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.

AstraZeneca and the European Commission reached an agreement to end legal proceedings over the advance purchase agreement for the delivery of the COVID-19 vaccine.

Under the agreement, AstraZeneca has said it will deliver 60 million doses of the vaccine by the end of the third quarter 2021, 75 million by the end of the fourth quarter 2021 and 65 million by the end of the first quarter 2022. Member states will be provided with regular deliveries and there will be rebates in the event of any delays.

“We are fully committed to manufacture [the vaccine] for Europe following the release for supply of more than 140 million doses to date at no profit,” said Ruud Dobber, executive vice president of Biopharmaceuticals at AstraZeneca.

Legal proceedings by the European Commission against AstraZeneca were initiated in Brussels on 21 April 2021, and court hearings were scheduled for the end of September 2021.

To date, AstraZeneca and its partners have supplied more than 1.1 billion doses of vaccine to over 170 countries; approximately two thirds have gone to poorer countries.

Moderna announced it has started submission to the U. Food and Drug Administration (FDA) for the evaluation of a booster dose of its COVID-19 vaccine and expects to submit data to the European Medicines Agency and other regulatory authorities around the world in the coming days.

The submitted data shows “robust antibody responses against the Delta variant,” said Stéphane Bancel, CEO of Moderna.

The phase II study of the vaccine was amended to offer a booster dose to interested participants six months following their second dose, with 344 volunteers taking up the offer. Neutralising antibody levels had waned significantly prior to boosting. The booster dose raised neutralising levels significantly.

After a third dose, a similar level of neutralising antibodies was seen across age groups, notably in older adults aged 65 and above. The safety profile following dose three was similar to that observed for the second dose.

People who catch SARS-CoV-2 despite having received one or two doses of vaccine have significantly lower odds of severe disease or hospital admission than unvaccinated people, according to a large-scale study investigating COVID-19 breakthrough infections.

Researchers also found that the odds of experiencing Long COVID, with symptoms lasting 28 days or more after a positive test were cut in half for people who received two vaccines doses, in the study published in The Lancet Infectious Diseases journal.

Those most vulnerable to a breakthrough infection after their first vaccine dose included frail older adults aged 60 years and above, and older adults living with underlying conditions such as obesity, heart disease, kidney disease, and lung disease.

In all age groups, people living in deprived areas, such as densely populated urban settings, were more likely to experience a breakthrough infection.

“We are at a critical point in the pandemic as we see cases rising worldwide due to the Delta variant,” said co-author Claire Steves of King’s College London. The Delta variant is now causing most infections in Europe and the rest of the world, and other data shows vaccines are less effective against it.

“Breakthrough infections are expected and don’t diminish the fact that these vaccines are doing exactly what they were designed to do - save lives and prevent serious illness,” Steves said.

The researchers used self-reported data collected by the UK COVID symptom social media app. Of 1.2 million adults who reported to the app who received at least one dose of any vaccine between 8 December 2020 to 4 July 2021, fewer than 0.5% reported a breakthrough infection more than 14 days after their first dose. Of those who had received who received two doses, fewer than 0.2% experienced a breakthrough infection more than seven days after the second dose. In total, there were 2,370 positive cases after 971,504 second vaccine.

Among those who did experience a breakthrough infection, the odds of that infection being asymptomatic increased by 63% after one vaccine dose and by 94% after the second dose. Researchers also found that the odds of hospitalisation were reduced by approximately 70% after one or two doses, and that the odds of experiencing severe disease, defined as having five or more symptoms in the first week of illness, were lessened by approximately one third. In addition, the odds of Long COVID, having symptoms for 28 days or more after infection, were reduced by 50% after two doses.

Based on current evidence, there is no urgent need for the administration of booster doses of vaccines to fully vaccinated individuals in the general population, according to a technical report issued by the European Centre for Disease Prevention and Control (ECDC).

However, additional doses should be considered for people with severely weakened immune systems as part of their primary vaccination.

Evidence on vaccine effectiveness and duration of protection shows that all vaccines authorised in the EU are currently highly protective against COVID-19-related hospitalisation, severe disease and death.

At the same time, about one in three adults over 18 years is still currently not fully vaccinated. “In this situation, the priority now should be to vaccinate all those eligible individuals who have not yet completed their recommended vaccination course,” the European Medicines Agency said in a statement.

EMA is currently assessing data on booster doses, and said while it does this member states “may consider preparatory plans for administering boosters.”

The first of the so-called second wave of COVID-19 vaccines, which have been designed from the ground up to be more accessible and affordable, has started a phase III clinical trial.

The vaccine, GBP510, developed by South Korean biotech SK Bioscience, will be administered in combination with an adjuvant from GlaxoSmithKline (GSK), which is intended to increase the immune response.

The randomised global trial will enrol around 4,000 participants from a range of countries to evaluate GBP510's safety and immunogenicity compared to the AstraZeneca/Oxford University COVID-19 vaccine. The study will be one of the first global phase III trials to directly compare two different COVID-19 vaccines.

"We are grateful that we were able to advance to the phase III study with the unprecedented support of global initiatives, including GSK, the Coalition for Epidemic Preparedness Initiative (CEPI), and the Bill & Melinda Gates Foundation,” said Jaeyong Ahn, CEO of SK Bioscience.

“While many countries have made good progress with vaccination, there remains a need for accessible and affordable COVID-19 vaccines to ensure equitable access and to protect people across the world,” said Thomas Breuer, chief global health officer at GSK.

The move to phase III follows positive interim phase I/II data which showed that all participants who received the adjuvanted vaccine developed strong neutralising antibody responses, demonstrating a 100% seroconversion rate. Neutralising antibody levels were between five and a maximum of eight times higher than in people who had recovered from COVID-19.

