MHRA gives approval for first UK COVID-19 vaccine

 

The first COVID-19 vaccine for the UK, developed by Pfizer BioNTech, has today been given approval for use following a thorough review carried out by the Medicines and Healthcare products Regulatory Agency (MHRA).

 

The decision by the UK regulatory authority was made with advice from the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body. A dedicated team of MHRA scientists and clinicians carried out a rigorous, scientific and detailed review of all the available data, starting in October 2020.

 

This was done using a regulatory process known as a ‘rolling review’. A ‘rolling review’ can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible. This is done as the packages of data become available from ongoing studies on a staggered basis.

 

The MHRA expert scientists and clinicians reviewed data from the laboratory pre-clinical studies, clinical trials, manufacturing and quality controls, product sampling and testing of the final vaccine and also considered the conditions for its safe supply and distribution.

 

The National Institute for Biological Standards and Control, part of the agency, has been and will continue doing, independent laboratory testing so that every batch of the vaccine meets the expected standards of safety and quality.

 

MHRA Chief Executive, Dr June Raine said:

 

“We have carried out a rigorous scientific assessment of all the available evidence of quality, safety and effectiveness. The public’s safety has always been at the forefront of our minds – safety is our watchword.

 

“I’m really pleased to say that the UK is now one step closer to providing a safe and effective vaccine to help in the fight against COVID-19 – a virus that has affected each and every one of us in some way – and in helping to save lives.

 

“We are globally recognised for requiring high standards of safety, quality and effectiveness for any vaccine. Our expert scientists and clinicians worked tirelessly, around the clock, carefully, scientifically, robustly and rigorously poring over hundreds of pages and tables of data, methodically reviewing the data.

 

“Vaccines are the most effective way to prevent infectious diseases. They save millions of lives worldwide.”

 

This article is being shared under the Open Government Copyright licence.

 

 

Pharmacy included in £500 bonus for health and social care staff

 

First Minister Nicola Sturgeon has announced a one-off payment for Scotland’s lifesavers and care-givers on the frontline throughout the coronavirus (COVID-19) pandemic.

 

A pro-rated payment of £500 will be made as soon as is practicable to all NHS and social care workers employed since 17th March 2020 – including staff who have had to shield, or who have since retired.

 

It has been confirmed that pharmacy team members will be included in this ‘thank you’ payment.

 

This investment of around £180 million will see over 300,000 staff gain some benefit from this bonus, including nurses, pharmacists, pharmacy team members, porters, doctors, primary care staff, homecare workers, care home staff, hospice staff and residential child care staff.

 

The First Minister said:

 

“Back in the spring, at the height of the first wave of COVID, many of us publicly  – and often loudly – showed our appreciation for the work our NHS and social care staff were doing.

 

“The applause was important, but it was never enough. Our appreciation must be shown in a more tangible way.

 

“We’re in the early stages of negotiating a new pay deal for NHS Agenda for Change staff for 2021/22. The UK Government’s public sector pay policy will not make that task easy, but we will do our level best to give NHS staff the pay increase they deserve. However, these negotiations will take time to conclude.

 

“Those who have worked in our hospitals and care homes – at the sharpest end of the COVID trauma – deserve recognition now.

 

“So I can announce today that, on behalf of us all, the Scottish Government will give every full-time NHS and social care worker £500 as a one-off thank you payment for their extraordinary service in this toughest of years. Those who work part-time will get a proportionate share.

 

“The money will be paid in this financial year and it will be separate from any negotiations about pay for the longer term. There are no strings attached.

 

“Of course, a payment like this can never come close to expressing our full admiration for those who have cared for us so heroically. But to our health and care workers, it is a demonstration of what we collectively owe you – and a heartfelt thank you for the sacrifices you have made.”

 

Director of Operations at Community Pharmacy Scotland (CPS) welcomed the inclusion of pharmacy in this gesture and said:

 

“CPS is delighted with the news yesterday that pharmacy team members will be financially recognised by Scottish Government due to their contribution through this pandemic.

