Kineret receives positive CHMP opinion for treatment of COVID-19 pneumonia

The European Medicines Agency has recommended approval for use of Kineret in COVID-19 to the European Commission, which will issue a final decision.

The European Medicines Agency has recommended approval for use of Kineret in COVID-19 to the European Commission, which will issue a final decision.

The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of Kineret (anakinra), a treatment for coronavirus disease in adult patients with pneumonia. The drug – by Swedish Orphan Biovitrum AB (Sobi) – is for patients with diseases requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure.

The positive opinion of the CHMP is based on results from the SAVE-MORE phase 3 clinical study, which found that early identification of candidate patients with soluble urokinase plasminogen activator receptor (suPAR), followed by treatment with anakinra, resulted in a 64% relative reduction of patients progressing into severe disease and death.

The study also saw a 55% relative decrease in mortality, which reached 80% relative decrease in mortality for patients with cytokine storm. COVID-19 infection can lead to death due to an overreaction of the infected person’s inflammatory response, often referred to as a ‘cytokine storm’. Anakinra is an anti-inflammatory therapy that works by targeting the cytokines IL-1α/β, which contribute to COVID-19-induced hyperinflammation. Blocking this cytokine can therefore have an important impact on COVID-19 disease progression.

The SAVE-MORE study utilised learning from previous trials and demonstrated the efficacy of anakinra therapy in patients who had not yet progressed to severe respiratory failure, but who had a poor prognosis. This was identified by a plasma biomarker of inflammation.

“At a time when many countries still face enormous pressure as they continue to care for extremely ill patients, today’s positive opinion from the CHMP represents an important milestone for the treatment of COVID-19. If approved by the European Commission, this will be welcome news for many across Europe,” said Ravi Rao, head of research & development and chief medical officer at Sobi.

Study finds Omicron multiplies 70 times faster than Delta, UK COVID-19 cases exceed 75,000

A warning has been issued to UK MPs from the head of NHS England that hospitalisations could exceed numbers recorded in January 2021.

A warning has been issued to UK MPs from the head of NHS England that hospitalisations could exceed numbers recorded in January 2021.

A study run by researchers in Hong Kong has found that the Omicron variant of COVID-19 multiplies 70 times faster than Delta in human airways. However, the virus was seen to replicate less rapidly than the original strain of the virus in human lung tissue, potentially indicating a lower severity of the disease.

Dr Michael Chan Chi-Wai, the professor who lead the research, warned that it was important to note that “by infecting many more people, a very infectious virus may cause more severe disease and death even though the virus itself may be less pathogenic”. The study was published by the Li Ka Shing Faculty of Medicine at the University of Hong Kong (HKUMed).

The research arrives as the head of UK Health Security Agency, Dr Jenny Harries, has warned MPs that the Omicron variant is “probably the most significant threat” since the start of the pandemic. Harries told MPs to expect “staggering” rates of confirmed cases over the coming days. The head of the NHS in England has additionally warned that the increase in Omicron infections could lead to a higher number of COVID-19-related hospitalisations that at the height of the pandemic. Amanda Pritchard, chief executive of NHS England, has warned MPs that hospitalisations could exceed the record high of 3,812 on 09 January 2021.

Dr Harries described the “absolutely astounding” demand for lateral flow tests of which the public ordered around 200,000 packs between the hours of 6am and 8am on Wednesday 15 December 2021 alone. Yesterday, 78,610 new COVID-19 cases were reported in the UK. Professor Andrew Hayward, SAGE subcommittee New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG) member, warned on BBC Breakfast that among tested and untested individuals in the population, around 150,000 had the infection.

Hayward warned on BBC Breakfast that the capacity of tests sits at around 600,000 a day, and that: “We’re soon going to exceed that number just in cases alone”.

Needle free COVID-19 vaccine trialled in UK

The DIOSvax technology produced by the University of Southampton aims to predict how the virus could mutate.

The DIOSvax technology produced by the University of Southampton aims to predict how the virus could mutate.

A new needle-free vaccine, developed by the University of Southampton using DIOSvax technology is being trialled in the UK. The vaccine uses a jet of air to push through the skin rather than a needle and differs from the mechanism found in Pfizer and Moderna vaccines.

“This isn't simply ‘yet another’ coronavirus vaccine as it has both COVID-19 variants and future coronaviruses in its sights,” said Saul Faust, clinical chief investigator and director of the National Institute for Health Research (NIHR) Southampton Clinical Research Facility. “This technology could give wide-ranging protection to huge numbers of people worldwide.”

