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

The European Medicines Agency has started evaluating an application for the use of a booster dose of COVID-19 Vaccine Janssen to be given at least two months after the first dose to people aged 18 years and older.

The agency’s human medicines committee will carry out an accelerated assessment of data, including results from more than 14,000 adults who received a second dose of the COVID-19 vaccine Janssen or placebo two months after the initial dose.

The outcome of this evaluation is expected within weeks.

A survey of 3,821 Flemish employees, representative for gender, age and education level, who were surveyed end March 2020, showed a large majority (65.9%) were satisfied with the increase in teleworking during the pandemic, according to researchers at the University of Ghent.

Almost half of the employees doing more teleworking said it is beneficial for stress (45.7%) and burnout prevention (42.7%), and on-the-job concentration (44.7%). In addition, more than half (55.7%) feel that homeworking has had a positive effect on their work-life balance.

The main problem is social isolation, with two-thirds of respondents reporting a weaker bond with their colleagues (64.0%), and more than half feeling less connected with their employer (56.0%).

“Notwithstanding the exceptional time of sudden, obligatory and high-intensity telework, Flemish employees in general mainly attribute positive characteristics to telework, such as a better work-life balance and increased concentration,” said researcher Eline Moens.

Whether telework is seen as positive or negative differs from employee to employee and from job to job.

The personal context was important as well: gender, age, whether you have children or not, turns out to be important for the evaluation of telework.

Overall, the experience of teleworking during the pandemic led to an increased desire do more teleworking in the future (62.7%).

“The question is to what extent employees will be able to force these aspirations regarding more telework in the workplace after the pandemic. In our opinion, how employers have experienced the extended telework will be decisive in this respect,” said researcher Stijn Baert
 

New data from the European Centre for Disease Prevention and Control (ECDC) show that antibiotic consumption decreased by more than 18% between 2019 and 2020.

This is the largest annual decrease in the two decades of reporting via the European Surveillance of Antimicrobial Consumption Network. The decrease was observed in 26 of the 27 reporting countries of the EU and European Economic Area. The changes were largest and most consistent in the primary care sector, and are most likely a result of the COVID-19 pandemic, according to ECDC.

From 2016 and 2019 there was decrease in the population-weighted mean annual change in the consumption of antibacterials of 1.8%. Between 2019 and 2020, the decrease was ten times higher, at 18.3%.

One explanation for the decrease is a general drop in the number of primary care consultations during the COVID-19 pandemic, with people more cautious about seeking healthcare for mild or self-limiting infections, or due to difficulties in getting medical appointments.

Another is that the large decrease in prescribing of antibiotics commonly used to treat respiratory tract infections reflects the reported low incidence of non-COVID-19-related respiratory tract infections. This has been attributed to measures put in place as a response to the pandemic, including physical distancing, face masks and promotion of hand hygiene.

Prior to the COVID-19 pandemic, the primary care sector accounted for about 80% to 90% of all antibiotic prescriptions, mainly for respiratory tract infections.

ECDC said it remains to be seen if the decline in antibiotic consumption observed in 2020 will be sustained throughout 2021, and what implications the decrease may have on antimicrobial resistance in Europe overall.

The European Medicines Agency has begun the formal review of US biotech Novavax’s COVID-19 vaccine, Nuvaxovid, saying the assessment will proceed under an accelerated timeline, and the outcome could be known within weeks.

The short timeframe is possible because EMA has already reviewed a substantial portion of the data on the vaccine during a rolling review, looking at preclinical data, manufacturing and data on the vaccine’s safety, immunogenicity and efficacy against COVID-19 from clinical studies.

"Novavax looks forward to providing an additional vaccine option in Europe, built on a proven, well-understood technology platform,” said Stanley Erck, CEO of Novavax.

Nuvaxovid has been evaluated in two phase III trials: a trial in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha variant and 89.7% efficacy overall; and a trial in the US and Mexico that demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall.

The vaccine is engineered from the genetic sequence of the first strain of SARS-CoV-2 virus that causes COVID-19.

Researchers at Sheffield University have measured the economic impact of COVID-19 on the UK’s arts, culture and heritage sector, showing that nationally output fell dramatically as COVID-19 hit in March 2020.

There was a decline of around one third between the second quarter of 2019 and the same three months in 2020, in real terms. The creative, arts and entertainment sub-sector, and the libraries, archives, museums and other cultural activities sub-sector, were the worst hit, with declines of 63% and 45% respectively.

