News

HDA UK Media and Political Bulletin – 07 January 2021

Media Summary

UK health leaders call for clarity on Covid vaccine supplies

Financial Times, Sarah Neville & Helen Warrell, 07 January

The Financial Times reports that doctors and public health leaders in the UK have criticised a lack of transparency over the timing and quantity of COVID-19 vaccine supplies.They have added that logistical issues, such as reliable delivery schedules, will be crucial to meeting the government’s ambitious targets.

Ruth Rankine, who represents primary care networks for the NHS Confederation, said: “What we’re asking for is greater clarity about what is coming and when so that primary care can properly plan, both in terms of booking patients in and their workforce and staff rotas. The system was currently working on a “push model” and sites have little control over what they get and when they get it”.

Ms Rankine said she hoped the situation would improve as the Oxford/AstraZeneca vaccine was rolled out. But she cautioned that in order to meet the government’s target “we would need to see a much more effective supply chain in terms of numbers of the vaccines and numbers of sites being able to take part in the vaccination programme”.

Supply issues are also affecting hospitals at the forefront of the vaccination programme. Chris Hopson, Chief Executive of NHS Providers, said: “Trusts are in a position to administer more vaccines but at the moment there are constraints on supply arriving with them.” However, he said he believed supplies would increase quickly in the coming days.

 

COVID-19: What does it take to vaccinate 14 million people in six weeks?

Sky News, Philip Whiteside, 06 January

Sky News reports that the Government’s ambition to vaccinate 14 million people by the middle of February means that the roll-out of the vaccine will have to be scaled up significantly if the target is to be reached. However, this article outlines a number of challenges that remain at different stages of the programme, from manufacture right through to administration.

Since the approval of the Pfizer jab, the Government has built up a network of vaccination centres and hubs, with around 730 in England so far. Boris Johnson says there will be around 1,000 by the end of the week but experts say more will be needed if enough people are to be reached.

The Pharmaceutical Services Negotiating Committee said a better national plan was required, and similar calls were made by the Association of Independent Multiple Pharmacies and the Royal Pharmaceutical Society. PSNC Chief Executive Simon Dukes told Sky News: “If it is to achieve the government’s ambitious COVID-19 vaccination plan, we believe the NHS must look to community pharmacies.”

 

Parliamentary Coverage

Delegated Powers and Regulatory Reform Committee – 33rd Report – Medicines and Medical Devices Bill: Government Response

Delegated Powers and Regulatory Reform Committee Report, 07 January

The Delegated Powers and Regulatory Reform Committee has today published a letter from Lord Bethell, Parliamentary Under Secretary of State at the Department of Health and Social Care, concerning the recommendations made in the Committee’s report of 22 July 2020 on the Medicines and Medical Devices Bill.

In his letter, Lord Bethell introduces a number of amendments, intended to respond to concerns raised by the Committee. These include the introduction of:

  • Greater checks and balances in the exercise of the delegated powers, including the introduction of an overarching focus on safety; and
  • Strengthening the oversight of regulations establishing information systems.

The letter in full can be found here.

 

Further Amendments made to Medicines and Medical Devices Bill

House of Lords, 07 January

Further amendments have been tabled to the Medicines and Medical Devices Bill ahead of its report stage in the House of Lords.

Amendments include:

  • Safety of human medicines: An amendment which would require the Secretary of State to publish the criteria that would be used to determine whether the benefits of regulations that may impact on the safety of human medicines outweigh the risk. The amendment also requires the appropriate authority to publish their assessment of this.
  • Safety of medical devices: An amendment which would require the Secretary of State to publish the criteria that would be used to determine whether the benefits of regulations that may impact on the safety of medical devices outweigh the risk. The amendment also requires the appropriate authority to publish their assessment of this.
  • Medical devices: An amendment which would require the Secretary of State to create a statutory committee to provide advice in relation to medical devices.
  • Northern Ireland: This new Clause would require the Secretary of State to report on regulatory divergence between Northern Ireland and the rest of the UK.

The running list of amendments can be found here.

 

Oxford/AstraZeneca vaccine to be rolled out to GP services

NHS England Statement, 07 January

NHS England has confirmed that the new Oxford/AstraZeneca COVID-19 vaccine is being rolled out to General Practice-led services from today.

Seven vaccination centres will come online next week, alongside more hospitals, GP-led services and a number of pilot pharmacy vaccine services. The seven mass vaccination sites are in Stevenage, London, Newcastle, Manchester, Surrey, Bristol and Birmingham;

The NHS is also offering GP services an extra £10 for every care home resident vaccinated in January.

An NHS Statement on the Oxford/AstraZenece vaccine can be found here.

 

House of Commons, Written Question, 06 January

Julian Sturdy (Conservative, York Outer): To ask the Secretary of State for Health and Social Care, what plans his Department has to utilise community pharmacies in the roll-out of COVID-19 vaccines.

