08 Apr 2021

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

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.

 

The head of the World Health Organisation Tedros Adhanom Ghebreyesus, has hit out at the disparity in access to COVID-19 vaccines, saying, “It’s right that all governments want to prioritise vaccinating their own health workers and older people first. But it’s not right that younger, healthier adults in rich countries are vaccinated before health workers and older people in poorer countries.”

There will be enough vaccine for everyone, Ghebreyesus said. “But right now, we must work together as one global family to prioritise those most at risk of severe disease and death, in all countries.”

Over the past nine months, WHO has been working through the ACT Accelerator and the COVAX vaccines programme to lay the ground for the equitable distribution and deployment of vaccines. It has secured two billion doses of vaccines from five producers, with options on more than one billion more doses. The aim is to start deliveries in February.

But several WHO member states have questioned whether COVAX will get the vaccines it needs, and whether high income countries will keep the promises they have made to donate vaccines.

“The promise of equitable access is at serious risk,” Ghebreyesus said. More than 39 million doses of vaccine have now been administered in at least 49 higher income countries. Just 25 doses have been given in one lowest income country.

“I need to be blunt: the world is on the brink of a catastrophic moral failure,” said Ghebreyesus. “Even as they speak the language of equitable access, some countries and companies continue to prioritise bilateral deals, going around COVAX, driving up prices and attempting to jump to the front of the queue.”

The situation is compounded by the fact that most manufacturers have prioritised getting regulatory approval in rich countries where the profits are highest, rather than submitting full dossiers to WHO, according to Ghebreyesus. “It’s not too late. I call on all countries to work together in solidarity to ensure that within the first 100 days of this year, vaccination of health workers and older people is underway in all countries,” he said.

 

The European Medicines Agency said it has begun the rolling review of Johnson & Johnson’s single dose COVID-19 vaccine, weighing up the evidence that is available currently, in advance of a formal application for marketing approval from the company.

The European Commission has agreed to buy 200 million doses, with the option to secure up to 200 million additional doses.

Johnson & Johnson announced last month that it has completed recruitment to the phase III trial of the vaccine, enrolling approximately 45,000 participants. There is a high level of COVID-19 infection in the countries where the trial is being conducted and the company expects there will be enough cases to show if the vaccine is effective by the end of January.

If so, Johnson & Johnson said it expects to apply for emergency use approval from the US FDA in February, with applications to other regulators made in parallel.

The latest data from the phase I/IIa trial published this week in the New England Journal of Medicine, show the vaccine prompted an immune response that lasted for at least 71 days, in participants aged 18-55 years. After a single vaccination, neutralising antibodies against COVID-19 were detected in over 90% of study participants at day 29 and 100% of participants aged 18-55 years at day 57.

Data on durability of immune responses in trial participants aged over 65 years will be available in late January and longer-term follow-up to one year is planned.

 

The Swiss federal government has secured 7.5 million doses of Moderna’s COVID-19 vaccine following approval by the regulator Swissmedic, with first deliveries to the country expected to begin next week.

The authorisation is based on a rolling submission of data, including an analysis from the phase III clinical study published on 30 November.

The Moderna vaccine is also approved in the US, EU, Canada, Israel and the UK and is under review in other countries and by the World Health Organisation.

 

As it defends itself against criticisms of the slowness of the centralised procurement of COVID-19 vaccines, the European Commission said it concluded exploratory talks with French biotech Valneva to buy its potential vaccine. The contract involves an initial 30 million doses with an option for up to 30 million more.

This is in addition to contracts already signed with AstraZeneca, Sanofi/GlaxoSmithKline, Janssen, Pfizer/BioNtech, CureVac, and Moderna. The Commission has also had talks with US biotech Novavax.

The agreement with Valneva further complements the EU vaccines portfolio, said Commission president, Ursula von der Leyen. “The continuing COVID-19 pandemic in Europe and around the globe makes it more important than ever that all member states have access to the broadest possible portfolio of vaccines,” she said.

 

The European Medicines Agency said it has received an application for approval of the COVID-19 vaccine developed by AstraZeneca and Oxford University and will decide on the application on 29 January, during the monthly meeting of its scientific committee for human medicines (CHMP).

The agency said such a short timeframe for evaluation is only possible because it has already reviewed some data on the vaccine during a rolling review. During this phase, EMA assessed preclinical data, data on quality its ingredients and the way it is manufactured and also considered some evidence on safety and efficacy from a pooled analysis of interim clinical data from four ongoing clinical trials in the UK, Brazil and South Africa.

