COVID-19 Vaccine Update: Moderna to Apply For Rolling Review of Experimental Candidate in Europe
Under normal circumstances, a drug regulator applies for a review by the regulatory body only after completion of the clinical trials. But in case of a raging epidemic or pandemic, the vaccine maker seeks a "rolling review". In this process, the regulatory body begins analysing the trial data before the completion of the final round of tests.
New Delhi, October 8: Moderna Inc, the US-based drugmaker which is in the final phase of developing a COVID-19 vaccine, said on Thursday that it will apply for a "rolling review" of its candidate in Europe. The announcement came days after the continent's medicine regulator launched the process of rolling approval for Moderna's competitors. COVID-19 Vaccine May Be Ready by End of 2020, Says WHO Chief Tedros Adhanom Ghebreyesus.
In the past week, the European Medicines Agency announced a rolling review of the vaccine candidate of Oxford University and UK's drugmaker AstraZeneca Plc. This was followed by the start of a similar rolling review of the candidate being jointly developed by US' pharmaceutical giant Pfizer and Germany's BioNtech.
What is The 'Rolling Review' of a Vaccine Candidate?
Under normal circumstances, a drug regulator applies for a review by the regulatory body only after completion of the clinical trials. But in case of a raging epidemic or pandemic, the vaccine maker seeks a "rolling review". In this process, the regulatory body begins analysing the trial data before the completion of the final round of tests.
The rolling review process is aimed at completion of the regulatory inspection process by the time the final phase of trials are completed. In this way, the vaccine can be rolled out to the masses shortly after the completion of tests.
Moderna, in its statement released today, said it would present the same set of data before the European Medicines Agency as it has provided to the Food and Drug Administration (FDA) in the United States. The company also added that it would not immediately enforce patents on its technology to develop the vaccine, thereby allowing other developers to benefit from the same.
(The above story first appeared on LatestLY on Oct 08, 2020 11:40 PM IST. For more news and updates on politics, world, sports, entertainment and lifestyle, log on to our website latestly.com).