MHRA reassure public on AstraZeneca vaccine

 

Following suspensions by some countries of the COVID-19 Vaccine AstraZeneca over suspected blood clots, the MHRA confirms that the benefits of the vaccine in preventing COVID-19 far outweigh the risks. People should still go and get their COVID-19 vaccine when asked to do so.

 

The UK regulator, following a rigorous scientific review of all the available data, said that the available evidence does not suggest that blood clots in veins (venous thromboembolism) are caused by COVID-19 Vaccine AstraZeneca. This follows a detailed review of report cases as well as data from hospital admissions and GP records. This has been confirmed by the Government’s independent advisory group, the Commission on Human Medicines, whose expert scientists and clinicians have also reviewed the available data.

 

The MHRA’s advice remains that the benefits of the vaccines against COVID-19 continue to outweigh any risks and that the public should continue to get their vaccine when invited to do so.

 

Dr June Raine, MHRA Chief Executive, said:

 

“We continually monitor safety during the use of all vaccines to protect the public and to ensure the benefits continue to outweigh the risks.

 

“Our thorough and careful review, alongside the critical assessment of leading, independent scientists, shows that there is no evidence that that blood clots in veins is occurring more than would be expected in the absence of vaccination, for either vaccine.

 

“We have received a very small number of reports of an extremely rare form of a blood clot in the cerebral veins (sinus vein thrombosis, or CSVT) occurring together with lowered platelets soon after vaccination. This type of blood clot can occur naturally in people who have not been vaccinated, as well as in those suffering from COVID-19.

 

“Given the extremely rare rate of occurrence of these CSVT events among the 11 million people vaccinated, and as a link to the vaccine is unproven, the benefits of the vaccine in preventing COVID-19, with its associated risk of hospitalisation and death, continue to outweigh the risks of potential side effects.

 

“You should therefore continue to get your jab when it is your turn.

 

“While we continue to investigate these cases, as a precautionary measure we would advise anyone with a headache that lasts for more than 4 days after vaccination, or bruising beyond the site of vaccination after a few days, to seek medical attention.

 

“However, please remember that mild flu-like symptoms remain one of the most common side effects of any COVID-19 vaccine, including headache, chills and fever. These generally appear within a few hours and resolve within a day or two, but not everyone gets them.

 

“We will continue to robustly monitor all the data we have on this extremely rare possible side effect.

 

Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines, said:

 

“The independent COVID-19 Expert Working Group of the Commission on Human Medicines, together with leading haematologists, conducted a rigorous analysis of all available evidence regarding reports of blood clots (thromboembolic events) and COVID-19 Vaccine AstraZeneca.

 

“Our review has found that the available evidence does not suggest that blood clots are caused by COVID-19 Vaccine AstraZeneca.

 

“We have been closely reviewing all reports of blood clots in the vein (venous thromboembolism, or VTE) following vaccination. There is no evidence either that VTE is occurring more often in people who have received the vaccine than in people who have not, for either vaccine.

 

“However, we will continue to closely monitor the reports where cerebral sinus venous thrombosis has occurred in conjunction with lowered platelets to understand whether there is any potential association. This type of blood clot can rarely occur naturally in unvaccinated people as well as in people with COVID-19 disease. In the UK, 5 possible cases of this have been reported to us so far, after 11 million doses of COVID-19 Vaccine AstraZeneca.

 

“Further work with expert haematologists is underway to further understand the nature of these cases and whether there is a causal association with any of the vaccines. Given the extremely rare rate of occurrence of these events, the benefits of the AstraZeneca COVID vaccine, with the latest data suggesting an 80% reduction in hospitalisation and death from COVID disease, far outweigh any possible risks of the vaccine in the risk groups currently targeted in the UK.”

 

Royal Pharmaceutical Society Chief Scientist Professor Gino Martini said:

“I hope that any concerns about potential links between the Oxford-AstraZeneca COVID-19 vaccine can now be discarded given the positive verdicts delivered by the EMA, the WHO and the MHRA, who have all now said the is safe, effective and can continue to be used. The vaccine is playing a crucial role in protecting vulnerable groups from hospitalisation and death and helping to decrease infection rates across the UK.

“The MHRA is renowned as a world-class regulator of medicines and vaccines. They are continuing to monitor the Oxford/AstraZeneca vaccine closely as part of a ‘rolling review’ approach to COVID-19 jabs, through rigorous checks and processes, at they would for any other vaccine or medicine.

“As trusted health professionals, pharmacists are playing a key role in administering COVID-19 vaccinations and have contributed enormously to the success of the programme so far. We have full confidence in these vaccines and can confidently state that pharmacists can continue administering them to patients. It is so important that we get all those at risk from the virus vaccinated as soon as possible.”

 

Elements of this article are being shared under the Open Government Copyright licence.

 

 

Moderna Covid-19 vaccine approved by UK regulator

 

The Covid-19 vaccine developed by Moderna has today been given regulatory approval for supply by the Medicines and Healthcare products Regulatory Agency (MHRA).