The vaccine is being developed by SK Bioscience in collaboration with the Institute for Protein Design at the University of Washington, with $213 million funding from the Gates Foundation and CEPI as part of the 'Wave 2' vaccine investment project to develop more accessible and affordable COVID-19 vaccines.

Results from the phase III study are expected in the first half of 2022.

People infected with the SARS-CoV-2 Delta variant that is now causing most infections across Europe and the rest of the world have approximately double the risk of hospitalisation compared with those infected with the Alpha variant that was dominant from December to May, according to a study of more than 40,000 cases from England between 29 March and 23 May 2021, published in The Lancet Infectious Diseases.

Around one in 50 patients in the study was admitted to hospital within 14 days of their first positive COVID-19 test. After accounting for factors that are known to affect susceptibility to severe illness from COVID-19, including age, ethnicity, and vaccination status, the researchers found the risk of being admitted to hospital was more than doubled with the Delta variant compared with the Alpha variant.

The study is the first to report hospitalisation risk for the Delta versus Alpha variants based on cases confirmed by whole genome sequencing, which is the most accurate way to determine which variant is involved.

The Delta variant was first reported in India in December 2020 and early studies found it to be up to 50% more transmissible than the Alpha variant of COVID-19 that had previously gained dominance worldwide, after it was first identified in Kent, UK.

During the study period, there were 34,656 cases of the Alpha variant (80%) and 8,682 cases of the Delta variant (20%). While the proportion of Delta cases in the study period overall was 20%, it grew to account for around two thirds of new COVID-19 cases in the week starting 17 May 2021, indicating it had overtaken Alpha to become the dominant variant in England.

The study demonstrates the effectiveness of COVID-19 vaccines. Only 1.8% of people hospitalised with either variant had received both doses of a vaccine; 74% of cases were unvaccinated, and 24% had received one dose.

Five new UK COVID-19 research projects were announced on Thursday, which will receive a total of over £4 million from UK Research and Innovation, to study the durability of vaccine responses, low responses linked with health conditions, and the effect of booster doses.

The studies will research the strength and durability of the immune response in a wide range of people, including those with conditions that result in a weakened immune system, such as HIV, B cell lymphoma, inflammatory bowel disease and chronic myeloid leukaemia; people who are obese; healthcare workers; and people in the general population who have a weak immune response to vaccination.

The research aims to determine how long immunity from vaccination lasts; identify groups of people at risk from low vaccine responses; and determine if and when vaccine boosters are required for these groups, as well as the wider population.

One of the studies will potentially involve administering booster doses to participants with a low vaccine response and monitoring the effect it has on their immune systems.

Another study, conducted across the UK, South Africa and Brazil, will monitor immunity and vaccine effectiveness to virus variants.

Researchers in another study will monitor the effect the effect of different levels of weight loss on the immune response of 200 people with severe obesity, who are taking part in an existing weight loss study.

Rob Buckle, chief scientist of the Medical Research Council said vaccines have proved to be an invaluable tool in the fight against COVID-19, but there are still questions to be answered. “These studies will help provide guidance to policy makers and clinicians on a range of issues, including when and for whom booster shots are necessary,” Buckle said.

The European Medicines Agency (EMA) gave approval for a new manufacturing site to start producing the Pfizer/BioNTech COVID-19 vaccine, a move that will increase capacity and supply of COVID-19 in the EU.

The facility in Saint Rémy sur Avre, France, operated by Delpharm and will manufacture finished product and is expected to supply an additional 51 million doses in 2021 alone.

EMA has also approved a new manufacturing line at BioNTech’s manufacturing site in Marburg, Germany. That will increase the capacity to manufacture the active substance that forms the basis of the vaccine by approximately 410 million doses in 2021.

In addition, EMA gave its stamp of approval to an additional US manufacturing facility for Moderna’s COVID-19 vaccine, in Bloomington, Indiana.

These recommendations do not require a European Commission decision, which means the sites can produce vaccines for the EU market immediately.

The SARS-CoV-2 virus that causes Covid-19 mutates almost once a week, significantly more than the rate estimated previously, according to a new European Research Council funded study by scientists at Edinburgh and Bath universities. They say their findings indicate that new variants could emerge more quickly than was thought.

SARS-CoV-2 was thought to mutate about once every two weeks, but this estimate overlooked many mutations that happened but were never sequenced. That is because they were so called negative mutations which don’t survive long enough to be sequenced and so are missing from calculations of the mutation rate.

Allowing for these missing mutations, the researchers estimate the true mutation rate of the virus is at least 50% higher than previously thought.

The researchers say their findings, published in the journal Genome Biology and Evolution, reinforce the need to isolate individuals with weakened immune systems who struggle to contain the virus.

Laurence Hurst, professor of evolutionary genetics at Bath University, said, “With the great number of genomes of SARS-CoV-2 now sequenced, we can say something about both how many and why these mutations are missing, despite the fact that we can’t fully study them directly.”

The European Commission has approved a €108 million Danish aid measure for coronavirus-related research and development at vaccines specialist Bavarian Nordic, under the state aid temporary framework.

The public support will take the form of a repayable advance to support the development of a coronavirus vaccine in-licensed by Bavarian Nordic from two other Danish biotechs, which is currently in phase II clinical development. The money will fund the phase III trial to confirm safety and demonstrate efficacy, develop manufacturing processes, and work to secure regulatory approvals.

The Commission said the aid is in line with the temporary state aid framework. In particular, it will cover less than 80% of the R&D costs and will be fully recovered if the vaccine is approved.

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