. This is also in line with the stated principle of the US FDA. The FDA has said that an emergency use authorization would be granted only after it has been determined that “the known and potential benefits outweigh the known and potential risks. of the vaccine “.
In conducting this assessment, the Indian expert committee would also be willing to examine data generated during trials conducted in other countries, such as the Serum Institute and Pfizer applications.
The Indian authorities also noted that an application does not always have to lead to an approval, which will be granted only after rigorous scientific analysis of the submitted data. Committees of subject matter experts can reject a request or request more information if they are not satisfied.
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