COVID-19: Keep up to date with the latest pharmaceutical and healthcare news as the pandemic evolves
RDIF confirms Sputnik V COVID vaccine’s efficacy
15th December 2020
The Russian Direct Investment Fund has released a new analysis of data obtained 21 days after administering the first dose of the vaccine, showing efficacy of 91.4%
The Russian Direct Investment Fund (RDIF) has confirmed efficacy of over 90% for the Sputnik V vaccine.
Evaluation of efficacy was carried out among volunteers (22,714) 21 days after receiving the first dose of the vaccine or placebo upon reaching the third and final statistically significant representative control point of the trial.
The data analysis at the final control point of the trials demonstrated a 91.4% efficacy rate.
The analysis was carried out on the basis of 78 confirmed cases identified in the placebo group (62 cases) and in the vaccine group (16 cases).
The vaccine shoed 100% efficacy against severe coronavirus cases, the group said, noting that there were 20 severe cases of coronavirus infection among confirmed cases in the placebo group and no severe cases in the vaccine group.
According to the RDIF, the Sputnik V vaccine is “one of the most competitive vaccines globally”, given that it is based on “a safe and proven platform of human adenoviral vectors”, that cost of one dose is less than $10 for international markets, and that production of the dry form of the vaccine, which is stored at a temperature of 2 to 8 degrees Celsius, “enables easier distribution” in international markets.
Green light for UK trial of nasal coronavirus vaccine
15th December 2020
The trial is expected to begin next month, with first data anticipated in the second quarter of 2020
Open Orphan and Codagenix have received approval from the UK’s independent Medicines and Healthcare Products Regulatory Agency (MHRA) to conduct a Phase I study of its COVID-19 vaccine.
The study will assess the safety and immunogenicity of a single-dose nasal vaccine candidate COVI-VAC in 48 healthy young adult volunteers.
COVI-VAC uses the entire virus in a weakened form, and so has the potential to induce broad antibody, cellular and mucosal immunity with a single intra-nasal dose.
According to Open Orphan, it could be one of the first vaccines to provide long-term immunity from COVID-19.
“We believe COVI-VAC, a needle-free, single dose vaccine, is well-suited to address potential gaps in supplying the global community, as there is likely to be significant unmet need even after the initial roll-out of first generation COVID-19 vaccines,” added Sybil Tasker, Codagenix' chief medical officer.
The study is expected to begin next month, with first data read outs expected in early Q2 2020.
New variant of coronavirus identified in the UK
15th December 2020
PHE says it is investigating more than a thousand cases of the new strain
Health officials say they have identified a new strain of coronavirus in the UK, as a soaring number of cases has pushed several areas in the South East into into Tier 3 lockdown.
Health and social care secretary Matt Hancock and chief medical officer Professor Chris Whitty have stressed that at present there is nothing to suggest that the new variant causes more severe disease or that vaccines would be ineffective.
The strain was identified due to Public Health England’s (PHE) enhanced monitoring following the increase in cases seen in Kent and London. The variant has been named ‘VUI – 202012/01’ (the first Variant Under Investigation in December 2020).
As of 13 December, 1,108 cases with this variant have been identified, predominantly in the South and East of England.
PHE said it is working with partners to investigate and plans to share its findings over the next two weeks, but also stressed that there is no evidence to suggest that the strain has any impact on disease severity, antibody response or vaccine efficacy.
Also, while high numbers of cases of the variant virus have been recorded in some areas where there is also a high incidence of COVID-19, it is not yet known whether the variant is responsible for these increased numbers of cases.
“The best way to stop infection is to stick to the rules – wash our hands, wear a face covering and keep our distance from others,” stressed Dr Susan Hopkins, Test and Trace and PHE joint medical advisor.
As of tomorrow, almost 11 million in London and areas of Essex and Hertfordshire will be in the highest level of the current lockdown structure, in a bid to rein in rising rates of the virus.