 

This follows a thorough and rigorous assessment by the MHRA’s teams of scientists, including advice from the independent Commission on Human Medicines, which reviewed in-depth all the data to ensure this vaccine meets the required standards of safety, quality and effectiveness.

 

This is the third COVID-19 vaccine to be approved for use by the MHRA and is the second mRNA vaccine (the Pfizer/BioNTech vaccine approved in December 2020 is also an mRNA vaccine).

 

MHRA Chief Executive Dr June Raine said:

 

“Today’s approval brings more encouraging news to the public and the healthcare sector. Having a third Covid-19 vaccine approved for supply following a robust and thorough assessment of all the available data is an important goal to have achieved and I am proud that the agency has helped to make this a reality.

 

“The progress we are now making for vaccines on the regulatory front, whilst not cutting any corners, is helping in our global fight against this disease and ultimately helping to save lives. I want to echo that our goal is always to put the protection of the public first.

 

“Once in use, all Covid-19 vaccines are continually monitored by the MHRA. This ensures that the benefits in protecting people against Covid-19 continue to far outweigh any potential side-effects. Meantime, even if you have had a vaccine it is vital that everyone follows the national lockdown restrictions and remembers ‘stay alert, protect the NHS and save lives’ at all times.”

 

Professor Sir Munir Pirmohamed, Chair of the Expert Working Group of the Independent Commission on Human Medicines said:

 

“We are delighted to be able to give a positive recommendation for the Moderna vaccine which will help in the roll-out of the Covid-19 vaccination programme.

 

“As with all the Covid-19 vaccine data we have seen to date, we have ensured a robust and thorough safety assessment has been carried out with the independent experts that sit on this group.”

 

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

 

V-Day

 

The biggest vaccine campaign in NHS history, nicknamed ‘V-Day’, kicked off this morning, as 90-year-old grandmother Margaret Keenan became the first person in the world to receive the Pfizer COVID-19 vaccine following its clinical approval.

 

Pharmacy teams have been working rapidly across the UK to ensure the safe delivery of the first UK COVID-19 vaccine across the country today.

 

At 6.31 am early riser Margaret, known to friends and family as Maggie, was given the life-saving jab by nurse May Parsons at her local hospital in Coventry.

 

Margaret commented:

 

“I feel so privileged to be the first person vaccinated against COVID-19, it’s the best early birthday present I could wish for because it means I can finally look forward to spending time with my family and friends in the New Year after being on my own for most of the year.”

 

“I can’t thank May and the NHS staff enough who have looked after me tremendously, and my advice to anyone offered the vaccine is to take it – if I can have it at 90 then you can have it too!”

 

NHS England chief executive Sir Simon Stevens praised all those involved in delivering the new vaccine programme.

 

“Less than a year after the first case of this new disease was diagnosed, the NHS has now delivered the first clinically approved COVID-19 vaccination – that is a remarkable achievement,” Stevens said:  “A heartfelt thank you goes to everyone who has made this a reality – the scientists and doctors who worked tirelessly, and the volunteers who selflessly took part in the trials. They have achieved in months what normally takes years.

 

“My colleagues across the health service are rightly proud of this historic moment as we lead in deploying the PfizerBioNTech vaccine.

 

“I also want to thank Margaret, our first patient to receive the vaccine on the NHS. Today is just the first step in the largest vaccination programme this country has ever seen. It will take some months to complete the work as more vaccine supplies become available and until then we must not drop our guard. But if we all stay vigilant in the weeks and months ahead, we will be able to look back at this as a decisive turning point in the battle against the virus.”

 

NHS nurse May Parsons said it was a “huge honour” to be the first in the country to deliver the vaccine to a patient.

 

Speaking at University Hospitals Coventry and Warwickshire NHS Trust, nurse May Parsons, said:

 

“It’s a huge honour to be the first person in the country to deliver a COVID-19 jab to a patient, I’m just glad that I’m able to play a part in this historic day.

 

“The last few months have been tough for all of us working in the NHS, but now it feels like there is light at the end of the tunnel.”

 

 

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

 

 

Details of first Covid-19 vaccine phase in Scotland revealed

 

Dr Gregor Smith has written to NHS and public sector leaders outlining how the 476,000 doses of the Pfizer BioNtech vaccine that Scotland will receive over this month will be used.

 

NHS boards are being asked to prioritise staff providing the vaccine and workers deemed most at-risk because of their age.

 

Care home residents and staff will be vaccinated in the initial wave but a ‘limited supply’ means this will not be offered to all over-80s.

 

The UK’s Medicines and Healthcare products Regulatory Agency last week approved the first covid-19 vaccine for use in the country, with the first vaccinations taking place tomorrow.

 

Scottish Health Secretary Jeane Freeman said the vaccine would be first given to priority groups where it could “address 99% of preventable deaths associated with covid-19”.

 

The list of who gets the vaccine was developed by the expert Joint Committee on Vaccination and Immunisation (JCVI), who said vaccinations should start with care home residents and staff, before moving to over-80s and healthcare workers, followed by other age and clinically vulnerable groups.

