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.
The government’s move to maintain the existing regulations until April 1, 2026, comes amid ongoing discussions about the risks associated with PoC assembly.
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.