 

US biotech Moderna said EU deliveries of its COVID-19 vaccine will begin on Monday, 11 January from its central hub in Europe, after the European Commission granted a conditional marketing authorisation for the product on 6 January. Vaccine shipments will be delivered to one pre-agreed central location within each member state, from where each country will coordinate national distribution.

Manufacturing of the vaccine drug substance is carried out by bioprocess specialist Lonza at its site in Switzerland, with filling of vials and packaging done by ROVI in Spain. Further fill and finish capacity will be provided by Recipharm in France in the first half of 2021.

On 18 December last year the Commission exercised an option to order an additional 80 million doses of Moderna’s vaccine against COVID-19, bringing order commitment for 2021 to 160 million doses.

The product has also been authorised for use in the US, Canada, Israel and the UK.

 

German biotech CureVac has secured the heft of German pharma Bayer, as it steers its COVID-19 vaccine through the final stages of clinical testing and onto the market.

Under the terms of the agreement, Bayer will support the further development, supply and key operations around CureVac´s COVID-19 vaccine, contributing expertise and established infrastructure in areas including clinical operations, regulatory affairs, pharmacovigilance, supply chain and support in selected countries.

Stefan Oelrich, president of the Bayer’s pharmaceuticals division said, “We are highly committed to making our capabilities and networks available to help end this pandemic.”

“We are very happy to join forces with Bayer, whose expertise and infrastructure will help us make our vaccine candidate CVnCoV even more rapidly available to as many people as possible,” said Franz-Werner Haas, CEO of CureVac. “We now also have another strong partner on our side to get the vaccine to the people who need it following the receipt of the requisite regulatory approvals.”

The companies said they plan to combine their strengths to supply hundreds of millions of CVnCoV doses around the world, once approvals are granted.

The European Commission has pre-ordered 225 million doses, and has options to buy 180 million more.

 

The European Medicines Agency has recommended approval for US biotech Moderna’s COVID-19 vaccine, which becomes the second vaccine to be approved in the EU.

The European Commission has pre-ordered 160 million doses of the Moderna vaccine, for distribution across the EU.

“This vaccine provides us with another tool to overcome the current emergency,” said Emer Cooke, executive director of EMA. “As for all medicines, we will closely monitor data on the safety and effectiveness of the vaccine to ensure ongoing protection of the EU public.”

The decision is based on a phase III placebo controlled trial involving around 30,000 people.

The trial showed a 94.1% reduction in the number of symptomatic COVID-19 cases in people who received the vaccine, with 11 of 14,134 vaccinated people contracting symptomatic COVID-19 infections, compared to 185 infections in 14,073 people in the placebo arm. That translates to 94.1% efficacy.

The vaccine also showed 90.9% efficacy in participants at risk of severe COVID-19 infections, including those with chronic lung disease, heart disease, obesity, liver disease, diabetes or HIV infection. The high efficacy was also maintained across genders, racial and ethnic groups.

 

US biotech Moderna said Israel’s Ministry of Health has given its COVID-19 vaccine emergency authorisation and the first of six million doses are expected to be delivered to the country shortly.

This is the third regulatory authorisation for Moderna’s vaccine, and its first outside north America.

Earlier approvals were granted in the US on 18 December and Canada on 23 December. The vaccine is currently under review by the European Medicines Agency and regulators in Singapore, Switzerland and the UK.

At present Moderna has manufacturing capacity in place to produce 600 million doses in 2021, but said it is working to increase this to one billion doses.

 

A meeting of the European Medicines Agency (EMA) expert committee on human medicines held on Monday failed to conclude its deliberations on whether or not to approve US biotech Moderna’s COVID-19 vaccine. The agency did not issue a formal statement, but said on Twitter that the meeting will continue on Wednesday 6 January.

That follows a defensive statement put out after office hours on 30 December, in which EMA said it needed more data in order to approve the AstraZeneca/Oxford University COVID-19 vaccine, which was approved by the UK Medicines and Healthcare products Agency earlier on the same day.

“Additional scientific information on issues related to quality, safety and efficacy of the vaccine is deemed necessary to support the rigour required for a conditional marketing authorisation and this has been requested from the company,” EMA said.  

On 21 December EMA issued a positive opinion, recommending member states approve the Pfizer/Biontech COVID-19 vaccine. At a press briefing called to discuss that decision the new head of EMA, Emer Cooke, said the conditional marketing approval from EMA required greater oversight than emergency authorisations to use the Pfizer/BioNTech vaccine granted elsewhere. It “creates additional obligations for us as a regulatory authority,” she said.

Pfizer and BioNTech will have to conduct post market studies, looking at how long protection lasts, how good the vaccine is at preventing severe COVID-19 disease, and how well it protects people with weakened immune systems, children and pregnant women.

 

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