 

“It has been said many times that community pharmacy team members have been going above and beyond through this period and have played an integral part of the NHS response to Covid 19. This recognizes this in real terms.

 

“The details of this unique payment to individuals from Scottish Government will have to be worked through as pharmacies are independently contracted to deliver NHS services and the NHS is not the direct employer of individuals who work in community pharmacy teams. CPS will work to deliver as practical a solution as is possible in a timely manner and work will start on this, with our members and Scottish Government, in the coming days and weeks.”

 

This circular is being shared under the Open Government Copyright licence.

 

 

Pharmacy teams vital to covid-19 vaccine programme success

 

Following the news that COVID-19 vaccinations could be provided by the NHS from as early as next month, President of the Royal Pharmaceutical Society Sandra Gidley said:

 

“Pharmacy teams are ready to support vaccination programmes against COVID-19 as and when new vaccines become available after safety standards are met. Pharmacy has a track record of delivering vaccination programmes across the healthcare system and must be involved in providing COVID-19 vaccines to enable the widest possible access for patients. We recognise the impact this could have on teams already stretched to capacity, but through collaboration with primary care colleagues, we can help ensure an agile and flexible approach to vaccine provision across the country.

 

“To protect the workforce, it’s essential that pharmacy teams have parity of access to the vaccination alongside other colleagues in the NHS. Pharmacy has played a central role in the pandemic and experienced enormous pressures on the frontline patient care, staying open throughout to provide medicines and advice. It is vital staff are in the first wave of those vaccinated to ensure the wellbeing of the workforce.

 

“We are meeting with the UK Government this week to discuss this issue and how pharmacists can be integrated into vaccine programmes in the future.”

 

 

PharmaDoctor launch rapid COVID-19 antigen testing service package

 

PharmaDoctor has announced the launch of its new Rapid COVID-19 Antigen Testing Service Package, available to community pharmacists.

 

The PharmaDoctor Package includes the following:

 

  • A free COVID-19 Testing Service consultation eTool – the eTool guides pharmacists through the test consultation, records the patient’s past experience of COVID and records past or current test results. Open access to the service data will be made available to Public Health Organisations to support disease surveillance.

 

  • Exclusive supply of Fortress Rapid Antigen Test Kits – producing a test result from a nasal swab in only 15 minutes without the need for further analytical equipment or a lab analysis.

 

  • Free patient referrals via PharmaDoctor’s online service advertising campaign – to support social distancing, patients are able to register for the service (here) and begin their consultation online via the patient end of the eTool.

 

  • Free marketing support materials – a full suite of B2C POS posters, template social media adverts and videos to help pharmacists to promote their new service inpharmacy and online.

 

Commenting on the new service package, PharmaDoctor’s CEO, Graham Thoms, said:

 

“We’re delighted to bring pharmacists this new COVID-19 Rapid Antigen Testing Service Package, including the exclusive supply of Fortress Rapid Antigen Test Kits to our pharmacy partners.  During the current pandemic, pharmacies continue to play a key role in the communities they serve, so now pharmacists can offer their customers access to an affordable   rapid private COVID-19 testing service which will be a vital part of helping us all get back to some kind of normality.”

 

“We believe our service package will enable pharmacies to offer customers the most affordable private COVID-19 Testing Service in the UK with a recommended service price of only £70-£80 which is nearly half the price of other services recently reported in the media”.

 

Pharmacists can order the free support package and Rapid COVID-19 Test Kits via their usual PharmaDoctor account.

 

PharmaDoctor has said that if pharmacists have customers who need proof of a negative COVID-19 test result for the purposes of travelling (Fit to Fly tests), they will need to complete a PCR test, which involves a swab sample and lab analysis rather than rapid tests.

 

PharmaDoctor already supplies thousands of PCR tests to its partner pharmacies, so pharmacists can also order these test kits along with the new Rapid Antigen Test Kits by logging into their PharmaDoctor account here.

