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.

The Commission has established a portfolio of ten potential COVID-19 treatments and says it will expedite access to the drugs across Europe, once they are approved.

The list includes possible treatments for COVID-19 that are in the process of being authorised and which should therefore soon be available on the European market.

While vaccination against COVID-19 offers the best protection against infection, the Commission says at the same time it is ensuring that the appropriate treatments are available for those who are infected.

“We have already signed four joint procurement contracts for different treatments related to COVID-19 and we are ready to negotiate more. Our aim is to allow at least three treatments in the coming weeks, and possibly two more by the end of the year, and to help member states to access them as soon as possible,” said Stella Kyriakides, health commissioner.

The list was drawn up by a group of independent scientific experts who examined 82 drugs at an advanced stage of clinical development, taking into account the different types of product needed for different patient populations and at varying stages, and degrees of severity of the disease.

This list of ten treatments includes three categories and will continue to evolve as new scientific data becomes available:

 

1. Antiviral monoclonal antibodies, most effective in the early stages of infection:

Ronapreve, a combination of two monoclonal antibodies casirivimab and imdevimab, from Regeneron Pharmaceuticals and Roche

Xevudy (sotrovimab), from Vir Biotechnology and GlaxoSmithKline

Evusheld, a combination of the two monoclonal antibodies tixagevimab and cilgavimab, from AstraZeneca

 

2. Oral antivirals to be used as soon as possible after infection:

Molnupiravir, from Ridgeback Biotherapeutics and Merck Sharp Dome

PF-07321332, from Pfizer

AT-527 from Atea Pharmaceuticals and Roche

 

3. Immunomodulators for the treatment of hospital patients:

Actemra (tocilizumab), by Roche

Kineret (anakinra) by Swedish Orphan Biovitrum

Olumiant (baricitinib), Eli Lilly

Lenzilumab, by Humanigen

The COVID-19 pandemic made visible the poor state of health data research in Germany. While urgent issues regarding the transmission dynamics of the virus, interaction with other health conditions, and recording and assessment of reactions to vaccines, were being intensively studied and answers being found in other European countries, in Germany this is only happening with delays, requires great effort - or is even entirely impossible.

Against this backdrop, the Interdisciplinary Commission for Pandemic Research of the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) has now issued a statement, in which it calls for data for health-related research to be made more accessible and more linkable.

The Commission points out that research in Germany is not only suffering from a lack of data and methodological underpinnings, but that much needed progress in health-related research is blocked, as access to existing data is often inadequate and that linking such data is associated with significant organisational and legal obstacles.

In its statement, the Commission highlights five fields of action that are interconnected factually and temporally, and should be addressed jointly.

Development of a system of consent for legally compliant and trust-based use of data is required as a first step. In addition, electronic patient records should be developed further to feature an opt-out approach for consent to data collection. National disease registers or epidemiological registers should be established and expanded to avoid incomplete data analysis and duplicates, detect gaps and harness linkage potential. It must also be ensured that these registers are searchable and can be linked to other data sources.

The Commission also says that data should be consolidated and that a sustainably funded central data integration body should be established. This body should function as a trust agency that is legally and organisationally able to grant access to data and to link different sets of data.

The onset of pandemic may have amplified existing gender inequalities in academia, according to an analysis of data on over five million academic authors by Flaminio Squazzoni and colleagues at the University of Milan.

The study of 2,329 academic journals found that during the first wave of the COVID-19 pandemic fewer manuscripts were submitted by women than men, and that this gender gap was especially prominent in the medical research and for women in earlier stages of their careers.

While the onset of the COVID-19 pandemic prompted unusually high numbers of submissions of academic articles, lockdown policies forced academics to handle new family responsibilities, potentially exacerbating known family-related challenges for women in academia. Previous studies have examined this possibility, but the findings have been inconsistent.

Squazzoni and colleagues applied statistical analyses to submission data from 2,329 journals published by Elsevier. They also examined data on academics who were invited to review submissions as part of the peer-review process. In total, data on over five million authors working between February 2018 and May 2020 was analysed.

Between February and May of 2020, submissions to Elsevier journals increased by 30% compared to the same period in 2019. However, women submitted fewer manuscripts than men across academic fields including medicine, life sciences, physical sciences, and social sciences. This gender gap was especially strong in health and medicine, the field that is most directly related to COVID-19, and for women towards the beginning of their careers.

Meanwhile, for most academic fields, similar proportions of women and men accepted invitations to review manuscripts. However, this was not the case for health and medicine, in which women were less involved.

Overall, these findings suggest that the onset of the pandemic may have fostered an environment that was relatively advantageous for men in academia. Given the importance of publishing for academic career success, the gender deficits observed in this study could potentially have long-term effects that deepen gender inequality in academia.

