UK COVID-19 Update: MHRA Assessing Oxford Vaccine, R Falls

Tim Locke

November 27, 2020

These are the UK coronavirus stories you need to know about today.

MHRA Assessing Oxford Vaccine

The MHRA has been asked to assess the Oxford/AstraZeneca vaccine.

Chief Executive Dr June Raine said in a statement: "We are pleased to have received the letter from the Department of Health and Social Care requesting review of the Oxford/AstraZeneca COVID-19 vaccine candidate.

"Our job will be to rigorously assess the latest data and evidence to be submitted of the vaccine’s safety, quality, and effectiveness.

"We will seek advice from the Government’s independent advisory body, the Commission on Human Medicines. The Commission will critically assess the data too before advising the UK Government on the safety, quality, and effectiveness of any potential vaccine.

"The safety of the public will always come first. Our role is to work to the highest standards and safety is our watchword."

Last week the MHRA was asked to assess the Pfizer/BioNTech vaccine.

Experts have responded to AstraZeneca planning an additional trial to clear up potential uncertainty over its interim results.

The vaccine performed better when people had a half dose before a full dose rather than two full doses due to a lucky 'mistake'. However, there are concerns over reports the half dose group had a lower age profile.

AstraZeneca Chief Executive Officer Pascal Soriot told Bloomberg: "Now that we’ve found what looks like a better efficacy we have to validate this, so we need to do an additional study."

Professor Helen Fletcher, London School of Hygiene & Tropical Medicine, and UKRI Director of International Development, told the Science Media Centre: "In my opinion this will not necessarily delay licensure as even the efficacy in the high dose vaccine group is greater than 50% which was the minimal level defined in the WHO Target Product Profile (TPP) and also the level defined by the US FDA. 

"It is not unusual to take a licensed vaccine and then – typically some years later – perform studies to alter the dose or schedule to try and optimise the performance of the vaccine.  In fact the Oxford Vaccine Group, headed by Andy Pollard, has done many studies like this in the past with licensed vaccines for children and infants.  It’s entirely possible AZ and Oxford could license the high dose and then quickly seek an amendment to use the low dose when they have sufficient data.  I think this is just another example of how vaccine development has accelerated to respond to COVID-19."

The Huffington Post reported Downing Street wanted the union flag (union jack) printed on the Oxford vaccine kits.

Number 10 said there were no plans for the flag to be put on doses, but didn't deny that the request had been made.

Green Book

Public Health England has added a new chapter on COVID-19 vaccination to the 'Green Book' immunisation guide.

The information covers storage, dosing, and schedules, subject to regulatory approval.

Training and information materials and e-learning modules are being made available, together with a competency assessment tool.

Head of Immunisations, Dr Mary Ramsay, commented: "Health and social care workers are highly skilled in delivering millions of vaccines every year, from flu to MMR.

"They will be at the forefront of this exciting next step to help tackle the pandemic – our new guidance will support them in delivering any approved COVID-19 vaccines safely and at pace."

R Falls

The UK's R number has dropped again to 0.9-1.0 from 1.0-1.1 last week. That's the lowest it has been since August.

The growth rate is -2% to 0% per day.

Professor Liam Smeeth, London School of Hygiene and Tropical Medicine, commented via the Science Media Centre: "It is increasingly clear that the stricter measures implemented in recent weeks are having an impact. Infections were rising rapidly – and everything we know, including direct experience from the first wave – tells us that infections would have carried on rising and would still be rising now.

"The collective actions of society have quite literally re-shaped the pandemic. Working together we have been able to control this virus. Obviously the terrible economic and social impacts, and the ongoing health impacts, mean there is little impetus to celebrate. But this should not detract from just what an amazing achievement controlling viral spread has been." 

In today's daily data another 16,022 UK positive tests were reported and 521 deaths.

There are 16,064 COVID-19 patients in hospital and 1456 ventilator beds are in use.

Tier Trouble

Boris Johnson is facing a backbench rebellion next week when MPs vote to approve the new tier allocation under which 99% of England will go into the higher tiers 2 and 3.

The Tory COVID Recovery Group described the plan as "authoritarianism at work".

The PM may need Labour support to get the measures approved.

At a Downing Street briefing, England's CMO, Professor Chris Whitty, urged people to avoid physical contact with grandparents and elderly relatives during the 5 days of Christmas relaxed lockdown.

