Rolling review has become a need in the hour for most of the researchers who have been developing the covid-19 vaccine. A neck and neck competition is making the companies to vie for all short cut routes to produce the vaccine. Earlier it was fast track approval that came to light. Now rolling review is one such similar method where everyone are banking on.
What is rolling review?
Rolling review facilitates a country’s drug regulator assess submitted clinical trial data of the vaccine candidate on a real-time basis without having to wait for the entire data to be categorize.
The UK based Medicines and Healthcare products Regulatory Agency (MHRA) has kickstarted an accelerated or rolling review of AstraZeneca’s covid-19 vaccine candidate lately.
Regulators will get access to review trial data in real time under a rolling review process. It is fabricated to condensed the lengthy time period and help amp up the approval time of vaccines.
Clinical trials are evidently time-consuming process during the development of a new drug or vaccine. As reported earlier, as the phases of trial progresses the challenges too increase time to time in reporting the safety profile, drug adverse reactions etc of the participants. Regulatory body of the state and Institutional ethical committee will review the process. But with covid impact researchers are appealing the regulatory bodies to boost up the process.
Vaccines under rolling review
This process has already begun in neighbouring countries for certain vaccine candidates such as the Oxford and AstraZeneca’s COVID-19 vaccine. Now India is eyeing to introduce too.
The MHRA has begin a rolling review of Aztrazeneca’s vaccine candidate AZD1222, which is in the third phase. Last week the regulatory agency has started an accelerated review of Moderna’s mRNA-based vaccine candidate, Pfizer and BioNTech’s potential COVID-19 vaccine.
Experts have their say
Now the question remains to be answered whether rolling review of Covid-19 vaccine is worthy to escalate the process. Indian Council of Medical Research (ICMR) chief scientist and senior epidemiologist Dr Samiran Panda said, “India could already be considering it. I can see it happening quite proactively.”
There could be a bridging study that one could do in India. It is a smaller study involving less number of Indians and can skip waiting for many months for the trial data. Data from the earlier study done abroad and India can be collated,” Samiran added.
Dr Gagandeep Kang, microbiologist and professor at the Christian Medical College in Vellore expressed his view saying that, rolling review is a good choice as they keep regulators and developers connected. It makes standard review and for developers to put forth all ncessary safety and efficacy profile in sequential order rather than one large dossier at the end.
Anant Bhan, a researcher at Bioethics and global public health policy expert said however had a different take. “While this could help expedite the regulatory approval process, it could also mean that not the entire dataset and information on safety and efficacy of the vaccine candidate in the clinical trial is available to make a decision, and hence requires caution”, he stated.
Review status in India
As of now, controllers and analysts are likewise anticipating the clinical preliminary information for stage one and two of the Bharat Biotech shot for Covid-19, Covaxin.
In spite of the fact that the information has been notified to the Drug controller general of India (DCGI), which has given an approval to the firm to lead stage 3 trials in the nation, the information is yet to be disclosed.
Reportedly, Serum Institute of India, which has joined with Oxford-AstraZeneca to make and lead clinical preliminaries of its expected immunization in India, the organization declined to remark on the issue.
The administration likewise accepts that optimizing the cycle can’t be an alternative on the off chance that it hampers security. Authorisation of emergency use in limited way is another methodology unless there is a dire need.