AstraZeneca has confirmed that clinical trials assessing its Oxford University-partnered coronavirus vaccine AZD1222 have resumed in the UK, following a green light by the Medicines Health Regulatory Authority (MHRA).

Early September a standard review process triggered a voluntary pause to vaccination across all global trials, to allow review of safety data by independent committees, and international regulators, after one trial volunteer experienced an unexplained illness.
The UK committee has now concluded its investigations and recommended to the MHRA that trials in the country are safe to resume. The drug giant said that it could not disclose further medical information but that all trial investigators and participants will be updated with the relevant information.

AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech.

Four newly published papers on the use of corticosteroids to treat COVID-19 back prior evidence that outcomes for patients severely affected by the virus can be significantly improved, with one suggesting the risk of death can be cut by up to 20%.

The papers – all published in the Journal of the American Medical Association (JAMA) – include findings of the REMAP-CAP study led in the UK by Professor Anthony Gordon from Imperial College London, which found that patients in intensive care treated with a regular fixed dose of the steroid hydrocortisone for seven days had a better chance of recovery.

A separate study led by researchers at the University of Bristol and the NIHR’s Bristol Biomedical Research Centre provides an evidence summary of global steroid use across seven randomly controlled trials (RCTs) in 12 different countries.

It included data drawn from REMAP-CAP and the NIHR-funded RECOVERY trial – which has already shown that the steroid dexamethasone can be successfully used to treat moderate to severe COVID-19 – and concluded that corticosteroids can slash the risk of death in the most ill patients by up to 20%.

“These findings offer further evidence that corticosteroids can be an important part of COVID-19 treatment for severe patients,” Professor Jonathan Van-Tam, deputy chief medical officer.

“Steroids are not a cure, but they help improve outcomes. Having a choice of different types of steroids, all of which seem to improve patient recovery, is great as it helps ease the problem of drug supply issues,” added Professor Gordon, chair in Anaesthesia and Critical Care at Imperial and a consultant in Intensive Care Medicine at Imperial College Healthcare NHS Trust.

Pfizer and BioNTech have concluded exploratory talks with the European Commission for a proposed supply of 200 million doses of their investigational BNT162 mRNA-based vaccine candidate against SARS-CoV-2 to EU nations, with an option to purchase a further 100 million doses.

Deliveries could potentially start by the end of 2020, subject to clinical success and regulatory authorisation.

The companies said they will now enter into contract negotiations with the European Commission to finalise the deal.

“Pfizer and BioNTech’s anticipated agreement with the European Commission is an important step forward in our shared goal to have millions of doses of a vaccine against COVID-19 available for vulnerable populations before the end of the year,” said Albert Bourla, Pfizer’s chairman and chief executive.

The companies said they are on track to seek regulatory review of BNT162b2 in October 2020.

Eight new research projects investigating the transmission of coronavirus have been awarded a total of £5.3 million by the NIHR and UK Research and Innovation (UKRI), in the hope that findings will help shape COVID-19 policy decisions on prevention and containment.

The projects are researching how the virus spreads in schoolchildren, healthcare workers and a strictly Orthodox Jewish community, as well as in medical settings and on surfaces in public spaces.

Two of the newly funded research projects are looking at the role schoolchildren play in coronavirus transmission, with one group of researchers mapping spread of the virus in schools in Bristol, and another working to identify how symptomatic or asymptomatic children transmit the virus and how long they are infectious.

Given that healthcare workers have a high risk of exposure to coronavirus, particularly from aerosols generated during some medical procedures, another of the newly funded projects will assess the amount, type and infectiousness of aerosol generated during a variety of procedures.

Also, as transmission of coronavirus in healthcare settings “is likely to have had a considerable role in the spread of the pandemic in the UK,” NIHR and the UKRI are funding two studies investigating how transmission in healthcare settings compares with that among the general public.

A separate multidisciplinary research project will test different surfaces and coatings that may kill coronavirus, to develop new approaches to prevent transmission in public spaces, as the virus can survive on some hard surfaces for up to three days.

The Orthodox Jewish community has experienced a high number of COVID-19 cases, and so one of the newly funded projects will work with one such community to understand how community structures, such as household size, might contribute to transmission, including the role of children.

“Understanding which factors are important in COVID-19 transmission and therefore how the disease spreads is important for targeting measures to control the pandemic,” said Professor Chris Whitty, chief medical officer for England and head of the NIHR. “These eight new research projects funded by NIHR and UKRI will help us to understand transmission in a number of key groups and settings.”

Verona Pharma has kicked off a pilot study to investigate the efficacy and safety of ensifentrine delivered via pressurised metered-dose inhaler (pMDI) formulation in patients hospitalised with COVID-19.

The study will evaluate the effect of ensifentrine on key outcomes in patients hospitalised with COVID-19, including facilitation of recovery from the viral infection, clinical status improvement and reduction in supplemental oxygen use and progression to mechanical ventilation.

Ensifentrine is a first-in-class product candidate that combines bronchodilator and anti-inflammatory activities in one compound. Clinical data from studies of the drug in the treatment of other respiratory diseases have shown that the drug improved oxygenation, reduced inflammation in the lungs and enhanced mucus clearance, the firm noted.

“Therapies are urgently needed to treat patients hospitalised with COVID-19,” said Mike Wells, a pulmonologist and Principal Investigator at the University of Alabama at Birmingham. “Ensifentrine has demonstrated impressive effects on improving lung function and symptoms in patients with obstructive lung diseases, along with notable anti-inflammatory effects following inhaled dosing in clinical trials to date.  Combined with positive safety results, ensifentrine has the potential to significantly benefit patients suffering from COVID-19.”