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.
Denmark, Finland and Sweden have paused the use of Moderna’s COVID-19 vaccine in younger people, over concerns about the risk of myocarditis.
Although extremely rare, the condition, which causes inflammation of the heart muscle, has been linked to Moderna’s vaccine around the world.
Cases of myocarditis occur more often in adolescents and adults under 30 years of age, more often in males than in females, more often after a second dose of vaccine than after a first dose.
Sweden now advises the Moderna vaccine should not be given to people under 30, while Finland and Denmark advise against its use in those under 18 years of age.
Achiko AG has launched a pilot programme in Indonesia of its non-invasive, saliva-based COVID-19 diagnostic test, AptameX, combined with its digital health passporting app, in one integrated platform and said it is in the process of getting EU CE mark approval, with a view to launching the diagnostic/passport combination in Europe.
It is expected that COVID-19 will be present for years to come and pose an ongoing threat to people’s health and well-being, and the economies for many countries, said Steven Goh, CEO of Achiko. “Against this backdrop, the cost of testing and the ease of managing test results become a key success factor in the fight against the ramifications of the pandemic. The combination of AptameX and [the passport app] can make testing affordable to workplaces and communities and bring the cost of frequent testing down,” he said.
The first stage of the pilot will be held in three sites in Indonesia, with the objective of confirming health economics and showcasing the service. Zurich-based Achiko is currently hiring and training staff to support commercial roll out.
US biotech Moderna announced it will build a mRNA vaccines facility in Africa with the goal of producing up to 500 million doses per annum. The company anticipates investing up to $500 million in this new facility, which is expected to include drug substance manufacturing with the opportunity for fill/finish and packaging capabilities at the site. It will begin the process of selecting a country and a site soon.
“We have been humbled to play a critical role in combatting the COVID-19 pandemic globally with our mRNA vaccine. We view Moderna’s work as only just beginning,” said Stephane Bancel, Moderna CEO. “We are determined to extend Moderna’s societal impact through the investment in a state-of-the-art mRNA manufacturing facility in Africa.”
“While we are still working to increase capacity in our current network to deliver vaccines for the ongoing pandemic in 2022, we believe it is important to invest in the future. We expect to manufacture our COVID-19 vaccine, as well as additional products within our mRNA vaccine portfolio at this facility,” Bancel said.
To date, Moderna has supplied more than 500 million doses of its COVID-19 vaccine, and recently announced several initiatives aimed at continuing to increase capacity “at a significant pace”.
The European Medicines Agency has changed its recommendations on booster doses of the Pfizer/BioNTech COVID-19 vaccine, saying boosters “may be considered” at least six months after the second dose for people aged 18 years and older.
This is an about turn for EMA, which on 2 September put out a joint statement with the European Centre for Disease Control, saying evidence on vaccine effectiveness and duration of protection showed that all vaccines authorised in the EU remained effective in preventing COVID-19-related hospital admissions, severe disease and death.
The change is based on the evaluation of data showing a rise in antibody levels when a booster dose of the Pfizer vaccine is given approximately six months after the second dose in people from 18 to 55 years old.
A number of countries in Europe have gone ahead with booster programmes despite EMA’s emergency use authorisation for Pfizer’s vaccine not specifying it is safe and effective when used in this way.
EMA said the risk of inflammatory heart conditions or other very rare side effects after a booster is not known and is being carefully monitored. More information about the booster recommendations for Pfizer’s vaccine will be available in the updated product information.
EMA is also currently evaluating data to support a booster dose for Moderna’s COVID-19 vaccine.
At the same time, EMA said an extra dose of either Pfizer or Moderna’s vaccines may be given to people with severely weakened immune systems, at least 28 days after their second dose.
The recommendation comes after studies showed that an extra dose of these vaccines increased the ability to produce antibodies against the SARS-CoV-2 virus in organ transplant patients with weakened immune systems.
As yet, there is no direct evidence that the ability to produce antibodies in these patients protects against COVID-19, but it is expected that the extra dose would increase protection at least in some patients. The product information of both vaccines will be updated to include this recommendation.
Real world US data shows two doses of the Pfizer/BioNTech vaccine are 90% effective at preventing COVID-19 hospital admission across all variants of the SARS-CoV-2 virus, including Delta, for at least six months, according to a study published in The Lancet.
However, over time, two doses are not so good at preventing infections, with effectiveness declining steadily, from 88% within one month of receiving two vaccine doses, to 47% after six months.
The researchers say this study underscores the importance of improving COVID-19 vaccination rates worldwide and monitoring vaccine effectiveness to determine which populations should be prioritised to receive boosters.
“Our study confirms that vaccines are a critical tool for controlling the pandemic and remain highly effective in preventing severe disease and hospitalisation, including from Delta and other variants of concern. Protection against infection does decline in the months following a second dose,” said Sara Tartof, of the Kaiser Permanente Southern California Department of Research & Evaluation, one of the study authors.
The researchers analysed 3.4 million electronic health records from the Kaiser Permanente Southern California health system between 4 December 2020, and 8 August 2021. During this time, 5.4% (184,041 people) were infected with SARS-CoV-2. Among those who were infected, 6.6% (12,130) were hospitalised. The average time since being fully vaccinated was between three to four months.
Whole genome sequencing showed the Delta variant comprised 28% of the overall proportion of positive sequences. During the study period, the proportion of positive cases in the US attributed to Delta increased from 0.6% in April 2021 to nearly 87% by July 2021, confirming the Delta variant had become the dominant strain.
Vaccine effectiveness against Delta infections at one month after two doses of vaccine was 93% and fell to 53% after four months. Effectiveness against other variants one month after receiving two doses was 97% and declined to 67% after four months.
The researchers did not observe a difference in the rate of waning between SAR-CoV-2 variant type, suggesting reduced protection from infection was similar regardless of the variant identified and therefore that declining effectiveness is a result of waning vaccine effect affecting all strains in circulation, rather than a variant that is insensitive to the vaccine.
The safety committee of the European Medicines Agency has concluded that there is a possible link between rare cases of venous thromboembolism (VTE) and Johnson & Johnson’s single dose COVID-19 vaccine.
VTE occurs when a blood clot forms in a deep vein, usually in a leg, arm or groin, and travels to the lungs, blocking the blood supply, with possible life-threatening consequences.
This safety issue is distinct from another very rare side effect, of thrombosis with thrombocytopenia syndrome, when blood clots occur despite a low level of the platelets that cause blood to clot.
VTE was included in EMA’s risk management plan for Johnson & Johnson’s COVID-19 vaccine, because a higher proportion of cases of VTE observed within the vaccinated group versus the placebo group in the large clinical study which was used to authorise the vaccine.
EMA has now reviewed new data from this study, as well as new evidence from another large clinical trial. In the second study there was no increase in venous thromboembolic events among individuals who received the Johnson & Johnson vaccine. However, EMA also reviewed real world data from vaccination campaigns, and when taking all evidence into account, the safety committee concluded there is a “reasonable possibility” rare cases of VTE are linked to this vaccine .
EMA is recommending listing VTE as a rare side effect of the Johnson & Johnson vaccine in the product information, together with a warning to raise awareness among healthcare professionals and people receiving the vaccine, especially those who may have an increased risk of VTE.
The safety committee also assessed cases of immune thrombocytopenia (ITP) - in which the immune system mistakenly targets blood platelets that are needed for normal blood clotting - that have been reported following vaccination with Johnson & Johnson’s and AstraZeneca’s Covid-19 vaccines.
As a result, EMA recommended updating the product information of both vaccines to include ITP as an adverse reaction with an unknown frequency.
A total of 37% of people had at least one long-COVID symptom diagnosed in the 3-6 month period after COVID-19 infection, with the commonest symptoms being breathing problems, abdominal symptoms, fatigue, pain and anxiety/depression.
Researchers at Oxford University investigated long COVID symptoms in over 270,000 people recovering from COVID-19 infection, using patient records from the US TriNetX network, which holds records of 81 million people.
In all, 57% of patients with a recorded diagnosis of COVID-19 subsequently presented to their doctors with symptom(s) of long COVID between 0 – 6 months after infection. More than a third (37%) did not report until three to six months after they contracted COVID-19, indicating they are not persisting acute symptoms. The researchers say it may be that new symptoms emerge some time after initial infection.
Severity of infection, age, and sex, affected the likelihood of long-COVID symptoms, with long-COVID symptoms more frequent in those who had been hospitalised. They were also slightly commoner in women. There was no difference seen between people of different ethnicities.
Older people and men had more breathing difficulties and cognitive problems, whereas young people and women had more headaches, abdominal symptoms and anxiety/depression. Many patients had more than one long-COVID symptom, and symptoms tended to co-occur more as time progressed.
The study, published in PLOS Medicine, does not explain what causes long-COVID symptoms, or say how severe they are, or how long they will last.
Max Taquet, of Oxford University, who led the analysis said, “The results confirm that a significant proportion of people, of all ages, can be affected by a range of symptoms and difficulties in the six months after COVID-19 infection. These data complement findings from self-report surveys, and show that clinicians are diagnosing patients with these symptoms. We need appropriately configured services to deal with the current and future clinical need.”
Research of different kinds is urgently needed to understand why not everyone recovers rapidly and fully from COVID-19, said Paul Harrison, who headed the study. “We need to identify the mechanisms underlying the diverse symptoms that can affect survivors. This information will be essential if the long-term health consequences of COVID-19 are to be prevented or treated effectively,” he said.
The European Medicines Agency has started evaluating an application for the use of a booster dose of Spikevax, Moderna’s COVID-19 vaccine, to be given at least 6 months after the second dose in people aged 12 years and older.