 

Disconnection of GB End-Users from NMVO

SecurMed Statement, 06 January

SecurMed has confirmed that all GB end users had their accounts locked at 23.00 on 31st December 2020 and subsequently all GB end user security certificates have been revoked. A verification test and analysis of logs was successfully completed. All Northern Ireland users remain connected to the UKNI Medicines Verification System.

A statement from SecurMed regarding EU Exit and UK MVS can be found here.

 

Factsheet: Falsified Medicines

Department of Health and Social Care, Policy Paper, 05 January

The Department of Health and Social Care has updated its FMD factsheet in relation to the Medicines and Medical Devices Bill 2020, following the end of the transition period. While the UK has a low prevalence of falsified medicines, and has robust strategies and operational protocols in place to protect patients, without the powers provided by the Bill it would be unable to put in place a bespoke falsified medicines system.

As part of the UK’s commitment to protecting patients, the DHSC is looking to establish a national scheme to continue to deter falsified medicines. It has committed to public consultation on the need and details of any national scheme, as well as a specific consultation on the use of data collected as part of any scheme. The DHSC expects to have a staged approach to engagement and consultation across the supply chain, with an initial aim of issuing a public consultation within 12 months of Royal Assent, subject to other priorities around medicines regulation.

The full policy paper can be read here.

 

Full Coverage

UK health leaders call for clarity on Covid vaccine supplies

Financial Times, Sarah Neville & Helen Warrell, 07 January

This article is subject to copyright terms and conditions. Please access the full article here.

 

COVID-19: What does it take to vaccinate 14 million people in six weeks?

Sky News, Philip Whiteside, 06 January

The government has promised to vaccinate nearly 14 million people by the middle of February, but experts say it will be an “ambitious” challenge.

Around 1.3 million people in the UK have now received one of the two vaccines currently being rolled out, but the distribution effort will have to be scaled up significantly if the target is to be reached.

So far, the most that have been put in arms in the course of a week is around 610,000 doses, but the government plans to ramp that up so, potentially, two million doses a week will be distributed.

The 13.9 million total that is needed, according to COVID Vaccine Minister Nadhim Zahawi, is made up of all residents in care homes and their carers, everyone over 70 years old, all frontline healthcare and social care workers and everyone who is clinically extremely vulnerable.

Mr Zahawi told Sky News the UK will have to roll out more than two million jabs a week to meet its target, and acknowledged it would require a “Herculean effort”.

  1. Manufacture

Currently, two vaccines have been given approval to protect against COVID-19 in the UK: the Pfizer/BioNTech vaccine, which was approved in early December and the AstraZeneca/Oxford candidate which was licensed in late December.

The Pfizer vaccines destined for the UK are manufactured in Belgium.

They’re produced in vials which contain about five doses each, placed in trays of around 100, and these trays are stacked in bespoke freezer boxes which keep the vaccine at -70C.

Once thawed, they can be stored for up to five days in a fridge.

AstraZeneca, which has the capacity to make vaccines in the UK, will get its initial doses from Netherlands and Germany, due to a “quirk of the programme”.

Ian McCubbin, Manufacturing Lead for the government’s vaccine taskforce, said the vast majority of the 100 million doses it will produce for the UK will be made in Britain, with only those needed right at the start of the rollout coming from Europe.

Two firms, Oxford BioMedica, of Oxford, and Keele-based Cobra Biologics will make the vaccine with another firm, Wockhardt, in Wrexham, providing what is known as “fill and finish” capability.

Getting the vaccines that are produced abroad to the UK should not be a problem as the government has said it will provide military aircraft in the event of blockages.

The vaccines makers have said it will not be manufacturing capacity that will prevent the government reaching its target.

Pfizer said on 2 January that “deliveries are on track” and a key member of the AstraZeneca team told The Times it will be able to supply two million doses a week by the third week of January.

But the so called “fill and finish” part of the process could continue to hold up supplies, with England’s Deputy Chief Medical Officer Jonathan Van-Tam saying a shortage of materials needed to produce and package vaccines could slow down the national rollout.

For this and other reasons, Chief Medical Officer Chris Whitty warned at the end of last week vaccine shortages were likely to cause problems for “several months”.

It has led the British Medical Association to say it needs “a guarantee” that supply lines are in place.

  1. Approval

Even if supplies can be guaranteed, they still have to meet the approval of regulators – a process that can hold up distribution.

In early January, almost 3.5m doses of the Oxford-AstraZeneca vaccine were understood to be awaiting approval by the Medicines and Healthcare Products Regulatory Agency (MHRA), with only 530,000 cleared for use following a process known as “batch testing”.

Each individual batch of biological medicines like vaccines has to undergo independent testing to ensure it is safe, a process that can take up to three weeks.

  1. Distribution/logistics

The biggest factor in distributing the vaccines is the temperatures they have to be stored at, with AstraZeneca being much easier to store and transport.

Whereas the Pfizer option needs moving in trays with dry ice being used to keep the interiors of the boxes cold, the Oxford/Astra candidate can be kept at fridge temperature (2C to 8C).

