COVID-19: Keep up to date with the latest pharmaceutical and healthcare news as the pandemic evolves

 

AZ says its COVID-19 vaccine protects against severe disease caused by variants

23rd July 2021

Real-world data shows jab is effective after one dose against hospitalisation/death caused by Beta and Delta variants

AstraZeneca (AZ) has announced that new real-world data from Canada shows its COVID-19 vaccine – Vaxzevria – was found to be highly effective after one dose against severe disease or hospitalisation caused by the Beta and Delta variants.

The pre-print results, from the Canadian Immunization Research Network (CIRN) with support from Public Health Agency of Canada and the Canadian Institutes of Health, showed one dose of Vaxzevria was 82% effective against hospitalisation or death caused by the Beta and Gamma COVID-19 variants.

On top of that, AZ’s jab showed high efficacy against the Delta and Alpha variants, showing an 87% reduction and 90% reduction of hospitalisations or deaths respectively.

One dose of Vaxzevria had lower efficacy against milder symptomatic disease than against severe disease, although AZ added that the indicated two dose schedule of the vaccine is known to enhance efficacy in this disease setting.

The vaccine’s effectiveness against any symptomatic disease was 50% for the Beta or Gamma variants, and 70% and 72% against the Delta and Alpha variants respectively.

The analysis included 69,533 individuals who tested positive for COVID-19 from December 2020 to May 2021 in Ontario, Canada, with 28,705 testing positive for non-variants of concern and 40,828 testing positive for a variant of concern.

“With different variants threatening to disrupt our route out of the pandemic, this real-world evidence shows that Vaxzevria, along with other vaccines used in Canada, provides a high level of protection against the most serious forms of the disease, even after just one shot,” Said Mene Pangalos, executive vice president, BioPharmaceuticals R&D at AZ.

“It is essential that we continue to protect as many people as possible in all corners of the world in order to get ahead of this deadly virus,” he added.

 

New advice issued on COVID-19 vaccination of children and young people

20th July 2021

The UK’s JCVI has advised vulnerable children should be offered Pfizer/BioNTech vaccines

The UK’s Joint Committee on Vaccination and Immunisation (JCVI) has advised that children with an increased risk of serious illness from COVID-19 should be offered the Pfizer/BioNTech vaccine.

The new advice comes following a request from the Department of Health and Social Care (DHSC) for guidance relating to a possible extension of the COVID-19 vaccination programme in England.

The JCVI, which advises UK health departments on immunisation, considered all the available evidence relating to vaccinating children and young people under the aged of 18 years.

Children at risk of developing severe COVID-19 disease includes those aged 12 to 15 years old with severe neurodisabilities, Down’s syndrome, immunosuppression and multiple or severe learning disabilities.

The JCVI has also recommended that children and young people aged 12 to 17 years old who live in the same household as an immunosuppressed person should also be offered the vaccine.

“The primary aim of the vaccination programme has always been to prevent hospitalisations and deaths. Based on the fact that previously well children, if they do get COVID-19, are likely to have a very mild form of the disease, the health benefits of vaccinating them are small,” said Anthony Harnden, deputy chair of the JCVI.

“The benefits of reducing transmission to the wider population from children are also highly uncertain, especially as vaccine uptake is very high in older people who are at highest risk from serious COVID-19 infection. We will keep this advice under review as more safety and effectiveness information becomes available,” he added.

The JCVI added that there are minimal health benefits of offering a universal COVID-19 vaccination to children, as evidence shows that COVID-19 rarely causes severe disease in children without underlying health conditions.

 

Report finds almost 100% of people tested positive for antibodies after second vaccine dose

16th July 2021

Over 207,337 participants tested themselves for COVID-19 antibodies at home between 12 and 25 May 2021

A new report from Imperial College London and Ipsos MORI has shown that almost 100% of people tested positive for antibodies 14 days after their second dose of the Pfizer/BioNTech or AstraZeneca COVID-19 vaccines.

The latest antibody surveillance report saw over 207,337 participants test themselves at home using a finger prick test between 12 and 25 May 2021.

The aim of the report is to track COVID-19 antibodies across England, following either natural infection with the virus or after vaccination.

The proportion of people testing positive for antibodies following one dose of either vaccine peaked at four to five weeks after the first dose, and started to decline before rising again ‘substantially’ for those who had a second dose.