CR UK makes further cuts in COVID's wake
8th December 2020
The charity is slashing £45 million from its research budget
Cancer Research UK has announced further catastrophic cuts in the wake of the coronavirus pandemic, slashing £45 million from its research budget, leaving dozens of potential life-saving projects and hundreds of world-class scientists unfunded.
This move follows an earlier £44 million cut made to current grants at the start of the pandemic, and the charity saying it would not be able to fund any new clinical trials this year.
The new cuts have led to 24 fewer research programmes, 68 fewer projects and 12 fewer fellowships, and CR UK says there will be around 328 fewer researchers working on their research.
The charity stresses that these cuts to the research portfolio “will not only slow down future breakthroughs for people with cancer but could seriously reduce the chances of reaching the charity’s goal of three in four surviving their cancer by 2034.”
The drop in income caused by the pandemic means that around 100 fewer grants will be funded, spanning longer-term multi-million-pound research programmes, specific research projects and fellowships that support scientists at all career stages.
Moreover, the charity said it will have to continue looking at ongoing reductions in other parts of the research budget.
If the situation remains unchanged, CR UK has warned that it could be spending £150 million less per year by 2024 as it faces a potential £300 million decline in fundraising income over the next three years.
“COVID-19 has slowed down our efforts to beat cancer. The closures of our charity shops and the cancellation of our fundraising events across the country means we have less money available for life-saving research, but we will never stop,” said Michelle Mitchell, the charity's chief executive.
“We have always relied on the generous donations of all our supporters, but we need them now more than ever so we can continue to achieve these ambitions and so that together, we can still beat cancer.”
Dr Iain Foulkes, executive director of research and innovation at Cancer Research UK, added: “As a charity, we fund around half of the UK’s publicly funded cancer research. Medical research charities like Cancer Research UK are the life blood of research and development in the UK, and we have all felt the devastating blow of the pandemic on our income.
“The recent Government spending review was a step in the right direction for cancer services in the UK, but we need urgent clarification to what measures are being put in place to support medical research charities through the Life Sciences Charity Partnership Fund. As a country that relies so heavily on charity-funded research, the UK risks weakening its reputation as a world-leader in science if charities don’t receive the right support.”
World first as UK launches COVID-19 vaccination programme
8th December 2020
A 90 year-old woman in Coventry has become the first person in the UK to be given the vaccine
The UK has embarked on a large-scale vaccination programme to protect the population against COVID-19, with Margaret Keenan becoming the first in the world to receive the Pfizer/BioNTech COVID-19 jab outside of trials, in what many are describing as a landmark moment in the pandemic.
“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,” said NHS England chief executive Sir Simon Stevens.
“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.”
“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,” added Keenan, who turns 91 next week.
The phased vaccination programme will see patients aged 80 and above who are already attending hospital as an outpatient, and those who are being discharged home after a hospital stay, among the first people protected from contracting novel coronavirus with BNT162b2.
Care home providers are also being asked by the Department of Health and Social Care to begin booking staff in to vaccination clinics, while GPs will begin vaccinating care home residents.
The vaccine is typically delivered by a simple injection in the shoulder but there is a complex logistical challenge in that it needs to be stored at -70C before being thawed out and can only be moved four times within that cold chain ahead of use.
The UK's Medicines and Healthcare products Regulatory Agency granted emergency use authorisation for the vaccine early December, on the back of a rolling submission including data from a Phase III clinical study, which showed an efficacy rate of 95% in people without prior SARS-CoV-2 infection and also in those with and without prior infection.
In the trial, BNT162b2 was generally well tolerated with no serious safety concerns reported by the Data Monitoring Committee to date.
NHS launches 40 ‘long COVID’ clinics
16th November 2020
It is hoped that the move will help to tackle the persistent symptoms – such as fatigue and brain fog – suffered by people who have developed the condition
The NHS is rolling out a network of more than 40 long COVID specialist clinics in the next few weeks to help thousands of patients who are suffering debilitating effects of coronavirus months after infection.