Since the Pfizer jab started to be distributed, the government has built up a network of vaccination centres and hubs, with around 730 in England so far.

Boris Johnson says there will be around 1,000 by the end of the week but experts say more will be needed if enough people are to be reached.

The healthcare sector is also urging a sizeable upscaling in the number of distribution points, with loud calls from the bodies that represent chemists, like Boots, Lloyds and independent stores.

The Pharmaceutical Services Negotiating Committee (PSNC), which represents pharmacists working on the front line, said a better national plan was required.

PSNC Chief Executive Simon Dukes, told Sky News: “If it is to achieve the government’s ambitious COVID-19 vaccination plan, we believe the NHS must look to community pharmacies.

“Pharmacies have a great track-record in vaccinations. Although some pharmacies are already up and running delivering COVID-19 vaccinations there is as yet no national plan to let pharmacies vaccinate their local communities: the NHS and government must now set out this plan.

“Pharmacies have been open throughout the COVID-19 pandemic offering healthcare advice close to people’s homes: we must now make the most of this formidable healthcare network to help with this latest challenge.”

Similar calls were made by the Association of Independent Multiple Pharmacies and the Royal Pharmaceutical Society.

Mr Zahawi said hospitals were used first in the rollout so it can be done in a “careful way”, followed by GPs and then by pharmacies.

  1. Administration

Once the vaccines have made it to the distribution points, they still have to be put into people’s bodies.

Some have claimed it is similar to the effort required to inoculate adults every year against influenza, but for flu the UK usually reaches only around 70-75% coverage of the key demographic of the over-65s, according to Prof Nilay Shah, of Imperial College London, which is around nine million people out of 12 million in total. He adds that this is usually achieved over the period from September to January, five months.

A number of commentators have said that it could be a lack of qualified staff that holds up distribution.

This an increasingly acute issue as healthcare workers themselves become affected by ballooning COVID infection rates across society as a whole.

But doctors themselves say there could be a range of other factors that could slow the process down.

Dr Richard Vautrey, the British Medical Association’s GP committee chair, told Sky News: “To reach this target within the time frame set out by government there will need to be a step-change.

“Once they have supplies, GPs need to be given the flexibility to let them focus on the vaccination campaign as a priority, and there must be honesty around what services will need to be paused to allow this to happen.

“Crucially, we need to be able to deliver vaccines from as many practices as possible, rather than larger sites – and with the launch of the AstraZeneca vaccine NHS England must allow us to do so.

“We also need a clear and consistent national vaccination plan, a reliable IT system, and bureaucracy must be greatly reduced, not least by slashing red tape preventing retired doctors and other healthcare workers from assisting the effort.

“But vitally, given the intense pressures on the NHS currently, if doctors and their colleagues, including those giving the vaccinations, are able to continue caring for patients they must be protected themselves – those risking their own health on the frontline must be vaccinated as soon as possible.”

The NHS is recruiting people to help with the distribution and has placed adverts in an attempt to recruit more people to help, but the numbers required are significant. Prof Shah said Imperial College estimates that 15,000 will be needed to reach a total of 250,000 vaccinations a day and double that for the half a million a day needed to exceed the two million doses that will likely be available.

If AstraZeneca is able to produce two million doses by the third week of January and Pfizer even more, a lack of qualified staff to carry out the distribution offers the prospect of doses sitting and waiting to be injected, with no one able to do the work.

  1. Monitoring

As the vaccinations are dispensed, it will be essential to continue to monitor the distribution effort, to make sure it is being successful, which will also limit the speed at which it can progress.

This is especially critical as the government is pressing ahead with a plan to administer the first dose of the AstraZeneca vaccine to as many people as possible, before offering the second after 12 weeks – way beyond the 21 days that its efficacy was tested against.

The effectiveness of this will only become apparent if accurate and detailed records are kept of what happens to many of those who are given the alternative regime.

Conclusion

Experts say reaching the target could be possible, but it would depend on a whole series of actions being coordinated.

Prof Nilay Shah, head of department of chemical engineering, Imperial College London, said: “Our analysis indicates that at steady-state it would be possible, with a great deal of co-ordination of manufacturing, logistics, rapid training of vaccination administration personnel, co-operation of patients, it should be possible to reach daily vaccination levels of 300,000 to 500,000 doses per day.

“These levels are several times higher than those achieved in peak influenza vaccination but in principle are achievable with additional resources and effective co-ordination.

“At 400,000 doses per day, assuming we move to seven-days-a-week operation, that is 50 days, which would get us to mid-Feb (for 100% coverage). It’s an ambitious target and needs everything to click every day.

“If the aim is for the first dose for the top four priority groups by mid-February, then we would need to hit 200,000 doses a day, again this is achievable but everything needs to go right every single day.”

HDA UK Media and Political Bulletin – 07 January 2021

From Factory to Pharmacy

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