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

13 Jan 2022 | 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.

People without immunity against COVID-19 were at considerably lower risk of infection and hospitalisation as the number of family members with immunity from a previous infection or full vaccination increased, according to a nationwide study in Sweden, carried out by researchers at Umeå University.

While there is plenty of evidence to show vaccines strongly reduce the risk of COVID-19, less is known about the influence of vaccination on transmission of the virus in high-risk environments, such as within families.

The researchers found there was a dose-response association between the number of immune individuals in each family and the risk of infection and hospitalisation of non-immune family members in a study involving 1.8 million individuals from more than 800,000 families.

“The results strongly suggest that vaccination is important not only for individual protection, but also for reducing transmission, especially within families, which is a high-risk environment for transmission,” says Peter Nordström, professor of geriatric medicine at Umeå University.

“It seems as if vaccination helps not only to reduce the individual’s risk of becoming infected, but also to reduce transmission, which in turn minimises not only the risk that more people become critically ill, but also that new problematic variants emerge and start to take over,” said Marcel Ballin, co-author of the study. “Consequently, ensuring that many people are vaccinated has implications on a local, national, and global scale.”

A large-scale trial in Sweden succeeded in increasing the vaccination rate by four percentage points with the modest inducement of €20 (200 Swedish kronor). The promised reward helped to raise the already high rate in the trial from 72 percent to 76 percent.

“Our study shows that financial incentives can increase vaccination rates, even in places like many EU countries where they are already high,” said behavioural economist Armando Meier, senior research fellow at the University of Lausanne, Switzerland, who is co-author of the research published in Science.

The study was conducted between May and July 2021 with a representative sample of around 8,300 people between 18 and 49 years old. As soon as a vaccination was approved for their age group, the study participants were asked through an online survey whether or not they intended to get vaccinated.

Participants were then randomly assigned to five different groups. The members of the first group were promised a financial reward if they got vaccinated within 30 days. In three of the other groups, the scientists used other methods to try to increase the vaccination rate, such as sharing information on the safety and effectiveness of COVID-19 vaccines and emphasising that vaccination helps others.

Participants in the fifth group, which served as a control group, were not offered anything.

The researchers checked whether the individuals had actually been vaccinated against COVID-19 in the following 30 days through an anonymous linkage with data from the Swedish health authorities. They found that the prospect of a payment not only increases the declared vaccination intention, but actually leads to higher vaccination uptake.

“We also discovered, somewhat surprisingly, that the vaccination rate rose for everyone, regardless of gender, age and level of education. This indicates that monetary incentives have the potential to increase the rate among people regardless of background. The results also show that the incentives have an effect even in countries with relatively high vaccination levels such as Sweden”, said Erik Wengström, professor of economics at Lund University.

By contrast, other methods with which the researchers attempted to influence the behaviour of the participants were less successful. These included asking participants to name people close to them whom they could protect by getting vaccinated. While these “nudges” increased intentions to vaccinate in the short term, like information and reminders, they ultimately failed to translate into higher vaccination uptake.

Co-author Florian Schneider said, “The results put into perspective the fear that financial rewards are counterproductive and could deter undecided individuals from getting vaccinated, by fuelling suspicion, for instance. On the contrary, even modest monetary incentives can have a positive effect on the vaccination rate.”

The researchers also looked at whether it could it be cost effective for governments to pay people to get vaccinated.

“There is no detailed cost analysis in the study, but it is reasonable to assume that it would be cost-effective for society. The incentives can be considered as a stimulus package, transferring money from the government to people’s pockets, which at the same time would save people’s lives,” said co-author Pol Campos-Mercade.

“Even with low incentives, we can increase the vaccination rate against COVID-19. The result does not necessarily mean that we should pay people; we do not take a stand on whether it is ethically acceptable to pay people to get vaccinated or not. However, as the pandemic continues, incentives should be one of the tools worth considering in the fight to reduce the spread of COVID-19,” said Wengström.

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.

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