According to the findings, over 90% of people aged over 65 years old tested positive for antibodies, jumping to 95% in those aged over 75 years old.

The report also found that 36% of people aged 18 to 24 years old tested positive for antibodies, with a quarter of respondents in this age group reporting that they had received one or two jabs compared to 99% of those aged over 75 years old at the time of the report.

Other findings from the study show that the prevalence of antibodies was 30% lower in men compared to women.

This is due ‘in part’ to uptake of the vaccine, as 75% of women had received at least one vaccine dose compared to 70% in men.

Women were also found to have a higher antibody positivity after a single dose of the vaccine compared to men.

“It is incredibly reassuring to see nearly every single person who took part in the REACT study developed detectable antibodies following two doses of the vaccine. It goes to show once again how two doses are vital for the best possible protection,” said vaccines minister Nadhim Zahawi.

“Our vaccination programme is working and is severely weakening the link between cases, hospitalisations and deaths. We are continuing to make strong progress in boosting uptake for people living in deprived areas, as well as black and minority ethnic communities by working closely with faith and local leaders,” he added.

 

New hope for long COVID blood tests after antibody discovery

13th July 2021

Researchers discover presence of 'autoantibodies' in people with persistent COVID-19 symptoms

A blood test for long COVID could be only six months away after researchers from Imperial College London discovered distinct antibodies in patients with persistent symptoms.

The researchers discovered the presence of autoantibodies in patients with Long COVID, which were not observed in people who recovered quickly from the disease or who had not tested positive.

These autoantibodies – unlike typical antibodies – attack healthy cells by mistake, which can cause more damage and illness to the body.

In the preliminary study, researchers compared the blood of dozens of COVID-19 patients as well as individuals who have not had the virus.

Although the study is small, professor Danny Altmann – lead of the research team at Imperial College London – called the discovery ‘a very exciting advancement’.

“It’s hard to escape a prediction that 100,000 new infections a day equates to 10,000 to 20,000 long Covid cases a day, especially in young people. That’s a lot of damage to a lot of lives. And it’s hard to see that we’d have the healthcare provision to deal with it on that scale. All of us working on this could not be more alarmed,” said Altmann.

“I’m fairly optimistic, so I’d hope that within six months we’d have a simple blood test [for long COVID] that you could get from your GP,” he told BBC’s Panorma.

 

Over 600,000 COVID-19 tests genomically sequenced in the UK

5th July 2021

The UK is estimated to contribute around 23% of all COVID-19 sequencing uploaded to GISAID

The UK has sequenced over 600,000 positive COVID-19 tests, providing ‘invaluable data’ in the fight against the virus, the Department of Health and Social Care (DHSC) announced last Friday.

According the DHSC, the UK is estimated to contribute around 23% of all COVID-19 sequencing across the globe uploaded to GISAID.

In the early stages of the pandemic, the COVID-19 Genomics UK (COG-UK) consortium was created to enable the delivery of large-scale and rapid whole-genome virus sequencing for local NHS centres and the government.

The data collected by COG-UK has aided public health agencies in decision making for managing COVID-19 outbreaks and for informing vaccine development efforts.

When sequenced, virus genome data can then be combined with clinical and epidemiological datasets to help inform UK public health interventions and policies.

In a statement, the DHSC added that this information will also enable the evaluation of novel treatments and non-pharmacological interventions in the future, as well as provide information on community transmission and outbreaks.

The UK’s genomic sequencing has also been used to rapidly detect the Delta variant first identified in India, in a bid to deploy additional support to areas where the variant of concern has been prevalent.

“The UK has an established history of scientists developing incredible genomic technology striving to improve patient outcomes around the world. Every single test sequenced helps us to learn more about this awful virus, and brings us one step closer to defeating it,” said Health and Social Care Secretary Sajid Javid.

 

JCVI recommends booster COVID-19 jabs for most vulnerable groups

1st July 2021

Interim advice says boosters could be offered to priority groups from September

Interim advice from the Joint Committee on Vaccination and Immunisation (JCVI) recommends plans to offer COVID-19 booster vaccines to the ‘most vulnerable’ groups from September.

