An expert has warned that staff will not have the “skills or experience” to perform the assembly required in a new technique for vaccine and pharmaceutical product distribution, called Point of Care (PoC) manufacturing.
The PoC process allows some hospitals and other permitted “points of care” to assemble or prepare vaccines and other treatments on-site, after the raw material is shipped to the distribution points. This became a widespread practice in the UK during the COVID-19 roll out of mRNA treatments.
Speaking to The Epoch Times via email, Hedley Rees, the owner of Pharmaflow and a consultant pharmacologist with over forty years of experience, said: “Point of care manufacture has been introduced into the NHS when staff do not have the skills or experience to ensure safe working practices. This is a dangerous experiment.”
As PoC vaccine assembly gains traction, concerns about potential hazards have emerged. These include compromised quality control, complex regulatory oversight, lack of skilled personnel, cross-contamination, logistical challenges, and difficulties in emergency response.
Mr. Rees’s discussions with the Medicines and Healthcare products Regulatory Agency (MHRA) have involved questioning the oversight of manufacturing new vaccine technologies within hospital pharmacies.
The MHRA clarified its role, stating that the Care Quality Commission (CQC) would be assuming oversight.
MHRA Has ‘All But Disintegrated’
Mr. Rees added: “The MHRA I used to work with as a consultant to the industry has all but disintegrated.
“The skilled inspectors of pharmaceutical facilities have left over the past ten years and either not been replaced, or their responsibilities handed over to raw recruits.”
Addressing these concerns back in July, Dr. Laura Squire, chief healthcare quality and access officer, outlined the proposed PoC “Master File” system to oversee vaccine manufacturing.
Responding to a pre-submitted question to the MHRA’s March board meeting, Ms. Squire stated that, “good manufacturing practice inspection would cover the control site.”
However, critical details, such as the identity and location of control sites and leadership, remain unaddressed, leaving questions about the plan’s effectiveness.
Serious allegations surrounding the MHRA have also been levied by an independent criminologist, sparking concerns about the authorization and approval process of Pfizer’s COVID-19 vaccine, and leaving question marks over rapid rollouts for future treatments.
Criminologist Josh Guetzkow, a professor at the Hebrew University of Jerusalem, made the case that the MHRA may have misled a senior minister over the product type that was being submitted for approval.
In a supporting letter to Mr. Guetzkow’s research from a British MP, the MHRA has been accused of misleading officials about Pfizer’s COVID-19 vaccine safety, including inadequate testing, suppression of adverse reactions, and misrepresentation of effectiveness.
Allegations Of Misconduct
In the letter from July 24, addressed to the attorney general, Andrew Bridgen, the MP for North West Leicestershire, brought attention to potential allegations of misconduct within the MHRA.He emphasised the MHRA’s crucial role in maintaining public confidence in medicine safety and urged adherence to relevant legislation and core values.
Maintaining that the MHRA could have misled ministers, Mr. Guetzkow’s research and supporting documents, submitted by Mr. Bridgen, show that when filing for approval of the Pfizer vaccine, only one production process was shown to ministers.
Mr. Guetzkow’s research examined the manufacturing process of a batch of the vaccine titled “EJ0553” and its role in the BioNTech/Pfizer COVID-19 vaccine trial.
The study contrasts lot EJ0553 with other trial ‘lots,’ relying on data from Japan’s PMDA, Australia’s TGA, and the U.S. FDA via FOI requests.
The analysis sheds light on crucial differences between lot EJ0553 and trial batches, providing valuable insights into the vaccine’s production and clinical trial variances.
According to the evidence, the product that subsequently made its way to many vaccine rollout centres followed a substantially different method of production.
Critics also argue that the MHRA’s inspections during the vaccine’s production may have been insufficient, raising several questions about the safety and quality of the product which was given to the public.
Comparisons with the way the rollout was performed, when contrasted with the MHRA’s internal Orange Guide 2022 (which lays out the standards for quality control in treatment rollouts), have fueled concerns about the level of quality control.
This is in particular due to the unprecedented use of mRNA technology in Pfizer’s vaccine formula, which left regulators with little quality control criteria to act on.
Speaking to this, Mr. Rees continued: “The last time MHRA approved a new drug, prior to SARS-CoV-2, was 1995. From then on, approvals were centralised in the European Medicines Agency (EMA), based then in Canary Wharf.
“The skills needed to evaluate an application to market a drug either moved to Canary Wharf or were lost to other opportunities. I honestly don’t know how they could have known the SARS-coV-2 injections were safe, let alone effective.”
Speaking to The Epoch Times, Mr. Bridgen spoke of his concerns at a possible dumbing down of the regulatory process, suggesting that, “The MHRA has moved from a regulator to an enabler.”
He spoke of the dangers of, “Allowing new products to move at ’the speed of science,'” which he believed could allow for regulatory errors along the way, without proper testing.
Mr. Bridgen pointed out that treatment for Swine Flu was withdrawn for 100 thousand adverse effects, while according to the latest statistics, reported side effects for the mRNA vaccine now stand at one in 50 thousand.
‘Full Indemnity For Big Pharma’
He added that the lack of due process surrounding the roll-out was, “effectively full indemnity for big pharma.”Mr. Bridgen stated that because of the speed at which the process of authorisation took, it “couldn’t have gone along with their (MHRA) protocols.”
He added that repeating this formula in the future would be “a recipe for disaster.”
Speaking about the allegations, Mr. Rees added that the, “MHRA did not physically inspect any of the UK sites manufacturing the SARS-CoV-2 injections, but awarded them manufacturing licences anyway.
“That is gross negligence—how did they know the facilities complied with Good Manufacturing and Distribution Practice? Then, MHRA approved all the injections in the knowledge that these legally enforceable standards had not been met.”
Historically, there is very little precedent to compare the MHRA’s actions to.
Mr. Bridgen and others have repeatedly pointed back to comments made in 2014, when former chief scientific advisor to the government, Sir Patrick Vallance, said: “In the future, medicines will come to market quicker with less data, with more research being conducted in the post-license phase.”
At the time, Mr. Vallance was working for GlaxoSmithKline.
Some now believe that the so-called “Point of Care” manufacturing process may be the result of this approach and may become the norm for more rapid medical rollouts.
The Epoch Times has reached out to both the MHRA and Pfizer for comment.
