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.
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Moderna said it is today submitting its COVID-19 vaccine to the European Medicines Agency for conditional approval, after announcing new data from the phase III study of mRNA-1273.
The second analysis, conducted after 196 volunteers in the trial contracted COVID-19, confirms the efficacy observed at the first interim analysis and indicates vaccine efficacy of 94.1 per cent.
The company also announced it is asking for emergency use authorisation from the US Food and Drug Administration.
The phase III study enrolled more than 30,000 participants in the US. The primary endpoint is based on the number of confirmed COVID-19 cases, starting two weeks after the second dose of vaccine. Of the 196 cases in the latest analysis, 185 were in the placebo group, versus 11 cases in the mRNA-1273 group. A secondary endpoint looked at severe cases of COVID-19, of which all 30 cases occurred in the placebo group. There was one COVID-19-related death, which occurred in the placebo group.
Moderna said efficacy was consistent across age, race and ethnicity, and gender demographics. The 196 COVID-19 cases included 33 older adults, aged 65+, and 42 participants identifying as being from diverse communities. No new serious safety concerns have been identified.
EU leaders held a virtual meeting with Australian prime minister Scott Morrison today, in which they reconfirmed their resolve to work together to fight COVID-19, agreeing to strengthen bilateral research and innovation cooperation, and to share research data to combat the pandemic.
They also agreed to work together to ensure universal, equitable and early access to safe, effective and affordable COVID-19 vaccines, diagnostics and therapeutics. The EU and Australia have both committed funding to the almost €16 billion raised through the EU-led coronavirus global response pledging marathon.
Charles Michel, president of the European Council, the president of the European Commission, Ursula von der Leyen and Morrison, between them stressed the importance of continued international support for the Access to COVID-19 tools accelerator and the COVAX facility, which will make COVID-19 vaccines available to low income countries.
The leaders also agreed the EU and Australia will continue to work together to strengthen the World Health Organisation, and to improve global preparedness and response to health emergencies.
US biotech Moderna announced the European Commission has approved an agreement to secure 80 million doses of its COVID-19 vaccine mRNA-1273.
Under the terms of the agreement, the commission has the option to increase its purchase from 80 million doses to a total of up to 160 million doses. The value of the contract was not disclosed.
The agreement will be finalised following a review by member states. Delivery of the vaccine could begin by the first quarter 2021 if it is approved for use by the European Medicines Agency, which started a rolling review of mRNA-1273 on November 17.
In Europe, Moderna is working with partners Lonza of Switzerland and ROVI of Spain, for manufacturing and fill and finish outside the US. This is a dedicated supply chain to support Europe and countries other than the US. The company says it is on track to manufacture 500 million to 1 billion doses globally in 2021.
On November 16, Moderna announced that the independent data safety monitoring board for the phase III study said the trial had met the pre-specified statistical criteria and mRNA-1273 has efficacy of 94.5 per cent.
The second interim analysis of the phase III clinical trial data of the Russian COVID-19 vaccine Sputnik V, showed it is 91.4 per cent effective.
The calculation was based on the analysis of data on 18,794 volunteers who received both the first and second doses of the Sputnik V (the V stands for vaccine) or placebo, at the second control point, of 39 confirmed cases of COVID-19 infection as of November 23, 2020.
That analysis was made seven days after volunteers received the second dose of the vaccine. Preliminary data from volunteers 21 days after the second dose indicates efficacy is above 95 per cent.
The Russian Direct Investment Fund, the sovereign wealth fund that is funding development of the vaccine, said the cost in international markets will be less than US$10 per dose for the two dose vaccine. The fund currently has agreements in place with foreign pharmaceutical companies to manufacture 1 billion doses and is assessing other applications to further increase production capacity. The vaccine will be free for Russian citizens.
Currently, 40,000 volunteers are taking part in the phase III double-blind, randomised, placebo-controlled clinical post-registration study of the Sputnik V vaccine in Russia. There were no unexpected adverse events and monitoring of the participants is ongoing.
Sputnik V is based on a human adenoviral vector platform that has proven safe and effective with no long-term side effects in more than 250 clinical trials globally conducted during the past two decades. More than 100,000 people have received approved and registered drugs that use inactivated human adenoviruses, which cause the common cold, as the therapeutic delivery vehicle.
The interim analysis of the phase III interim trial of AstraZeneca/Oxford University’s COVID-19 vaccine, conducted after 131 people in the trial contracted the infection, shows it is 70.4 per cent effective when combining data from two dosing regimens. In the two different regimens vaccine efficacy was 90 per cent in one, when the immune system was primed with a half dose, followed by a full dose, compared to 62 per cent in those receiving two full doses.
There early signs that the vaccine could reduce virus transmission and serious disease, with no hospitalised or severe cases in anyone who received the vaccine.
AstraZeneca and the researchers at Oxford University are stressing a critical attribute of their vaccine, which is that it can be easily administered in existing healthcare systems, being stored at fridge temperature of 2-8 °C and distributed using existing logistics.
Large scale manufacturing is ongoing in over 10 countries to support equitable global access, and AstraZeneca said the safety and efficacy data will now be submitted to the European Medicines Agency, the UK Medicines and Healthcare products Agency and other regulators for approval.