Scientists at Southampton University have developed a new method to safely clean and reuse facemask respirators using low-temperature plasma technology.

They say the method could help in future pandemics by providing contingency options should a shortage of personal protective equipment (PPE) for frontline healthcare staff occur again.

The study showed that the technology can remove 99.99% of coronavirus from contaminated facemasks, while maintaining their ability to filter out harmful airborne droplets.

The technique could reduce by approximately 70% the plastic waste caused by facemasks.

Min Kwan Kim, lecturer in astronautics , who led the research said, “Although most of the masks are considered one-time use, the reuse of masks may need to be considered as a crisis capacity strategy.”

Other techniques to decontaminate PPE have been trialled, including hydrogen peroxide, ultraviolet irradiation, and moist heat. However, these can negatively affect mask performance, either by damaging the filters or leaving residues that are harmful to skin.

The research team applied microdroplets containing SARS-CoV-2 to FFP2 and FFP3 facemasks, the most commonly used by frontline healthcare staff. A prototype decontamination system was then used to apply cold plasma to the samples for two, five and ten minutes. They then tested the samples for the presence of residual SARS-CoV-2 and transmitted aerosols of sodium chloride through the samples to monitor filter performance.

The results showed that the samples that were treated for ten minutes had been successfully decontaminated and the researchers found no significant impact on the filters for both the FFP2 and FFP3 masks.

Pfizer and its partner BioNTech announced topline results from a phase III trial evaluating the efficacy and safety of a booster dose of their COVID-19 vaccine in more than 10,000 individuals 16 years of age and older.

In the trial, a booster dose administered to individuals who previously received the primary two doses restored protection against COVID-19 to the high levels achieved after the second dose, showing a relative vaccine efficacy of 95.6% when compared to those who did not receive a booster. These are the first efficacy results from any randomised, controlled COVID-19 vaccine booster trial.

“We look forward to sharing these data with health authorities and working together to determine how they can be used to support the rollout of booster doses around the world,” said Albert Bourla, CEO of Pfizer.

During the study, there were five cases of COVID-19 in the booster group, and 109 cases in the non-booster group. The adverse event profile was generally consistent with other clinical safety data for the vaccine, with no safety concerns identified.

The companies said they plan to share these data with the US Food and Drug Administration, European Medicines Agency, and other regulatory agencies as soon as possible.

In the US a booster dose is authorised for emergency use in people 65 years of age and older. Booster doses of the vaccine are approved in the EU, with recommendations for population subgroups varying based on local health authority guidance.

A Canadian study exploring cross-cultural differences in knowledge and attitudes towards COVID-19 shows that people in Europe had the least knowledge of COVID-19 and the lowest tendency to care about the coronavirus, while people in the US had the lowest tendency to comply with public health restrictions.

As the pandemic began to unfold, people in the Middle East and Asia were the most aware of COVID-19. People in the Middle East were also the most afraid of the coronavirus.

The study was led by researchers at McGill University who conducted a survey of 1,296 participants in 8 different countries over 5 continents in April 2020. The aim was to measure whether age, gender, education, and occupational status had an impact on knowledge of the coronavirus.

Knowledge of COVID-19 was higher among females overall, particularly in regions like Oceania Africa, the Middle East, Europe, and South Asia. However, in north America, knowledge of COVID-19 was higher among males.

The researchers note the COVID-19 death toll was highest in the US and in Europe compared to other regions and suggest that perhaps with more awareness of COVID-19 in advance, the damage could have been reduced.

Effective pandemic management requires support from the general population to combat the spread of the disease and previous studies of contagious disease outbreaks, like the H1N1 flu, have shown that improved knowledge increases the uptake of preventive measures and influences protective behaviour at the individual and community level.

Despite the severe COVID-19 situation in Europe, researchers found that in April 2020 only 35.5% of people wore a mask. This rate was significantly lower compared to the overall mask wearing rate of 78.1%.

Antibodies in the airways quickly wane after SARS-CoV-2 infection, but vaccination results in a strong increase in antibody levels, especially after two doses, according to a new study from Karolinska Institutet.

The results suggest that having a second dose of vaccine after recovering from COVID-19 may be important for protecting against re-infection and to prevent transmission.

“What makes the study unique is that we have looked at samples from both blood and airways, which has given us new knowledge of the local immune response where the virus infects,” said Anna Smed-Sörensen, research group leader at the Department of Medicine, Solna, Karolinska Institutet. “Since it is more difficult to sample the airways, we know much less about antibody levels there than in the blood.”

