UK COVID-19 Daily: MHRA approves remdesivir

  • Tim Locke, Medscape.com

  • UK Medical News
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These are the UK coronavirus stories you need to know about Tuesday.

UK COVID-19 Update: MHRA Approves Remdesivir 

Remdesivir (Gilead) has become the first COVID-19 treatment to get a positive scientific opinion from the MHRA under the Early Access to Medicines Scheme.

This support for the antiviral drug doesn't replace licensing procedures but allows use before formal approval is granted.

The manufacturer is not charging the NHS for the drug that's delivered by infusion, and clinical trials are ongoing.

The Department of Health and Social Care said allocation of the drug "will be based on expert clinical advice and will take into consideration the situation where it is most likely to provide the greatest benefit".

The MHRA scientific opinion says: "Remdesivir is indicated for the treatment of adults and adolescent patients aged ≥ 12 years and weighing at least 40 kg hospitalised with suspected or laboratory-confirmed SARS-CoV-2 infection and severe disease.

Patients with severe disease are those with an SpO2 ≤ 94% on room air or requiring supplemental oxygen, or requiring non-invasive or invasive ventilation or extracorporeal membrane oxygenation (ECMO).”

The guidance cautions include insufficient data for use in under-12s, warnings over renal impairment, pregnancy, and breastfeeding.

Safety data will be collected about the medication's use.

MHRA Chief Executive Dr June Raine said in a news release: "We are committed to ensuring that patients can have fast access to promising new treatments for COVID-19. We will continue to work closely with the Department of Health and Social Care and other healthcare partners on protecting public health in the UK by prioritising our essential work on clinical trials, access to medicines, and the development of vaccines."

Health and Social Care Secretary for England, Matt Hancock, told the Downing Street briefing: "This is probably the biggest step forward in the treatment of coronavirus since the crisis began."

Commenting via the Science Media Centre, Dr Stephen Griffin, associate professor in the School of Medicine, University of Leeds, welcomed the announcement: "Remdesivir is perhaps the most promising direct-acting antiviral drug in current trials targeting COVID-19."

He continued: "Rolling out remdesivir via the EAMS will likely mean that the most severe COVID-19 patients will receive it first. Whilst this is clearly the most ethically sound approach, it also means that we ought not to expect the drug to immediately act as a magic bullet."

UK Hydroxychloroquine Trial Continues Despite WHO Safety Concerns

A UK study into hydroxychloroquine as a COVID-19 treatment is to continue despite the World Health Organisation (WHO) suspending its trial, underway in several countries, due to safety concerns.

Hydroxychloroquine is one of the drugs in Oxford's RECOVERY trial. Prof Peter Horby, professor of emerging infectious diseases and global health in the Nuffield Department of Medicine, University of Oxford, said in a statement: "The WHO decision to temporarily suspend hydroxychloroquine in their trial is based on data from a study that has looked at routinely collected data from hospitalised patients, and which reports an increased risk of death in patients who were given hydroxychloroquine. However, these types of studies are difficult to interpret because the decision to give the drug will be based on the severity of disease in the patient. It’s a bit like giving diabetic drugs to diabetics: the drug doesn’t cause the disease, you are given the drug because of the disease. The authors have tried to control for this “indication bias" in the study but it is very hard to do it fully. 

"In response to that paper, we looked very carefully at our data over the weekend, to make sure we are not putting patients at risk. Since RECOVERY patients are randomised, our data are much less vulnerable to the biases that plague studies that use routine health care data. An independent committee has looked at our data and did not see any safety concerns. We discussed our findings with Medicines and Healthcare products Regulatory Authority, who have agreed with our interpretation that the data provide reassurance that continued enrolment into the hydroxychloroquine arm is safe and that we should press ahead with getting a reliable answer on hydroxychloroquine through the RECOVERY trial."

Cummings and Other Questions

Matt Hancock faced question after question from journalists about Dominic Cummings and public mistrust following his admission of a long drive to another home under lockdown for childcare reasons.

However, it was the first question from a Brighton vicar called Martin that eluded new information.

He asked if the Government will review all penalty fines imposed on families travelling for childcare purposes during lockdown. He didn't mention the PM's chief adviser by name.

"That's a very good question," Mr Hancock said. "And we do understand the impact and the need for making sure that children get adequate childcare. That is one of the significant concerns that we've had all the way through this.

"And so I think especially coming from a man of the cloth, I think that is perfectly reasonable to take away that question. I'll have to talk to my Treasury colleagues before I can answer it in full."

Later, in response to a question about tracking and tracing he suggested compliance with the rules was a "civic duty".

