News

HDA UK Media and Political Bulletin – 08 January 2021

Media Summary

Analysis: vaccination rollout plagued by shortages and logistical problems

The Telegraph, Bill Gardner, 07 January

The Telegraph reports that the vaccine rollout has faced a series of logistical problems leading to delayed deliveries, ultimately slowing down the countrywide vaccination programme.

Dr Ammara Hughes, of the Bloomsbury Surgery in North London, said: “I did tell Matt Hancock that our deliveries are quite ad hoc to say the least, and he seemed quite surprised. It’s frustrating because we’ve had to cancel appointments, and we do have the capacity to vaccinate three to four thousand patients a week – if we have the supply.”

Birmingham leaders have also reported supply issues, saying the city had not been supplied with a single dose of the Oxford vaccine, with supplies of the Pfizer jab due to “run out” on Friday. A source close to the Pfizer distribution has suggested there must be a “buffer” of doses waiting somewhere in the UK to be delivered, adding they believed there could be delays occurring once the vaccine is reaching the Government’s designated sites.

Once it reaches these storage facilities, it is then the Government’s responsibility to arrange logistics and get the doses out to vaccination sites, the source said. One NHS source suggested there was a problem with the time taken by Public Health England to safety check vaccines at a single giant warehouse in Merseyside before transporting deliveries to NHS vaccine hubs. Public Health England, however, denied the claims with Interim Chief Executive Michael Brodie insisting, “We have delivered 100 per cent of orders from the NHS on time and in full.”

 

Government to consult on national falsified medicines detection system

The Pharmaceutical Journal, Corrinne Burns, 07 January

The Pharmaceutical Journal reports that a public consultation has been promised by the UK Government on the details of a potential national scheme to replace the Falsified Medicines Directive, which ceased to apply in Great Britain at the end of the Brexit transition period.

The government has said it plans to consult the public on a national scheme to detect falsified medicines in the supply chain within a year after laws enabling the potential new scheme are enacted.

General Manager of SecurMed, Jerome Bertin, said that, when considering the proposals, “some sort of hybrid national scheme that takes into account what the whole of the UK requires, not just Great Britain (GB), will be needed”.

He added that “when considering the GB element of the national scheme, the DHSC/MHRA will want to take into account the positive benefits and features of EU FMD, while resolving and simplifying some of the more unworkable or onerous requirements for the UK medicines supply chain”.

 

UK left trailing as EU quickly approves Moderna’s COVID-19 vaccine

Pharma Phorum, Richard Staines, 07 January

Pharma Phorum reports that the European Union has approved Moderna’s coronavirus vaccine, while the UK faced a delay in approval due to changes to post-Brexit drug approval rules. The first deliveries into Europe are set to begin next week.

In usual circumstances, companies are required to submit an identical filing request to the MHRA after a CHMP positive opinion. The UK regulator would then follow the decision of the European Commission, which nearly always rubber-stamps the CHMP’s decision within a few weeks. But on this occasion the process has not been possible because of the accelerated timelines for vaccine approval because of the pandemic.

 

Parliamentary Coverage

Medicines and Healthcare products Regulatory Agency – Moderna vaccine becomes third COVID-19 vaccine approved by UK regulator

Medicines and Healthcare products Regulatory Agency Press Release, 08 January

The COVID-19 vaccine developed by Moderna has today been given regulatory approval for supply by the MHRA. This follows a thorough and rigorous assessment by the MHRA’s teams of scientists, including advice from the independent Commission of Human Medicines, which reviewed in depth all the data to ensure this vaccine meets the required standards of safety, quality and effectiveness.

A full press release on the approval can be found here.

 

Prime Minister Boris Johnson announcing an update on COVID-19 vaccines

Prime Ministerial Press Conference, 07 January

In a press conference delivered yesterday, the Prime Minister said that vaccination distribution and logistics would be significantly expanded at pace with the help of third party organisations such as the Army and St Johns Ambulance.

Boris Johnson went on to say that;

  • By the end of the week over 1,000 GP sites, 223 hospitals, 7 giant centres, and 200 community pharmacies would all become vaccination sites – they should be able to provide hundreds of thousands of vaccines each day by 15 January;
  • The plan was for people to be able to acquire a vaccine within 10 miles of their residence;
  • He is confident that the UK had enough vaccine supply to vaccinate all those in the four most vulnerable categories;
  • The Army was working “hand in glove” with the NHS to set up the vaccination network;
  • The full vaccine deployment plan would be published Monday, alongside daily updates on the progress being made.

