The National Pharmacy Association has said it supports the Government’s proposal to introduce a temporary authorisation that will allow healthcare professionals to provide a tested but unlicensed Covid-19 vaccine to patients.
Following a public consultation on changes to the Human Medicines Regulations, the Government said it planned to “strengthen existing regulations that allow for the temporary licencing of medicines and vaccines on an exceptional basis pending the grant of a full licence".
A coronavirus vaccine is not yet available but if an unlicensed one does emerge, it could be used under regulation 174, which provides for a temporary authorisation of an unlicensed medicine or vaccine. The Department of Health and Social Care said regulation 174 will be robustly scrutinised and “reviewed within a year of any first use".
NPA policy manager Helga Mangion said the organisation was “pleased” with the DHSC’s “commitment to robust scrutiny, objectivity and safety” and supported the government’s position.
“In our submission [to the consultation] we reiterated the need for their objectives to be reviewed on a regular basis in line with new research and pandemic progression.
“We foresee community pharmacies will also have a crucial role to play in ensuring as many people as possible get protected by any future coronavirus vaccine.
“Provided the appropriate safety, quality and efficacy measures have been put in place, the NPA is supportive of the deployment of effective and legal mechanisms for bringing this pandemic under control.”
Sir Jeremy Farrar, a member of the government’s Scientific Advisory Group for Emergencies group, told Sky that more than one Covid-19 vaccine will be available “in the first quarter of next year".