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.

Curevac has withdrawn its COVID-19 vaccine from the approval process at the European Medicines Agency, after ditching it in favour or a second generation product.

The company said recent communication with EMA indicated the earliest approval date was the second quarter of 2022 and by this time, it expects the second generation vaccine programme, being advanced in partnership with GlaxoSmithKline, will have progressed to late stage clinical development.

The decision is also reflects the evolving dynamics of the pandemic response towards a greater need for differentiated vaccines to address the fact that SARS-CoV-2 is becoming endemic. As a result, the existing advanced purchase agreement with the European Commission, which was predicated on employing the first generation vaccine to address the acute pandemic need, will cease.

CureVac is assessing the possibility of leveraging existing commitments for the second generation vaccine.

CureVac and GSK have tightened their collaboration by adding further resources and experts to accelerate development and manufacturing of the broad second generation programme. The companies anticipate entering clinical development in the next months, aiming to achieve regulatory approval for an improved COVID-19 vaccine in 2022.

“We remain committed to making a difference with a safe and efficacious vaccine. This goal has not changed, but the requirements to effectively address the virus and emerging variants have changed,” said Franz-Werner Haas, CEO of CureVac.

EMA said it has been looking at data on the Curevac vaccine since February 2021, as part of a rolling review, whereby the company submits data as they become available in order to speed up the evaluation of an eventual marketing authorisation application.

The agency said it had raised some questions about the vaccine’s quality, impacting the benefit-risk balance of the vaccine, and the fact that results of the main clinical study showed only a modest vaccine efficacy in adults. These issues “still remained to be satisfactorily addressed,” EMA said.

The vaccine was only 47% effective in preventing COVID-19 infections in the 40,000-person phase III study.

A survey of 321 scientists who have spoken to the media about COVID-19, many of whom had also commented on social media about the pandemic, has found that 15% experienced death threats and 22% received threats of physical or sexual violence.

The survey, carried out by the journal Nature, found that more than a quarter of the respondents said they ‘always’ or ‘usually’ received comments from trolls or personal attacks after speaking about COVID-19. More than 40% experienced emotional or psychological distress.

Respondents who reported most frequently being trolled online or receiving personal attacks were also most likely to say that their experiences had greatly affected their willingness to speak to the media in the future. Some anonymous respondents wrote that they were hesitant to speak about some topics because they saw the abuse received by others.

However, scientists generally appreciated their interactions with media despite their other experiences: overall, 85% of researchers rated their experiences with the media during the pandemic as ‘always’ or ‘mostly’ positive; 84% said they were able to get their message out to the public; and 63% said speaking to the media was personally rewarding.

Michael Head, senior research fellow in global health at Southampton University, said, “I myself have received plenty of abuse throughout the pandemic. For those of us who have been pulling apart anti-vaccine misinformation from pre-pandemic times, the presence of these attempts at intimidation is very wearying, but not surprising.

He added, “In my view, the intensity of such harassment has gone up significantly across the pandemic, including becoming more organised and frightening than simply mindless comments on social media.”

The misinformation spread around Europe and North America also has far-reaching consequences in terms of inducing vaccine hesitancy further afield, Head said.

A large scale French study has confirmed the effectiveness of three COVID-19 vaccines, with real world data showing the risk of being admitted to hospital with severe disease was cut by over 90% at 14 days after the second dose.

The research, carried out by the government health data research body Epi-Phare, used information on 22.6 million people aged 50 to 74, and 7.2 million aged over 75.

In each cohort half were vaccinated, with either the Pfizer/BioNTech, Moderna or AstraZeneca vaccines, and half were not.

Among those vaccinated aged 50 to 74 years, just over 53% had received Pfizer vaccine, 7.1% Moderna and 39.2% AstraZeneca. Among those aged 75 years and older, just over 85% had received Pfizer, 8.7% Moderna, and 6.1% AstraZeneca.

Epi-Phare says the results are very consistent, highlighting the significant effectiveness of the three vaccines, with reduction in the risk of hospitalisation from the 14th day after the injection of the second dose greater than 90% in both age groups, for each vaccine. The reduction in the risk of death was also cut by 90%.

The effectiveness of vaccination against severe forms of Covid-19 did not appear to wane over the follow-up period of up to 5 months.

To examine the impact of the Delta variant, the reduction in the risk of hospitalisation for COVID-19 was estimated during the start of circulation of the Delta variant in France, between 20 June and 20 July 2021. Over this period, efficacy was 84% ​​in the cohort aged 75 and over and 92% in the cohort aged 50 to 74. The researchers say that although based on a short period, this provides the first evidence on the effect of the Delta variant on risk reduction.

There will be continued monitoring to measure the evolution of efficacy over a longer period and to better characterise the impact of the Delta variant.

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.

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