Gilead Sciences has released data from its IV Outpatient Study (GS-US-540-9012, PINETREE) showing that its antiviral drug Veklury (remdesivir) cuts the risk of severe COVID for people at high risk of progression due to comorbidities or age.

In the trial, Veklury demonstrated a statistically significant 87% reduction in risk for hospitalisation or all-cause death by Day 28 and 81% reduction in risk for medical visits due to COVID-19 or all-cause death by Day 28. No deaths were observed.

Gilead said these results “complement positive results from ACTT-1 and other studies in hospitalised patients”, pointing out that Veklury helped patients recover faster and with reduced likelihood of disease progression.

However, this new data contradicts the results of two other, much larger studies. Neither the World Health Organization’s Solidarity – the world’s largest study for potential COVID treatments – nor the European Union-funded DisCoVeRy trial observed any clinical benefit of the antiviral drug.

The DisCoVeRy trial, data from which was published in The Lancet Infectious Diseases in September, studied more than 850 people at nearly 50 sites across five European countries who had shown symptoms for seven days and required oxygen between March 2020 and January 2021.

Responding to the DisCoVeRy data, Gilead stressed the need to focus on clinical outcomes rather than “measures of treatment efficacy”, adding that it did not believe this data “alters the demonstrated benefit risk profile of Veklury”.

Veklury is the only drug approved for the treatment of COVID-19 and is indicated for adults and paediatric patients 12 years and older for the treatment of COVID-19 requiring hospitalisation in the US, EU and around the world.

Following results from a trial of booster jabs, 30 million people across the four countries of the UK will be offered a COVID-19 vaccine booster dose at least six months after their second dose.

Health secretary Sajid Javid said the decision to launch a booster programme was made on the advice of the country’s expert panel, the Joint Committee on Vaccination and Immunisation (JCVI).

He pointed to signs that the vaccines’ effectiveness may decrease in vulnerable groups. “There is evidence that the protection offered by COVID-19 vaccines reduces over time, particularly for older people who are at greater risk, so booster doses are an important way of keeping the virus under control for the long term,” he said.

In addition to anyone 50 or over, those eligible for a booster jab include residents in care homes, frontline health and social care workers, those aged 16 to 49 with underlying health conditions and adult household contacts of immunosuppressed individuals.

The government is already offering booster shots to half a million people who are classed as clinically extremely vulnerable.

Recent data from the Office of National Statistics showed that the unvaccinated accounted for around 99% of all deaths involving COVID-19 in England in the first half of this year.

After months of controversy, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have given a green light to the COVID-19 booster programme in the US.

The FDA’s decision to extend the emergency use authorisation (EUA) for Pfizer’s Comirnaty vaccine came just days after it convened a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC).

At the meeting, the programme was approved for high-risk groups but a call to offer booster shots to all Americans was firmly rejected by 16 of the 18 experts.

The FDA has defined the scope of the booster programme, limited its approval to people 65 and older, adults 18 and over who are at high risk of severe COVID-19 and adults over 18 who are at “frequent institutional or occupational exposure to SARS-CoV-2”.

“After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 vaccine to allow for a booster dose in certain populations such as healthcare workers, teachers and daycare staff, grocery workers and those in homeless shelters or prisons, among others,” said acting FDA commissioner, Janet Woodcock.

The booster shot must be given at least six months after “completion of the primary series”, stipulated the FDA. Comirnaty was fully approved a month ago for all adults 16 years and older.

French specialist vaccine company Valneva has announced that the UK government has terminated a supply agreement worth up to €1.4bn for its COVID-19 vaccine candidate, VLA2001, citing a breach of obligations.

The potential vaccine is currently in phase 3 trials in the UK, with data expected to be ready for regulatory review by the end of the year.

The company ‘strenuously denies’ that it has breached its obligations under the agreement with the UK government (HMG).

“Valneva has worked tirelessly, and to its best efforts, on the collaboration with HMG including investing significant resources and effort to respond to HMG’s requests for variant-derived vaccines,” said the company in a statement. “Valneva continues to be committed to the development of VLA2001 and will increase its efforts with other potential customers to ensure that its inactivated vaccine can be used in the fight against the pandemic.”

The agreement allows the UK government to terminate the contract early in a relatively wide range of circumstances including safety issues, lack of efficacy or a breakdown in supply as well as financial difficulties.

UK health secretary Sajid Javid cited “commercial reasons” for cancelling the contract, adding that “it was also clear to us that the vaccine in question… would not get approval by the MHRA here in the UK”.

Since the UK announcement, an unnamed source in the French government has spoken of “ongoing and advanced” discussions between Valneva and the European Commission.

Analysis from Moderna on the effectiveness – and waning effectiveness – of its mRNA jab, mRNA-1273 “adds to evidence of potential benefit of a booster dose of mRNA-1273”, said Moderna.

The analysis – from the one-year follow-up of the phase 3 COVE study – shows that those vaccinated more recently had fewer breakthrough infections (88 cases) than those who received mRNA-1273 last year (162 cases). While the reduction in incidence rates was not significant, there is a “numerical trend”, said Moderna, adding that the analysis “quantifies the impact of waning immunity”.

The company also released new data from a real-world study following more than 350,000 recipients of the vaccine that showed high levels of immunity to the delta variant. mRNA-1273 had a vaccine effectiveness of 87% against COVID-19 diagnosis and 96% against COVID-19 hospitalisation.

“It is promising to see clinical and real-world evidence adding to the growing body of data on the effectiveness of the Moderna COVID-19 vaccine,” said Moderna CEO, Stéphane Bancel. “The increased risk of breakthrough infections in COVE study participants who were vaccinated last year compared to more recently illustrates the impact of waning immunity and supports the need for a booster to maintain high levels of protection.”

Two US government departments – Health and Human Services (HHS) and Defense (DoD) – will purchase an additional 1.4 million doses of Regeneron’s REGEN-COV (casirivimab and imdevimab) amid surging demand for the antibody cocktail.

REGEN-COV has been authorised for emergency use in the US for both treatment and prevention of COVID-19 in patients deemed to be at high risk of progressing to severe disease.

REGEN-COV has not been approved by the Food and Drug Administration but was made available in November 2020 under emergency use approval for the treatment of COVID-19. The cocktail is not suitable for patients that already have severe COVID-19 but can be given to adults and children 12 or over with mild to moderate disease who are at high risk for progression to severe COVID-19, including hospitalisation or death.

In August, the emergency use was extended to cover post-exposure prophylaxis in adult and children 12 or over of COVID-19 who are at high risk for progression to severe COVID-19, including hospitalisation or death, and who have been in close contact with someone with the disease.

Under the new deal, the US government will pay $2,100 for each 1,200 mg dose of REGEN-COV, although patients receive the antibody combo free of charge.

Regeneron is collaborating with Roche to increase global supply of REGEN-COV, with Roche primarily responsible for development and distribution outside the US, although the Basel-based company will manufacture approximately one-third of the newly ordered US doses.x