EMA responds to MEPs’ inquiry on COVID vaccines, data integrity concerns

Regulatory NewsRegulatory News | 07 December 2021 |  By 

The European Medicines Agency (EMA) on Friday responded to an inquiry from several members of the European Parliament (MEPs) concerning the agency’s reviews of the mRNA COVID-19 vaccines developed by Pfizer/BioNTech and Moderna, as well as a report published last month in The BMJ that raised concerns about data integrity at a US trial site for Pfizer’s vaccine.
In her response to the inquiry, sent by MEPs Michèle Rivasi, Piernicola Pedicini and Tilly Metz, EMA Executive Director Emer Cooke stressed the rigorousness of EMA’s assessments and its adherence to EU legislation pertaining to clinical trials. Cooke also downplayed the impact of the data integrity concerns raised in The BMJ article, as the concerned trial site only accounted for a small percentage of enrollment in the trial.
In response to a question from the MEPs on the additional data and studies used to support EMA’s recommendation for booster doses of Pfizer/BioNTech’s Comirnaty and Moderna’s Spikevax, EMA said its Committee for Medicinal Products for Human Use (CHMP) reviewed data from studies carried out by independent researchers to base its decision to recommend additional doses for immunocompromised people and studies conducted by the companies to support its recommendation for boosters in people with healthy immune systems.
“EMA’s assessment reports on boosters for Comirnaty and Spikevax are available on EMA’s website,” the agency notes. EMA also said it plans to publish the clinical data contained in the applications from both companies, which will consist of clinical overviews, clinical summaries, clinical study reports, study protocols, case report forms and the statistical analyses plans in the first quarter of 2022.
BMJ report
The MEPs also pressed EMA on a report published in The BMJ last month that cited data integrity and laboratory management issues at a Texas-based clinical site operated by clinical research organization (CRO) Ventavia Research Group.
In response to a question about the adequacy of the data submitted by Pfizer in support of Comirnaty, EMA responded that it “receives extensive data, including full clinical study reports with individual patient-level data, in marketing authorisation applications.” Further, EMA said that, “Although EMA does not request raw data sets or re-analyse such data, studies supporting the marketing authorisation of a medicine must comply with strict rules and are regulated,” citing international good clinical practice (GCP) standards and routine inspections to confirm compliance.
The agency added that it “sought reassurance that the applicant’s studies were GCP compliance” during its assessment and “considered a report of a GCP inspection of a site in Germany by Regierungspräsidium Karlsruhe and the Paul Ehrlich-Institut; reports from a GCP inspection by US Food and Drug Administration (FDA) of six investigator sites in the United States; and reports and the summaries of the outcome from two GCP inspections by the National Administration of Drugs, Foods and Medical Devices (the Argentinian medicines authority) conducted at the single site located in Argentina,” before determining that there were no concerns warranting an EMA inspection.
Yet, the agency said it is aware of the “reported irregularities” and is reviewing the claims made in The BMJ alongside the FDA. However, EMA said that the deficiencies, “Do not jeopardize the quality and integrity of the data from the main Comirnaty trial and have no impact on the benefit-risk assessment or on the conclusions on the safety, effectiveness and quality of the vaccine.” EMA notes that the pivotal trial for the vaccine enrolled approximately 44,000 individuals at 150 sites around the globe.
In contrast, the company at the center of The BMJ report, Ventavia, enrolled about 1,000 participants from three sites in the US, which accounts for less than 3% of the trial’s total enrollment.
“The issues affected one of those 3 sites and mainly concerned a lack of trained staff which resulted in deficiencies such as delays in data entry and queries resolution. The marketing authorisation holder audited the company at the end of 2020, and corrective actions were taken, including oversight visits and hiring of additional staff. These actions were deemed appropriate,” EMA said.
The agency also responded to a question about the decision by several European countries to suspend the use of Moderna’s Spokevax for men under 30 years of age due to the risk of myocarditis and pericarditis.
EMA said that its Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed recent data on those risks from two large European epidemiological studies that found those conditions “only occur very rarely after vaccination with Comirnaty and Spikevax, meaning that up to a maximum of 1 in 10,000 vaccinated people may be affected, though the risk is highest in younger males. The risk was also higher for males who received Spikevax, and EMA notes that PRAC has already recommended revising the product information to reflect these findings.


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