Booster doses would be given to vaccinated people who have completed their primary vaccination, to restore protection after it has waned.
EMA said it will carry out an accelerated assessment of data submitted, including results from an ongoing clinical trial. Based on this review, it will recommend whether the product information should be updated to say booster doses are appropriate.
While it is looking at the file, EMA and the European Centre for Disease Prevention and Control (ECDC) have both said they do not consider the need for COVID-19 vaccine booster doses to be urgent in the general population, EMA’s stance is that it is evaluating Moderna’s application to ensure evidence is available to support further doses as necessary.
Advice on how vaccinations should be given remains the prerogative of immunisation experts in each EU member state. EMA said member states “may already consider preparatory plans” for giving boosters and additional doses.
Spikevax is currently authorised for use in people aged 12 and older.
The COVID-19 pandemic has triggered life expectancy losses not seen since World War 2 in western Europe, and which exceed those in central and eastern Europe following the break up of the Soviet Union, according to new research.
The researchers brought together a dataset on mortality from 29 countries, spanning most of Europe, the US and Chile, for which official death registrations for 2020 have been published. In 27 of the 29 countries there were reductions in life expectancy in 2020, and at a scale which wiped out years of progress on mortality, according to a paper published in the International Journal of Epidemiology.
Women in 15 countries and men in 10 countries were found to have a lower expectancy at birth in 2020 than in 2015, a year in which life expectancy was already negatively affected by a significant flu season.
The study was led by scientists at Oxford University’s Centre for Demographic Science. Author José Manuel Aburto said, “For western European countries such as Spain, England and Wales, Italy, Belgium, among others, the last time such large magnitudes of declines in life expectancy at birth were observed in a single year was during World War 2.”
The scale of the life expectancy losses was sobering across most countries studied, with twenty two countries having losses in life expectancy greater than six months in 2020. “Females in eight countries and males in 11 countries experienced losses larger than a year,” Aburto said. “To contextualise, it took on average 5.6 years for these countries to achieve a one year increase in life expectancy recently. [That] progress [was] wiped out over the course of 2020 by COVID-19.”
Across most of the 29 countries, males saw larger life expectancy declines than females. The largest drop was observed among males in the US, who saw a decline of 2.2 years relative to 2019 levels, followed by males in Lithuania, where 1.7 years was wiped off life expectancy.
Another author, Ridhi Kashyap said the large declines in life expectancy observed in the US can partly be explained by the notable increase in mortality at working ages observed in 2020. “In the US, increases in mortality in the under 60 age group contributed most significantly to life expectancy declines, whereas across most of Europe increases in mortality above age 60 contributed more significantly,” Kashyap said.
In addition to these age patterns, the analysis reveals that most life expectancy reductions across different countries were attributable to official COVID-19 deaths.
“While we know that there are several issues linked to the counting of COVID-19 deaths, such as inadequate testing or misclassification, the fact that our results highlight such a large impact that is directly attributable to COVID-19 shows how devastating a shock it has been for many countries,” said Kashyap. “We urgently call for the publication and availability of more disaggregated data from a wider range of countries, including low- and middle-income countries, to better understand the impacts of the pandemic globally.”
Life expectancy refers to the average age to which a newborn will live if current death rates continued for their whole life. It does not predict an actual lifespan, but rather provides a snapshot of current mortality conditions. This allows for a comparison of the size of the mortality impacts of the pandemic between different countries and populations.
Researchers at the Institute of Medical Virology at Goethe-University, Frankfurt am Main, and at the School of Biosciences at Kent University in the UK have identified a protein they say may critically contribute to severe forms of COVID-19.
They found that the infection of human cells with SARS-CoV-2 virus resulted in increased levels of CD47, a protein found on the cell surface. CD47 acts as a ‘do not eat me’ signal to the immune system, protecting cells from being destroyed. Virus-induced CD47 on the surface of infected cells is thought to protect them from immune system recognition, enabling the production of larger amounts of virus, resulting in more severe disease.
Well-known risk factors for severe COVID-19 such as older age and diabetes are associated with higher CD47 levels. High CD47 levels also contribute to high blood pressure, which is a large risk factor for COVID-19 complications such as heart attack, stroke, and kidney disease.
The researchers say their data suggest that age and virus-induced high CD47 levels contribute to severe COVID-19 by preventing an effective immune response and increasing disease-associated tissue and organ damage. Drugs targeting CD47 are in development so this discovery may result in improved COVID-19 therapies.
Martin Michaelis, professor of molecular medicine at Kent University, said, “We may have identified a major factor associated with severe COVID-19. This is a huge step in combatting the disease and we can now look forward to further progress in the design of therapeutics.”
Jindrich Cinatl of the Institute of Medical Virology, Goethe-University, said the additional insights into the disease processes underlying COVID-19 may help in the design of better therapies. “Through this avenue, we have achieved a major breakthrough and exemplified that the fight against the disease continues.”
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