"Would I encourage someone to hug and kiss their elderly relatives? No I would not," he said.

Prof Whitty also said he'll be "on the wards" over Christmas.

Today is the first day of Northern Ireland's latest 2 week 'circuit breaker' lockdown.

The Scottish Government plans to significantly expand testing services for patients in hospitals, health and social care staff, and communities in the highest Level 4 areas.

From next week, all emergency admissions will be tested for COVID-19, and twice-weekly lateral flow testing will be introduced for all frontline healthcare staff working in hospitals, COVID-19 assessment centres, and the ambulance service.

Testing will be introduced for all elective admissions to hospital from mid-December.

The First Minister of Wales Mark Drakeford announced nationwide new indoor hospitality and entertainment restrictions from next Friday, including the closure of cinemas and bowling alleys.

Few Lung Cancer Video Consultations

Only 5% of lung cancer patients are being offered video consultations during the pandemic, according to a report from the British Thoracic Oncology Group (BTOG), the UK Lung Cancer Coalition, the Roy Castle Lung Cancer Foundation, and Lung Cancer Nursing UK.

  • 69% of patients were not given a choice between telephone or video consultations

  • 76% of healthcare professionals had not received training or guidance on virtual appointments

  • 65% of health professionals said a a lack of computer equipment to hold video consultations was a regular problem

Online surveys were carried out from 29 September to 19 October 2020 with 105 patients and carers and 80 healthcare professionals mostly working in secondary and tertiary care.

Professor Sanjay Popat, consultant thoracic medical oncologist, Royal Marsden NHS Foundation Trust, BTOG steering committee chair, said: "This survey exposes some of the huge infrastructure changes that need to happen to make video consultations workable long-term in both secondary and tertiary lung cancer care settings."

Pandemic Teamwork

BAME doctors were less likely than their White counterparts to report improvements in workplace teamwork, according to a GMC report on medical education and practice.

Dr Chaand Nagpaul, BMA council chair, commented that the findings were "deeply concerning", and said: "BMA surveys have highlighted time and time again that doctors from BME backgrounds can be less confident in raising concerns, more fearful of being blamed if something goes wrong, and are more likely to experience bullying or harassment in the workplace."

Cardiac Rehabilitation 

The number of people having cardiac rehabilitation in the UK fell by 33% as the pandemic first hit, an audit for the British Heart Foundation (BHF) found.

Reasons included fewer going to hospital with heart attacks, many cardiac operations were postponed, there were fewer referrals to rehabilitation services, social distancing, and redeployment of healthcare professionals.

Director of the National Audit of Cardiac Rehabilitation, Professor Patrick Doherty, said in a statement: "Data from this year’s report shows the negative impact the pandemic has had on participation [in] routine services. However, it should also be noted that the report highlights that, despite significant staff redeployment to fight COVID-19, clinical teams from over 230 NHS programmes have adapted their services.

"This has resulted in a 36% increase in supported self-managed cardiac rehab, such as people doing it at home or online. Innovation is as important as ever, and the BHF and the National Audit of Cardiac Rehabilitation will explore the extent to which people have benefitted from these changes in 2021."

Bereavement

New research on bereavement has found that during the pandemic 51% of survey respondents who lost loved ones were not given support information, and 85% were unable to say goodbye as they would have liked.

The interim findings from the universities of Bristol and Cardiff, and Marie Curie, are published online.

One bereaved daughter commented in the survey: "We basically listened to him die on the phone over 5 days which was the most horrific experience for us and of course, Dad. We can only hope that he knew we loved him and hadn’t abandoned him in these last days."

Dr Emily Harrop, Marie Curie Palliative Care Research Centre, Cardiff University, said in a news release: "It is crucial that policy makers and those providing care and support to patients make changes to better support family members and close friends before and after a death."

Home Abortion Pill Consultation

A consultation has begun on whether England's temporary pandemic measures allowing home use of abortion pills up to 10 weeks’ gestation following a remote consultation will be extended.

In September, the BMA's Annual Representative Meeting voted to press for the emergency regulations to continue on a permanent basis.

The consultation is open until 26 February 2021.

See more global coronavirus updates in Medscape’s Coronavirus Resource Centre.

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