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

02 Dec 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.

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.

The global picture of access to COVID-19 vaccines is “unacceptable” according to the organisations leading the Covax initiative, which was set up to ensure equitable distribution, in their latest supply forecast.

To date, only 20% of people in low- and lower-middle-income countries have received a first dose of vaccine compared to 80% in high- and upper-middle income countries, according to a joint statement by the Coalition for Epidemic Preparedness Innovations, Gavi, the Vaccine Alliance and the World Health Organisation.

Covax’s ability to protect the most vulnerable continues to be hampered by export bans, the prioritisation of bilateral deals by manufacturers and countries, ongoing challenges in scaling up production by some key producers, and delays in filing for regulatory approval, the statement says.

According to the supply forecast, Covax expects to have access to 1.425 billion doses of vaccine in 2021. Of these doses, approximately 1.2 billion will be available for lower income economies, enough to protect 20% of the population, or 40% of all adults, in 92 countries. The key Covax milestone of two billion doses released for delivery is now expected to be reached in the first quarter of 2022.

Covax says it is working closely with governments to ensure the conditions are in place to ensure successful rollout of vaccines. It is now calling on donors and manufacturers to recommit their support and prevent further delays to equitable access.

Manufacturers are asked to deliver vaccine supplies in accordance with firm commitments and provide transparency on timelines, to allow countries to plan in advance.

Countries which are ahead of Covax in manufacturer queues and that have already achieved high vaccination coverage, are asked to give up their places in the queue to Covax.

EMA has started evaluating an application for the use of a booster dose of the Pfizer/BioNTech COVID-19 vaccine, to be given six months after the second dose in people aged 16 years and older.

The booster doses would be given to vaccinated people to restore protection after it has waned.

EMA said it will carry out an accelerated assessment of data, including results from an ongoing clinical trial in which around 300 adults with healthy immune systems received a booster dose approximately six months after the second dose.

The outcome of this evaluation is expected within the next few weeks.

Separately, EMA is also assessing data from the literature on the use of an additional, third dose of an mRNA vaccine in severely immunocompromised people who do not achieve an adequate level of protection from standard primary vaccination and may need another dose as part of their primary vaccination.

Although EMA and the European Centres for Disease Control say they don’t consider the need for COVID-19 vaccine booster doses to be urgent,  EMA is evaluating the application for boosters to ensure evidence is available to support further doses as necessary.

Advice on how vaccinations should be given remains the prerogative of the national immunisation advisory groups.

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