You can read the Prime Minister’s statement here.

 

Health and Social Care Committee – “Coronavirus: recent developments”

Parliamentary Committee, 07 January

During a session of the Health and Social Care Committee on “Coronavirus: recent developments,” MPs heard from:

  • Health and Social Care Secretary Matt Hancock
  • Clara Swinson, Director General, Global and Public Health at Department for Health and Social Care
  • The committee discussed the third national lockdown, vaccine dosing regimens and the vaccination of vulnerable groups.

On the role of pharmacies in the vaccine roll-out, Mr Hancock said pharmacists were playing an important role in rolling out the flu vaccine but noted that the Pfizer vaccine had needed to be stored at very low temperatures. The role of pharmacies would be expanded with the Oxford-AstraZeneca vaccine with more sites coming on stream in the coming week, including 200 pharmacy sites.

The Health Secretary said community pharmacies would play a key role in ensuring the vaccine reached all parts of all communities because of their high-level of engagement. He added GPs also had an important role to play as well.

A transcript of the committee session will be included here once available.

 

Full Coverage

Analysis: vaccination rollout plagued by shortages and logistical problems

The Telegraph, Bill Gardner, 07 January

It was supposed to be a triumphant moment – Matt Hancock watching on as a GP injected the first dose of the Oxford vaccine into a patient’s arm.

But in scenes likened to political satire The Thick of It, the Health Secretary’s visit to a north London surgery descended into farce when he turned up only to discover that the delivery of the jabs had been delayed.

Instead, Mr Hancock was challenged by a senior GP over the stuttering start to the UK’s vaccination programme, with doctors across the country complaining of delayed deliveries and vital appointments cancelled at the last minute.

Dr Ammara Hughes of the Bloomsbury Surgery in north London, told how she even “felt a bit sorry” for the Health Secretary as his visit turned sour.

“It was a PR disaster for him, I suppose,” Dr Hughes told The Telegraph. “A poor woman from NHS England told us the Health Secretary was arriving to watch us give the first Oxford jabs, and we were delighted.

“We’d been promised that 400 Oxford doses would arrive in the morning, but then we got a late call to say there had been a 24-hour pushback. So when Mr Hancock arrived, we didn’t have any. We had to do the Pfizer jab instead.

Ad hoc deliveries

“I did tell him that our deliveries are quite ad hoc to say the least, and he seemed quite surprised and said he would take it away. It’s frustrating because we’ve had to cancel appointments, and we do have the capacity to vaccinate three to four thousand patients a week – if we have the supply.”

At a Downing Street press conference, Boris Johnson announced that almost 1.5 million people have now been vaccinated across the UK, adding that the Army will use “battle preparation techniques” to keep up the pace of the rollout.

However, he cautioned that hiccups in the delivery plan, which will be set out in full detail on Monday, were likely.

“Of course in the early phases there is going to be lumpiness and bumpiness in the distribution,” he said. “Today it may be that some GPs aren’t getting the consignments expected. Other GPs are doing an incredible job getting jabs into people’s arms.”

Birmingham shortage

However, Birmingham leaders said the city had not been supplied with a single dose of the Oxford vaccine, with supplies of the Pfizer jab due to “run out” on Friday.

An open letter addressed to the Health Secretary from council leaders and Birmingham’s 10 MPs sought “urgent clarity and reassurance,” adding: “It remains unclear who is responsible for overseeing the vaccination programme in Birmingham and whom we should hold to account for progress and delivery.”

West Midlands Mayor Andy Street later said he had been assured supplies of the Oxford vaccine will be delivered to the city on Friday.

Meanwhile, GPs in other parts of the country said they were having to cancel dozens of appointments as promised deliveries failed to turn up.

Don’t blame the surgery

In a message to patients, one surgery in Surrey said: “Unfortunately, all appointments that had been made this week for the over-80s Covid vaccinations have had to be cancelled due to a logistical delivery problem that was beyond our control. We know how frustrating this is but please DO NOT blame the surgery as it really isn’t our fault.”

Another in Binscombe announced that all upcoming appointments would be cancelled “due to a problem in the supply chain”.

Elsewhere, Gillian McLauchlan, Deputy Director of Public Health at Salford Council, told councillors at a local scrutiny committee: “We have no control over vaccine supplies. We are told literally two days in advance ‘your next lot of vaccines are coming’.”

