LIVE BLOG: R&D response to COVID-19 pandemic

26 Oct 2021 | Live Blog
Covid 19 blog

The coronavirus pandemic is disrupting universities and research institutes across the world. But the same institutions are also working very hard to find out how the disease can be stopped and its effects mitigated.

Follow this live blog for the latest updates on how the crisis is impacting research and innovation, and what governments, funders, companies, universities, associations and scientists are doing to stop or cope with the pandemic.

You can read the full archive of this blog here and here.

Johnson & Johnson announced new data showing that protection against COVID-19 increases when a booster shot of its vaccine is administered, with the safety profile remaining consistent and the vaccine generally well-tolerated when administered as a booster.

“Our large real world evidence and phase III studies confirm that the single shot Johnson & Johnson vaccine provides strong and long lasting protection against COVID-19-related hospitalisations. Additionally, our phase III trial data further confirm protection against COVID-19-related death,” said Mathai Mammen, global head of research & development, Johnson & Johnson.

“It is critical to prioritise protecting as many people as possible against hospitalisation and death given the continued spread of COVID-19,” said Paul Stoffels, chief scientific officer. “A single shot COVID-19 vaccine that is easy to use, distribute and administer, and that provides strong and long lasting protection is crucial to vaccinating the global population. At the same time, we now have generated evidence that a booster shot further increases protection against COVID-19 and is expected to extend the duration of protection significantly.”

In what it says is the largest real world evidence study for a COVID-19 vaccine reported to date in the US, the vaccine was 81% effective in preventing COVID-19-related hospital admissions. There was no evidence of reduced effectiveness over the study duration, including when the Delta variant became dominant in the US.

The study included 390,000 people who received the Johnson & Johnson COVID-19 vaccine and approximately 1.52 million matched unvaccinated people.

When a booster of the Johnson & Johnson COVID-19 vaccine was given two months after the first dose, antibody levels rose to four to six times higher than seen after the single shot.

When a booster of the Johnson & Johnson COVID-19 vaccine was given six months after the single shot, antibody levels increased nine-fold one week after the booster, and continued to climb to 12-fold higher four weeks after the booster. All rises were irrespective of age.

Researchers in the UK have used population level databases to develop an algorithm that can predict individuals who are at risk of hospitalisation and death if they contract COVID-19, despite being fully vaccinated.

The QCovid tool is based on data from 6.9 million vaccinated individuals, of whom 5.2 million had received two doses, a cohort that is representative of the UK population as a whole. Health databases are linked, meaning each person could be followed up via their general practitioner records, by referring to COVID-19 testing results and through hospital admission and death records.

Vaccines are providing a high level of protection but a small number of people are still experiencing serious illness if they get COVID-19, with age remaining by far the greatest risk factor. Also remaining at risk are those whose immune systems are compromised as a result of chemotherapy, because they are taking immune-supressing medicines following a solid organ transplant, or who have HIV/AIDS.

Applying the algorithm to UK data on hospital admissions and deaths showed some groups that were classified as being at high risk before vaccination, are no longer at higher risk of hospitalisation and death once they have been vaccinated. That includes ethnic minorities, apart from those of Indian or Pakistani heritage.

The risks identified by the algorithm have been validated against separate datasets, showing what the researchers say is “excellent ability” to identify those at highest risk of death and “very good” ability to identify who will need hospital care. The research was published in the British Medical Journal.

The tool can be used to identify those who would benefit from booster doses of vaccine or to decide who should receive new treatments, such as expensive antibody drugs, that help the body to fight infections.

Reporting the first results of a pivotal trial of any COVID-19 vaccine in children under 12 years of age, Pfizer and German biotech BioNTech said their mRNA vaccine was safe, well tolerated and showed robust neutralising antibody responses in children age 5 – 11.

The companies said they will submit the data to the European Medicines Agency, the US Food and Drug Administration and other drug regulators as soon as possible.

The trial used two doses of 10 micrograms administered 21 days apart. While that is a smaller dose than the 30 microgram dose used for people 12 and older, the antibody responses were comparable.

“We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorisation, especially as we track the spread of the Delta variant and the substantial threat it poses to children,” said Albert Bourla, CEO of Pfizer.

Since July, cases of COVID-19 in children have risen by about 240% in the US, Bourla noted. “These trial results provide a strong foundation for seeking authorisation of our vaccine for children 5 to 11 years old.”

