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.
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A clinical trial looking into alternating COVID-19 vaccines launching in the UK today will examine whether different vaccines can safely be used for a single person.
The study, backed by £7 million of government funding, will be the first in the world to assess the effects of using different vaccines for the first and second dose, for example, Oxford University/AstraZeneca’s vaccine for the first dose, followed by Pfizer/BioNTech’s vaccine for the second, and vice versa.
It will also gather evidence on whether different intervals between the first and second dose have an impact on the immune response.
The trial will recruit 820 volunteers over the next 2 – 3 weeks, at eight sites across the UK. It is not studying efficacy, but rather assessing the immune response to mixed vaccination. Initial results are expected in June.
As they are approved and become available, other vaccines will be added to the study.
Matthew Snape, principal investigator, said if mixed schedules are as good as two doses of the same vaccine, it will provide more flexibility with vaccines rollout and help deal with any disruption to supplies.
Deputy chief medical officer Jonathan Van-Tam said, “Given the inevitable challenges of immunising large numbers of the population against COVID-19 and potential global supply constraints, there are definite advantages to having data that could support a more flexible immunisation programme.”
It is also possible that by combining vaccines the immune response could be enhanced. “Unless this is evaluated in a clinical trial we just won’t know,” Van-Tam said.
UK pharma company GlaxoSmithKline and German biotech CureVac announced a new €150 million collaboration to jointly develop next generation mRNA vaccines for COVID-19, aiming to provide protection again multiple variants of the SARS-CoV-2 virus that are emerging in a single vaccine.
GSK will also use its manufacturing facilities in Belgium in support of the manufacture of up to 100 million doses of CureVac’s first generation COVID-19 vaccine CVnCoV in 2021, which is in a phase IIb/III trial.
In the co-development agreement, GSK and CureVac will share resources and expertise to develop a vaccine offering broader protection against different SARS-CoV2 variants, and to enable a quick response to new variants that emerge in the future. The development programme begins immediately, with the target of introducing a vaccine in 2022, subject to regulatory approval.
GSK will make an upfront payment to CureVac of €75m and a further payment of €75m, conditional on the achievement of specific milestones.
The vision is that next generation COVID-19 vaccines may either be used to protect people who have not been vaccinated before, or to serve as boosters in the event that COVID-19 immunity gained from an initial vaccination reduces over time.
French biotech Valneva reported the UK government has exercised an option to order 40 million more doses of its COVID-19 vaccine for supply in 2022. This brings the total volume ordered by the UK to 100 million doses, with the UK government also holding options over a further 90 million doses for supply between 2023 and 2025.
The Nantes-based company is in advanced discussions with the European Commission for the supply of up to 60 million doses, but has yet to sign a formal advance purchase agreement to supply vaccine to the EU.
The total value of the 190 million UK doses, if all options are exercised, is up to €1.4 billion. Valneva announced last week that it has commenced production at its facility in near Edinburgh, in parallel with ongoing clinical trials, in order to optimise the timeline for potential deliveries of the vaccine. The phase I/II clinical study is now fully enrolled and is expected to read out within the next three months.
Thomas Lingelbach, CEO of Valneva said, “We are very pleased to extend our supply commitment to the UK. Assuming success, we believe that our vaccine, which has commenced commercial production at our site in Scotland, can make a major contribution to the UK’s vaccination efforts later this year as well as in 2022. This new development in our partnership underlines the need for our inactivated vaccine approach and we will continue to work closely with the Vaccines Task Force on execution.”
In the midst of acrimony over supplies to the EU, the European Medicines Agency has now granted a conditional marketing authorisation for the COVID-19 vaccine developed jointly by AstraZeneca and Oxford University.
EMA based its opinion on data from a rolling review of trial data from the primary analysis of the phase III clinical development programme led by Oxford University, which included 23,745 volunteers aged 18 years and older. Additional safety and efficacy data from ongoing clinical trials is expected to be published in the coming weeks.
