COVID-19: Keep up to date with the latest pharmaceutical and healthcare news as the pandemic evolves
MHRA OKs Celltrion's Phase I trial of COVID drug
31st July 2020
The trial will enrol patients with mild symptoms of SARS-CoV-2 infection to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of CT-P59
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a green light for a Phase I trial assessing Celltrion's potential COVID-19 treatment CT-P59.
The trial is designed to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of the antiviral antibody treatment.
Celltrion says it plans to conduct further global Phase II/III trials in patients with mild and moderate COVID-19 and anticipates results from these pivotal studies by the end of the year.
A clinical trial investigating CT-P59 in the preventative setting, by enrolling people in close contact with COVID-19 patients globally, is also planned with top-line data expected in the first quarter of next year.
“This is a timely approval from the UK regulatory authority for the Phase I clinical trial with CT-P59 as the global pandemic continues to grow and there remains a significant need for a safe and effective treatment for COVID-19,” said Dr Sang Joon Lee, senior executive VP of Celltrion.
“We are rapidly advancing our COVID-19 programme with CT-P59, including a Phase I clinical trial in healthy volunteers in Korea. Furthermore, we are making efforts to ensure that if the clinical trial programme is successful we are able to scale up manufacturing appropriately.”
Celltrion said it is due to start full-scale commercial production of CT-P59 in September this year, and that it will secure manufacturing capacity to produce enough of the treatment for up to 5 million patients a year.
New research to investigate higher COVID-19 risk among BAME groups
29th July 2020
It is hoped that the six new projects, which total £4.3 million worth of funding, will further understanding on the link between ethnicity and susceptibility to the virus
Six new projects hoping to further improve understanding of the links between ethnicity and susceptibility to COVID-19 are being funded by the NIHR and UK Research and Innovation (UKRI).
The projects will seek to explain and mitigate the disproportionate death rate from COVID-19 among people from Black, Asian and minority ethnic (BAME) backgrounds, including BAME health and social care workers.
The move follows emerging evidence showing people from BAME backgrounds are nearly twice as likely to die of COVID-19 than white people.
Specifically, the projects will receive funding of £4.3 million to: explore the impact of the virus specifically on migrant and refugee groups; work with BAME communities to create targeted, digital health messages; introduce a new framework to ensure the representation of people from BAME backgrounds in COVID-19 clinical trials; and the creation of one the UK’s largest COVID-19 cohorts.
"With evidence showing that people from Black, Asian and minority ethnic backgrounds are more severely affected by COVID-19, it is critical that we understand what factors are driving this risk to address them effectively," said chief medical officer for England and head of the NIHR Professor Chris Whitty.
“The diverse range of projects funded by the NIHR and UKRI will help examine this association in detail, so that new treatments and approaches to care can be developed to target the ethnicities most at risk. This research will have embedded patient and public involvement with Black, Asian and minority ethnic groups at all stages of the research."
“Urgent action must be taken to determine and address the factors underlying this disparity,” added UKRI chief executive, Professor Dame Ottoline Leyser. “There is unlikely to be a simple answer and we must consider all possibilities, including the role of racial and social inequalities, so that we can save as many lives as possible during this pandemic and any future outbreaks.”
The NIHR is also working to encourage people from BAME backgrounds to take part in COVID-19 research and ensure that researchers include these communities in their studies.
Sanofi/GSK sign deal with UK gov for COVID-19 vaccine
29th July 2020
The companies have agreed to supply up to 60 million doses
Sanofi and GSK have reached an agreement with the UK government for the supply of up to 60 million doses of their COVID-19 vaccine.
The vaccine candidate, developed by Sanofi in partnership with GSK, is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine, and GSK’s established pandemic adjuvant technology.
Sanofi is leading the clinical development and registration of the vaccine, with a Phase I/II study scheduled to start in September followed by a Phase III trial by the end of this year.
The firms believe regulatory approval could be achieved by the first half of 2021 if the trials are successful.
Sanofi and GSK said they are also are scaling up manufacturing of the antigen and adjuvant to produce up to one billion doses per year overall.