“As new variants emerge and immunity begins to wane, we need newer technologies,” said Professor Jonathan Heeney at the University of Cambridge, who helped developed the vaccine with research company DIOSynVax. “It's vital that we continue to develop new generation vaccine candidates ready to help keep us safe from the next virus threats.”

While most existing COVID-19 vaccines use mRNA technology to target the spike protein of virus samples found in January 2020, DIOSvax aims to predict how the virus could mutate, allowing it to target emerging variants.

“DIOS-CoVax vaccines target elements of the virus structure that are common to all known ‘beta-coronaviruses' – those coronaviruses that are the greatest disease threats to humans. These are structures that are vitally important to the virus life cycle, which means we can be confident that they are unlikely to change in the future,” Professor Heeney explained. “These next generation DIOSvax vaccines should protect us against variants we've seen so far – alpha, beta, delta variants, for example – and hopefully future-proof us against emerging variants and potential coronavirus pandemics.”

It is hoped that the needle-free mechanism will additionally help those with needle phobias receive full COVID-19 vaccination. If successful, the technology has the potential to be scaled up and manufactured as a powder to boost global vaccination efforts, particularly in low- and middle-income countries.

Vaccines still provide ‘significant protection’ against severe COVID-19

Omicron has been the latest variant to test the effectiveness of COVID-19 vaccines.

Omicron has been the latest variant to test the effectiveness of COVID-19 vaccines.

COVID-19 vaccines appear to have become less effective in preventing severe COVID-19 disease and death, but they still provide ‘significant protection’, says the World Health Organisation (WHO), according to Reuters.

The Omicron variant, first detected in South Africa and Hong Kong last month, has now been reported by 77 countries. WHO director general Tedros Adhanom Ghebreyesus emphasised that it should not be dismissed as “mild”.

“Omicron is spreading at a rate we have not seen with any previous variant,” Tedros told an online briefing. “Even if Omicron does cause less severe disease, the sheer number of cases could once again overwhelm unprepared health systems. Evolving evidence suggests a small decline in the effectiveness of vaccines against severe disease and death, and a decline in preventing mild disease or infection.”

Tedros added that vaccine booster shots can play an important role in curbing the spread of Omicron, as long as people most in need of protection receive access to jabs.

Mike Ryan, WHO’s emergencies director, expressed that the vaccines are not failing and provide significant protection against severe disease and death. “The question is how much protection are the current vaccines that we are using, which are currently life-saving against all the variants, and to what extent do we lose any protection against severe illness and death against Omicron. The data is pointing towards there being significant protection.”

While there is still further evidence needed to evaluate whether Omicron is less harmful than Delta, current hospitalisation rates indicate that the new variant is causing fewer infections. The NHS is still facing the threat of becoming overwhelmed in the coming months due to the alarming rate at which Omicron is rising.

UK COVID-19 vaccine pledge faces logistical challenges

The public have been assured more sites, mobile units and pop-ups would be set up across the country to fulfill the vaccination pledge ahead of the original deadline of 31 January 2022.

The public have been assured more sites, mobile units and pop-ups would be set up across the country to fulfill the vaccination pledge ahead of the original deadline of 31 January 2022.

In the wake of rising Omicron cases, the UK government has pledged that boosters will be offered to all over-18s by the end of December 2021, cutting short their initial deadline of 31 January 2022. This has led to the PM and the NHS appealing for volunteers to help administer jabs and run vaccination centres.

Prime Minister Boris Johnson and NHS England chief executive Amanda Pritchard are calling for “tens of thousands” of trained volunteers to “join the national mission” and support the booster deployment.

According to the BBC, Number 10 has said that hundreds more sites, mobile units and pop-ups would be set up across the country including at football stadiums, shopping centres and racecourses in the next week.

On the morning of Monday 13 December 2021, the NHS website crashed as tens of thousands of people attempted to log on and book their COVID-19 booster jab. This is the second time that the website has crashed, following Boris Johnson’s announcement on Sunday 12 December of the vaccine pledge. People are also facing difficulties with ordering lateral flow tests as these are no longer available via the Government website.

Long queues are now forming outside walk-in clinics across England as many people rush to receive their booster. Dr Jess Harvey, from Shropshire, has encouraged people who are frustrated with long waiting times in clinics and on booking websites to be patient as “there is increased capacity that’s going to be created”.

As it stands, there are nearly 3,000 vaccine sites across the country run by over 90,000 volunteers. The UK Health Security Agency (UKSHA) estimates that the current number of daily Omicron infections is around 200,000, acccording to Health and Social Care Secretary Sajid Javid.