For the sector as a whole, gross value added fell by around 20% (real change, constant prices), compared to around 10% for the UK economy overall.

The dramatic falls in output mask some significant variations between sub-sectors ranging from an estimated plus 17% to minus 70%.

Activities that grew, or were only subject to modest declines (+17% to -5% range) in output, included computer games, software, educational book publishing, TV broadcasting and libraries.

Activities very badly affected (-30% to -70% range) included cinema, performing arts, museums and historical sites.

Long-term exposure to air pollution is associated with a higher risk of developing COVID-19 among those people who get infected, shows a study led by the Barcelona Institute of Global Health (ISGlobal).

A series of studies have indicated that regions with higher pre-pandemic levels of air pollution had a higher incidence of COVID-19 cases and deaths. However, the reasons for this association are not yet clear; air pollution could favour airborne transmission of the virus, or it could increase an individual’s susceptibility to infection or disease.

“The problem is that previous studies were based on reported cases, which had been diagnosed, but missed all the asymptomatic or undiagnosed cases,” said Manolis Kogevinas, ISGlobal researcher and first author of the study.

The research team combined technology for measuring a series of virus-specific antibodies in a cohort of adults living in Catalonia, with information on the long-term exposure of such individuals to air pollutants.

The study included 9,605 participants among which there were 481 confirmed cases (5%). In addition, blood samples from over 4,000 participants were taken to determine the presence and quantity of antibodies to five viral antigens. Of these, 18% had virus-specific antibodies, but no association was found between infection and exposure to air pollutants.

However, among those who got infected, an association was found between higher exposure to air pollution and higher levels of antibodies. There was also an association between higher exposure to air pollution and disease symptoms, particularly for severe cases that ended in the hospital or in intensive care.

“Our study provides the strongest evidence globally on the association of ambient air pollution and COVID-19,” said Kogevinas. “These results are in line with the association between air pollution and hospitalisation described for other respiratory diseases such as influenza or pneumonia.”

Air pollution could also contribute by promoting the development of cardiovascular, respiratory or other chronic conditions, which in turn increase the risk of severe COVID-19.

The European Medicines Agency has recommended approval of two monoclonal antibody drugs, Ronapreve and Regkirona for treating COVID-19.

The drugs can now be used in patients aged 12 years of age on older who do not require oxygen, but are at increased risk of their disease becoming severe.

Whilst conducting its review, EMA gave advice to member states on the use of the two therapies, which means they are already available in some countries.

The antibodies are designed to attach to the spike protein of SARS-CoV-2, via which the virus enters human cells. That preferential attachment blocks the virus’ route into cells in the respiratory tract.

EMA evaluated data from studies showing that treatment with Ronapreve or Regkirona significantly reduces hospitalisation and deaths in COVID-19 patients at risk of severe COVID-19.

Another study showed that Ronapreve reduces the chance of contracting COVID-19 if a household member is infected.

Overall 0.9% of patients treated with Ronapreve, 11 of 1,192 in the study, were hospitalised or died within 29 days of treatment. That compared with 3.4% of patients on placebo (40 out of 1,193 patients).

Ronapreve was also found to be effective at preventing symptoms in infected people. Amongst the people who tested positive for SARS-CoV-2 after contact, 29% of people (29 out of 100) who received Ronapreve developed symptoms compared with 42.3% of people (44 out of 104) who received a placebo.

A main study in patients with COVID-19 showed that Regkirona treatment led to fewer patients requiring hospitalisation or oxygen therapy or dying, when compared with placebo.

Among the patients at increased risk of their illness becoming severe, 3.1% of patients treated with Regkirona (14 out 446) were hospitalised, required supplemental oxygen or died within 28 days of treatment, compared with 11.1% of patients on placebo (48 out of 434).

The European Commission has agreed a contract for 55,000 courses of Ronapreve with its manufacturer, Swiss pharma Roche.

Pfizer and the UN-backed Medicines Patent Pool (MPP), announced the signing of a voluntary license agreement for Pfizer’s COVID-19 oral antiviral drug Paxlovid, which has been shown to cut the risk of hospitalisation or death by 89%.

The agreement will enable MPP to support additional production and distribution of the drug by granting sub-licenses to generic medicine manufacturers, with the goal of providing greater access for low and middle income countries.

