The UK government has decided to extend emergency regulations to ensure the swift administration of COVID-19 and influenza vaccines, including controversial assembly via Point of Care (PoC) manufacturing.
The PoC process, allowing certain authorised points of care to assemble vaccines and treatments on-site after receiving raw materials, gained traction during the COVID-19 rollout of mRNA treatments in the UK.
Despite its widespread adoption, concerns have been raised regarding the competency of staff involved in PoC manufacturing.
The government stated that “The consultation received 220 responses, with significant support expressed (over 80%) for each proposal.”
It added: “Several responses highlighted how these regulations have improved the delivery of Covid and flu vaccinations in a safe and effective way, allowing vaccines to be deployed at speed and scale, whilst maintaining patient safety.”
These more lenient regulations, introduced in response to the pandemic, were amended to allow vaccines to be safely deployed at speed and scale, addressing concerns related to workforce availability and streamlined processes.
The announcement came alongside confirmation of a continuation of regulations ensuring the safe and swift administration of COVID-19 and influenza vaccines.
Warnings About PoC Assembly Voiced
Earlier this month, warnings surfaced about potential hazards related to PoC assembly, highlighting compromised quality control, regulatory challenges, and a lack of skilled personnel.Experts, including Hedley Rees, owner of Pharmaflow and a consultant pharmacologist, have voiced alarm, citing the absence of necessary skills and experience among health care workers involved in this process.
Speaking to The Epoch Times last month, 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.”
In light of these concerns, the government’s decision to extend regulations ensuring vaccine delivery safety raises questions about the implications of PoC manufacturing on the overall quality and safety of vaccines.
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 is the regulatory body responsible for ensuring that medicines, medical devices, and blood components used in the UK are safe, effective, and of high quality.
The MHRA clarified its role, stating that the Care Quality Commission would be assuming oversight.
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.”
During the pandemic, the MHRA played a pivotal role in the approval and monitoring of COVID-19 vaccines and treatments.
Addressing these concerns back in July, Dr. Laura Squire, chief health care quality and access officer, outlined the proposed PoC “Master File” system to oversee vaccine manufacturing.
Critical Details Remain Unaddressed
However, critical details, such as the identity and location of control sites and leadership, remain unaddressed, leaving questions about the plan’s effectiveness.Alongside the announcement on the continuation of PoC manufacturing, the consultation was also used to extend two further regulations.
The government will continue allowing providers operating under NHS arrangements or the medical services of His Majesty’s Armed Forces to now transfer COVID-19 and influenza vaccines between locations without the necessity of holding wholesale dealer’s licences.
This change aims to simplify the vaccine supply chain.
Secondly, an extended workforce is now legally permitted to administer COVID-19 and influenza vaccines without requiring the direct involvement of a prescriber.
This flexibility in vaccine administration comes with the condition of following an approved protocol, in an attempt to ensure both legality and safety in the process.