The interim advice provides information for the booster doses, with the JCVI recommending the additional jabs for individuals who are most vulnerable to serious COVID-19 ahead of winter.

According to the Department of Health and Social Care (DHSC), the two-stage programme will occur alongside the annual flu vaccination programme.

In the first stage, the JCVI advice is to offer a booster jab to all adults aged over 16 years who are immunosuppressed, those living in care homes for older adults, all adults aged 70 years or over, adults aged 16 years and over who are considered clinically extremely vulnerable and frontline health and social care workers.

Following this, the second stage will see booster jabs offered to all adults aged 50 years and over, all adults aged 16 to 49 years who are in a flu or COVID-19 at-risk group and adult household contacts of immunosuppressed people.

The final JCVI advice, expected to be published before September, will consider the latest epidemiological situation, as well as additional data from clinical trials such as Cov-Boost and the real-time surveillance of the effectiveness of vaccines over time and emerging variants.

“We welcome this interim advice, which will help us ensure we are ready in our preparations for autumn. We look forward to receiving the committee’s final advice in due course,” said Sajid Javid, Health and Social Care Secretary.

“We need to learn to live with this virus. Our first COVID-19 vaccination programme is restoring freedom in this country, and our booster programme will protect this freedom. We are working with the NHS to make sure we can rapidly deliver this programme to maintain protection for people in the winter months,” he added.

The JCVI will consider the benefits of booster jabs in younger adults at a later time, according to the DHSC, as most individuals in this group will receive their second COVID-19 vaccine dose ‘in late summer’.

 

'Indian' variant of coronavirus now dominant strain in the UK

4th June 2021

Officials warned that early evidence suggests there may be an increased risk of hospitalisation for Delta compared to the Alpha (Kent) strain

According to Public Health England's weekly coronavirus variant cases data, cases of the Indian or Delta (VOC-21APR-02) variant in the UK have risen by 5,472 since last week to 12,431.

While there is some regional variation, PHE officials says they now believe that Delta (VOC-21APR-02) has overtaken Alpha (VOC-20DEC-01; Kent) as the dominant SARS-CoV-2 variant in the UK.

PHE also noted that early evidence suggests there may be an increased risk of hospitalisation for Delta compared to Alpha, although it did stress that more data is needed to confirm this observation.

This week, 278 people with the Delta variant attended A&E, resulting in 94 people being admitted to hospital overnight. Last week, 201 people attended A&E, with 43 admissions. The majority of these had not been vaccinated.

The most affected areas remain Bolton, where cases have risen by 795 to 2149, and Blackburn with Darwen which has seen 368 new cases, bringing it to 724 in total. However, PHE said there are “encouraging signs that the transmission rate in Bolton has begun to fall and that the actions taken by residents and local authority teams have been successful in reducing spread”.

“With this variant now dominant across the UK, it remains vital that we all continue to exercise as much caution as possible. The way to tackle variants is to tackle the transmission of COVID-19 as a whole. Work from home where you can, and practice ‘hands, face, space, fresh air’ at all times,” said Dr Jenny Harries, chief executive, UK Health Security Agency.

Over half of UK adults fully vaccinated

Meanwhile, the government said that over half of UK adults have now been vaccinated with a second dose of the COVID-19 vaccine, and more than 75% of people are now vaccinated with a single dose.

Health services across the UK have now administered a total of 66,180,731 vaccines between December 8 and June 2, including 39,758,428 people with first doses (75.5%) and 26,422,303 people with both doses (50.2%).

Appointments for second doses have been brought forward from 12 to eight weeks for the remaining people in the top nine priority groups who have yet to receive both doses, to ensure people have the strongest possible protection against COVID-19.

The move follows updated advice from the independent experts at the Joint Committee on Vaccination and Immunisation (JCVI), which recommended reducing the dosing interval to counter the threat of new variants of concern.

 

J&J resumes roll-out of COVID-19 vaccine in EU

21st April 2021

EMA's safety committee has confirmed the overall benefit-risk profile of the jab

Johnson & Johnson (J&J) is planning to resume the roll-out of its COVID-19 vaccine in the EU following updated guidance from the European Medicines Agency’s (EMA) safety committee.

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed a small number of cases of very rare blood clots in combination with low platelet counts in individuals who have received the J&J vaccine.