The researchers examined how the levels and durability of antibodies to SARS-CoV-2 differed between individuals who had mild to severe COVID-19. 147 patients were recruited in March to May 2020 and monitored for up to eight months after infection. In 20 of the patients, they also studied antibody levels after vaccination and compared the results with a control group that had not previously had COVID-19.

Their results show that individuals who had more severe COVID-19 infections had higher antibody levels upon recovery, compared to individuals with mild disease. The antibodies in the blood remained at measurable levels for at least eight months, while those in the airways were short-lived and disappeared after three months.

“The positive news is that the antibodies quickly returned after vaccination in those who previously had COVID-19, not only in the blood but also in the airways,” said Smed-Sörensen. “We found that the antibody levels in the airways after two doses of vaccine were often even higher than they were during the course of the disease. People who had not had COVID-19 before vaccination had much lower or undetectable levels.”

“Our results demonstrate that to only study blood does not reflect the antibody levels in the respiratory tract, which likely play a major part in neutralising the virus locally,” said Karin Loré, professor in the Department of Medicine. “Completing the vaccination with a second dose may therefore be important for achieving optimal immune responses and reducing the spread of infection between individuals.”

The level of antibodies required for protection against infection remains unknown, as well as whether the rapid drop in antibody levels in the airways allows for re-infection. The researchers will now continue to analyse samples from additional longitudinal time points and examine the inflammatory environment in the respiratory tract during infection, convalescence and after vaccination.

Valneva said it is moving to submit its COVID-19 vaccine for approval by the UK regulator MHRA and to the European Medicines Agency, after reporting positive results in a phase III trial.

The vaccine, VLA 2001, successfully met two primary endpoints, generating higher levels of neutralising antibodies than AstraZeneca’s approved vaccine, against which it was compared, and with more than 95% of participants developing antibodies against the SARS-CoV-2 virus.

In addition, VLA2001 was well tolerated, with fewer side effects reported than with the AstraZeneca vaccine.

The trial was designed to show the immune response generated by VLA2001 is non-inferior to that generated by AstraZeneca’s vaccine; it was not able to assess how effective VLA2001 is in preventing infection. There were cases of infection in participants who received VLA2001, but none required hospital admission.

The occurrence of COVID-19 cases was similar between both vaccines. Valneva said the complete absence of any severe COVID-19 cases suggests that both vaccines can prevent severe COVID-19.

VLA2001 is based on traditional inactivated virus vaccine technology. Thomas Lingelbach, CEO of Valneva, said, “These results confirm the advantages often associated with inactivated whole virus vaccines. We are committed to bringing our differentiated vaccine candidate to licensure as quickly as possible and continue to believe that we will be able to make an important contribution to the global fight against the COVID-19 pandemic.”

The results are “both impressive and extremely encouraging,” said Adam Finn, professor of paediatrics at Bristol University, who was principal investigator for the trial. “This is a much more traditional approach to vaccine manufacture than the vaccines so far deployed in the UK, Europe and north America and these results suggest this vaccine candidate is on track to play an important role in overcoming the pandemic,” Finn said.

The Commission issued a report on the EU digital COVID certificate and its implementation across the EU, showing that the certificate has been a crucial element in Europe's response to the pandemic, with more than 591 million certificates generated.

The EU says it has set a global standard and is currently the only system in operation at international level. At present 43 countries across four continents are plugged into the system, and more will follow over the coming weeks and months.

Twenty member states also use the EU Digital COVID Certificate for domestic purposes, such as for the access to large events and restaurants, cinemas and museums, with an additional national legal basis.

The certificate, which covers COVID-19 vaccination, test and recovery, facilitates safe travel and has been key to support Europe's hard-hit tourism industry, the report says.

Commissioner for Internal Market, Thierry Breton said, “The EU system is adopted by countries around the world, demonstrating how Europe can set global standards through decisive and coordinated action.”

The European Medicines Agency has approved two additional manufacturing sites for the production of Pfizer/BioNTech’s COVID-19 vaccine in Italy.

Following the approval, the two sites will be operational immediately and will produce up to 85 million additional doses to supply the EU in 2021.

At the same time, EMA has approved a ready-to-use formulation of the vaccine, with much easier handling requirements than the original version. The new formulation does not require dilution prior to administration, will be available in a 10-vial pack size containing 60 doses, and can be stored at 2-8°C for up to 10 weeks

The current concentrated formulation requires dilution prior to administration, is available in a 195-vial, 1,170 dose, pack size and can be stored at 2-8°C for one month only.

The improvements will provide better storage, transport and logistic options for vaccine distribution and administration. The new formulation will be available in a phased rollout starting in early 2022.

EMA also announced it has started evaluating an application to extend the use of BioNTech/Pfizer’s COVID-19 vaccine to children aged 5 to 11.

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