There are now 4,713 confirmed cases of the Omicron variant, a number that is rapidly increasing. Of these cases, there are ten people, aged between 18 and 85, being hospitalised due to the effects of the variant.

Health minister welcomes new treatments for COVID-19 patients

The treatments are being offered as an addition to vaccinations to maximise protection against COVID-19

The treatments are being offered as an addition to vaccinations to maximise protection against COVID-19.

Xevudy (sotrovimab) has been approved for use by the Medicines and Healthcare products Regulatory Agency (MHRA) and will be distributed in due course. It is given intravenously (IV) as an IV infusion over 30 minutes and can reduce the risk of death and hospitalisation by 79% in high risk adults with COVID-19.

Xevudy works by binding the spike protein on the outside of the virus and prevents the virus from attaching to and entering human cells.

Other treatments include the oral antiviral Molnupiravir, which was approved by the MHRA on 04 November 2021. Another treatment is the monoclonal antibody treatment Ronapreve, which has only been used in hospitals until now.

Ireland’s health minister Robin Swann said: “We have repeatedly seen how the extraordinary efforts of scientists have helped us in the fight against this virus. From the development of life-saving vaccines to the creation of these new treatments, we should all be tremendously grateful to the experts that have helped get us this far.”

While most COVID-19 treatments have focused on hospitalised patients until now, new treatments have been authorised for use in eligible non-hospitalised patients to reduce the risk of serious illness, hospitalisation and death.

Swann added: “The approval of these drugs by the MHRA, and their deployment here in Northern Ireland and across the UK, will be hugely beneficial for those patients who are most at risk of becoming seriously ill if they contract COVID-19. Importantly, these ground-breaking treatments will help to reduce pressures on our over-stretched health service by keeping people out of hospital.

“Throughout the pandemic we have always been clear that we need to fight COVID-19 on all fronts. While these antivirals are an excellent addition, it remains vital that those who have not been vaccinated get their jab as soon as possible, and that those who are eligible for their booster come forward. This will ensure as many people as possible are protected over the coming months.”

WHO says vaccines should be effective against Omicron variant

A senior official at the World Health Organisation (WHO) has said that Omicron is ‘highly unlikely’ to fully bypass vaccine protections.

A WHO official has said that existing vaccines should still offer protection to people with the Omicron variant and should reduce the risk of severe COVID-19.

The first lab tests of the recently discovered variant in South Africa have hinted that it can partially evade the Pfizer jab but this does not mean that Omicron can completely negate the vaccine’s efficacy.

Preliminary data also suggests that Omicron does not make people sicker than the Delta variant, along with others. WHO emergencies director Michael Ryan told AFP news agency: “In fact, if anything, the direction is towards less severity.”

However, Ryan emphasised that there is still more research needed into the recent strain, adding “we have highly effective vaccines that have proved effective against all the variants so far, in terms of severe disease and hospitalisation, and there’s no reason to expect that it wouldn’t be so [for Omicron]”.

The new South African study has found that the Pfizer/BioNTech vaccine may result in up to 40 times fewer neutralising antibodies against Omicron than against the original COVID-19 strain. However, Professor Alex Sigal, a virologist at the Africa Health Research Institute, said that vaccination combined with previous infection could still be effective in neutralising against Omicron. Boosters will also provide a significant benefit.

Omicron is the most heavily mutated COVID-19 strain found so far with over 30 changes to its spike protein. This protein allows the virus to infect and take over human cells and is also the target of most existing vaccines. The recent variant was first identified in South Africa, which is currently experiencing a surge in the number of COVID-19 reinfections.

CHMP recommend approval for Roche’s COVID-19 therapy

According to clinical data, Roche’s new COVID-19 treatment Actemra/RoActemra lowered mortality risk in critically ill adult patients.

According to clinical data, Roche’s new COVID-19 treatment Actemra/RoActemra lowered mortality risk in critically ill adult patients.

Roche have announced the Committee for Medicinal Products for Human Use (CHMP) has recommended extending the marketing authorisation for Roche’s COVID-19 therapy, Actemra/RoActemra (tocilizumab), to include the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.

The CHMP began an accelerated analysis of the therapy in August 2021, reviewing data from four clinical trials and enrolling over 5,500 severe or critical COVID-19 patients. The clinical trial data revealed that Actemra/RoActemra lowered mortality risk in adults with severe or critical disease.

“As COVID-19 cases in Europe rise, and with pressure on hospitals likely to increase, the need for effective treatments for those suffering most severely with COVID-19 could intensify,” shared Levi Garraway, Roche’s chief medical officer and head of global product development. “We are proud that the CHMP has recognised the potential of Actemra/RoActemra as we continue our efforts to bring treatment options to those most in need.”