“We believe that this adjuvanted vaccine candidate has the potential to play a significant role in overcoming the COVID-19 pandemic, both in the UK and around the world,” said Roger Connor, President of GSK Vaccines
“We thank the UK Government for confirmation of purchasing intent, which supports the significant investment we are already making as a company to scale up development and production of this vaccine.”
“Through this agreement with GSK and Sanofi, the Vaccine Taskforce can add another type of vaccine to the three different types of vaccine we have already secured,” commented Kate Bingham, chair of the UK Government’s Vaccines Taskforce.
“This diversity of vaccine types is important because we do not yet know which, if any, of the different types of vaccine will prove to generate a safe and protective response to COVID-19. Whilst this agreement is very good news, we mustn’t be complacent or over optimistic.”
Pfizer and BioNTech select lead mRNA vaccine against COVID-19
28th July 2020
The companies have started a global pivotal Phase II/III safety and efficacy study
Pfizer and BioNTech have started a global Phase II/III safety and efficacy clinical study to evaluate a single nucleoside-modified messenger RNA (modRNA) candidate from their BNT162 mRNA-based vaccine programme against SARS-CoV-2.
The companies have chosen to advance their BNT162b2 vaccine candidate into study, at a 30µg dose level in a two-dose regimen, following review of preclinical and clinical data from earlier trials, and in consultation with the US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) and other global regulators.
BNT162b2 encodes an optimised SARS-CoV-2 full length spike glycoprotein (S), which is the target of virus neutralising antibodies.
The Phase II/III study should enrol up to 30,000 participants between 18 and 85 years of age. Its primary endpoints will be prevention of COVID-19 in those who have not been infected by SARS-CoV-2 prior to immunisation, and prevention of COVID-19 regardless of whether participants have previously been infected by SARS-CoV-2. Secondary endpoints include prevention of severe COVID-19 in those groups.
“Our selection of the BNT162b2 vaccine candidate and its advancement into a Phase II/III study are the culmination of an extensive, collaborative and unprecedented R&D programme involving Pfizer, BioNTech, clinical investigators and study participants with a singular focus of developing a safe and effective COVID-19 RNA vaccine,” said Kathrin Jansen, senior vice president and head of Vaccine Research & Development, Pfizer.
“The initiation of the Phase II/III trial is a major step forward in our progress toward providing a potential vaccine to help fight the ongoing COVID-19 pandemic, and we look forward to generating additional data as the programme progresses.”
Gov unveils plans to boost UK's vaccines manufacturing capabilities
24th July 2020
New state-of-the-art centre to scale up COVID-19 vaccine and gene therapy manufacturing gets £100 million investment
The government is streaming an additional £100 million into ensuring that any COVID-19 vaccine making it to the finish line can be produced at scale in the UK.
The investment will fund a state-of-the-art Cell and Gene Therapy Catapult Manufacturing Innovation Centre in Braintree, Essex, to accelerate the mass production of a successful COVID-19 vaccine on domestic shores.
Due to open in December next year, the Centre will have the capacity to produce millions of doses each month, ensuring the UK has the capabilities to manufacture vaccines and advanced medicines, including for emerging diseases, into the future.
The government initiative will upgrade an existing facility to create a fully-licensed manufacturing centre, boosting the UK’s ability to respond to diseases like coronavirus and to prepare for potential future pandemics.
The centre will complement the Vaccines Manufacturing and Innovation Centre (VMIC), which is currently under construction in Oxfordshire with support from a £93 million government investment.
The government has also invested an additional £38 million in establishing a rapid deployment facility, opening later this summer, that will support efforts to ensure a successful vaccine is widely available to the public as soon as possible while the new centre is under construction.
“We are taking all necessary steps to ensure we can vaccinate the public as soon as a successful COVID-19 vaccine becomes available,” noted Business Secretary Alok Sharma, commenting on the move.
“This new Cell and Gene Therapy Catapult Manufacturing Innovation Centre, alongside crucial investment in skills, will support our efforts to rapidly produce millions of doses of a coronavirus vaccine while ensuring the UK can respond quickly to potential future pandemics.”
