News

HDA UK Media and Political Bulletin – 7 June 2021

Media Summary

COVID-19: Matt Hancock says UK has ‘enough’ vaccine supply as regulator approves Pfizer jab for 12 to 15-year-olds
Sky News, Sophie Morris, 5 June 2021

Sky News reports that the Health Secretary has stated that children will be able to get a COVID-19 jab if it is clinically advised for them to get one.

Health Secretary Matt Hancock has said the UK has “enough supply” to offer a COVID-19 jab to children after the medicines regulator approved the Pfizer-BioNTech vaccine for 12 to 15-year-olds.

The Medicines and Healthcare products Regulatory Agency (MHRA) said the decision followed a “rigorous review” of safety and effectiveness in that age group – and that the benefits of having the COVID jab outweighed the risks.

The Joint Committee on Vaccination and Immunisation (JCVI) will now advise whether routine vaccination should be offered to those aged 12 to 17.

COVID-19 vaccine: Second jab date changes could ‘jeopardise’ rollout
BBC News NI, Louise Cullen, 5 June 2021

BBC News NI reports that the number of people looking to change their second COVID-19 vaccination appointment has risen considerably.

According to the head of the vaccine roll-out, about 2,500 requests to change appointments have been made in Northern Ireland in the last seven to 10 days.

The number of people seeking to rearrange their appointment has increased, whilst restrictions have started to ease.

Patricia Donnelly, the head of Northern Ireland’s vaccination programme, warned mass changes could “jeopardise” the programme.

Pharmacy COVID-19 test kit distribution service to launch in Scotland
Chemist and Druggist, Beth Gault, 4 June 2021

The Chemist and Druggist reports that the Scottish Government has announced the lateral flow device distribution service for community pharmacies will launch across Scotland on 7th June 2021.

The community pharmacy COVID-19 test kit distribution service, publicly known as Pharmacy Collect, will enable asymptomatic people to collect test kits free of charge from community pharmacies from 7th June 2021.

Pharmacies that sign up to the service will be paid £450 to cover the set-up costs, cost of implementing a new standard operating procedure, and staff training. Each pharmacy will receive a £2 distribution fee per kit.

Pharmacy teams will need to opt-in to provide the service and order test kits from the participating wholesalers, Alliance Healthcare and Sigma Pharmaceuticals or Phoenix for Rowlands pharmacies. The test kits will be supplied free of charge.

In a letter to pharmacies sent on 2nd June 2021, the Interim Chief Pharmaceutical Officer, Alison Strath, said making the test kits available from pharmacies is “part of the Scottish government’s COVID-19 route map” to help suppress the virus.

EU to remove Brexit barriers to medicine supplies for Northern Ireland
The Telegraph, James Crisp, 4 June 2021

The Telegraph reports that Brussels will offer to remove barriers to British medicine supplies to Northern Ireland in a bid to break the deadlock in Brexit border negotiations with the UK next week.

The European Union is expected to set out the plan for the Northern Ireland Protocol in London on Wednesday.

Under the protocol Northern Ireland continues to follow EU rules for medicines and medical equipment after Brexit. Checks on medical supplies to Northern Ireland from Britain, including for the NHS, will commence at the end of 2021, following a year-long grace period.

British manufacturers of non-branded drugs have warned that generic medicines make up four out of every five medicines prescribed in the NHS.

European Commission officials are working on a long-term solution to avoid any disruption to medical supplies in Northern Ireland ahead of Wednesday talks in London. Their proposal will involve changing EU law for Northern Ireland’s benefit which will require the agreement of the 27 member states.

This was also reported by Politico.

 Parliamentary Coverage

The MHRA concludes positive safety profile for Pfizer/BioNTech vaccine in 12- to 15-year-olds
Medicines and Healthcare products Regulatory Agency, 4 June 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) authorised an extension to the current UK approval of the Pfizer/BioNTech COVID-19 vaccine, to allow its use in 12- to 15-year-olds

This follows a review of the safety, quality and effectiveness of the vaccine in this age group by the MHRA and the Government’s independent advisory body, the Commission on Human Medicines (CHM).

Dr June Raine, MHRA Chief Executive said: “We have carefully reviewed clinical trial data in children aged 12 to 15 years and have concluded that the Pfizer/BioNTech COVID-19 vaccine is safe and effective in this age group and that the benefits of this vaccine outweigh any risk.

Full Coverage

COVID-19: Matt Hancock says UK has ‘enough’ vaccine supply as regulator approves Pfizer jab for 12 to 15-year-olds
Sky News, Sophie Morris, 5 June 2021

The health secretary says children would be able to get a jab should it be clinically advised for them to get one.

Health Secretary Matt Hancock has said the UK has “enough supply” to offer a COVID jab to children after the medicines regulator approved the Pfizer-BioNTech vaccine for 12 to 15-year-olds.

The Medicines and Healthcare products Regulatory Agency (MHRA) said the decision followed a “rigorous review” of safety and effectiveness in that age group – and that the benefits of having the COVID jab outweighed the risks.

