MHRA approves Pfizer and AstraZeneca Covid-19 vaccines for booster doses

The Medicine Healthcare Regulatory Authority (MHRA) has provided an update on booster vaccines for Covid-19 and in doing so have approved the use of both the Pfizer and Astra Zeneca Covid-19 vaccines for booster doses.

The MHRA has said it will be for the JVCI to advise on whether booster jabs will be given and if so, which vaccines should be used.

The current supply of the Covid-19 vaccines made by Pfizer and AstraZeneca has been authorised on an emergency use basis by the MHRA under Regulation 174 of the Human Medicine Regulations 2012 and the changes today have been made to the Regulation 174 Product Information only. Both vaccines are also authorised under Conditional Marketing Authorisations (CMAs) but changes to these would follow a different procedure. Vaccines covered by CMAs can also be used as part of a deployment programme via “off-label” use under a prescriber’s direction.

This regulatory decision follows a careful review of available data on safety and effectiveness of booster or supplementary vaccine doses by the MHRA and the independent Commission on Human Medicines (CHM), which advises the government.

Dr June Raine, MHRA Chief Executive said:

“We are committed to getting safe and effective Covid-19 vaccines to the UK public. This means ensuring that existing Covid-19 vaccines can continue to be used in the most effective way possible.

“We know that a person’s immunity may decline over time after their first vaccine course. I am pleased to confirm that the Covid-19 vaccines made by Pfizer and AstraZeneca can be used as safe and effective booster doses. This is an important regulatory change as it gives further options for the vaccination programme, which has saved thousands of lives so far. It will now be for the JVCI to advise on whether booster jabs will be given and if so, which vaccines should be used.

“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 booster jabs.”

Elements of this story have been shared under the Open Government license.

Online course: Community pharmacy pneumococcal vaccination service

This course is designed to support you to build your knowledge of pneumococcal disease and the associated available vaccinations. As you embark on any vaccination service in community pharmacy it is very important that you are up to date with the clinical area.

Learning objectives for this module include the following:

  • Understand where to seek up to date information on pneumococcal disease and vaccination including how guidance currently varies across the UK.
  • Learn about the cause, characteristics and epidemiology of pneumococcal disease.
  • Learn about pneumococcal pneumonia.
  • Find out about the epidemiology of pneumonia and how pneumonia fits in the overall picture of pneumococcal disease.
  • Understand how to assess who is suitable for the pneumococcal vaccination.
  • Understand how to address vaccine hesitancy and also learn about when it can be helpful to suggest the pneumococcal vaccination to your patients.
  • Find out and become familiar with the pneumococcal vaccines available.
  • Learn about how to store, prepare and administer the vaccines available.
  • Describe the information you should give to patients after the vaccination.
  • Pre-empt some of the questions that patients may ask.

The course is free of charge. We ask you to register before embarking on the course. You can record your learning and have it emailed to you via our revalidation CPD form and successful completion of the quiz at the end of the course will mean you receive a certificate of successful completion.

References

  1. Immunisation procedures, The Green Book chapter 4 available here Green-Book-Chapter-4.pdf (publishing.service.gov.uk) [accessed 25.6.2021]

Report warns against silo approach to vaccination

 

A study published today says Scotland has to work across its traditional boundaries to ensure the people who are not being reached by the covid vaccination programme – often also the ones potentially most at risk of serious harm from infection – are identified and supported to get protected.

 

Voluntary Health Scotland (VHS), a network of voluntary health organisations across Scotland, says there is a clear moral and human rights duty to those vulnerable groups, who are falling through the gaps in the way covid-19 vaccination is being delivered, to ensure “they are not failed by this crucially important public health intervention”.

 

VHS says it undertook the research to try to identify how to make the vaccination process as easy as possible for everyone including those most at risk because they are homeless, prisoners, people living in poverty, people who abuse drugs and alcohol, black and ethnic minority groups, gypsy travellers, refugees and asylum seekers.

 

The report, Vaccine Inclusion: reducing inequalities one vaccine at a time, concludes that the task of identifying and supporting everybody to get the vaccine is a responsibility of entire communities, not just the NHS, warning “against viewing the covid-19 vaccination programme as a silo rather than part of a wider whole-system, preventative approach to public health and health inequalities”.

 

It makes a series of recommendations including the need to gather and analyse local data on uptake of vaccination in different communities and groups, and a programme of outreach vaccination clinics with affordable transport to allow people to get to them.

