Moderna’s Omicron BA.1 targeting bivalent booster – mRNA-1273.214 – has been recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for children between the ages of six and 11 years.

The CHMP, which issued a positive opinion for use of the booster for those aged 12 years and older earlier in 2022, recommends that mRNA-1273.214 be given to children at least three months after the last prior dose of a COVID-19 vaccine.

Its latest decision was supported by the data based on clinical studies, which evaluated a booster dose of the company’s original Spikevax vaccine for children between the ages of six and 11 years who had already been given a primary series of the Moderna COVID-19 vaccine.

The company’s paediatric application also included clinical trial data from a phase 2/3 trial in which the BA.1 booster met all primary endpoints, including superior neutralising antibody response against Omicron when compared to a dose of the company’s BA.4/BA.5 prototype vaccine – mRNA-1273 – in those who had not had COVID-19 prior to that point.

A phase 2/3 trial evaluating mRNA-1273.214 as a booster and a primary series for children between the ages of six months and five years is also currently underway, with initial results expected in early 2023.

The US Food and Drug Administration (FDA) has authorised bivalent Moderna and Pfizer/BioNTech COVID-19 boosters that have been adapted for the Omicron variant for children aged six months and older.

The Pfizer/BioNTech BA.4/BA.5 Omicron-adapted bivalent vaccine can now be used for children aged six months to four years who have not yet received the third dose of the three-dose primary series with the monovalent Pfizer/BioNTech COVID-19 vaccine.

Moderna’s bivalent vaccine has been authorised for children aged six months to five years as a single booster after completion of primary vaccination with the company’s monovalent vaccine.

Both bivalent vaccines include mRNA components that target both the original strain and the BA.4/BA.5 Omicron subvariants.

The authorisation of the Pfizer/BioNTech bivalent vaccine was supported by the FDA’s previous analyses of the effectiveness of primary vaccination with the monovalent Pfizer/BioNTech vaccine for those aged 16 years and older and for children aged six months to four years.

For the authorisation of Moderna’s bivalent vaccine, the FDA relied on previously evaluated immune response data from a clinical study of adults of a booster dose of the company’s investigational bivalent COVID-19 vaccine that targets both the original strain of SARS-CoV-2 and BA.1.

In a summit held by the World Health Organization (WHO) on 7 December 2022, WHO member states were united in an agreement to develop and produce the first draft of a pledge created to protect the world from future pandemics.

The legally binding ‘zero draft’ of the pandemic accord is entrenched in the WHO Constitution and the member states plan to reconvene for discussion in February.

The agreement by the Intergovernmental Negotiating Body (INB), involving WHO’s 194 member states, marked a significant moment in the global process in learning from the COVID-19 pandemic. It also served as an important milestone in recognising how the global community can prevent a repeat of the severe global impact of COVID-19.

The INB met at the WHO headquarters in Geneva from 5 to 7 December 2022 for its third meeting since its launch in December 2021, after a special session of the World Health Assembly.

As part of its discussions on 7 December, the INB’s Bureau agreed to develop the zero draft of the pandemic accord as a starting point for negotiations at the fourth INB meeting in early 2023.

Kinarus Therapeutics’ (Kinarus) COVID-19 treatment, KIN001, protects against Omicron subvariants, showing strong antiviral activity against BA.2 and BA.5, according to new preclinical data announced by the company.

KIN001 is an orally administered combination of two drugs – pamapimod and pioglitazone – that provides both antiviral and anti-inflammatory protection. The drug combination is also able to reduce tissue fibrosis, which is something that may lower the likelihood of experiencing ‘long COVID’ symptoms.

Unlike other antivirals and monoclonal antibody therapies that target SARS-Cov2 directly, KIN001 targets cell pathways in the body that enable the SARS-Cov2 virus to replicate. By doing so, it inhibits the ability of the virus to replicate, thereby reducing the potential for the emergence of escape mutants.

KIN001 is also currently being evaluated in the phase 2 KINFAST trial to treat non-hospitalised COVID-19 patients with a positive SARS-CoV-2 test. The primary endpoint of the study, which is recruiting in Switzerland and Germany, is to reduce the severity and duration of COVID-19 symptoms.

In addition to BA.5, which has been the dominant subvariant of COVID-19 in the US since July 2022, emerging Omicron subvariants BQ.1 and BQ.1.1 are being closely tracked by the US Centers for Disease Control and Prevention.

Pfizer and Clear Creek Bio have announced a collaboration to discover and develop novel papain-like protease (PLpro) inhibitors and potentially introduce a new class of oral treatments for COVID-19.

Under the terms of the exclusive licence agreement, the companies will jointly identify a PLpro candidate to progress into the clinic. Once selected, Pfizer will be solely responsible for further development and commercialisation activities.

Clear Creek Bio will receive an undisclosed upfront payment from Pfizer and will be eligible to receive future potential milestone payments, as well as royalties.

SARS-CoV-2 has two essential proteases, the main protease and the PLpro, and both are required to fully process the viral polyprotein and assemble a functional replicase complex. In addition to its vital role in viral replication, the PLpro also contributes to dysregulation of host innate immunity and immune evasion.

The programme will expand Pfizer’s anti-infective pipeline and, if successful, will complement its existing portfolio of COVID-19 therapies with direct-acting antiviral agents against different SARS-CoV-2 targets.

This includes Paxlovid (nirmatrelvir and ritonavir), an orally administered drug that can be given at the first sign of infection to treat patients with mild-to-moderate COVID-19 in adults and paediatric patients.