Lords urge government to act to now avert winter COVID-19 spike
24th July 2020
The House of Lords Science and Technology Committee has written to the prime minister with recommendations for dampening the expected surge in cases
The House of Lords Science and Technology Committee 'strongly recommends' that the government takes immediate action to slash the likelihood of a resurgence of COVID-19 in the winter.
In a letter to the prime minister, Committee Chair Lord Patel highlighted evidence heard from top medical and scientific advisors that ‘it will be vital to suppress levels of infection of the virus to as low as possible before the winter’ and that 'more could be done to reduce levels of infection'.
The Committee stressed that not enough is being done to reduce infection levels before October, especially in England, and calls for a target for the levels of infection the government aims to be at by October.
The letter also expresses concerns over 'stretching the NHS and the Test and Trace system beyond capacity if preparations and testing are not geared up now'.
It also notes that during the winter months the number of people presenting with COVID-like symptoms will 'increase significantly, and warns that the government 'may be underestimating testing requirements'.
The letter says that more testing must be done in high-risk environments and high-exposure occupations, and that multiplex testing strategies that could distinguish the virus from other illnesses must be explored urgently.
Lord Patel stressed that a more local response will be absolutely 'critical' as case numbers reduce, and expressed concerns over imbalances between national and local management of the pandemic in England.
Also, noting that the government’s public messaging 'falls short', the Committee called on the PM quickly to quickly put in place a public health campaign focusing on behaviours that can help suppress virus transmission.
The move follows research indicating that COVID-19 is worse in colder months than warmer ones, and that dry indoor air could encourage its spread, and a report by the Academy of Medical Sciences warning that hospital deaths related to the virus could hit 119,000 between September 2020 and June 2021 if action is not taken now to reduce its spread.
COVID-19 more severe in colder months, research suggests
23rd July 2020
Findings "paint a grim picture" for this winter, the researchers warn
Environmental temperature and humidity have an effect on the severity of COVID-19 symptoms, researchers from Europe and China have concluded.
Looking at outcomes relating to than 40,000 patients with COVID-19 amid the pandemic, the research indicates that disease caused by the virus is worse in colder months than warmer ones, and that dry indoor air could encourage its spread.
Data from nearly 7,000 patients admitted to hospital with COVID-19 in Croatia, Spain, Italy, Finland, Poland, Germany, the UK and China was analysed and mapped against local temperature and estimated indoor humidity.
The findings revealed that severe COVID-19 outcomes, including hospitalisation or need for ventilation, decreased in most European countries over the course of the pandemic, alongside the transition from winter to early summer.
Also, there was a corresponding decrease in deaths from the disease, with an approximate 15% fall in mortality for every one degree Celsius rise in temperature.
In direct contrast, severity of symptoms and mortality stayed consistent in China, where the first wave of the pandemic occurred solely throughout the winter.
Data from more than 37,000 people in the UK using the COVID Symptom Study app revealed a similar drop in the severity of reported symptoms from March through May, as the country's climate warmed, which researchers say was too significant to be explained by other factors such as treatment improvement and so indicates a seasonal affect on the virus.
“Our findings point to a role for seasonality in the transmission and severity of COVID-19, and also argue for increased humidity and hydration as a way to combat the virus. This paints a grim picture for the next winter in Europe when more severe “winter” COVID-19 is expected to return - something we are currently observing in the southern hemisphere,” said Dr Gordan Lauc, honorary visiting Professor at King’s and lead author of the study.
“This study highlights the importance of gathering long-term data about the incidence, symptoms and progression of COVID-19 from as many people as possible,” added Professor Tim Spector from King’s College London. “By understanding the many factors that contribute to the severity and spread of the disease, we can implement effective measures to control it over the coming months.”
The findings are particularly pertinent given recent warnings about the ability of the NHS to cope with a second wave of the pandemic in the winter.
A recent report by the Academy of Medical Sciences indicates that there could be a peak in hospital admissions and deaths in January and February 2021 similar to or worse than the first wave in spring 2020, which would coincide with a period of peak demand on the NHS.