‘Forgiveness and the forbearance’

Officials are trying to “iron out” issues with the deliveries, according to a health minister Lord Bethell, who asked for the “forgiveness and the forbearance” of any patients who are having to wait for their jab.

“It is true sometimes we have to line up people for appointments and the delivery of the vaccines, which is an extremely delicate task, is not proved to be always as reliable as we always hope,” he said in the Lords.

Both AstraZeneca and Pfizer have said they are supplying the vaccine as quickly as possible and to schedules agreed with the Government.

However, there are thought to have been long periods needed for regulators to test batches of vaccines before they are released to the NHS.

Delivered but not administered

The Medicines and Healthcare products Regulatory Agency (MHRA) is understood to have taken on more staff to help speed this process up from 20 days down to four.

A source close to the Pfizer distribution told The Telegraph “millions” of doses had already been sent to the UK, but as of January 3 only 1.1 million people had received their first dose, according to NHS data.

The source added there must be a “buffer” of doses waiting somewhere in the UK to be delivered.

They added they believed there could be delays occurring once the vaccine is reaching the Government’s designated sites.

Once it reaches these storage facilities, it is then the Government’s responsibility to arrange logistics and get the doses out to vaccination sites, the source said.

One NHS source suggested there was a problem with the time taken by Public Health England to safety check vaccines at a single giant warehouse in Merseyside before transporting deliveries to NHS vaccine hubs.

“Those checks are slowing down the delivery coming into the NHS, so it doesn’t automatically get from the warehouse straight out to where it’s needed,” the source said.

Public Health England, however, denied the claims with Interim Chief Executive Michael Brodie insisting it was “categorically untrue to suggest that there have been any delays in delivering the vaccine from PHE warehouses to NHS hospital hubs”.

“We have delivered 100 per cent of orders from the NHS on time and in full,” he said.

New guidance

Meanwhile, GPs have been issued with new guidance in a bid to speed up the process and vaccinate as many people as possible.

The advice from NHS England, seen by The Telegraph, suggests four-person teams could administer more than 100 jabs an hour.

And it says there is no need to keep patients under observation for 15 minutes if they have been given the Oxford vaccine.

The requirement to keep patients under watch after the Pfizer jab was introduced after two health workers with a history of allergies had an allergic reaction to it, but the new guidance says this is not needed for the Oxford jabs.

 

Government to consult on national falsified medicines detection system

The Pharmaceutical Journal, Corrinne Burns, 07 January

A public consultation is promised on the details of a potential national scheme to replace the Falsified Medicines Directive, which ceased to apply in Great Britain at the end of the Brexit transition period.

The Royal Pharmaceutical Society has previously called for “robust plans” to be put in place “to help authenticate the legitimacy of medicines that move between the EU and the UK”

The government has said it plans to consult the public on a national scheme to detect falsified medicines in the supply chain within a year after laws enabling the potential new scheme are enacted.

In published documents relating to the Medicines and Medical Devices Bill, the government has said it is “committed to a public consultation around 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 documents said the government aims to begin consultation within 12 months of the Bill receiving Royal Assent.

The Bill, which was first laid before parliament on 13 February 2020, aims to introduce delegated powers allowing existing regulatory frameworks to be updated following Brexit and includes broad proposals for a national scheme to combat falsified medicines.

The national scheme would replace the Falsified Medicines Directive (FMD), which was introduced across the EU in February 2019. The FMD ceased to apply in Great Britain when the Brexit transition period ended on 31 December 2020.

Under the terms of the withdrawal agreement, the FMD continues to apply in Northern Ireland, and the UK Medicines Verification System (UK MVS) became the UKNI MVS from 1 January 2021. The UKNI MVS is, like the original UK-wide system, operated by SecurMed.

Jerome Bertin, General Manager of SecurMed, said that, when considering the proposals, “some sort of hybrid national scheme that takes into account what the whole of the UK requires, not just Great Britain (GB), will be needed”.

He added that “when considering the GB element of the national scheme, the DHSC/MHRA (Department of Health and Social Care/Medicines and Healthcare products Regulatory Agency) will want to take into account the positive benefits and features of EU FMD, while resolving and simplifying some of the more unworkable or onerous requirements for the UK medicines supply chain”.

Bertin said a “key factor” will be around “access to, and additional uses of, data within the system”.