 

In a letter published this week but dated 4th December Scotland CMO Dr Gregor Smith says a further ‘phased approach’ is required because of a ‘limited vaccine supply’ and outlines a breakdown of where the first jabs will go.

 

The Pfizer BioNtech vaccine requires two jabs per person, so half of the 476,000 will be held back to be used as second doses.

 

Top of the initial priority groups are care home residents, who will have doses taken to them by the NHS, followed by staff in these homes.

 

The NHS is being asked to assist care home staff in getting to NHS board vaccination centres, as well as by vaccinating in care homes.

 

 

The third group is health and care staff in ‘direct face to face’ contact with patients, who will be vaccinated in the same centres.

 

Boards are asked to vaccinate to cover vaccinators and ‘others based on a risk assessment taking into account factors such as those who are working in covid red areas and age (older staff)’.

 

The next group is long-stay inpatients in hospitals aged over 80, who have a similar level of risk as care home residents.

 

The letter states that over-80s who are not in these groups are not being recommended for vaccination at this stage.

 

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.

 

COVID-19 vaccination programme to start in Scotland next week

 

Deliveries of the first coronavirus (COVID-19) vaccine to Scotland are expected to be made early next week with injections being given from Tuesday 8th December.

 

Following the news that the Medicines and Healthcare Products Regulatory Agency (MHRA) has confirmed that the vaccine developed by Pfizer and BioNTech has been authorised for use in the UK.

 

The vaccine, which must be stored at well below freezing, will be transported to 23 locations around Scotland in temperature-controlled lorries.

 

Everyone being vaccinated will need two vaccines, between 21 and 28 days apart.

 

Those giving the vaccination to others will receive the injection first. The programme will then follow the independent advice received from the Joint Committee on Vaccination and Immunisation (JCVI), which recommends prioritising those with the greatest clinical need – including those aged over 80, and health and social care workers. The storage requirements mean logistics around delivery to care homes are more challenging and they are currently under consideration.

 

Health Secretary Jeane Freeman said:

 

“Today’s announcement confirming that a safe and effective vaccine can now be used is the best news than any of us have heard about the virus since the pandemic began.

 

“As long as we receive the first doses of the vaccine when we expect to, we will begin vaccinating from Tuesday next week.

 

“It is, of course, worth remembering that everyone will require two vaccines, with the second vaccine between 21 and 28 days after the first,  so even for those who are among the first, there will be very few completed until early next year.

 

“We intend to vaccinate the vaccinators first, followed by the priority groups recommended by the JCVI, however, we also need to take account of the conditions attached to the authorisation to supply the vaccine which will present challenges around transporting the vaccine to care homes and individual homes.

 

“We are therefore in the process of working through how we can ensure people in priority groups in those settings can be vaccinated.

 

“For all the difficulties that lie ahead, it should give us all a real hope that the end of the pandemic is in sight.”

 

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

 

 

Safety paramount to the COVID-19 vaccine programme

 

Following the news that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved the Pfizer BioNTech COVID-19 vaccine for rollout in the UK from next week, the RPS is calling for the safety of pharmacy teams and their patients to be prioritised by ensuring that teams receive the vaccination at the same time as other health professionals.

 

In a statement on pharmacists’ role in the vaccination programme, RPS recognises that any vaccination strategy must minimise disruption to routine practice across all sectors and ensure that patients can still access the medicines, services and health care they need, whilst utilising the expertise and leadership of pharmacists from all sectors of the NHS to deliver the Covid-19 vaccination.

 

It also highlights how pharmacists can help with strategic planning, oversight of vaccination distribution arrangements as well as operational roles in preparation for the vaccine programme rollout.

 

Other key points in the statement highlight the importance of:

 

  • The role of pharmacists in providing information to the general public about the vaccine to maximise its uptake
  • Using the skills of pharmacists in all sectors as part of a networked approach.
  • Encouraging collaboration between health professionals
  • Undertaking vaccination training and access up to date information about the vaccines
  • Guaranteed supply of clinical consumables used for vaccinations

 

Sandra Gidley, President of the RPS, said:

 

“It is welcome news to all that a COVID-19 vaccination has been approved for widespread use in UK and we are now taking steps to understand the logistical arrangements for the vaccine programme. It is crucial that those at high risk from COVID-19 are vaccinated as soon as possible, in what is already being described as the largest vaccination campaign this country will have ever seen.

 

“Pharmacists have the expertise to play a crucial role in administering COVID-19 vaccinations, having delivered on many effective flu vaccination programmes in the past. We need assurances from the NHS and governments that the programme will not disrupt our already stretched workforce but make way for greater collaboration between health professionals and minimise the impact on routine practice.

 

“Safety is absolutely our number one priority, both for patients and for those administrating the vaccine. Pharmacists and their teams have been caring for the public and exposing themselves to the virus all through the pandemic, so it’s only fair that they are protected with this vaccine and continue to receive all forms of protective equipment.”

 

Read the full statement here.