The world’s first COVID-19 human challenge study is set to begin in the UK after receiving ethics approval, the government has announced.

The study has already received a £33.6m investment from the UK government, and will initially involve up to 90 healthy adult volunteers who will be exposed to the novel coronavirus in a safe and controlled environment.

In this first stage of the study, researchers will aim to discover the smallest amount of the virus it takes to cause COVID-19 infection in small groups of healthy young people aged between 18-30 years old who are at a low risk of harm.

This stage – known as the virus characterisation study – will initially use the version of the SARS-CoV-2 virus that has been circulating in the UK since the beginning of the pandemic in March 2020.

Following this, researchers will administer vaccine candidates that have already been proven safe in clinical trials to a small number of volunteers, who will then be exposed to COVID-19.

This will help researchers to identify the most effective vaccines and accelerate their development, the government said.

The COVID-19 human challenge study is part of a partnership between the UK’s Vaccines Taskforce, Imperial College London, the Royal Free London NHS Foundation Trust and hVIVO.

The World Health Organization (WHO) has given AstraZeneca (AZ) and Oxford University’s COVID-19 vaccine an emergency use listing (EUL) for all adults.

The formal EUL follows a recommendation from the WHO’s Strategic Advisory Group of Experts (Sage) that backed the use of the vaccine in adults, including those aged over 65.

The EUL covers the use of the AZ/Oxford vaccine in a two-dose regimen, to be administered at a four- to 12-week interval.

This dosing interval was recommend by the WHO’s Sage, which also recommended the use of the vaccine in countries with high levels of new variants – including the South African B1.351 variant.

“[The WHO] approval endorses that the vaccine can be used to help protect populations across the world, including adults over 65 years and in countries where different variants of the SARS-CoV-2 virus are in circulation,” said Pascal Soriot, chief executive officer of AZ.

In June 2020, the Serum Institute of India signed a licensing deal with AZ to provide one billion doses of the Oxford-partnered vaccine to low- and middle-income countries.

Following the WHO’s EUL, the Serum Institute and AZ will work with the international vaccine-sharing facility COVAX to begin supplying the vaccine globally.
AZ said in a statement that it expects over 300 million doss of the vaccine to be made available to 145 countries through COVAX in the first half of 2021.

The US Food and Drug Administration (FDA) has approved more ‘flexible’ storage of the Pfizer/BioNTech COVID-19 vaccine after receiving new stability data from the companies.

On 19 February, Pfizer/BioNTech submitted data to the FDA that demonstrates the stability of their mRNA-based COVID-19 vaccine at warmer temperatures.

This data showed that undiluted frozen vials of the vaccine can be stored at temperatures of -25°C to -15°C for up to two weeks – the temperatures commonly found in pharmaceutical freezers and refrigerators.

Prior to the FDA authorisation for the new temperatures, the label stated that the vaccine must be stored in an ultra-cold freezer at temperatures between -80ºC and -60ºC, where it can be stored for up to six months.

The agency said that the alternative temperature for storage of frozen vials does not apply to the storage of thawed vials of the vaccine before dilution – which can be held in a standard refrigerator for up to five days.

Pfizer will continue to ship the BioNTech-partnered vaccines in its ‘specially designed’ ultra-cold shipping containers, that can also be used as temporary storage for up to 30 days.

The new flexible storage of the vaccine will alleviate some of the challenges Pfizer/BioNTech have been facing with the roll-out of the jab.

The European Commission has announced that the EU will double its contribution to the international vaccines-sharing facility COVAX, with an additional pledge of €500m.

The additional €500m contribution comes from a new €300m EU grant and €200m in guarantees by the European Fund for Sustainable Development plus (EFSD+).

The new funds double the EU’s previous €500m commitment to COVAX, made up of a €100m grant and €400m in guarantees from the EU budget.

In total, the EU is now set to contribute €1bn overall to COVAX, in a bid to bolster the facility’s target of delivering 1.3 billion vaccine doses to 92 low- and middle-income countries by the end of 2021.

“Last year, as part of our coronavirus global response, we committed to ensuring universal access to vaccines everywhere on earth, for everyone who would need them. COVAX is best placed to help us reach this goal,” said Ursula von der Leyen, president of the European Commission.

“This is why we decided to double the European Commission’s contribution to COVAX, to €1bn. With this new financial boost we want to make sure vaccines are soon delivered to low- and middle-income countries. Because we will only be safe if the whole world is safe,” she added.

COVAX is the vaccine pillar of the World Health Organization’s ACT Accelerator that is working to accelerate development, production and equitable access to COVID-19 tests, treatments and vaccines.

Pfizer/BioNTech and Moderna are set to increase supplies of their respective COVID-19 vaccines to the European Union (EU), according to two separate announcements detailing the new agreements.

In a statement published on 17 February, Pfizer/BioNTech announced that they have signed a new agreement with the European Commission (EC) for the supply of an additional 200 million doses of their COVID-19 vaccine, marketed as Comirnaty in the EU.

Of those agreed doses, around 75 million are to be supplied in the second quarter of 2021, the companies said.

In total, the number of Comirnaty doses to be delivered to EU member states by the end of 2021 is now 500 million.

The EU also has an option to increase this to 600 million doses, as part of the new agreement with Pfizer/BioNTech.

By the end of 2021, Pfizer/BioNTech are aiming to manufacture approximately two billion doses of their vaccine globally, if all goes to plan with regards to their continuous process improvements, expansion at current facilities and addition of new suppliers and contract manufacturers.

Separately, the EC also announced on 17 February that it has signed a new deal with Moderna for an additional 150 million doses of the company’s COVID-19 vaccine, to be delivered in 2021.

Under the terms of the deal, the EU will also have an option to secure a further 150 million doses in 2022.

Novavax has announced that it is to provide 1.1 billion cumulative doses of its COVID-19 vaccine, NVX-CoV2372, to the international vaccines-sharing facility COVAX.

The memorandum of understanding between Gavi, the Vaccine Alliance and Novavax for the vaccine doses was announced on 18 February.

The doses of NVX-CoV2373 for COVAX will be manufactured and distributed by Novavax and the Serum Institute of India (SII) – Novavax has licensed its technology for NVX-CoV2372 to the SII with no upfront, milestone or technology transfer payments.

While the SII will work to provide the majority of its supply of the vaccine to low-, middle- and upper-middle-income countries, Novavax is expected to primarily supply doses to high-income countries.

“We are proud to partner with all the COVAX collaborators and Serum Institute of India to provide global public health leadership and ensure that all countries have broad access to NVX-CoV2373,” said Stanley Erck, president and chief executive officer of Novavax.

COVAX co-leader CEPI committed approximately $400m to advance the early clinical development of Novavax’s COVID-19 vaccine, as well as manufacturing scale-up in multiple facilities across the globe.

A number of rolling reviews of the vaccine are currently being conducted by regulatory authorities across the globe, including the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada.