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Plans for expanded workforce to deliver unlicensed Covid vaccine become law



New laws that will see midwives and paramedics administer vaccines and grant the MHRA powers to approve an unlicensed Covid vaccine are being introduced today.

They follow the Government’s public consultation launched in August and come as Pulse exclusively revealed yesterday that preparations are being made for a possible start to a Covid vaccination programme in December.

Following the changes, ‘midwives, nursing associates, operating department practitioners, paramedics, physiotherapists and pharmacists’ can be trained to give both Covid and flu vaccines.

The Government said that the legal amendments to the Human Medicine Regulations 2012 will also:

  • Allow for the temporary licencing of medicines and vaccines, on an exceptional basis, pending the grant of a full licence.
  • Give part immunity from civil liability to companies producing the vaccine, rather than just healthcare workers and manufacturers.
  • Ensure that the vaccines and treatments used in response to certain specific types of public health threat, such as a Covid-19 vaccine, can be promoted as part of national vaccination or treatment campaigns.
  • Allow armed services to transfer Covid and flu vaccines ‘under authorised arrangements’ by providing an exemption from the need for a wholesale dealer’s licence.

Health secretary Matt Hancock said: ‘The NHS has vast experience in vaccinating millions of people against diseases every year.

‘These legal changes will help us in doing everything we can to make sure we are ready to roll out a safe and effective Covid-19 vaccine as soon as it has passed clinical trials and undergone rigorous checks by the regulator.’

Based on the consultation, which saw 191,740 responses in just three weeks, the Government has made three key amendments to proposals.

These include ‘requirements for the supervision of an additional experienced vaccinator’  in relation to the expanded workforce that can deliver Covid and flu vaccines.

The Government has also committed to a formal review of the new regulations allowing the use of unlicensed medicines or vaccines ‘within a year of any first use’.

It has also changed the ‘objective bystander’ test that relates to loss of immunity from civil liability where conditions are breached to make this a person who has ‘relevant expertise in the subject matter of the breach’.

The BMA’s GP Committee has said that expanding the workforce who are trained and able to give immunisations ‘would be helpful’ in light of a mass Covid vaccination campaign.

Yesterday, Pulse could reveal that there is currently no agreement over who is going to administer the vaccines, including whether it will be GPs.

Pulse has learned from a number of sources that discussions are taking place between NHS England, the BMA and other groups over who will be administering vaccines and who will be the first cohorts to receive the vaccine.

There is no guarantee the vaccine will be ready by December, but a source close to the discussions told Pulse the feeling is ’50/50′.

It comes as the Government has procured 65m syringes from one manufacturer as part of preparations for a potential Covid-19 vaccine which were due for delivery in September.

Pulse reported in August that the DHSC is considering yet-to-be-licensed flu vaccines as a way to procure enough stocks for this year’s expanded campaign.

The Joint Committee on Vaccination and Immunisation last month said people living in care homes and the staff looking after them should be at the very top of the list for a potential Covid-19 vaccine. Healthcare and social care workers would be next in the list of priorities, according to its updated analysis of who is most at risk.

READERS' COMMENTS [4]

David Jarvis 16 October, 2020 6:01 pm

I do wonder who makes simple things complex and why. We have a paramedic who can take blood and stick IV lines in. And recently drained a haemothorax at the road side but needs to do a 2 day course to be able to give flu jabs. These courses are classic jobs for the Rear Echelon MF and if they were sorted then it would free up some highly trained staff to do covid jabs. I mean if they can fill 2 days on giving a vaccine then there knowledge and skills must be vast. I would struggle to fill 10 minutes.

Donald Couper 16 October, 2020 9:26 pm

David,
You are quite correct in highlighting unecessary red tape. There are a lot of recently retired NHS staff who could fulfill this role easily.
I wonder if it has anything in common with the NHS reluctance to use local authority track and trace, or private laboratory capacity for testing? There needs to be greater openess on how these seemingly perverse decisions come to be made from government, and the opposition needs to drive this.

Patrufini Duffy 16 October, 2020 11:06 pm

My free transformative suggestion. Postman Pat.

David Church 17 October, 2020 10:59 am

Why would the MHRA ‘approve’ an unlicensed vaccine?
Why can’t they just ‘License’ it?
What is wrong with it that it cannot be licensed?
Should I decline to have or give it because it is unlicensed?
Will MHRA answer these predictable, reasonable, and serious questions?