 

VHS says the third sector and community partners need to have a bigger role in “planning, communications and delivery of public health interventions to try to prevent, mitigate and reduce health inequalities”.

 

The authors conclude that, while Scotland is vaccine confident nation and uptake of vaccines is generally high, this confidence and uptake is not being seen to the same extent in areas of deprivation and amongst certain ethnic minority groups.

 

You can read the report in full on the VHS website.

 

By John Magill

 

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.

 

 

Community pharmacy vaccination service begins

 

Northern Irish Health Minister Robin Swann has today launched a new community pharmacy Covid-19 vaccination service. The new service will see almost 350 community pharmacies throughout Northern Ireland begin to administer the vaccine and will mean eligible members of the public will be able to avail of the vaccine at a location more local to them.

 

At present this applies to those aged 50 years and over. This latest development follows the official opening of the Covid-19 vaccination centre at the SSE arena in Belfast earlier today.

 

Speaking during a visit to Timoney Pharmacy in Lambeg, Health Minister Robin Swann said:

 

“This is a significant day in our vaccination journey and I am delighted to formally launch this new Covid-19 vaccination service in community pharmacies across Northern Ireland.”

 

“Community pharmacy teams have remained dedicated to providing the public with vital health care and support through what have been very challenging times. Pharmacists have a wealth of expertise, skills and experience which makes them very well-placed for delivering the Covid-19 vaccine. The addition of this new service will help speed up the roll-out of the existing programme by increasing capacity and local accessibility to vaccines for the general population, particularly for those who may find it more difficult to travel to one of the mass vaccination centres.”

 

After receiving her vaccine at the pharmacy, Chief Pharmaceutical Officer Cathy Harrison said:

 

“Community pharmacies have played a vital role throughout the pandemic and will continue to do so as they join the vaccination roll-out programme. Over the course of the past year, the general public has come to rely on community pharmacists more than ever before due to their accessibility and the addition of this new service will greatly benefit the people of Northern Ireland.

 

“Given the high demand for vaccines we anticipate that community pharmacies will be a popular option for those who are eligible so please be patient with pharmacy teams.”

 

Joe Brogan, Head of Pharmacy and Medicines Management at the Health and Social Care Board said:

 

“The COVID vaccination campaign is one of the ways that we as a society will move forward. It is vital that our population has every opportunity to access this service and it’s fantastic to have almost 350 additional locations where people can book an appointment for a vaccine at a time and a place that suits them.

 

“I wish to recognise the tremendous response of community pharmacy teams in supporting the response to COVID and support our pathway out of the pandemic.”

 

Gerard Greene, Chief Executive of Community Pharmacy NI said:

 

“I am delighted to see the rollout of the community pharmacy vaccination programme. This will bring a further boost to the regional and national vaccination programme and ensure that even more people in our communities are protected from the virus.

 

“The advantage in being able to receive the vaccine at participating local community pharmacies is their accessibility so people can get the vaccine at a location more convenient to them.

 

“We do ask the public for patience over the coming weeks as this new service gets up and running. Pharmacists will be vaccinating the public along with their usual work in ensuring the safe supply of medicines and provision of medical advice.

 

“As clinically trained vaccinators, community pharmacists are looking forward to beginning vaccinating their communities and contribute even further to the wider Covid-19 response.”

 

Read more

 

Partnership to shake up traditional pharmacy distribution model

 

Scottish NHS staff offered at least a 4% pay rise

 

Five year Welsh hospital pharmacy plan revealed

 

 

NI pharmacies join vaccination programme

 

Community pharmacies across Northern Ireland will join the Covid-19 vaccination programme from the end of this month, Health Minister Robin Swann has announced.

 

The plan will see hundreds of community pharmacies provide vaccine jabs to members of the public, complementing the work of GP practices and vaccination centres. Over 300 pharmacies have signed up to be part of the scheme to date.

 

The official launch of the roll-out to community pharmacies will be on March 30th, although it is expected that many will have started before then.

 

The Health Minister said:

 

“I am delighted to confirm yet another positive development in our drive to protect the people of Northern Ireland from Covid-19.

 

“Community pharmacists are an integral part of the health and social care family. Their contribution to getting as many people vaccinated as possible will be invaluable.”