AstraZeneca said it is working with the EU for vaccinations to begin across member states. Problems in scaling up the manufacturing process at facilities in Belgium and the Netherlands mean the company will deliver only 40 million of an expected 80 million doses by the end of March. The EU has ordered 300 million doses of the vaccine in total.
It is hard to get to the bottom of the legal position. The contract with AstraZeneca has been published by the European Commission, but it is redacted to the extent it is impossible to interpret key aspects.
Professor Andrew Pollard, director of the Oxford vaccine group and chief investigator on the Oxford vaccine trials, said, “The approval by the European Commission is an important milestone in extending access to the Oxford/AstraZeneca vaccine in our region.”
AstraZeneca is now seeking emergency use listing from the World Health Organisation for an accelerated pathway to make the vaccine available in low income countries. The company has said it will supply the vaccine at cost in all markets during the pandemic.
The vaccine can be stored, transported and handled at normal refrigerated conditions for at least six months and administered within existing healthcare settings.
The European Commission has put in place what it calls a targeted “transparency and authorisation mechanism”, under which individual member states could stop COVID-19 vaccines being exported outside the EU.
The Commission said the move is an effort “to ensure timely access to COVID-19 vaccines for all EU citizens and to tackle the current lack of transparency of vaccine exports outside the EU.”
President of the European Commission Ursula von der Leyen said, “This transparency and authorisation mechanism is temporary, and we will of course continue to uphold our commitments towards low and middle income countries.”
The measure is limited to vaccines for which the EU has agreed advance purchase agreements, said executive vice president and Commissioner for trade Valdis Dombrovskis. “The aim is to provide greater clarity on vaccine production in the EU and their exports – this transparency has been lacking and is vital at this time.”
The Commission worked “for the best part of the last year” to get advance purchase agreements with vaccine producers, said Commissioner for health Stella Kyriakides. “We gave upfront funding to companies to build the necessary manufacturing capacity to produce vaccines, so deliveries can start as soon as they are authorised. We now need transparency on where the vaccines we secured are going and ensure that they reach our citizens.”
The restriction on export of COVID-19 vaccines outside the EU applies until the end of March 2021.
After delaying its COVID-19 vaccine development plan at the end of last year, French pharma Sanofi is now stepping in to help increase supplies of the Pfizer/BioNTech product that is currently the only vaccine available for use in the EU.
Sanofi will provide BioNTech access to its production infrastructure and from summer 2021 will do late stage manufacturing at its facility in Frankfurt to supply over 125 million doses of COVID-19 vaccine for the EU.
British national Paul Hudson, CEO of Sanofi said, “Although vaccination campaigns have started around the world, the ability to get shots into arms is being limited by lower than expected supplies and delayed approval timelines owing to production shortages. We have made the decision to support BioNTech and Pfizer in manufacturing their COVID-19 vaccine in order to help address global needs, given that we have the technology and facilities to do so.”
Sanofi will continue to develop its COVID-19 vaccine, after phase I/II study showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years, but a low immune response in older adults likely due to an insufficient concentration of the antigen.
It plans to initiate a new phase II study in February, with support from the US Biomedical Advanced Research and Development Authority, to evaluate an improved antigen formulation in order to achieve high-level immune response across all age groups.
French biotech Valneva said it has commenced production of its COVID-19 vaccine candidate in Scotland, after signing a deal with the UK government in September last year.
Production has begun in parallel with the ongoing clinical trials, in order to speed the product to market, if the vaccine is found to be safe and effective.
In September 2020, Nantes-based Valneva announced a major COVID-19 vaccine partnership with the UK government for the supply of up to 190 million doses of its COVID-19 vaccine. If vaccine development is successful, Valneva will supply the UK with 60 million doses in the second half of 2021.
The company announced in January 2021 that it is in advanced discussions with the European Commission for the supply of up to 60 million doses but has yet to sign a formal advance purchase agreement.
The phase I/II clinical study is now fully enrolled and is expected to report initial results in April 2021.
