Findings highlight the fragilities of the manufacturing process, but companies aren’t willing to release information.
Documents leaked from the European Medicines Agency (EMA) following a cyber attack in December show that some early commercial batches of Pfizer-BioNTech’s COVID-19 vaccine had lower than expected levels of intact mRNA molecules.
These molecules instruct our cells to make a harmless piece of coronavirus protein, triggering an immune response and protecting us from infection if the real virus enters our bodies.
The complete, intact mRNA molecule is essential to the potency of the vaccine.
But in a special report for The BMJ today, journalist Serena Tinari shows that the EMA was concerned about the difference in quality between clinical batches and proposed commercial batches of Pfizer-BioNTech vaccine.
Specifically, EMA had major concerns over unexpectedly low quantities (around 55%) of intact mRNA in batches of the vaccine developed for commercial production.
It is an issue relevant not just to Pfizer-BioNTech’s vaccine but also to those produced by Moderna, CureVac, and others, as well as a “second generation” mRNA vaccine being pursued by Imperial College London.
In an email dated November 23, 2020, a high ranking EMA official outlined a raft of issues. In short, commercial manufacturing was not producing vaccines to the specifications expected, and regulators were unsure of the implications on safety and efficacy.
EMA responded by filing two “major objections” with Pfizer, along with a host of other questions it wanted addressed.
Ultimately, on December 21, EMA authorized Pfizer-BioNTech’s vaccine and a report published on its website, noted, “the quality of this medicinal product, submitted in the emergency context of the current (COVID-19) pandemic, is considered to be sufficiently consistent and acceptable.”
However, it’s unclear how the agency’s concerns were satisfied, writes Tinari.
The BMJ asked Pfizer, Moderna, and CureVac, as well as several regulators, what percentage mRNA integrity they consider acceptable for vaccines against COVID-19.
None offered any specifics, and in subsequent correspondence, EMA, US Food and Drug Administration (FDA), and Canadian medicines regulator Health Canada all stated that specific information related to the acceptability criteria is confidential.
Pfizer also declined to comment on what percentage mRNA integrity it is aiming for, nor would it address questions about the cause of the unexpectedly low percentage mRNA integrity in certain batches, leaving open the question of whether it could happen again.
Moderna declined to respond to any of The BMJ‘s questions, while CureVac told The BMJ that “it is too soon to give details.”
The shortage of information may reflect the lack of certainty, even among regulators, about how to assess the evidence fully for this novel technology, suggests Tinari.
Professor of biopharmaceutics, Daan J.A. Crommelin, told The BMJ that, “For small, low molecular weight products, the active pharmaceutical ingredient integrity is typically close to 100%.”
But for mRNA vaccines? “Experience with mRNA integrity is limited.”
Reference: “The EMA covid-19 data leak, and what it tells us about mRNA instability” by Serena Tinari, 10 March 2021, The BMJ.
Those medical agencies are in too close relations with the pharma industry, no wonder that they approve now also 6 and 7 digit price shields and even “custom” designed medicaments for very rare diseases. Nobody interested to investigate possible bribery?
These companies are going to great lengths to avoid liability from any complications or side effects their product might cause, this itself should be a warning sign. Let alone the amazingly fast development, non existent safety testing, previous lawsuits where they injured and murdered people, were found guilty and paid millions, the obvious conflict of interest in their studies, they refuse to provide information about their products, keep lying saying its a safe product, are collaborating with other companies for profit reasons (passports), thousands of doctors and journals are warning of the lack of data to confirm safety and effectiveness, vaccines were not designed to stop transmission but to reduce the disease symptoms, serious adverse events were reported at a rate far superior to other vaccines, including people with permanent injury or dying…
The reason these vaccines were developed so quickly is because of funding. Also, there were reports of Russian disinformation with regards to these vaccines. So just calm down, the vaccines are safe.
Please also have a look at the interview of a German molecular biologist talking about the dangers of the mRNA vaccine production process and why this vaccine can actually alter your DNA. https://bit.ly/vaxxbombshell
THIS IS TRUTH
THE CORONA SCANDAL: THE GREATEST CRIME AGAINST HUMANITY IN THE HISTORY OF THE WORLD: