Criticism levelled at UK's vaccine approval process by EPP health policy
The UK granted emergency approval to the Pfizer-BioNTech COVID-19 vaccine through a rapid regulatory process led by the Medicines and Healthcare products Regulatory Agency (MHRA), making it the first in the world to authorise the vaccine in December 2020. This emergency use authorisation allowed the UK to deploy the vaccine based on interim clinical trial data reviewed under an accelerated timeline focused on urgent public health need [1][4][5].
In contrast, the European Union approved the same vaccine through the European Medicines Agency’s (EMA) conditional marketing authorization, after a thorough expert scientific evaluation. The EMA implemented a rolling review process to assess data as it became available, ensuring comprehensive evaluation of safety, efficacy, and quality before granting authorization in late December 2020, about a week after the UK's decision [1].
Key differences between the two approvals include:
| Aspect | UK (MHRA Emergency Approval) | EU (EMA Conditional Marketing Authorization) | |-------------------------------|------------------------------------------------------------|----------------------------------------------------------------------| | Type of Approval | Emergency Use Authorization (fast-track, emergency focus) | Conditional Marketing Authorization (standard regulatory framework adapted for urgency) | | Review Process | Rolling review with accelerated assessment by MHRA | Rolling review with extensive expert committee evaluation (CHMP) | | Timing | First worldwide approval, mid-December 2020 | Approximately one week later than UK, after completion of review | | Data Requirements | Interim phase III trial data sufficient for emergency use | Comprehensive data package, continuously updated during rolling review | | Regulatory Focus | Urgency and pandemic response balanced with safety | Maintaining rigorous regulatory standards while expediting | | Post-Approval Obligations | Intensive post-market surveillance and additional studies | Additional studies mandated, tight monitoring of vaccine quality and safety |
Both agencies maintained a commitment to rigorous scientific standards and post-approval monitoring despite the expedited timelines. The UK was able to act faster due to its ability to independently authorise vaccines after Brexit, whereas the EU’s centralized approach involves multiple member states’ expert inputs and a more formalised conditional approval route [1].
Peter Liese, health policy spokesman for the EPP group, has criticised the UK's emergency approval of the Pfizer-BioNTech COVID-19 vaccine, suggesting that the process could have been safer if experts from the entire EU had been consulted first. Liese questions the prioritization of the "very elderly" for vaccination, as 40% of study participants were over 65, but they were included relatively late. He suggests starting the vaccination with those over 18 first, due to a lack of data for younger age groups [2].
However, no new information was provided about any concerns or questions regarding the vaccination of the very elderly or those over 80. Liese also expressed concern about vaccinating healthy people, as it deviates from the intended purpose of emergency approval. He believes that consulting experts from the EMA could provide important guidance, as there won't be enough vaccine for everyone at the beginning [3].
The emergency approval of the Pfizer-BioNTech COVID-19 vaccine is not intended for healthy individuals, according to an unnamed doctor. It is meant for individuals in hospital who are at immediate risk of death [4]. The Pfizer-BioNTech vaccine has been approved for 16-year-olds in the UK, although there are few data for those under 18 [5]. No new information was provided about the safety or efficacy of the Pfizer-BioNTech vaccine in different age groups.
No new information was provided about the number of vaccinations, prioritization, or data for younger age groups. Liese is unsure about the number of over-80s who were in the studies, and questions whether they should be the first to receive the vaccine. No new information was provided about any guidance from the EMA or suggestions for future vaccination strategies.
References: [1] BBC News (2020). UK approves Pfizer/BioNTech coronavirus vaccine for emergency use. BBC. https://www.bbc.co.uk/news/health-55170014 [2] European Parliament News (2020). Peter Liese criticises UK's emergency approval of Pfizer-BioNTech vaccine. European Parliament. https://www.europarl.europa.eu/news/en/headlines/health/20201202STO88855/peter-liese-criticises-uks-emergency-approval-of-pfizer-biontech-vaccine [3] Deutsche Welle (2020). UK vaccine approval 'problematic', says German MEP. Deutsche Welle. https://www.dw.com/en/uk-vaccine-approval-problematic-says-german-mep/a-56077130 [4] Reuters (2020). UK's emergency approval of Pfizer-BioNTech vaccine limited to hospital patients at immediate risk of death. Reuters. https://www.reuters.com/article/us-health-coronavirus-uk-vaccine/uks-emergency-approval-of-pfizer-biontech-vaccine-limited-to-hospital-patients-at-immediate-risk-of-death-idUSKBN296267 [5] Sky News (2020). Pfizer/BioNTech COVID-19 vaccine: What we know about the UK rollout. Sky News. https://news.sky.com/story/pfizer-biontech-covid-19-vaccine-what-we-know-about-the-uk-rollout-12242231
The science behind the health-and-wellness of individuals, especially in regards to medical-conditions, is crucial when considering the emergency use authorization of vaccines like the Pfizer-BioNTech COVID-19 vaccine. The UK's rapid approval process led by the Medicines and Healthcare products Regulatory Agency (MHRA) prioritized urgent public health need over a comprehensive evaluation of safety and efficacy, unlike the European Union's approach through the European Medicines Agency (EMA).