The clinics will house doctors, nurses, therapist and other NHS staff under one roof offering physical and psychological assessments of those experiencing enduring symptoms.
Long COVID, which is thought to affect more than 60,000 people in the UK, can cause continuing fatigue, brain fog, breathlessness and pain.
NHS England has provided £10 million to fund the clinics, with ten sites already earmarked for the Midlands, seven in the North East, six in the East of England, South West and South East respectively, five in London and three in the North West.
These services will be accessed via referral from a GP other healthcare professional, allowing doctors an opportunity to rule out any other possible underlying causes for symptoms, such as suspected stroke, lung cancers or respiratory conditions.
The NHS has also launched a new taskforce to help the NHS manage its approach to long COVID and produce information and support materials to boost understanding of the condition.
Older people, women and those with a greater number of different symptoms in the first week of their illness were found to be more likely to develop long COVID in a study by Kings College London, with one in 10 still experiencing side effects eight weeks after infection.
“Long COVID is already having a very serious impact on many people’s lives and could well go on to affect hundreds of thousands,” said NHS chief executive Sir Simon Stevens.
“That is why, while treating rising numbers of patients who are sick with the virus and many more who do not have it, the NHS is taking action to address those suffering ongoing health issues.”
According to recent evidence, long COVID can be categorised into four different syndromes: post intensive care syndrome, post viral fatigue syndrome, permanent organ damage and long term COVID syndrome.
£12.2m boost for coronavirus genomic surveillance
16th November 2020
The funds will help expand the scale of SARS-CoV-2 virus sequencing in the hope of revealing new opportunities for intervention
The COVID-19 Genomics UK (COG-UK) Consortium is being given £12.2 million from the Department for Health and Social Care Testing Innovation Fund to expand whole genome sequencing of positive SARS-CoV-2 virus samples.
The funding will facilitate the genome sequencing capacity needed to meet the expected rise in COVID-19 cases in the UK this winter, which will help to map how the virus spreads and evolves.
The investment enables COG-UK to grow and strengthen current genomic surveillance efforts spearheaded by the Wellcome Sanger Institute and the University of Cambridge, together with the four UK Public Health Agencies and other COG-UK partners, to boost sequencing capacity and cut turnaround time from sample to genome sequence.
It is hoped that integrating real-time sequencing data within the four UK Public Health Agencies and NHS Test and Trace will not only help strengthen infection control measures but also the identification of patterns that might reveal otherwise unidentifiable opportunities for intervention.
Led by Professor Sharon Peacock of the University of Cambridge & Director Of Science at Public Health England, COG-UK is an innovative partnership of NHS organisations, the four Public Health Agencies of the UK, the Wellcome Sanger Institute and 12 academic institutions from across the UK providing world leading expertise in SARS-CoV-2 genomics and supporting sequencing and analysis capacity nationwide.
“To fully understand the spread and evolution of the SARS-CoV-2 virus, we must sequence and analyse the viral genomes,” said Professor Sharon Peacock, director of the COG-UK Consortium, Professor of Public Health and Microbiology at the University of Cambridge and a director Of Science (Pathogen Genomics) at Public Health England.
“The pattern of accumulation of mutations in the genomes enables us to determine the relatedness of virus samples and define viral lineages in order to understand whether local outbreaks are caused by transmission of single or multiple viral lineages. Analysis of viral genome sequences also allow us to monitor the evolution of SARS-CoV-2 and assess whether specific mutations influence transmission, disease severity, or the impact of interventions such as vaccines.”
J&J launches second PhIII COVID-19 trial
16th November 2020
Janssen will enrol participants in countries with high incidence of COVID-19, including the UK
Johnson & Johnson group Janssen has initiated a second Phase III study of its experimental COVID-19 vaccine.
