What is status of covid-19 or coronavirus vaccine Emergency approval in India
What are these covid-19
vaccine candidates or how many covid-19 vaccine in race for emergency approval
or what is emergency approval for vaccine
?
Three vaccine developers
have sought emergency use approval while their candidates are still in trials.
India’s regulations provide for ‘accelerated approval in special situations. What
are the rules?
THREE
VACCINE developers have now made applications to the
Central Drug Standard Control Organisation (CDSCO), India’s drug regulator,
seeking emergency use approval for their candidate Covid-19 vaccines which are
still under trials. None of these has yet generated data about the
effectiveness of their vaccine from phase-III trials conducted in India, which
is a mandatory requirement in the normal process of approval. And each of the
three presents a slightly different case, which the CDSCO will have to evaluate
and decide on.
What
are these covid-19 vaccine candidates ?
COVISHIELD:
Pune-based Serum Institute of India has sought approval for its version of the
vaccine developed by Oxford University and AstraZeneca, which it has been testing
in India for the last few months. The candidate is currently in phase-III trials
in India. In its application, Serum has submitted the safety data from phase I and
phase II trials, while the effectiveness data has been sourced from phase-III
trials of the same vaccine in the UK and Brazil.
COVAXIN:
Bharat Biotech, a Hyderabad based company which is developing a vaccine, Covaxin,
in collaboration with National Institute of Virology, an ICMR institute in
Pune, has started phase-III trials only recently, and is yet to enroll all the participants
as per its design. Its application is based mainly on the safety data from
phase-I and phase-II trials.
BNT162b2:
US pharmaceutical major Pfizer hasn’t carried out clinical trials in India of
its vaccine, developed in collaboration with BioNTech, but has still sought an
approval to use it here based on the results of the trials conducted in the US.
The Pfizer BioNTech vaccine is the first one to receive the regulator’s
approval anywhere in the world, having been granted emergency use authorization
in the UK last week.
What
are the regulatory provisions for approval of vaccines in India?
Clinical trials of new
drugs and vaccines, as well as their authorization, are governed by the New
Drugs and Clinical Trials Rules, 2019. These Rules do not use the term
"authorization for emergency use". The term is widely used by
regulatory agencies in the US and other countries, and has become very popular
in the context of the current disease. However, that does not mean that the
Indian regime does not have the provision of “special conditions” such as those
currently in place.
The 2019 legislation
provides for an "immediate authorization process" in a number of
cases that could include one such as the current epidemic. In such cases, there
is a provision for the licensing of a drug that is in clinical trials, as long
as there is a first case of a product with a meaningful medical benefit ”.
"Immediate accreditation may also be given to a new drug if it is intended
to treat a serious, life-threatening, or particularly significant disease in
the country, and to address unmet medical needs," one of the appropriate
provisions says the Regulations.
The definition of a new
drug in 2019 Rules includes a vaccine. In addition, it makes it clear that a
new drug, or vaccine, can be considered for approval if “significant”
performance is reported even in phase II trials. “If significant performance is
maintained in the prescribed capacity in phase II clinical trials of a new
investigative drug for unmet medical needs for serious and life-threatening
diseases in the country, it could be considered a commercial center approval. licensing
authority based on phase II clinical trial data.
In such cases,
additional licensing studies may need to be conducted after approval has been
granted to public information…, ”says the Rules. Accordingly, the approval
given for drugs or prescriptions for medical trials is temporary, and is valid
for one year only. Such provision, therefore, makes Barat Biotech eligible to
apply for accreditation, although there are still phases of phase-III clinical
trials.
How
different are Indian regulations from those elsewhere?
Some provisions in the
2019 Rules, like those mentioned above, are different compared to what has been
prescribed by the US Food and Drugs Administration (FDA),which had issued very
specific guidelines for approval of vaccines for Covid-19.The FDA has made it
clear that an emergency use authorisation can be considered only after
sufficient data from phase-3 trials are generated, and an application cannot be
made on the basis of data only from phase-1 or phase-2 trials. It has also said
that preliminary phase 3 data should show at least 50% effectiveness in preventing
the disease, and that this data needed to be generated from “well over” 3,000 trial
participants.
What
about vaccines that have done well in trials outside the country?
Year 2019 Rules does
not specify whether the data from a trial conducted in another country may be
considered during the evaluation of an urgent application for a drug or vaccine
to be used in India. But Indian health officials have said that they have always
been open-minded, and it will all depend on what scientists and experts do with
the information presented to them. They emphasized that in evaluating vaccine
applications, study specialist committees will carefully consider the risks and
potential benefits to assess whether the vaccine is likely to offer significant
improvements in the current epidemic. This is in line with the stated policy of
the US FDA as well.
The FDA has said that
approval for emergency use will only be granted after it has been determined
that the known and potential benefits outweigh the known and potential risks of
the vaccine ”. In conducting this experiment, the expert committee in India may
agree to look at the data generated during the tests conducted in other
countries, as is the case with applications made by the Serum Institute and
Pfizer. Indian authorities have also indicated that the application should not
always lead to approval, which will only be granted after a thorough scientific
analysis of the presented data. Subject specialist committees may reject an
application or request additional information if they are not satisfied.