Under the terms of the license agreement qualified generic medicine manufacturers worldwide that are granted sub-licenses will be able to supply Paxlovid to 95 countries, covering up to 53% of the world’s population.

This includes all low- and lower-middle-income countries and some upper-middle-income countries in sub-Saharan Africa. Pfizer will not receive royalties on sales in low-income countries and will waive royalties on sales in all countries covered by the agreement while COVID-19 remains classified as a public health emergency of international concern by the World Health Organisation.

“Pfizer remains committed to bringing forth scientific breakthroughs to help end this pandemic for all people. We believe oral antiviral treatments can play a vital role in reducing the severity of COVID-19 infections, decreasing the strain on our healthcare systems and saving lives,” said Albert Bourla, Pfizer CEO. “We must work to ensure that all people, regardless of where they live or their circumstances, have access to these breakthroughs, and we are pleased to be able to work with MPP to further our commitment to equity.”

Charles Gore, Executive Director of MPP said, “[Paxlovid] is to be taken together with ritonavir, an HIV medicine we know well, as we have had a license on it for many years, and we will be working with generic companies to ensure there is enough supply for both COVID-19 and HIV.”

The global health agency Unitaid created MPP ten years ago “for this exact purpose”, to secure licenses that enable and accelerate access to affordable quality treatments for people in resource-limited settings, said Philippe Duneton, Executive Director of Unitaid. “This agreement could help us to reach more people more quickly as soon as the medicine is approved and, when coupled with increased access to testing, bring benefits to millions.”

MPP is inviting expressions of interest from generics manufacturers based anywhere in the world for sublicences to manufacture and sell co-packs of Paxlovid and ritonavir.

Scientists at University College London say that by designing next generation vaccines for COVID-19 to activate immune memory T cells, it may be possible to eliminate SARS-CoV-2 at the very start of an infection, thereby helping stop its spread.

The suggestion is based on research published in Nature today, describing how intensive monitoring of healthcare workers in London from before the pandemic took hold in March 2020, showed that despite their high risk, 58 participants did not test positive for COVID-19 at any point.

Analysis of their blood showed they had increased levels of memory T cells that reacted against SARS-CoV-2. These T cells target infected cells expressing replication proteins which the virus needs to spread once it enters a human host cell.

The proteins are common to all coronaviruses and remain highly conserved. Unlike the spike protein targeted by first generation vaccines, these are unlikely to change or mutate.

Leo Swadling, Medical Research Foundation Research Fellow at UCL and lead author, said it was known that some individuals remain uninfected despite having likely exposure to the virus.

“What we didn’t know is whether these individuals really did manage to completely avoid the virus, or whether they naturally cleared the virus before it was detectable by routine tests,” Swadling said. “By intensively monitoring health care workers for signs of infection and immune responses, we identified a minority with this particular SARS-CoV-2 specific T cell response.”

A vaccine that can induce T cells to recognise and target infected cells expressing replication proteins would be more effective at eliminating early SARS-CoV-2, and may have the added benefit of being active against other coronaviruses.

The European Commission has approved its eighth COVID-19 vaccines contract, signing a deal for French biotech Valneva to supply 27 million doses in 2022, and a further 33 million in 2023.

The contract includes the intention to adapt the vaccine to new variant strains of SARS-CoV-2, should that be necessary. With the product yet to be approved by the European Medicines Agency, initial supplies are expected in April 2022.

The agreement is a huge boost for the company, after the UK government cancelled a $1.65 billion contract to buy the vaccine in mid-September.

The vaccine uses traditional technology, in which a whole virus is inactivated. It is hoped that this might persuade people who were reluctant to receive vaccines based on novel mRNA and viral vector platforms, to get vaccinated.

While it is based on the original strain of SARS-CoV-2 that emerged in in Wuhan, in the phase III trial in the UK, the vaccine was effective in preventing severe disease at a time when the Delta variant was dominant.

None of the trial participants who contracted the infection was so seriously ill that they had to be admitted to hospital.

President of the European Commission, Ursula von der Leyen, said, “The contract allows for the vaccine to be adapted to new variants. Our broad portfolio will help us to fight COVID and its variants in Europe and beyond. The pandemic is not over. Everyone who can, should get vaccinated.”

Thomas Lingelbach, CEO of Valneva, said, “Our phase III results confirmed the advantages often associated with inactivated vaccines and we continue to believe that our differentiated vaccine candidate could make an important contribution to the global fight against the COVID-19 pandemic.”