 

Northern Ireland’s Chief Pharmaceutical Officer Cathy Harrison said:

 

“Community pharmacies are the most accessible healthcare service for the public and their involvement in the Covid-19 vaccination programme will build on the success of their role in Northern Ireland’s 2020/21 winter flu vaccination.

 

“I want to thank all the pharmacy staff involved and representatives of the community pharmacy sector for their support in bringing this plan to fruition.”

 

Joe Brogan, Head of Pharmacy and Medicines Management at the Health and Social Care Board, said:

 

“The Covid vaccination campaign is one of the ways that we as a society will move forward. It is vital that our population has every opportunity to access this service and it’s fantastic to have over 300 further points where people can book an appointment for a vaccine at a time and a place that suits them. I wish to recognise the tremendous response of community pharmacy teams in supporting the response to Covid and our pathway out of the pandemic.”

 

The Chief Executive of Community Pharmacy NI, Gerard Greene, said:

 

“This is a fantastic and welcome step forward. The accessibility and reach of the community pharmacy network, with pharmacists as skilled vaccinators, means they are well equipped to take part in the vaccine programme and further contribute to the pandemic response.

 

“Throughout the pandemic, the community pharmacy workforce has gone above and beyond to support patients across Northern Ireland. This latest example shows our pharmacists collaborating to ensure a smooth and safe vaccine programme to protect the public. This should be commended.

 

“We would also remind the public that community pharmacies remain open with support and guidance for any medical concern. The vaccination programme will not impact on other services and prescriptions will be dispensed in a safe, convenient and timely manner. Public health continues to be our top priority and the community pharmacy network remains committed to serving their communities. The Covid-19 vaccine is another example of community pharmacy playing that central role in primary healthcare.”

 

 

New data shows Covid-19 vaccines meet strict regulatory safety standards

 

Data published from UK’s independent medicines regulator confirms approved vaccines meet strict regulatory standards for safety.

 

Routine safety monitoring and analysis of the approved COVID-19 vaccines by the UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), shows that the safety of these vaccines remains as high as expected from the clinical trial data that supported the approvals. The safety profile of the vaccines remains positive and the benefits continue to far outweigh any known side-effects.

 

Over 10 million doses of the Pfizer/BioNTech and the Oxford University/AstraZeneca vaccines have been given across the UK and the MHRA has gathered a large amount of safety data. Data published today shows 22,820 reports of suspected side effects or an overall reporting rate of 3 in 1,000 doses of vaccine administered from 9 December 2020 to 24 January 2021. This reassuring data has shown that the vast majority of reported side effects are mild and all are in line with most types of vaccine, including the seasonal flu vaccine. These include sore arms and mild ‘flu-like’ symptoms, which reflect normal immune response to vaccines and are short-lasting.

 

The MHRA has today published its safety surveillance strategy for monitoring the safety of all UK-approved COVID-19 vaccines. This has been informed by the Government’s independent advisory body, the Commission on Human Medicines, and expertise across the UK public health sector.

 

The MHRA has also published today the first of what will be regular COVID-19 vaccine safety reports. These provide details on the suspected side-effects to the vaccines reported through its safety monitoring system, the Yellow Card scheme. This data has been thoroughly analysed by the MHRA’s scientists and safety experts together with all other sources of evidence.

 

The MHRA is working to actively promote reporting on COVID-19 vaccines from patients and healthcare professionals to the Coronavirus Yellow Card scheme. Anyone who has received the vaccine and thinks they may have suffered a side-effect, even suspected, is encouraged to report it to the MHRA here.

 

Safety monitoring of all medicines and vaccines used by the wider UK population is a key role of the MHRA. The safety of COVID-19 vaccines is continually monitored throughout their use in healthcare practice to ensure they remain safe and effective. The regulator does this by identifying and comparing new and emerging data from multiple sources with what it already knows from large-scale clinical trials.

Dr June Raine, MHRA Chief Executive, said:

 

“Vaccines are the most effective way to protect against COVID-19 and save lives and prevent serious complications from this terrible virus. The data we have collected provides further reassurance that the COVID-19 vaccines are safe and continue to meet the rigorous regulatory standards required for all vaccines. We remain confident that the benefits of these vaccines outweigh any risks.

 

“Our priority is to ensure the public has safe and effective vaccines and we will continue to analyse, monitor and review all the safety data for these vaccines. I’d like to thank everyone who has reported a potential side effect on us – every report matters.”

 

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