Pfizer, Moderna apply for EMA authorization; Janssen's candidate begins rolling review
Two vaccines against COVID-19 are under consideration for conditional marketing authorization by the European Medicines Agency (EMA), and a fourth vaccine candidate has entered the regulator’s rolling review process.The European regulator could deliver an opinion on applications “within weeks” for the two messenger RNA (mRNA) vaccines developed by collaborations between Pfizer and BioNTech and between Moderna and the National Institutes of Health.
“Such a short timeframe is only possible because EMA has already reviewed some data on the vaccine during a rolling review,” wrote EMA on 1 December, in announcing its receipt of the applications.
The rolling review process has allowed EMA to take in ongoing clinical trial data and begin quality assessments as the vaccine sponsors move through the clinical trial and marketing authorization application processes. (RELATED: EMA kicks off rolling review of AstraZeneca COVID vaccine candidate, Regulatory Focus 1 October 2020)
EMA’s process for issuing a conditional marketing authorization takes into account the need for alacrity in reaching a decision and allows for reaching a decision based on less data than usually would be required to support a full marketing authorization.
However, wrote the agency, “the data must show that the benefits of the medicine or vaccine outweigh any risks,” and ongoing post-marketing data collection will be needed to move any conditionally authorized vaccines to fully authorized status. Conceptually, the rolling review process is ongoing through the period of conditional authorization until a full marketing authorization is issued.
In addition to EMA’s role in speeding vaccine candidates through its review process to the point of recommending conditional marketing authorizations, “The European Commission will then fast-track its decision-making process with a view to granting a conditional marketing authorization valid in all… member states within days,” according to EMA.
The agency had previously announced that sponsors will be required to provide monthly safety reports in addition to submitting other required post-marketing data for conditionally authorized COVID-19 vaccines. EMA has also enacted additional transparency measures to build public confidence in vaccines and therapeutics to combat the novel coronavirus. (RELATED: EMA outlines regulatory transparency measures amid COVID pandemic, Regulatory Focus 30 October 2020)
As a newcomer to EMA’s rolling review process, the pharmaceutical company Janssen’s COVID-19 vaccine, Ad26.COV2.S, joins the University of Oxford and Astra Zeneca’s adjuvanted chimpanzee adenovirus vector vaccine and the two mRNA vaccines. The European regulator said that its decision to begin its fourth rolling vaccine review was based on pre-clinical and early clinical studies suggesting good immunogenicity for Janssen’s COVID-19 vaccine.