 

 

Spread of coronavirus in hospitals a risk to patient safety

 

Helping the healthcare system reduce the spread of COVID-19 in hospitals is the focus of a comprehensive report by the Healthcare Safety Investigation Branch (HSIB).

 

The report charts a four-month patient safety investigation that was launched following concern that patients were contracting COVID-19 after being admitted to hospital.

 

The aim of HSIB’s investigation was to understand the factors that could contribute to the risk of transmission, how the NHS operates to reduce that risk and where there may be opportunities to reduce that risk even further. The investigation represented the voices of those working across the health service, from strategic national planners to hospital porters. It also captured the experiences of patients and families, providing further insight into the challenges of managing the transmission of COVID-19.

 

The report concludes with short, medium and long term measures that support both immediate and future responses as the NHS continues to tackle the virus. The report makes eight safety recommendations, to the Department of Health and Social Care, NHS England and NHS Improvement and NHSX. The recommendations are as follows:

 

  1. It is recommended that the Department of Health and Social Care, working with NHS England and NHS Improvement, Public Health England, and other partners as appropriate, develops a transparent process to co-ordinate the development, dissemination and implementation of national guidance across the healthcare system to minimise the risk of nosocomial transmission of COVID- 19.
  2. It is recommended that NHS England and NHS Improvement:
    • Supports additional capacity for testing for NHS patients and staff (Pillar 1 testing).
    • Facilitates the accessibility of rapid testing for NHS trusts, as soon as an increase in rapid testing supplies becomes available.
  3. It is recommended that NHS England and NHS Improvement develops a national intensive infection prevention and control (IPC) safety support programme for COVID-19 which focuses on leadership, IPC technical support, education, practice, guidance and assurance and also develops a national IPC strategy which focuses on developing IPC capacity, capability and sustainability across the NHS in England.
  4. It is recommended that NHS England and NHS Improvement reviews the principles of the hierarchy of controls in its health building notes (HBN) and health technical memoranda (HTM) for the design of the built environment in existing and new hospital estate to reduce the risk of nosocomial transmission.
  5. It is recommended that NHS England and NHS Improvement responds to emerging scientific evidence and shared learning when reviewing guidance for NHS trusts on the role of hospital ventilation systems in nosocomial transmission.
  6. It is recommended that NHS England and NHS Improvement investigates and evaluates the risks associated with the potential impact of staff fatigue and emotional distress on nosocomial transmission of COVID-19.
  7. It is recommended that the Department of Health and Social Care reviews and identifies the mechanisms which enabled regional and local organisations to adapt and respond with agility during the pandemic. This should inform the development of a strategic approach to national leadership models at times of crisis and under normal
  8. It is recommended that NHSX considers how technology can assist in mitigating nosocomial transmission in the ward environment with regard to:
    • The use of digital communication technologies in assisting with the deployment of staff and the dissemination and circulation of key information
    • The increased use and availability of personal computing devices and electronic health record

 

Kathryn Whitehill, Principal National Investigator at HSIB commented:

 

“We were moved by stories shared and grateful for the input from families, staff and system leaders. We know the profound personal and organisational impact this virus has had; our intention is not to criticise the NHS response rather set out a prospective view of safety that supports their efforts as cases rise and we head into winter.

 

“The spread of coronavirus in hospitals presents a risk to patient safety. It also puts enormous strain on the workforce and the fear of contracting COVID-19 in hospital can deter patients from attending hospital who may need urgent treatment for other conditions.

 

“Our investigation sought to understand factors that helped or hindered efforts to manage the risk of transmission on hospital wards. We also examined the NHS response in the context of the ‘hierarchy of controls’ – a widely used approach that sets out measures to mitigate risk ranked by their effectiveness. Our report sets out 39 key findings that cover everything from hospital design and guidance to PPE and testing capacity. This detailed insight enabled us to develop safety recommendations that would aid short and long term planning and ensure that NHS trusts had measures they could implement immediately.”

