Pfizer and BioNTech’s 30µg booster dose of their Omicron BA.1 bivalent COVID-19 vaccine booster – Comirnaty – has been recommended for conditional marketing authorisation (CMA) by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for individuals 12 years and older, the companies announced.

The bivalent vaccine contains mRNA encoding the original SARS-CoV-2 spike protein – present in the original Pfizer/BioNTech COVID-19 vaccine – together with mRNA encoding the spike protein of the Omicron BA.1 subvariant.

If an authorisation is granted, doses of the booster will be available within the coming days to all 27 EU member states, supporting the start of the European vaccination campaigns. Local supply may vary based on individual country government requests, Pfizer outlined.

The recommendation is based on clinical data from the Pfizer/BioNTech Omicron BA.1 adapted bivalent vaccine phase 2/3 trial of participants 56 years and older. In this study, a booster dose of the Omicron BA.1-adapted bivalent vaccine elicited a superior immune response against Omicron BA.1 subvariant compared to the companies’ original COVID-19 vaccine.

The companies have also filed an application, which is currently under review, to the EMA for a booster dose of an Omicron BA.4/BA.5-adapted COVID-19 bivalent vaccine to ‘allow for flexible vaccination strategies’, Pfizer said in a statement.

Novavax’s COVID-19 vaccine – Nuvaxovid – has been granted expanded conditional marketing authorisation (CMA) by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in adolescents aged 12 to 17 years.

The decision was based on data from the ongoing paediatric expansion of the phase 3 PREVENT-19 trial of 2,247 adolescents aged 12 to 17 years old across 73 sites in the US to evaluate the safety, immunogenicity and efficacy of Nuvaxovid.

In the paediatric expansion, Nuvaxovid achieved its primary immunogenicity endpoint and demonstrated 80% clinical efficacy overall at a time when the Delta variant was the predominant strain in the US.

Preliminary safety data from the paediatric expansion showed the vaccine to be generally well tolerated. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups, and not considered related to the vaccine, the company reported.

Novavax’s protein-based vaccine, given in doses spread three weeks apart, contains the SARS-CoV-2 spike protein and Matrix-M adjuvant to enhance immune response and stimulate high levels of neutralising antibodies.

The next step for the vaccine is a policy recommendation for use from the UK Joint Committee on Vaccination and Immunisation (JCVI). Doses of Nuvaxovid will then be made available for use in adolescents based on the JCVI’s recommendation.

The World Health Organization (WHO) has announced the official establishment of the new Financial Intermediary Fund (FIF) for pandemic prevention, preparedness and response (PPR) by the FIF Governing Board, with the first calls for proposals for investments opening in November.

The fund, which was established at the FIF’s inaugural meeting, is set to provide a ‘dedicated stream’ of additional, long-term financing to strengthen PPR capabilities in low- and middle-income countries and address ‘critical gaps’ through investments and technical support at the national, regional and global levels, WHO outlined.

Over $1.4bn in financial commitments have already been announced and more are expected in the coming months.

The Technical Advisory Panel, appointed by the Government Board, will be chaired by WHO and will comprise of leading experts to ‘assess and make recommendations on the technical merits of proposals for funding, ensuring linkages to the International Health Regulations, as part of the broader global PPR architecture,’ WHO said.

The announcement follows approval by the World Bank’s Board of Directors in June, with the World Bank set to serve as the FIF’s trustee and host the Secretariat, which will include technical staff seconded from WHO.

Shionogi’s ensitrelvir fumaric acid (ensitrelvir) – an investigational protease inhibitor being evaluated as an antiviral treatment for COVID-19 – demonstrated a significant reduction in symptoms compared with a placebo in a phase 3 study in Asia.

The study was conducted in patients with mild to moderate symptoms of COVID-19 and assessed clinical symptom resolution with two dose groups of ensitrelvir, orally administered once daily for five days, compared to placebo.

A total of 1,821 predominantly vaccinated patients were enrolled in Japan, South Korea and Vietnam, irrespective of risk factors for COVID-19 progression.
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.

The five assessed symptoms were selected in consultation with medical experts and regulatory authorities, including the Ministry of Health, Labor and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and the US Food and Drug Administration (FDA), based on their scientific and medical validity.

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 – the dose level submitted for approval in Japan – compared to placebo.