Thomas Lingelbach, CEO of Valneva, said, “Our team in Scotland have done an amazing job to get manufacturing started so quickly. I would like to thank the UK Vaccines Taskforce and the National Institute for Health Research who have played vital roles in the rapid recruitment and enrollment of the volunteers for the clinical study.”
The UK is offering its genomics resources to help countries that lack their own capabilities track variants of the SARS-CoV-2 virus that causes COVID-19.
The New Variant Assessment Platform is intended to provide an early warning of mutations that could increase the virulence of the virus, or reduce the efficacy of vaccines and therapeutics.
Countries will be able to access the platform via the World Health Organisation.
The UK has led the world in tracking the evolution of the SARS-CoV-2 genome in real time through sequencing the virus from COVID-19 patients. It currently sequences samples from 5% of patients, and has contributed half of the sequences in the global database.
The initiative will give an early warning of new variants of concern, said Isabel Oliver, director of Public Health England’s national infection service. “We know that the virus will evolve over time,” she said.
A key example is the B 1.1.7 variant, first identified in the UK in December, which is known to be more transmissible, and which initial data indicate is 30 – 40% more lethal. It has since been picked up in more than 60 countries. Other variants of concern have been identified in South Africa and Brazil.
The EU is threatening to introduce export controls for COVID-19 vaccines in response to a row with AstraZeneca over supplies of its vaccine, following reports that the company is unable to meet previous commitments on deliveries. That is said to be as a result of problems at one of the manufacturing facilities.
As a result, deliveries of the AstraZeneca/Oxford University COVID-19 vaccine to the EU are expected to be 60% less than promised during the first quarter of the year.
“In the future, all companies producing vaccines against COVID-19 in the EU will have to provide early notification whenever they want to export vaccines to third countries,” EU health commissioner Stella Kyriakides said on Monday.
The proposal follows frustration in Brussels over an agreement with AstraZeneca to deliver around 80 million of the 300 million doses the Commission has ordered by the end of March. According to the company, it now expects that amount to be cut to 31 million doses due to "production problems" at a manufacturing site in the European supply chain.
In a statement on Monday, Kyriakides said the company’s explanations for the delay “have not been satisfactory”. A call with AstraZeneca CEO Pascal Soriot was scheduled for Monday evening.
“This new schedule is not acceptable to the EU,” Kyriakides said. “We want clarity and full transparency. The EU has pre-refinanced the development and production of the vaccine and wants to see the return. The EU wants to know exactly which doses have been produced, where, by AstraZeneca so far, and if or to whom they have been delivered.”
On 8 December, the UK Vaccine Taskforce, set up to procure COVID-19 vaccines, said rather than domestic production, the initial doses of the AstraZeneca vaccine were to be imported into the UK from mainland Europe, to get the vaccination programme off the ground as soon as the vaccine was approved by the UK regulator. That happened on 30 December.
The vaccine is not yet approved by the European Medicines Agency, but its decision is expected before Friday.
Frustration with AstraZeneca is heightened by the EU's slow vaccine rollout. Cheaper and easier to distribute compared to the approved vaccines from Pfizer/BioNtech and Moderna, officials had hoped the AstraZeneca vaccine would give the European rollout a big push.
A COVID-19 vaccine based on technology originally developed by the Pasteur Institute in Paris and taken forward by Vienna-based Themis Bioscience, has been dropped by Merck & Co. Inc.
The US pharma company said the vaccine has failed to demonstrate good enough immune responses in phase I studies in healthy volunteers.
Merck said it is also dropping a second programme it was developing in collaboration with the non-profit organisation, AIDS Vaccine Initiative Inc (IAVI), to develop a COVID-19 vaccine based on the same technology as Merck used in its approved vaccine against Ebola virus.
According to the company, the immune responses to both vaccine candidates were inferior to those seen following natural infection and those reported for other COVID-19 vaccines.
This is a double blow, given Merck’s vaccines development and manufacturing capacity.
Merck announced it was acquiring Themis in May 2020, taking on development of the COVID-19 vaccine, which had previously received funding from CEPI, the Coalition for Epidemic Preparedness Initiative.