The Joint Committee on Vaccination and Immunisation (JCVI) will now advise whether routine vaccination should be offered to those aged 12 to 17.

“We’ll take clinical advice from the Joint Committee on Vaccination and Immunisation on how that should be taken forward, and then we’ll follow that clinical advice.

“We have enough supply to be able to vaccinate children should that be the clinically advised thing to do.

“We now have a vaccine that’s approved for the use of children aged 12 and over, but I want to make sure this is all done following clinical advice, to make sure that we get this country out of this pandemic as safely as we can.”

Dr June Raine, MHRA chief executive, said: “We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved COVID-19 vaccines and this surveillance will include the 12- to 15-year age group.”

The Department for Health and Social Care added that it will continue to be “guided by the expert advisors”.

The Pfizer/BioNTech jab was approved for use in the UK for 16 and 17-year-olds in December 2020.

The JCVI’s current advice is that those aged 16 to 18 should be offered vaccination if they are in a priority Phase 1 group or they are the household contacts of someone who is immunosuppressed.

There is no routine vaccination of under 18s currently under way.

More than 2,000 children were involved in the clinical trial to determine the safety of the Pfizer/BioNTech vaccine, the chairman of the Commission on Human Medicines said.

Professor Sir Munir Pirmohamed said based on the data, the vaccine’s benefits “do outweigh any risk”.

He added out of the 2,000 children studied as part of the randomised, placebo-controlled clinical trials, there were no cases of COVID-19 from seven days after the second dose, compared with 16 cases in the placebo group.

In addition, data on neutralising antibodies showed the vaccine working at the same level as seen in adults aged 16-25 years.

“These are extremely positive results,” he said.

Meanwhile, Mr Hancock reiterated that it is “very early” to deem whether the 21 June lockdown easing date will go ahead.

The health secretary said: “It’s too early to make a decision about the step that will happen not before the 21 June – we’re looking at the data every single day, and we’ll make a decision and publish it later in this month.”

He added: “The most important data that we’re looking for ahead of making the decision about whether we can go ahead with step 4 on the 21 June is how effective the vaccine has been in breaking the link from cases to hospitalisations and deaths.

“We know that the vaccine works and has reduced by a long long margin your likelihood of ending up in hospital or even worse of dying from COVID, we know that it’s effective – we want to see in the real world data just how effective it is.

“Because we’ve seen the number of cases go up – we always expected that to happen – and we’ve not seen a rise in the number of people going to hospital in the same way.

“And we just want to see how effective the vaccine is at stopping what was an inevitable link from the increase in cases to the increase in hospitalisations.

“We’re looking very very carefully at the data and we’ll say more when we know more.”

Covid-19 vaccine: Second jab date changes could ‘jeopardise’ rollout
BBC News NI, Louise Cullen, 5 June 2021

The number of people seeking to change their second Covid-19 vaccination appointment has increased significantly.

As many as 2,500 requests to change appointments have been made in the last seven to 10 days, according to the head of the vaccine roll-out.

Second appointments are usually generated automatically when a person books their first.

Patricia Donnelly warned mass changes could “jeopardise” the programme.

The number of people seeking to rearrange their appointment has increased at the same time as restrictions have started to ease.

The automatic generation of second dates for vaccinations is in place so that the system can manage staffing, vaccine supply and available appointment slots.

Patricia Donnelly heads up the vaccine programme and is appealing to people to keep their allocated appointment.

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“Any large scale changes could potentially jeopardise the overall roll-out of the programme,” she said.

“I fully understand that we are all anxious to enjoy a more normal life including an opportunity to enjoy some of the things which have been denied us during the last 18 months.

“However, this programme is a massive and highly complex logistical undertaking requiring intense planning.

“The ongoing cooperation of everyone to come forward for their second dose on their appointed date is crucial.”

‘Snatching defeat from jaws of victory’

Speaking to BBC News NI, Ms Donnelly urged people to be “patient” if they have contacted a vaccination centre to request an appointment change.

“We’re not out of this pandemic yet and I think it’s very easy to forget that as life appears more normal and there are more cars on the road and people are returning to activities,” she said.

“This feels like snatching defeat from the jaws of victory.”

In cases in which rescheduling was unavoidable, the department said it would take time as the staff involved were already running the vaccination centres and organising the programme.

Second doses are required to maximise protection against the virus.

Northern Ireland has been gradually easing restrictions across a number of sectors, including international travel.

On Thursday, Portugal was removed on Thursday from the green list of countries for people travelling from Northern Ireland, instead being moved to the amber list.

It means those seeking a holiday there will have to self-isolate for 10 days on their return, as well as booking pre- and post-arrival testing.

The move comes just two weeks after the Stormont executive announced its travel green list green list of the 12 countries.

In Northern Ireland restaurants, cafes, bars and other hospitality venues have been allowed to operate indoors since 24 May, having been allowed to resume outdoor service at the end of April.

Hotels and bed-and-breakfasts have also reopened.

The reproductive rate or so-called R number of the virus in Northern Ireland has fallen slightly – it is now 0.8 to 1.0 compared with 0.8 to 1.1 last week.