The data was for 2,268 participants who were 5 to 11 years of age. Top line readouts for the other two age cohorts from the trial, of children 2 - 5 years of age and children 6 months to 2 years of age, are expected before the end of the year.

A request to the EMA to update the EU conditional marketing authorisation is now planned.

US biotech Gritstone Bio announced the first volunteer has been dosed in a phase I trial evaluating the ability of its second generation mRNA COVID-19 vaccine, GRT-R910, to boost and expand the immunogenicity of first generation COVID-19 vaccines in people aged 60 years or older. The single centre study is being conducted by Manchester University and its associated teaching hospital.

GRT-R910 uses lipid nanoparticles to deliver a broad set of antigens against SARS-CoV-2, including both stabilised spike protein and highly conserved regions of the virus viral protein. Gritstone says the self-amplifying properties and extended duration and magnitude of antigen production may make it possible to lower vaccine doses, or eliminate the need for repeat administration, and has potential to elicit immune responses across SARS-CoV-2 variants.

“Since viral surface proteins like the spike protein are evolving and sometimes partially evading vaccine-induced immunity, we designed GRT-R910 to have broad therapeutic potential against a wide array of SARS-CoV-2 variants, by also delivering highly conserved viral proteins,” said Andrew Allen, CEO of Gritstone.

The Gritstone trial, which is initially expected to enrol 20 volunteers, will explore the ability of GRT-R910 to boost and expand the immunogenicity of AstraZeneca's first-generation COVID-19 vaccine in healthy adults over 60 years of age.

“The observed waning of vaccine-elicited immune responses, particularly in older individuals, coupled with the prevalence of emerging variants, highlights the need for continued vigilance to keep COVID-19 at bay,” said Andrew Ustianowski, consultant in infectious diseases and tropical medicine at North Manchester General Hospital, who is lead investigator. “Using GRT-R910 as a boost vaccination is expected to elicit strong, durable, and broad immune responses, which are likely critical to maintaining protection in this vulnerable elderly population with increased mortality risk.” Ustianowski said.

With more than 70 per cent of adults in the EU fully vaccinated against COVID-19, the next and most urgent priority is to speed up global vaccination, Commission president Ursula von der Leyen said in the annual state of the union address.

“With less than 1% of global doses administered in low-income countries, the scale of injustice and the level of urgency are obvious. This is one of the great geopolitical issues of our time,” said von der Leyen.

The EU is investing €1 billion to ramp up mRNA production capacity in Africa and has so far committed to share 250 million doses. The Commission will add a new donation of another 200 million doses by the middle of next year.

At the same time, the EU will continue its efforts in Europe, aiming to address the “worrisome divergences” in vaccination rates between member states. “Let's do everything possible to ensure that this does not turn into a pandemic of the unvaccinated,” said von der Leyen.

The EU has an additional 1.8 billion doses of COVID-19 vaccines on hand and ready to use when booster shots are needed.

The final priority is to strengthen preparedness for future pandemics by setting up the European Health Union.  This will be backed by a new health preparedness and resilience research mission covering the whole of the EU, and backed by investment of €50 billion by 2027.

Cancer research and care groups in the UK have set up the Covid-19 research dashboard, a public resource that lists research projects looking at the impact of Covid-19 on cancer care and patients.

The dashboard was developed by the National Cancer Research Institute, Cancer Research UK, the National Cancer Registration and Analysis Service and the Cancer Alliance Data, Evaluation and Analysis Service. The intention is to drive collaborations in the field and identify gaps in research activity or opportunities for new research.

The Covid-19 pandemic has impacted cancer services and patients, prompting new research to quantify and understand this impact across the care pathway, including changes to the detection, treatment, and long-term follow-up of cancers and the effects of the pandemic, direct and indirect, on patients’ experiences and quality of life.

The list of ongoing and completed research projects has been collated and made publicly available to enable researchers to identify gaps in activity and opportunities for new research; avoid duplication of effort, support collaborations in the field and to understand potential data needs of this new research area.

To date, 89 studies have been identified and uploaded to the dashboard and it is hoped that researchers will submit their studies via an online form to ensure the dashboard remains a useful and up-to-date resource.

More than 140 Nobel laureates and former world leaders have written an open letter to the three candidates for the position of next German chancellor, Annalena Baerbock, Armin Laschet, and Olaf Scholz, calling on them to support a waiver of IP rights on COVID-19 vaccines.

