June 20, 2022 | By Sonia Elijah | TrialSiteNews |

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

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.’

Link To Read The Full Article Here

Thank you to JM