 

You can read the full report here.

 

 

Care home report criticised for not including frontline experiences

 

At least 78 older people were discharged from NHS hospitals to Scottish care homes after testing positive for covid-19 in the early months of the pandemic, a new report has found.

 

Public Health Scotland said that just 650 of the 3,599 people discharged from care homes between 1st March and 21st of April were tested for covid-19. Eight in ten people discharged were never tested.

 

Of those tested, 78 received a positive result while in hospital before being discharged to a care home.

 

However, the report does draw a link between the risk of outbreaks and the size of a home.

 

Nicola Sturgeon insisted that the report found no statistical relationship between hospital discharges and outbreaks in care homes.

 

But Scottish Care, which represents different social care providers, said:

 

“We should have initiated testing for all discharges much earlier than we did. The report makes it clear that there are real benefits from this testing process.”

 

CEO Dr Donald Macaskill described the report as “only part of the story” because it misses the experience of frontline care workers who believes hospital discharges led to the virus being introduced in their care home.

 

The report covers discharges that took place as hospitals attempted to free up capacity ahead of an anticipated surge in covid patients. At the time there was no requirement to test patients before sending them to a care home.

 

Advice changed on the 21st April to specify residents should receive two negative tests before discharge and that any new admissions to care homes should be isolated for 14 days.

 

Between this date and the end of May more than 90% of patients discharged to care homes were tested. Although the majority tested negative, 278 tested positive.

 

However 45 of these patients did not get a negative test result prior to their discharge, the figures suggest.

 

More than three-quarters of the 1,084 care homes in Scotland received a resident from hospital between March and May.

 

Just under half of the 4,482 covid-19 deaths in Scotland have happened in care homes.

 

Responding to questions today, Nicola Sturgeon said: “One of the things that the report does seem to find which is the most significant factor in outbreaks was the size of care home.

 

“That is not blaming care homes and it is not blaming staff it is simply recognising that bigger care homes, there are perhaps more interactions, there is perhaps more of the risk of community transmission getting into the care homes, so we have to think about how we work with and support larger care homes to better mitigate that.”

 

The First Minister added: “Let me be clear that this does not say that hospital discharge in all circumstances was not a factor at all, it just says that it wasn’t a statistically significant one.

 

“That doesn’t take away from the need for us to learn about what did happen in care homes so that we can make sure we make the changes that are designed to minimise and mitigate that for the future.”

 

The issue of hospital discharges rose up the agenda after a Sunday Post investigation found dozens of patients who had tested positive for covid were sent from hospitals into care homes near the beginning of the pandemic.

 

The true figure was thought to be higher as not all NHS boards responded to requests for information from the newspaper.

 

UK scientific advisors have previously said that outbreaks in care homes cannot be pinpointed to one single cause, with one top Scottish medic telling healthandcare.scot they were “complex and multi-factorial” and likely to be different for each facility.

 

Dr Macaskill of Scottish Care said:

 

“At the start of the pandemic all the emphasis was on the preservation of the NHS. Our politicians and medical advisors stood in front of posters which read ‘Protect the NHS’.

 

“The care home sector and its workforce played its part in that protection, and can be assured that in the majority of instances that support through enabling people to come home or be admitted, was not a significant risk factor for outbreaks.

 

“However, we need to ensure that where people are convinced there was a direct relationship between discharge and outbreak that this belief needs to be investigated.”

 

Dr Macaskill added: “Some of our members and staff who work in care homes in a few cases believe that Covid-19 was introduced into their care home community as a result of discharges. I hope the researchers can take some time to listen to the experience of staff in care homes where there have been significant outbreaks.

 

“At the moment we have one side of the story, what is missing is the frontline experience of our care sector and its staff, the voices of those who received care and their families.”

 

by Henry Anderson

 

This story has been supplied through our partnership with our friends at healthandcare.scot. Click here to head over and have a look if you haven’t already.