What the Leaked EMA Emails & Docs Reveal: Major Concerns with Pfizer C-19 Vaccine Batch Integrity and The Race to Authorise

You can read the full article in Trial Site News.

Trial Site News recently were able to review leaked internal emails from the European Medicines Agency (EMA) and meeting report between the agency and Pfizer. The EMA oversees the evaluation and supervision of medicinal products for the European Union. Like other regulatory health bodies, its main responsibility is to protect and promote public health. Snapshots of internal EMA email correspondence; a November 26, 2020, PowerPoint presentation from a pivotal meeting between Pfizer and the agency, as well as a confidential 43-page Pfizer report were provided by an anonymous source because of their trust in Trial Site’s commitment to transparency, accessibility, and accountability in furtherance of a highly ethical, quality-focused and public health-centric biomedical research industry.

Regulatory agencies, like the EMA, the Food and Drug Administration (FDA) in the U.S. and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) are chartered to make decisions based to better the public. External influences such as political or media pressure are not meant to be a driving factor in their decision-making, however, when it came to pandemic conditions and the fast-tracked conditional marketing authorization of the Covid-19 vaccines (particularly for the mRNA-based vaccines produced by Pfizer-BioNTech and Moderna), it appears the latter won the day.

The time period of the email correspondence in question stretches from November 10 – 25, 2020, just weeks before the EMA granted CMA (conditional marketing authorization) for the Pfizer-BioNTech Covdid-19 vaccine on December 21, 2020. The FDA granted EUA (emergency use authorization) for this vaccine on December 11 with the MHRA making it first to the finish line on December 2. Here this author uses the term ‘finish line,’ as the emails do reveal an intense, almost competitive-like rush to authorize the Covid-19 vaccines, as quickly as possible. Understandably, the world was gripped by a pandemic at the time, where there was immense impetus to authorize a vaccine to protect people from the novel coronavirus.

The Rush into EUA

In an email from Marco Cavaleri, at the time the EMA’s Head of Biological Health Threats and Vaccines Strategy, communicated with urgency how the U.S. FDA “are going to rush into EUA.”

Cavaleri refers to this ‘rush’ being ‘pushed hard by Azar and US GOV.’ Under the Trump administration, Alex Azar, former pharmaceutical executive was the United States Secretary of Health and Human Services (HHS) from 2018-2021. The FDA is an agency that falls directly under the HHS.

It’s worth noting that when Azar was former president of Lilly USA LLC, a division of Eli Lilly, drug prices skyrocketed under his leadership. The pharmaceutical company was also embroiled in a class-action lawsuit under his tenure where it was accused of exploiting the drug pricing system to increase profits for its insulin drug. Of course, this doesn’t necessarily mean this executive was complicit in any way, but the timing is noteworthy.

Cavaleri’s email speaks to the extent of how politics (and the US government) was driving the FDA’s regulatory process, making sure it was going at ‘warp speed’. And of course, on that note Trump’s Operation Warp Speed was to ensure all vaccine development records would be shattered. The intentions were undoubtedly good given the outbreak of the worst pandemic in a century.

However, across the Atlantic in Europe’s regulatory agency tension mounted as the pressure to accelerate deadlines made the air and general mood tense—the pressure and anxiety was palpable in the reviewed email exchanges.

Persons of high integrity and clarity as to their roles and commitments as stewards of public health emerged. For example, one individual demonstrated palpable concern over accelerated timelines to ensure they would meet the ‘deadline’ for vaccine authorization at the expense of a robust assessment. He was Noel Wathion, at the time the EMA’s deputy executive director, but who has since retired. This EMA official importantly pointed out, ‘We are speeding up as much as possible, but we also need to make sure that our scientific assessment is as robust as possible. Let’s not forget the responsibility/accountability attached to the recommendation to the EC to grant a CMA.’

Wathion assumes the FDA (and the MHRA’s) EUA would be issued before the EMA granted its own CMA, which turned out to be correct. What’s interesting is his concern to address the ‘damage limitation’ resulting from the probable outcome of the EMA finishing last in this regulatory race and his fear that this would result in public opinion and the media turning against the agency.   Speed seemingly superseded concerns of quality based on a careful review of these emails.

In a November 19 email, Wathion reveals a ‘rather tense’ TC (teleconference call) with the European Commissioner (Ursula von der Leyen) which was ‘at times even a bit unpleasant.’ This reflects the mounting pressure which the EMA staff were under to issue CMA quickly following an EUA granted by the FDA/MHRA for the Pfizer-BioNTech vaccine. Von der Leyen is implicated in potentially being responsible for this tense environment with ‘a delay of several weeks...not easily acceptable for the EC [European Commission].’

In early 2022, Trial Site News reported how von der Leyen was embroiled in scandal when a group of independent MEPs demanded her immediate resignation and full disclosure of a series of private text messages between her and Pfizer’s CEO, Albert Bourla. Only a small portion of these texts were ever disclosed. Of the ones that were, they revealed her negotiating portions of a European-wide vaccine deal, unilaterally with Bourla via a series of texts! Clearly standard protocols in Europe were thrown out the window in favor of expediency and this seemingly was tied to a unified competitive pressure on all three regulatory agencies.  

Wathion lays bare his reflections after this particular TC, and shockingly writes how ‘the political fall-out seems to be too high even if the “technical” level at the MSs [Member States] could defend such a delay in order to make the outcome of the scientific review as robust as possible.’  Put another way the continuous broadcast of science first appeared as a cover for politics first.

Wathion points out that a potential delay of several weeks to secure ‘robust assurance in particular as regards CMC and safety’ will be met with ‘criticism from various parties,’ including media, EC (European Commission) and EP (European Parliament). Wathion speaks of his fear that if the deadline ‘to align as much as possible with the “approval” timing by FDA/MHRA’ cannot be met- ‘we will be overwhelmed from all fronts and be in the middle of the storm.’ However, this potential delay appeared to be necessary ‘in order to make the outcome of the scientific review as robust as possible.’ This implies that speed at the expense of safety was the order of the day to avoid ‘political fallout.’ Clearly, politics was dictating Covid-19 vaccine authorisation protocol, not the science.

You can read the full article in Trial Site News.