It warns that the number of COVID-19-related hospital deaths (excluding care homes) between September 2020 and June 2021 could hit 119,900.
New data shows steep rise in people waiting for cancer tests
22nd July 2020
CR UK data also shows 2.3 million fewer tests have taken place compared to a year ago
Alarm bells are ringing again over the impact of the COVID-19 pandemic on cancer care in the UK, after Cancer Research UK unveiled new data showing a steep rise in the number of people waiting for diagnostic tests, and a study published in The Lancet warned that thousands may lose their lives because of the growing bottleneck.
According to the charity, at the end of May there were more than 180,000 people in England waiting for an endoscopy, marking a rise of 44% over the same time last year. Of these, 66% have been waiting six weeks or longer for testing.
The data also show that, compared to last year: 51% more people are waiting for colonoscopies and 46% more for flexi-sigmoidoscopies (used to detect bowel cancer); 44% more patients are waiting for gastroscopies (used to diagnose oesophageal and stomach cancer); and 23% more people are waiting for a cystoscopy (used for bladder cancer diagnosis).
CR UK said it is particularly concerned about these cancer types because endoscopies 'are proving particularly challenging to get back on track', as they are more invasive and need more stringent infection control measures.
However, the findings indicate that there are significant issues across the cancer diagnosis spectrum, as around 2.3 million fewer tests that help detect the disease have taken place since lockdown compared to the same time last year.
From March 1 to May 30 there was a 46% drop in numbers for seven tests that are commonly used to help spot the disease, including MRI scans, CT scans and ultrasound, as well as endoscopies, the charity revealed.
“We’re over the peak of the pandemic now, so it’s worrying there is an increasing number of patients whose lives are on pause while they wait for tests that could impact their chances of survival,” said Michelle Mitchell, CR UK's chief executive.
“It’s crucial the government works closely with the NHS to ensure it has the staff and equipment it needs to get services back on track before this situation gets even worse. But part of the reason the number of tests has reduced so dramatically is that people are delaying seeking help if they are worried about symptoms. So it’s more important than ever that anyone who is concerned about a change to their body speaks to their GP as soon as possible.”
“Even in ‘peace-time’ diagnostic testing was stretched to the limit, so the NHS faces a massive challenge to fast-track the millions of people waiting to find out if they have cancer,” added Professor Charles Swanton, CR UK’s chief clinician.
“An essential part of this is frequent COVID-19 testing of NHS staff and patients, including those without symptoms, so that vulnerable patients aren’t put at risk of contracting the virus and aren’t nervous about going to hospital. We need a clear and detailed plan in place to ensure increased capacity to diagnose cancer across the country to avoid further delays.”
ICR study highlights toll on survival
Meanwhile, The Lancet published a study showing that delays in patients presenting and being referred with suspected cancer by their GP, and resulting bottlenecks in diagnostic services, are likely to have had 'a significant adverse effect on cancer survival'.
Scientists at The Institute of Cancer Research, London, used 10-year cancer survival estimates for England for 20 common tumour types to create estimate the impact of reduced patient referrals through urgent GP pathways linked to the COVID-19 pandemic.
Researchers estimated that across all 20 cancer types, a uniform per-patient delay of one month in diagnosis just via the urgent referral pathway would result in 1,412 lives lost and 25,812 life-years lost if these disruptions lasted a full year, while a six-month delay would result in 9,280 lives and 173,540 life-years lost.
“It’s vital that we do everything we can to ensure cancer patients are not left further behind by the disruptions to care caused by the COVID-19 pandemic,” noted study lead Professor Clare Turnbull, Professor of Cancer Genomics at The Institute of Cancer Research, London.
“That means ramping up capacity as quickly as possible to allow cancer diagnostic services to clear the backlog.”
Interim data shows strong responses to AZ/Oxford Uni's COVID-19 vaccine
21st July 2020
Researchers reported a four-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95% of participants
A vaccine against SARS-CoV-2 being developed by AstraZeneca and the University of Oxford is showing strong promise in clinical trials.
Interim data from the ongoing Phase I/II COV001 trial, led by Oxford University, showed AZD1222 was tolerated and generated robust immune responses against the virus that causes COVID-19 in all evaluated participants.