"If you're phoned up and asked to self-isolate, even though you're perfectly healthy, because you've been in close contact with somebody who's tested positive, then it's your civic duty to then self isolate for yourself, for your community, for your family," he said.

He also confirmed the tracing programme could lead to "local lockdowns and focus on areas where there may be flare-ups".

Latest ONS Data

The latest COVID-19 data from the Office for National Statistics for England and Wales shows a total of 41,220 deaths between 28th December 2019 and 15th May 2020. Unlike the daily statistics confirmed by testing these include any death where COVID-19 was suspected and mentioned on the death certificate.

In Week 20 (to 15th May), 3810 deaths mentioned 'novel coronavirus (COVID-19)' (26.1%), the lowest for 6 weeks.

The proportion of all COVID-19 deaths occurring in care homes decreased to 37.2% in Week 20.

ONS also produced more social impact data, including:

  • 80% of adults in Great Britain worry about the effect COVID-19 is having on their life

  • People in London had the lowest awareness of the Government’s 'Stay at Home' guidelines last month, with awareness highest in the West Midlands

Daily Deaths and Data

Another 134 UK COVID-19 deaths were announced on Tuesday taking the total to 37,048.

For the first time since 18th of March there were no deaths from coronavirus recorded in Northern Ireland. 

Over the bank holiday weekend, 282 deaths were announced on Saturday, 118 on Sunday, and 121 on Monday. Figures are usually lower after bank holiday weekends due to reporting delays.

There were 109,979 tests counted on Monday. This figure includes home tests that have been sent out but not yet processed. The current target is 200,000 tests a day by the end of the month. The figures for the number of people tested have not been available since Friday.

Another 2004 positive cases were reported on Tuesday, and 8802 people are currently in hospital with coronavirus, including 98 NHS workers.

There were 471 COVID-19 hospital admissions in England on Monday, the lowest since data started to be collected on 20th March, and 11% of UK critical care beds are being used by COVID-19 patients.

England's Next Steps

As well as planning for some primary age children going back to school in England next Monday (June 1st) other lockdown relaxation measures were announced at the weekend.

Car showrooms and outdoor markets can also reopen next week as long as measures are taken to protect customers. Some car dealers have announced plans to trust customers to take test drives unaccompanied. 

From 15th June all other non-essential shops selling clothes, shoes, toys, furniture, books, and electronics, plus tailors, auction houses, photography studios, and indoor markets, will be allowed to open again.

Hairdressers, nail and beauty salons, pubs, and restaurants will remain closed.

More News in Brief

  • Mr Hancock announced the signing of contracts to manufacture 2 billion items of PPE in the UK. Globally, he said deals had been signed with more than 100 new suppliers. "While we continue to improve the logistics and work hard to get everyone the PPE that they need these new supplies mean that we're not simply keeping up with demand, we are now able to begin to replenish our stockpiles." However, no timescales were given.

  • Sports events in March before the lockdown have been linked to excess cases and deaths, the BBC reported. Professor Tim Spector from King's College London said local case rates "increased several-fold" around the Cheltenham Festival and Liverpool's Champions League match against Atletico Madrid. He added that the decision meant "people will have probably died prematurely".

  • The success of driving down COVID-19 in the community could be bad news for the University of Oxford's trial vaccine, project leader Professor Adrian Hill told the Sunday Telegraph. "It's a race against the virus disappearing," he warned. "We said earlier in the year that there was an 80% chance of developing an effective vaccine by September. But at the moment, there’s a 50% chance that we get no result at all. We're in the bizarre position of wanting COVID to stay, at least for a little while. But cases are declining."

  • New risk assessments for BAME health and care staff have been launched in Wales. Consultant Orthopaedic Surgeon Professor Keshav Singhal helped compile the evidence for the all-Wales COVID-19 Workforce Risk Assessment Tool. He said in a statement: "The launch and rollout of this tool will help allay anxieties particularly amongst the BAME staff, empower them and keep them safe from COVID-19 and help the employers in fulfilling their legal, moral and ethical obligations towards the safety of their staff."

  • Early results from the UK convalescent plasma trial have identified groups of COVID-19 patients whose plasma is most likely to save lives: males, over 35s, those ill enough to need hospital treatment. NHS Blood and Transplant (NHSBT) collects donations from recovered patients. NHSBT's Professor David Roberts said in a news release: "These initial results are in line with past findings. People who are more seriously ill produce more antibodies, which can be transfused to potentially help others."

  • Scotland's 'test and protect' programme will begin on Thursday starting with a team of 700 tracers using special contact tracing software. First Minister Nicola Sturgeon said: "The more effective it is, the more of the lockdown restrictions we will be able to lift."

Adapted from Medscape UK.