Data from phase 3 COVAVTA, EMPACTA and REMDACTA trials led by Roche and the company-supported RECOVERY trial by Oxford University in the UK were analysed by the committee. A final decision regarding the approval of Actemra/RoActemra is expected from the European Commission in the near future.

The therapy received an Emergency Use Authorisation (EUA) in the US and is also recommended by the World Health Organisation (WHO) to treat COVID-19. Following the recent emergence of the new SARS-CoV-2 ‘variant of concern’, Omicron (B.1.1.529), WHO has reported that interleukin 6 receptor blockers such as Actemra/RoActemra are expected to still be effective for managing patients with severe COVID-19.

Results from a prospective meta-analysis of almost 11,000 patients across 27 clinical trials found that treatment of hospitalised patients with severe or critical COVID-19, with IL-6 receptor blockers such as Actemra/RoActemra, were associated with improved mortality and reduced progression to invasive mechanical ventilation or death compared with usual care or placebo. These results were published by researchers from WHO in The Journal of the American Medical Association.

UK study shows mixing Pfizer and AstraZeneca COVID-19 vaccines with Moderna elicits better immune response

Results show support in favour of heterologous dosing which may help to advance vaccination programmes in poorer countries.

Results show support in favour of heterologous dosing which may help to advance vaccination programmes in poorer countries.

A British study mixing COVID-19 vaccines has found that people had a better immune response when they received their first dose of AstraZeneca or Pfizer-BioNTech shots, followed by Moderna nine weeks later, according to Reuters.

These results support mix-and-match dosing, otherwise known as heterologous dosing. This is expected to boost vaccine drives in poor and middle income countries, which may need to combine different brands between first and second shots if supplies are running low.

Matthew Snape, the Oxford professor behind the study dubbed Com-COV2, said: “We found a really good immune response across the board…, in fact, higher than the threshold set by Oxford-AstraZeneca vaccine two doses. I think the data from this study will be especially interesting and valuable to low- and middle- income countries where they’re still rolling out the first doses of vaccines.”

The study of 1,070 volunteers also found that a dose of the Pfizer-BioNTech vaccine, followed by a Moderna jab, was more effective than two doses of the standard Pfizer-BioNTech course.

Snape added: “We’re showing…you don’t have to stick rigidly to receiving the same vaccine for a second dose…and that if the programme will be delivered more quickly by using multiple vaccines, then it is okay to do so.”

Clinical studies of the Moderna vaccine have shown that antibody levels remain strong after six months, but studies after the six month mark have had mixed responses. Reports of waning antibody levels after two doses have added to the evidence that a booster strategy is essential. The increasing threat of the prolific Delta and Omicron variants have also ramped up the pressure to accelerate vaccination campaigns.

Next virus could be more lethal than COVID-19, warns Oxford vaccine creator

With the emergence of the new Omicron variant bringing into question the effectiveness of current vaccines, scientists caution that viruses will continue to evolve.

With the emergence of the new Omicron variant bringing into question the effectiveness of current vaccines, scientists caution that viruses will continue to evolve.

According to one of the scientists behind the Oxford AstraZeneca vaccine, another pandemic could be more contagious and more lethal than COVID-19. The COVID-19 pandemic has killed more than 5 million across the globe. Professor Dame Sarah Gilbert also warned that the current set of vaccines being used across the world could be less effective against the newly-discovered Omicron variant.

“This will not be the last time a virus threatens our lives and livelihoods,” said Dame Sarah, delivering the 44^th Richard Dimbleby Lecture. “The truth is: the next one could be worse. It could be more contagious, or more lethal, or both,” Dame Sarah continued, adding that the “advances we have made, and knowledge we have gained, must not be lost”.

Gilbert is a professor of vaccinology at the University of Oxford and is credited with saving millions of lives through her role in designing the anti-COVID-19 vaccine in record time. Prior to the emergence of COVID-19, Professor Gilbert worked on vaccines for over 10 years, using antigens from malaria and influenza.

“The spike protein of this variant contains mutations already known to increase transmissibility of the virus,” the professor shared, discussing the recently-discovered Omicron variant. “But there are additional changes that may mean antibodies induced by the vaccines, or by infection with other variants, may be less effective at preventing infection with Omicron.”

On Sunday 05 December, the UK reported a further 86 cases of the Omicron variant, bringing the total up to just under 250.

“We cannot allow a situation where we have gone through all we have gone through, and then find that the enormous economic losses we have sustained mean that there is still no funding for pandemic preparedness,” Dr Gilbert warned.