Moderna’s COVID-19 vaccine, mRNA-1273, has proven highly effective in a phase 2/3 study in adolescents aged 12 to 17.

The study enrolled 3,732 adolescent participants and randomised them to receive either two doses of mRNA-1273 or placebo.

The trial, known as TeenCOVE, met its primary endpoint of non-inferior immunogenicity compared to adult participants in the phase 3 study comparator group.

In addition, no cases of COVID-19 were observed after two doses of mRNA-1273 in the vaccine group, compared to four cases in the placebo group – reflecting a vaccine efficacy of 100% starting 14 days after the second dose.

Moderna added that since the incidence rate of COVID-19 is lower in this age group, the study also evaluated a secondary case definition based on the CDC definition of COVID-19.

This definition requires only one COVID-19 symptom and a nasopharyngeal (NP) swab or saliva sample that tests positive for SARS-CoV-2 by RT-PCR.

Using this definition, Moderna concluded that the vaccine efficacy for mRNA-1273 is 93% after the first dose.

The company plans to submit the data from the study to global regulators in early June.

“We are encouraged that mRNA-1273 was highly effective at preventing COVID-19 in adolescents. It is particularly exciting to see that the Moderna COVID-19 vaccine can prevent SARS-CoV-2 infection,” said Stéphane Bancel, chief executive officer of Moderna.

Novartis and Molecular Partners have announced the launch of a global phase 2/3 study for their novel COVID-19 therapeutic candidate ensovibep – also known as MP0420.

In October 2020, Novartis announced its collaboration with Molecular Partners, which included access to two anti-COVID-19 drugs, ensovibep and MP0423.

Both of these therapeutics – referred to as DARPin candidates – are designed to target a number of different sites on the SARS-CoV-2 virus simultaneously, with the aim of enhancing antiviral effects.

They have potential use as both prophylactics and treatments for COVID-19, Molecular Partners said in a statement.

Initial positive phase 1 study results found that ensovibep was safe and well tolerated, with no significant adverse events reported.

Preliminary results also found that extended exposure to the therapeutic in serum with a half-life of two to three weeks was ‘as expected’ from preclinical testing.

The newly launched phase 2/3 EMPATHY trial will explore the use of ensovibep for the treatment of COVID-19 patients who are in the early stages of infection. The study aims to determine if the novel drug can prevent symptoms from progressing to severe disease and hospitalisation.

Novartis and Molecular Partners are expecting to enrol 400 patients into the phase 2 stage to identify the optimal dose for safety and activity, with the first results anticipated in August.

Following months of ongoing disputes, the European Union (EU) is taking legal steps against AstraZeneca (AZ) over delayed deliveries of the Anglo-Swedish pharma company’s COVID-19 vaccine.

The EU’s legal proceedings against AZ were initially confirmed in April. European Commission spokesperson Stefan De Keersmaeker said: “The reason being the terms of the contract, or some terms of the contract, have not been respected, and the company has not been in a position to come up with a reliable strategy to ensure the timely delivery of doses.”

The EU is seeking a court order from the Brussels Court of First Instance which would ensure that AZ supplies the 300 million doses it had initially promised to the EU by the end of September – which would be a three-month delay on the original delivery schedule.

If AZ fails to meet this delayed schedule, lawyers for the European Commission have asked the court to fine the company €10m per infraction, in order to force the company to pay €10 per dose for each delayed day as part of compensation for what they
argue is a breach of contract.

The EU has alleged that AZ has failed to deliver the promised amount of doses of its Oxford University-partnered vaccine, with the initial dispute originating in January when the pharma company announced it would reduce initial deliveries to the bloc.