Johnson & Johnson has paused its Phase III COVID-19 vaccine trial after a participant developed an unexplained illness.

The company launched the ENSEMBLE trial late September to determine the safety and efficacy of its experimental vaccine JNJ-78436735, but has now temporarily paused all dosing in the trial to allow an independent data and safety monitoring board (DSMB) to investigate the event.

The exact nature of the unexpected illness remain unknown, as J&J says it cannot release more information on grounds of privacy.

The move follows news that the European Commission, acting on behalf of the European Union member states, has approved an advanced purchase agreement for 200 million doses of the vaccine.

Under the contract, EU member states also have the option to secure up to 200 million extra doses.

J&J has also announced plans to allocate up to 500 million vaccine doses towards international efforts to ensure access for lower income countries, with delivery set to begin mid 2021 depending on approval or authorisation from regulators.

Gilead has signed a joint procurement agreement with the European Commission (EC) to enable ‘rapid and equitable’ access to its COVID-19 antiviral remdesivir, sold under the brand name Veklury.

This new agreement allows participating countries in the EU, the European Economic Area (EEA) and the UK to purchase Gilead’s drug for both real-time demand and stockpiling needs.

It covers purchases of remdesivir over the next six months with the option to be extended beyond this, and replaces the initial emergency support instrument that enabled the EC to procure remdesivir for EU member states – including the UK – that ran from August through to October 2020.

Both agreements removed the need for country-by-country reimbursement processes that usually follow marketing authorisation, given the urgency of the pandemic.

The EC granted remdesivir conditional marketing authorisation back in July, based on data from the ACTT-1 trial that demonstrated clinical efficacy and safety of the drug in COVID-19 patients with pneumonia requiring supplemental oxygen.

AstraZeneca has moved its long-acting antibody (LAAB) combination AZD7442 into Phase III development, testing its potential as a preventative treatment for COVID-19.

One trial involving around 5,000 participants will assess the safety and efficacy of AZD7442 when used to prevent coronavirus infection for up to 12 months, while a second study will evaluate post-exposure prophylaxis and pre-emptive treatment in around 1,100 people.

AZ said it is also planning additional trials to evaluate AZD7442 in around 4,000 patients for the treatment of COVID-19.

AZD7442 was engineered using AZ’s proprietary half-life extension technology to increase the durability of the therapy for six to 12 months following the first administration.

By combining two LAABs, the company is hoping that AZD7442 can reduce the risk of resistance developed by the SARS-CoV-2, which causes COVID-19.

The UK government has announced a deal with Abingdon Health for the supply of the company’s rapid COVID-19 antibody tests.

The contract includes a first order for one million AbC-19 tests, which are set to be rolled out under the government’s COVID-19 surveillance studies. The aim of these studies is to gain a clear picture of how the virus has spread across the country, and develop understanding of how antibodies work.

It will also be able to help determine the efficacy of any vaccine currently in development, which provide protection by creating new antibodies against COVID-19.

Abingdon’s antibody test uses a small drop of blood from an individual by a finger prick, and shows results within 20 minutes without the need to go to a specialised laboratory. The test detects IgG antibodies to full trimeric spike proteins of the SARS-CoV-2 virus, which causes COVID-19. This means Abingdon’s test detects antibodies which interfere with the virus’s ability to enter the human cells.

The AbC-19 test has already received a CE mark, which means it conforms to health and safety standards for goods sold in the UK and EU. The test has also undergone an independent evaluation, commissioned by the UK government, which is set to be published in due course by Public Health England after a peer review.

“Our test will help give a picture of how many people in the UK have antibodies. This will be a crucial part of the understanding of immunity to COVID-19,” said Chris Yates, chief executive officer of Abingdon Health. “Mass testing will also help understand what the longevity of immunity is and, in time, help assess the efficiency of any vaccine on the market. In this respect, high-quality mass antibody,” he added.

Leading life sciences universities in London have come together to respond to the current COVID-19 pandemic with the launch of the ‘Testing Alliance’ to ramp up the number of tests carried out.

The Testing Alliance, created by life sciences cluster MedCity, brings together universities, healthcare institutes, industry and pathology service providers, which plan to utilise unused resources and build on existing infrastructure to offer at least 20,500 extra tests a day for COVID-19.

The Alliance will use existing and new laboratories to deliver large-scale diagnostic capabilities. Institutions involved in the alliance include Health Service Laboratories, UCL, King’s Health Partners and Imperial College London.

“We work to create powerful scientific networks and we’re proud that the latest collaboration we’ve brought together will help expand capacity for COVID-19 testing in the UK,” said Neelam Patel, chief executive of MedCity. “By using a well-established academic cluster, we are able to mobilise London’s world-leading institutions to refocus their space, equipment and people on this most pressing and unprecedented healthcare need,” she added