Andrew Pollard, director of the Oxford vaccine group and chief investigator of the Oxford trial, said, “These findings show that we have an effective vaccine that will save many lives. Excitingly, we’ve found that one of our dosing regimens may be around 90 per cent effective and if this dosing regime is used, more people could be vaccinated with planned vaccine supply.”
The AstraZeneca/Oxford University COVID-19 vaccine shows similar safety and strength of immune response in people aged 56 years and over to that seen in adults aged 18-55 years, according to phase II results published today in The Lancet.
The phase II trial found the vaccine causes few side effects, and induces immune responses in both parts of the immune system in all age groups and at low and standard dose, provoking a T cell response within 14 days of the first dose and an antibody response within 28 days of the booster dose of vaccination. Phase III trials are ongoing to confirm these results - as well as how effective the vaccine is in protecting against COVID-19 infection – in a broader range of people, including older adults with underlying health conditions.
The study is the fifth published clinical trial of a vaccine against COVID-19 tested in an older adult population. One study has shown similar immune responses in young and old adults (Moderna mRNA vaccine), while other trials have suggested lower responses in older adults, compared to younger adults receiving the same vaccine (CanSino single dose adenovirus-vector vaccine; Pfizer/BioNTech mRNA vaccine; and SinoPharm/Beijing Institute of Biological Products inactivated viral vaccine).
German biotech BioNTech and partner Pfizer announced that after conducting the final efficacy analysis in the phase III study, their COVID-19 vaccine, BNT162b2, met all of the study’s primary efficacy endpoints, with an efficacy rate of 95 per cent in participants without prior SARS-CoV-2 infection. The analysis is based on 170 cases of COVID-19, as specified in the study protocol, of which 162 cases of COVID-19 were observed in the placebo group versus eight cases in the BNT162b2 group. Efficacy was consistent across age, gender, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94 per cent.
There were ten severe cases of COVID-19, with nine of the cases occurring in the placebo group and one in the BNT162b2 vaccinated group. The vaccine was well tolerated, with most adverse events resolving shortly after vaccination.
The safety milestone required by the US Food and Drug Administration (FDA) for emergency use authorisation (EUA) has been achieved and Pfizer and BioNTech plan to submit a request within days to the FDA for an EUA. The data will also be submitted to other regulatory agencies around the world.
The phase III clinical trial of BNT162b2 began on July 27 and has enrolled 43,661 participants to date, 41,135 of whom have received a second dose of the vaccine candidate as of November 13, 2020. Approximately 42 per cent of global participants and 30 per of US participants have racially and ethnically diverse backgrounds, and 41 per cent of global and 45 per cent of US participants are 56-85 years of age. The trial will continue to collect efficacy and safety data in participants for an additional two years.
Based on current projections, the companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.
Pfizer said it is confident its existing cold chain infrastructure will be fit for distributing the vaccine, which needs to be keep at minus 70 degrees centigrade. The companies have developed specially designed temperature-controlled thermal shippers using dry ice to maintain temperature control. The shippers can be used be as temporary storage units for 15 days by refilling with dry ice. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment across their pre-set routes.
Pfizer and BioNTech plan to submit the efficacy and safety data from the study for peer review in a scientific journal once analysis of the data is completed.
Moderna announced that the European Medicines Agency (EMA) has started a rolling review of mRNA-1273, its vaccine against COVID-19, after confirmation the product was eligible to be submitted for approval on 14 October. The rolling review was accepted by EMA based on preclinical, clinical and manufacturing data available to date.
That followed the announcement on Monday that the independent, data safety monitoring board for the phase III study of mRNA-1273 had informed Moderna the vaccine shows efficacy of 94.5 per cent.
Moderna said it is now scaling up global manufacturing with Lonza of Switzerland and ROVI of Spain to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021.
The European Commission has signed an advance purchase agreement on behalf of member states to buy up to 405 million doses of the COVID-19 vaccine being developed by German biotech CureVac.
This follows on from the commission and the European Investment Bank providing funding for CureVac to support development of the vaccine. Ursula von der Leyen, commission president said if it is safe and effective, every member state will receive the vaccine at the same time, on a pro-rata basis.
This is the fifth contract for the EU’s COVID-19 vaccines portfolio. Von der Leyen said a sixth is under negotiation with US biotech Moderna, which yesterday announced that an interim analysis of the US phase III trial showed its vaccine was 94.5 per cent effective.
Last week the European Commission approved a fourth contract, with BioNTech and Pfizer, for the initial purchase of 200 million doses, plus an option to request up to a further 100 million doses, for their vaccine, which was also shown to be effective in the interim phase III analysis.
Before that, contracts were signed with Sanofi/GlaxoSmithKline, AstraZeneca and Johnson & Johnson.
Moderna said the independent safety board monitoring the phase III study of mRNA-1273, its COVID-19 vaccine, has informed Moderna the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with efficacy of 94.5 per cent. The study has enrolled more than 30,000 participants in the US.
The primary endpoint of the phase III study is based on the analysis of COVID-19 cases confirmed starting two weeks following the second dose of vaccine. This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus five cases in the mRNA-1273 group.
A secondary endpoint analysed severe cases of COVID-19, and included 11 severe cases, which all occurred in the placebo group, with none in the mRNA-1273 vaccinated group.
A concurrent review of the available phase III safety data did not report any significant safety concerns.