The two-dose regimen ENSEMBLE 2 trial will study the safety and efficacy of a two-dose regimen of the investigational vaccine for the prevention of COVID-19 in up to 30,000 participants worldwide.
Janssen will enrol participants in Belgium, Colombia, France, Germany, the Philippines, South Africa, Spain, the UK and the US, having selected clinical trial sites in countries and areas with high incidence of COVID-19 and the ability to achieve a rapid initiation.
The Phase III ENSEMBLE study of the single-dose regimen of JNJ-78436735 continues to enrol and vaccinate study participants.
The late-stage trials follow positive interim results from the ongoing Phase I/IIa clinical study, which is studying the safety profile and immunogenicity of both a single-dose and two-dose vaccination.
Interim analysis showed that a single dose of the COVID-19 vaccine candidate induced a robust immune response and was generally well-tolerated, the firm said.
New study assessing antibiotics for COVID-19 sepsis
2nd November 2020
It is hoped that findings from the NIHR-funded trial will help better inform treatment decisions
Researchers from an NIHR-funded study are looking at how to improve the use of antibiotics for patients with COVID-19 who are at risk of developing sepsis and thus organ failure and death.
The ADAPT-Sepsis study, which is being led by researchers at Salford Royal NHS Foundation Trust, actually started back in 2017 with the intention of making antibiotic prescribing for suspected sepsis more effective and targeted.
A key element of this is whether one of two different markers in the blood is more effective to better inform antibiotic treatment decisions for critically ill patients suspected of having developed sepsis.
Now, seriously ill COVID-19 patients are also being included in the study, in the hope of determining whether severe infections caused by coronavirus can be effectively treated with antibiotics.
The trial is one of a number of COVID-19 studies assigned urgent public health research status by the chief medical officer and deputy chief medical officer for England.
“During the first wave of the pandemic, there was widespread use of antibiotics in hospitalised patients with severe pneumonia and sepsis as a result of COVID-19. Research suggests that overuse of antibiotics is associated with further risk of hospital-acquired infection and sepsis as patients recover which can be even more difficult to treat,” noted chief investigator Professor Paul Dark, consultant in Critical Care Medicine at Salford Royal and Professor of Critical Care Medicine at The University of Manchester and the NIHR Manchester Biomedical Research Centre.
“This is why it is so important that hospital staff have the best possible guidance on antibiotic treatment decisions in adult patients with severe pneumonia and sepsis. As we go into winter and the second wave of the pandemic, we expect to see more patients with viral and bacterial respiratory infections and this study has a vital role in how we look after them and future patients.”
Data shows coronavirus infection rate might be slowing
1st October 2020
The R rate has fallen but prevalence of infection is at a record level
Data from over 80,000 volunteers in England tested between 18 and 26 September as part of the country’s largest study into COVID-19 indicate that the overall rate of infection could be slowing.
Interim findings from Imperial College London and Ipsos MORI show that round 1 in 200 people are infected with the virus but that the R rate has fallen to around 1.1.
The report does show that prevalence of infection increased across all age groups and regions, being highest in the 18 to 24 years age group, with 1 in 100 people infected, and a seven-fold increase in cases in those aged over 65.
The North West had the highest levels of infection and the number of infections in London increased five-fold.
“While our latest findings show some early evidence that the growth of new cases may have slowed, suggesting efforts to control the infection are working, the prevalence of infection is the highest that we have recorded to date,” said Professor Paul Elliott, director of the programme at Imperial from the School of Public Health.
“This reinforces the need for protective measures to limit the spread of the disease and the public’s adherence to these, which will be vital to minimise further significant illness and loss of life from COVID-19.”
The interim findings are from a study commissioned by the Department for Health and Social Care to examine levels of infection in the general population in England by testing over 150,000 participants each month over a two-week period.
The final report, based on data of all 150,000 volunteers to be tested between 18 September and 5 October, will be published next week.