The letter says Germany has a significant role to play in global efforts to bring the COVID-19 pandemic to an end, and the impact would be of huge significance to people in Germany and around the world.

German publicly-funded science led to the development the Pfizer/BioNTech vaccine, but this and other vaccines are “zero per cent effective” for those who cannot access them, the letter says.

“In light of this we are deeply concerned with Germany’s continued opposition to a temporary waiver of the World Trade Organization’s intellectual property rules, which thwart more rapid production of COVID-19 vaccines and access to technologies,” says the letter.

There are qualified manufacturers around the world which, with a temporary waiver of intellectual property rights and the necessary knowledge and technology transfer, could produce billions of additional doses of vaccines.

The position taken by Germany and some other countries is undermining the will of the more than 100 countries that do support negotiations on a waiver. “We write to express our hope that, after its general election, Germany will change its position” and will support negotiations on the waiver, the signatories say.

Pharming has announced top line results from two randomised, open label clinical trials of its immune-modulating drug Ruconest in the treatment of patients hospitalised with COVID-19.

The aim was to show the product prevented severe SARS-CoV-2 infection. In one study held in the US, patients treated with Ruconest plus standard of care had statistically significant lower disease severity scores at day seven, compared to patients who received standard of care alone.

However, in the second, investigator-led study, conducted in Switzerland, Brazil and Mexico, and funded through the Swiss National Research programme in COVID-19 of the National Science Foundation, there was no difference in disease severity at day seven between Ruconest treated patients and those receiving standard of care alone.

Leiden-based Pharming said the results of the Swiss study are difficult to interpret because there was a significant difference in disease severity at baseline, with patients in the Ruconest arm having more severe disease.

Anurag Relan, Pharming’s Chief Medical Officer said the results support the initial hypothesis on the need to control hyper-inflammatory processes in patients with severe COVID-19 infection. “It is unfortunate we cannot draw many conclusions from the investigator-led study, due to the imbalance between the Ruconest-arm and the control group at the start of the trial. We will analyse the full results of these studies as we design future clinical trials with Ruconest for the treatment of COVID-19,” Relan said.

French biotech Valneva said it is continuing phase III development of its COVID-19 vaccine after the UK government cancelled its order for 100 million doses.

The UK government alleges Valneva is in breach of its obligations under the contract between the two, something the company “strenuously denies”.

No details of the exact nature of the dispute were disclosed. The cancellation was unexpected, given the UK government’s investment in Valneva’s manufacturing facility in Livingston, Scotland, where commercial supplies of the vaccine are already being made. The government investment was due to be recouped once vaccine started to be supplied under the contract.

Valneva also has received UK government support with the clinical development of the vaccine, which is the only one in Europe using a whole, inactivated SARS-CoV-2 virus. This was seen as a key technology and an important way of spreading the risk in vaccines in development at the point Valneva was awarded the contract, worth up to €1.4 billion, a year ago.

The phase III clinical testing of the vaccine is ongoing under the supervision of Public Health England, with results expected to be available early in the fourth quarter of 2021. Last month, Valneva said it had started submission of data for the conditional approval of the vaccine with the UK Medicines and Healthcare products Regulatory Agency, and was expecting initial approval could be granted in late 2021.

Valneva said it has, “has worked tirelessly, and to its best efforts” on the collaboration with the UK government and will continue to develop the vacccine.

The European Medicines Agency has listed the rare autoimmune disorder, Guillain-Barre syndrome as a possible side effect of the AstraZeneca COVID-19 vaccine, following the latest review of reports of adverse events following administration of the product.

The information leaflet will be updated to reflect this. Pains in the legs and arms or stomach and influenza-like symptoms have also been included in the product information as side effects.

This follows the addition of a warning to raise awareness of cases of Guillain-Barré syndrome in July, since when EMA has been keeping reports of the syndrome under close monitoring. In a meeting earlier this week it assessed additional data supplied by AstraZeneca and the results from a scientific literature review.

A total of 833 cases of Guillain-Barré syndrome were reported with the vaccine worldwide up to 31 July 2021, at which point more than 592 million doses had been administered.

Based on the assessment of the data, and taking into account advice from neurological experts, EMA has now concluded that a causal relationship between the AstraZeneca vaccine and Guillain-Barré syndrome is at least a reasonable possibility and that the syndrome should therefore be added to the product information as a side effect.

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