COV001 is a blinded, multi-centre, randomised controlled Phase I/II trial with 1,077 healthy adult participants, aged 18-55 years. It assessed a single dose of AZD1222 against a comparator meningococcal conjugate vaccine, MenACWY. Ten participants also received two doses of AZD1222 one month apart.
The results, published in The Lancet, confirmed that a single dose of AZD1222 resulted in a four-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95% of participants one month after injection. In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection.
Neutralising activity against SARS-CoV-2 was observed in 91% of participants one month after vaccination and in 100% of participants who received a second dose.
On the safety side, transient local and systemic reactions – including temporary injection site pain and tenderness, mild-to-moderate headache, fatigue, chills, feverishness, malaise and muscle ache – were common in the AZD1222 group and comparable to previous trials and other adenoviral vector vaccines. No serious adverse events were reported with AZD1222, and reactions were lessened with the use of prophylactic paracetamol and occurred less frequently after a second dose, it was noted.
“The interim Phase I/II data for our coronavirus vaccine shows that the vaccine did not lead to any unexpected reactions and had a similar safety profile to previous vaccines of this type,” commented Professor Andrew Pollard, chief investigator of the Oxford Vaccine Trial at Oxford University and co-author of the trial.
“The immune responses observed following vaccination are in line with what we expect will be associated with protection against the SARS-CoV-2 virus, although we must continue with our rigorous clinical trial programme to confirm this. We saw the strongest immune response in participants who received two doses of the vaccine, indicating that this might be a good strategy for vaccination.”
Mene Pangalos, executive vice president, BioPharmaceuticals R&D, at AZ said interim results from the trial are “encouraging”.
“While there is more work to be done, today’s data increases our confidence that the vaccine will work and allows us to continue our plans to manufacture the vaccine at scale for broad and equitable access around the world.”
Late-stage Phase II/III trials are currently underway in the UK, Brazil and South Africa and are due to start in the US, which will help determine how well the vaccine will protect from the COVID-19 disease and measure safety and immune responses in different age ranges and at various doses.
“Developing a vaccine is an incredibly difficult challenge; the fact that there are multiple candidates in development is hopefully a sign that the hard work will ultimately pay off,” noted the Association of the British Pharmaceutical Industry's Richard Torbett.
“But we must be patient. Proving that a vaccine is safe and effective is a long process and we could still be many months away.”
PM to announce extra £3bn for NHS
17th July 2020
The funds are to help the health service prepare for a winter wave of coronavirus
Prime minister Boris Johnson is set to announce £3 billion in extra funding for the NHS to help it prepare for a second wave of coronavirus this winter.
According to various media reports, the money will be available immediately to enable the health service to free up capacity by utilising private hospitals to help clear the backlog of patients waiting for tests and treatments in the wake of the current pandemic.
The funds will also be used to maintain the Nightingale hospitals until Spring next year.
BBC News noted that the PM is also expected to announced plans to widen COVID-19 testing capacity at a press conference later today, with a new target of 500,000 tests a day by the end of October.
More detail on the government's road map for recovery is also expected.
The move comes amid huge concern that the NHS will buckle under the pressure of a second wave of coronavirus infections as it already grapples with existing disruption caused by the virus, a massive backlog of patients awaiting medical attention, and other challenges it normally faces in the winter period.
In the last week, the Academy of Medical Sciences urged the government to act now to minimise transmission of coronavirus in the community, reorganise health and social care staff and facilities to maintain COVID-19 and COVID-19-free zones, secure adequate PPE and increase testing capacity.
Dr Layla McCay, a director at the NHS Confederation, also stressed that “an effective test and trace system will be more important than ever to identify and isolate people at risk, and so is absolute clarity and consistency from the government on its public messaging as lockdown measures continue to be relaxed.”
A No 10 spokesperson told the Independent that the prime minister “is clear that now is not the time for complacency, and we must make sure our NHS is battle ready for winter.
“He will set out a broad package of measures to protect against both a possible second wave, and to ease winter pressures and keep the public safe.”