“We know that there is significant value, but also commercial sensitivity, in the data the UKNI Medicines Verification System holds in relation to the medicines supply chain. EU FMD provides strict controls on usage and access to the data to provide assurance to industry stakeholders about the security and protection of their commercially sensitive information. It is good to see that the proposed public consultation will have a specific focus on the use of data collected and we hope this resolves into similar strong controls over security, protection, access and usage of any data within the draft regulations for the GB element of an FM national scheme”.

Concerns about the use of data collected as part of a national system were raised in September 2020, when, in a House of Lords debate, Lord Clement-Jones said that Clause 3 of the Bill “considerably broadens the original data-collection provisions of the Falsified Medicines Directive”.

A spokesperson for the National Pharmacy Association said that “the end of FMD in Great Britain provides an opportunity to deliver the patient safety benefits of an anti-counterfeiting system — but in a way that is more flexible and in line with the way that medicine supply works in the UK”.

“There are different ways to prevent counterfeit medicines reaching patients — pharmacy-level scans at the point of supply is just one option. Ultimately, any effective system needs to protect patients and deter counterfeiters, without imposing a disproportionate burden of time and cost.”

The spokesperson added that “there should be much closer consultation with the supply chain stakeholders than was ever undertaken by the EU, to get a tailored system that meets the needs of the UK”.

Sandra Gidley, President of the Royal Pharmaceutical Society, said she “believes that it is vital that the patient safety benefits of an anti-counterfeiting system are delivered in a way that is flexible and in line with medicine supply systems in the UK”.

In October 2020, the Royal Pharmaceutical Society wrote to health secretary Matt Hancock calling for “robust plans” to be put in place “to help authenticate the legitimacy of medicines that move between the EU and the UK”.

 

UK left trailing as EU quickly approves Moderna’s COVID-19 vaccine

Pharma Phorum, Richard Staines, 07 January

The European Union has approved the coronavirus vaccine from Moderna, leaving the UK trailing because of changes to post-Brexit drug approval rules.

With the UK reeling from one of the worst outbreaks of the disease, it’s a worrying situation for one of the countries worst hit by the pandemic that is relying on vaccines to bring the virus under control.

The UK is in a national lockdown that could last into March, with more than 62,000 new cases and 1,000 coronavirus-related deaths recorded yesterday as a more transmissible strain threatens to overwhelm the country’s health service.

As things stand, the two rival mRNA-based vaccines from Pfizer/BioNTech and Moderna are now approved for use in the EU.

Meanwhile in the UK, the Pfizer/BioNTech and AstraZeneca shots have been quickly approved.

The UK government has an order for just 7 million shots of the Moderna vaccine covering just half a percent of the population, while the European Commission has secured 160 million doses, enough to cover around 18% of the population.

US-based Moderna said that first deliveries of the vaccine in Europe will begin next week.

Moderna’s vaccine is arguably the most effective approved so far at around 95%, while AstraZeneca’s rival that has been swiftly approved in the UK ahead of Europe works in around 62% of cases when given its recommend dose.

The Pfizer/BioNTech seems to be of comparable efficiency to the Moderna shot, and is being rolled out across the UK along with the AZ vaccine.

There is evidence to suggest the AZ vaccine’s efficacy could be improved to 90% by giving a half-dose to start with, but UK regulators have not been given sufficient evidence to approve this formulation.

After a rolling review began of Moderna’s vaccine late last year, the European Commission has issued a conditional marketing authorisation the day after it was backed by regulators from the CHMP scientific committee.

Moderna has said it is in talks with the UK regulator over approval, where European Commission decisions on medicines no longer automatically apply because of Brexit.

Under Brexit transition arrangements the Medicines and Healthcare products Regulatory Authority (MHRA) will continue to adopt decisions by the European Commission on medicines.

In usual circumstances companies are required to submit an identical filing request to the MHRA after a CHMP positive opinion

The UK regulator would then follow the decision of the European Commission, which nearly always rubber-stamps the CHMP’s decision within a few weeks.

But on this occasion the process has not been possible because of the accelerated timelines for vaccine approval because of the pandemic.

Questioned by Pharma Phorum, the MHRA was unable to comment on arrangements for the Moderna vaccine at the time of writing.

However, Moderna said separately that it is in talks with the MHRA to get the vaccine approved.

HDA UK Media and Political Bulletin – 08 January 2021

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