Pharmacy COVID test kit distribution service to launch in Scotland
Chemist and Druggist, Beth Gault, 4 June 2021

A lateral flow device distribution service for community pharmacies will launch across Scotland on June 7, the Scottish government has announced.

The community pharmacy COVID-19 test kit distribution service – which is known publicly as Pharmacy Collect – will enable asymptomatic people to collect test kits free of charge from community pharmacies from June 7. However, the service is being promoted to the public from today (June 4), a circular from the Scottish government confirmed.

Pharmacies that sign up to the service will be paid £450 to cover the set-up costs, cost of implementing a new standard operating procedure, and staff training. Each pharmacy will receive a £2 distribution fee per kit.

Pharmacy teams will need to opt-in to provide the service and then order test kits from the participating wholesalers, Alliance Healthcare and Sigma Pharmaceuticals – or Phoenix for Rowlands pharmacies only – which will be supplied free of charge.

Free lateral flow test kits have been available to everyone in Scotland since April 26, with people ordering online or on the phone and collecting from test sites.

In a letter to pharmacies sent on Wednesday (June 2), the interim chief pharmaceutical officer, Alison Strath, said making the test kits available from pharmacies is “part of the Scottish government’s COVID-19 route map” to help suppress the virus.

“It is important to note that members of the public self-administer the tests away from the pharmacy, e.g. at home,” she added. “The pharmacy is not involved in the generation of test results, supporting the reporting of results or the next steps for the person taking the test.”

England, Wales and Northern Ireland status
Pharmacies in England have been distributing lateral flow devices free of charge since March 29, while the Welsh government said it is working with Community Pharmacy Wales on a potential Pharmacy Collect model for the country.

Last month, in a letter to contractors in Northern Ireland outlining the pharmacy commissioning plan for 2021/22, Joe Brogan, assistant director of integrated care at the Health and Social Care Board said: “There are other service areas emerging such as supply of lateral flow diagnostic tests which I have no doubt community pharmacy will play a very able part.”

In a list of FAQs provided with the Scottish government circular, it stresses that “there are no geographical restrictions placed on the provision of the service”, so patients from one of the other home countries can still collect COVID-19 test kits from pharmacies in Scotland.

EU to remove Brexit barriers to medicine supplies for Northern Ireland
The Telegraph, James Crisp, 4 June 2021

Brussels will offer to remove barriers to British medicine supplies to Northern Ireland in a bid to break the deadlock in Brexit border negotiations with the UK next week.

The European Union is expected to set out the plan as an olive branch in tense negotiations over the Northern Ireland Protocol, in London on Wednesday, sources said.

Under the Protocol, which prevents a hard Irish border, Northern Ireland continues to follow EU rules for medicines and medical equipment after Brexit.

That will mean checks on medical supplies to Northern Ireland from Britain, including for the NHS, once a year-long grace period expires at the end of 2021.

Medicines made in Britain will also have to have separate licenses, testing and inspections before they can be used in Northern Ireland after the grace period.

About £600m worth of drugs are imported into Northern Ireland each year, with approximately 98 per cent coming from Britain.

British manufacturers of non-branded drugs have warned the generic medicines make up four out of every five medicines prescribed in the NHS.

Supplies of drugs for cancer, epilepsy and diabetes are at risk because of the cost of the extra red tape, they said.

European Commission officials are working on a long-term solution to avoid any disruption to medical supplies ahead of Wednesday talks in London.

Their proposal will involve changing EU law for Northern Ireland’s benefit, which is a significant move because it will require the agreement of the 27 member states.

Many of those governments are increasingly frustrated with perceived British belligerence over the Protocol, EU sources said.

Patience was running out with the UK, sources said after a meeting of ambassadors in Brussels.

Member states were increasingly willing to consider retaliatory measures to respond to perceived British belligerence over the Protocol, they said.

That could ultimately include triggering dispute resolution procedures in the Protocol which can, as a final result, end in tariffs and even the suspension of parts of the Brexit trade deal.

Britain infuriated the EU by unilaterally extending grace periods in the Protocol for some goods, which Brussels said broke international law.

The Commission has brought legal action against the UK for the alleged breach.

Were the UK to unilaterally extend the grace period on medicines, sources said, countries such as France would insist on much tougher retaliation.

The EU hopes for reciprocal offers from the UK at the meeting of the joint committee but there is pessimism there will be any breakthrough.

Those are expected to fall short of the EU suggestion that the UK align with EU food safety and animal health rules to minimise border checks.

But commission negotiators will press Lord Frost’s team for credible reassurances over a number of concerns.

Brussels suspects the UK, which enforces the EU customs code over British goods exported to Northern Ireland, is not carrying out any physical checks on shipments and only paper ones.

EU officials are also frustrated at the lack of progress on British commitments to build infrastructure at ports and to give them access to UK customs technology and databases.

There is also anger at Lord Frost, who is accused of stirring up Unionist anger against the Protocol.

On Thursday, he accused the EU of jeopardising the peace process by not adopting a “common sense” approach to the Protocol and the customs checks it introduced.

HDA UK Media and Political Bulletin – 7 June 2021

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