According to J&J, these very rare adverse events can occur within approximately one to three weeks following injection with its COVID-19 vaccine.

The PRAC has confirmed the overall benefit-risk profile of J&J’s COVID-19 vaccine, although J&J must update the product information for the jab to include information on the diagnosis and management of this type of rare adverse event.

J&J will now resume shipments of its COVID-19 vaccine in the European Union, Norway and Iceland, with updated EMA and Healthcare Professionals guidance to become available to national healthcare authorities.

"The safety and well-being of the people who use our products is our number one priority. We appreciate the rigorous review of the PRAC and share the goal of raising awareness of the signs and symptoms of this very rare event to ensure the correct diagnosis and appropriate treatment," said Paul Stoffels, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson.

"We strongly believe in the positive benefits of our single-shot, easily transportable COVID-19 vaccine to help protect the health of people everywhere and reach communities in need globally. We are committed to equitable access and to bringing an affordable COVID-19 vaccine to the public on a not-for-profit basis for emergency pandemic use,” he added.

In the US, the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) are currently reviewing the same blood clot cases.

Following an initial meeting of the CDC’s Advisory Committee on Immunisation Practices (ACIP), another meeting has been scheduled for 23 April for further discussion of the blood clot cases.

 

NHS extends ‘COVID-friendly’ at-home cancer care

31st March 2021

Funding for effective, 'less risky' treatments extended until summer 2021

The NHS has announced that thousands of people will benefit from the extension of ‘COVID-friendly’ cancer treatments which can be taken at home.

Since April, approximately 8,000 people have benefitted from treatment swaps, to enable cancer treatment to continue during the COVID-19 pandemic, with over 250,000 people beginning treatment for cancer since the start of the pandemic.

The NHS will continue to fund effective and ‘less risky treatment[s]’ for patients during the pandemic, with access to these drugs now extended until summer and potentially continuing until the end of March 2022.

Among the options available are targeted hormone therapies such as enzalutamide (Xtandi; Astellas/Pfizer) for prostate cancer and broadened use of lenalidomide (Revlimid; Bristol Myers Squibb) for myeloma.

Some ovarian cancer patients will also be able to receive trametinib (Mekinist; Novartis) as a tablet alternative to chemotherapy, to help reduce the impact on their immune systems.

“Cancer has been a priority throughout the pandemic which is why NHS staff have fast-tracked patient access to more convenient and kinder treatments to provide as many people as possible with safe and effective care, even as the NHS cared for more than 380,000 people seriously ill with COVID-19,” said Peter Johnson, NHS clinical director for cancer.

“Extending the use of ‘Covid friendly’ treatments for cancer is another example of how we are embracing the full range of treatment options and bringing the NHS to patients at home in many cases,” he added.

 

GSK agrees to support manufacture of Novavax' COVID-19 vaccine

30th March 2021

British drugmaker will help to produce up to 60 million doses for use in the UK

GlaxoSmithKline (GSK) has agreed in principle to support manufacturing of up to 60 million doses of Novavax’ COVID-19 vaccine candidate – NVX-CoV2373 – for use in the UK.

GSK has agreed with Novavax and the UK government Vaccines Taskforce to provide fill and finish manufacturing capacity at its Barnard Castle facility in the North East of England, starting as early as May 2021.

Fill and finish is the completion stage of vaccine manufacturing – during this stage, vials of the final vaccine are prepared and packaged for distribution and use.

According to GSK, the parties will negotiate a final agreement to include additional terms and conditions, although technology transfer between the two companies is set to begin ‘immediately’.

The protein antigen component of NVX-CoV2373 is produced by Novavax’ manufacturing partner FUJIFILM Diosynth Biotechnologies at its site in Billingham, Stockton-on-Tees.

“I’m delighted by GSK’s investment, which shows the strength of UK manufacturing, and will further boost our vaccine rollout,” said Prime Minister Boris Johnson.

“The Vaccines Taskforce has worked hand in glove with business to successfully deliver vaccines to the whole of the UK, and this agreement will continue to support our approach. We remain on track to offer a first jab to all over 50s by 15 April, and all adults by the end of July, and I want to once again encourage everyone to come forward for a vaccine when you’re called,” he added.

The UK government has signed an advance purchase agreement with Novavax for 60 million doses of NVX-CoV2373.

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