EMA chief says Pfizer, Moderna data ‘very robust,’ defends vaccine review approach

Regulatory NewsRegulatory News | 10 December 2020 |  By 

Emer Cooke, the European Medicines Agency’s (EMA) newly installed executive director, on Thursday told a European Parliament committee that data submitted in support of COVID-19 vaccines developed by Pfizer/BioNTech and Moderna are “very robust”.
The meeting occurred hours before the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee would meet to discuss authorizing the Pfizer/BioNTech vaccine for emergency use and just days following decisions by regulators in the UK, Canada and Bahrain to give the vaccine some form of emergency authorization.
Cooke defended the agency’s approach to pursue conditional marketing authorization for COVID-19 vaccines and EU member states’ collective decision not to issue temporary emergency authorizations, even though doing so would push back the rollout of the vaccines by days or weeks in the EU compared to other jurisdictions.
Despite the slower process, Cooke stressed that EMA staff and scientific committees are “working around the clock” and in shifts on the reviews. “Nobody is turning their phone off,” she said.
“The process for assessing the conditional marketing authorization application follows the same steps and committees as for our regular marketing authorization but in a very expedited manner due to the emergency and building on the scientific work that has been done over the past months during the rolling reviews. I want to really stress that the conditional marketing authorization is a formal marketing authorization with the corresponding rights, obligations and liabilities. It provides for an agreed plan with specific and legally binding obligations on the applicant to ensure that additional data continues to be generated so that we can review it on an ongoing basis,” Cooke said.
Cooke told the committee that EMA will stick to its previously stated timeline to complete its assessment of the Pfizer/BioNTech vaccine by 29 December and the Moderna vaccine by 12 January. (RELATED: MHRA authorizes Pfizer-BioNTech COVID vaccine as FDA, EMA set more conservative timeline, Regulatory Focus 2 December 2020; Health Canada authorizes Pfizer's mRNA vaccine under interim order, Regulatory Focus 9 December 2020).
“EMA is now assessing all the additional data submitted last week and if our experts find that they are sufficiently robust and complete, we could issue our opinion for conditional marketing authorization for the BioNTech-Pfizer vaccine by 29 December at the latest and for the Moderna vaccine on 12 January at the latest,” she said. (RELATED: Pfizer, Moderna apply for EMA authorization; Janssen's candidate begins rolling review, Regulatory Focus 1 December 2020).
Cooke acknowledged the decisions by other regulators but said she does not want to comment on their approaches. “I have to stress that the authorizations that are granted in these contexts are for use or temporary supply of unlicensed vaccines, they are not marketing authorizations as such,” she said, adding that by sticking to a centralized review process, “All member states, big or small, will benefit from the joint work done at the EU level.”
EMA’s evaluation will take into consideration findings from other regulatory authorities and that the agency has received case reports from two suspected adverse reactions to the Pfizer/BioNTech vaccine identified in the UK this week, Cooke said. “Our experts are reviewing those [and] are looking again through the data to see whether this could be linked to the vaccine.”
Cooke also addressed the recent cyberattack against EMA but did not provide many details beyond what was disclosed Wednesday. (RELATED: EMA hit by cyberattack, Pfizer-BioNTech documents accessed, Regulatory Focus 9 December 2020).
“We have been subject of a cyberattack over the last couple of weeks. This is being investigated. I can assure you that this will not affect the timeline for delivery of vaccines and that we are fully functional,” Cooke said, adding that the investigation involves experts from EU cybersecurity and law enforcement agencies, as well as the Dutch police.
European Parliament


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy