The Access to COVID-19 Tools Accelerator (ACT-A) has announced the launch of a six-month plan, outlining how world leaders and global health agencies should work in tandem with the public and other partners, in order to aid the transition for long-term COVID-19 management.

Set up in 2020, ACT-A was launched by the World Health Organization (WHO), the President of France, the President of the European Commission and the Bill & Melinda Gates Foundation, in response to the G20’s call for a global tool to accelerate the development of tests, treatments and vaccines and to ensure equitable distribution.

ACT-A is the only end-to-end multilateral solution to the acute phase of the COVID-19 pandemic.

Since the current ACT-Accelerator Strategic Plan & Budget: October 2021 to September 2022 ran until the end of September 2022, the partnership has set up a six-month transition plan, as outlined in its ACT-Accelerator Transition Plan (1 Oct 2022 to 31 Mar 2023).

Moreover, it highlights the work to be maintained, transitioned, or kept on standby, while also supporting the work of ACT-A agencies as they adjust the financing and implementation of their COVID-19 efforts.

Centring on three areas, the next step of ACT-A partners’ work involves focusing R&D and market to ensure a pipeline for new and enhanced COVID-19 tools, as well as securing institutional arrangements for sustained access for all countries to COVID-19 vaccines, tests and treatments.

Lastly, the partners will concentrate in-country work on new product introduction and the full vaccination of priority populations, such as healthcare workers and the elderly, in line with national and international targets.

Bristol Myers Squibb (BMS) has announced new retrospective analyses on serologic responses and clinical outcomes with COVID-19 vaccination in participants treated with Zeposia (ozanimod) from the ongoing phase 3 DAYBREAK open-label extension study in relapsing multiple sclerosis (MS).

The new analyses will be featured in the late-breaking research session at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis in Amsterdam.

The company reported that more than 92% of all patients in the analyses mounted a serological response following vaccination. Additionally, among participants with prior COVID-19 exposure, seroconversion was observed in 100% of individuals following full COVID-19 mRNA or non-mRNA vaccination.

COVID-19-related adverse events were reported in 10% of vaccinated participants, all of which were non serious, the company outlined.

Relapsing forms of MS are characterised by clearly defined, but unpredictable, attacks of worsening neurologic function, followed by partial or complete recovery periods. Approximately 85% of patients are initially diagnosed with relapsing forms of MS, compared with 10% to 15% with progressive forms of the disease.

Zeposia was initially approved by the US Food and Drug Administration for the treatment of relapsing forms of MS in March 2020, while the European Commission also authorised the drug for the treatment of adult patients with relapsing remitting MS with active disease in May 2020.

Pfizer and BioNTech’s Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine demonstrated a ‘substantial increase’ in antibody response above pre-booster levels after one week, according to early data from a phase 2/3 clinical trial in individuals ages 18 years and older.

A 30µg booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccine has already been authorised for emergency use by the US Food and Drug Administration (FDA) for ages 12 years and older and granted marketing authorisation in the EU by the European Medicines Agency (EMA) for the same age group.

The multi-centre, randomised, controlled phase 2/3 trial evaluating the safety, tolerability and immunogenicity of the booster showed similar responses across individuals aged 18 to 55 years and in those older than 55 years.

Moreover, when comparing responses in individuals older than 55 years who received either the bivalent vaccine, or the original vaccine, a 30µg booster dose of the original Pfizer/BioNTech COVID-19 vaccine elicited more limited increases in the neutralising antibody response against the Omicron BA.4/BA.5 variants.

This suggests that a booster dose of the bivalent vaccine provides better protection against the BA.4/BA.5 variants than the original vaccine for younger and older adults.

In terms of safety, the BA.4/BA.5-adapted booster was well tolerated, with early data indicating a favourable safety profile, similar to that of the original vaccine.

A gene associated with a higher immune response and protection after vaccination against COVID-19 has been identified by researchers at the University of Oxford.

The research provides some of the first evidence of a relationship between genetic factors and the way that people’s immune systems respond to COVID-19 vaccines.

In the study, which was published in Nature Medicine, the researchers found that those carrying a version of an HLA gene called HLA-DQB1*06 generated a higher antibody response than those who did not.

The HLA gene helps the immune system distinguish the body’s own proteins from foreign ones, such as those made by viruses and bacteria.

The researchers also found that those carrying this gene, present in two out of every five people in the UK, were less likely to experience COVID-19 infection following vaccination compared to those who did not have it.

The researchers initially analysed DNA samples from 1,190 participants who enrolled at the University of Oxford’s COVID-19 vaccine clinical trials, as well as from 1,677 adults who had enrolled on the com-COV research programme.

They also looked at DNA samples from children who had participated in clinical trials for the Oxford-AstraZeneca vaccine.

Shionogi and the Medicines Patent Pool (MPP) have signed a voluntary licence agreement for Shionogi’s COVID-19 oral antiviral candidate, ensitrelvir fumaric acid (ensitrelvir), to increase access in low- and middle-income countries (LMICs), the Japanese pharma announced.

The agreement will enable MPP to facilitate additional production and distribution of the investigational antiviral, pending regulatory authorisation or approval, by granting sub-licences to qualified generic manufacturers.

Under the terms of the licence agreement, qualified generic manufacturers that are granted sublicences by MPP will be able to manufacture and supply ensitrelvir to 117 countries.

Additionally, Shionogi will waive royalties on sales in all countries covered by the agreement for as long as COVID-19 remains classified as a ‘public health emergency of international concern’ by the World Health Organization.

The agreement follows positive results from a phase 3 trial of ensitrelvir in patients with mild to moderate symptoms of COVID-19, announced by Shionogi last month.

The study met its primary endpoint of reduction in the time taken to resolve five key COVID-19 symptoms – stuffy or runny nose, sore throat, cough, feeling hot or feverish, and low energy or tiredness – that are characteristic of an Omicron-variant infection.

In patients randomised within 72 hours from the onset of symptoms, ensitrelvir demonstrated a ‘statistically significant’ difference in the median time to first resolution of the five COVID-19 symptoms compared to placebo.

NHS England has reported that more than ten million people have now received their COVID-19 booster ahead of winter, hitting a significant milestone in the UK’s autumn booster campaign.

Around 2.3 million people received their autumn booster in one week alone, with the vaccination programme delivering an average of two million per week throughout October.

The high uptake comes amid warnings from health leaders of a COVID-19 and flu ‘twindemic’ this winter, with the public urged to come forward for their boosters.

The UK’s autumn booster campaign includes everyone aged 50 and over, those considered high-risk aged five years and over, care home staff, frontline health and social care workers, unpaid carers and household contacts of people with weakened immune systems and those who are pregnant.

Despite the milestone booster achievement, the NHS also said it is preparing for a challenging winter period, having outlined a package of measures in August that aims to boost capacity and resilience ahead of the substantial pressures expected.

England’s health chiefs outlined the measures in a letter to colleagues, including plans to create the equivalent of 7,000 more beds through a mixture of temporary units at hospital sites and 2,500 ‘virtual ward spaces’ where patients would be monitored at home.