Moderna’s chief executive officer Stéphane Bancel (pictured) said he expects interim results from the company’s COVID-19 vaccine trial in November, according to the Wall Street Journal.

Bancel added that the vaccine candidate could be granted an emergency use authorisation (EUA) by the US Food and Drug Administration (FDA) in December, assuming that the data from its phase 3 trial is positive.

Previously, Bancel told the Financial Times that Moderna’s vaccine candidate would be ready for EUA submission on 25 November.

Speaking at the WSJ’s annual Tech Live conference, Bancel said: “That first analysis is likely to occur in November, but it’s hard to predict exactly which week because it depends on the cases, the number of people getting sick.”

Moderna’s mRNA-based candidate, mRNA-1273, entered the 30,000-participant phase 3 trial in July. The study, which is being conducted in collaboration with the US National Institutes of Health (NIH), is investigating two shots of the candidate at a dosage of 100 µg.
For Moderna to apply for an EUA, 53 subjects in its phase 3 study need to be infected with the novel coronavirus, and the cases in the placebo arm need to be significantly higher than those in the vaccinated arm.

The UK government has signed a contract to develop a COVID-19 human challenge study model, which would be the first of its kind in the world if it goes ahead.

The contract, signed with Open Orphan subsidiary hVIVO, starts immediately and could be worth around £10m depending on the final number of volunteers included in the characterisation study.

The study will be sponsored by Imperial College London and conducted by hVIVO at The Royal Free Hospital’s specialist research unit in London.

The government has already secured the first three slots to test vaccine using the challenge study, which hVIVO said is expected to start in 2021. Each slot reservation has been secured at a respective cost of £2.5m each for a total of £7.5m, although it has not been yet disclosed which candidates have been selected.

If approved by regulators and an ethics committee in the UK, young and healthy volunteers will be purposely infected with the SARS-CoV-2 virus, which causes COVID-19.
Initially, researchers will aim to discover the smallest amount of the virus it takes to cause COVID-19 infection in small groups of healthy young people aged between 18-30 years old who are at a low risk of harm.

Medics and scientists will closely monitor the participants following exposure to the virus, carefully recording the effect in volunteers for 24 hours per day.
In a statement, the government said that it will invest £33.6m at this initial stage, otherwise known as a virus characterisation study.

Following the virus characterisation stage, a vaccine candidate that has been proven to be safe in initial trials will be given to a small number of healthy adult volunteers who are then exposed to the virus in a safe and controlled environment.

AstraZeneca (AZ) has confirmed that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has started a rolling review of its COVID-19 vaccine candidate.

AZ is evaluating the vaccine, AZD1222, in partnership with Oxford University, that originally developed the potential vaccine.

The two partners reached a development and distribution agreement for the vaccine in April, giving AZ responsibility for continuing the development and manufacturing of the vaccine as it advances through late-stage testing.

“We confirm the MHRA’s rolling review of our potential COVID-19 vaccine,” an AZ spokesman told Reuters.

The MHRA will review the vaccine candidate on a rolling basis, meaning that the agency will begin an independent assessment of the vaccine using information submitted by AZ.
It will then accept and consider new evidence as and when it becomes available, until the application is sufficient to warrant regulatory authorisation of the shot.

The Financial Times previously reported that AZD1222 triggers protective antibodies and T cell responses in both older and younger adults.

In addition to the promising immune response in older adults, AZ also said that adverse responses were lower among the elderly, according to Reuters.

“It is encouraging to see immunogenicity responses were similar between older and younger adults and that reactogenicity was lower in older adults, where the COVID-19 disease severity is higher,” said an AZ spokesman.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has begun a rolling review of Moderna’s mRNA-based COVID-19 vaccine.

The vaccine candidate, mRNA-1273, will be reviewed on a rolling basis, meaning that the MHRA will begin an independent assessment of the vaccine using information submitted by Moderna.

The MHRA will then accept and consider new evidence when it becomes available until the application is sufficient to warrant authorisation of the shot.
In October, Moderna completed enrolment of its late-stage phase 3 trial testing mRNA-1273 in 30,000 participants.

According to the company, 25,654 participants have now received their second vaccination with the vaccine candidate in the phase 3 COVE study.

Moderna’s COVID-19 vaccine entered phase 3 in record time, with the US National Institutes of Health (NIH) partnered study launching in July.

The primary endpoint of the COVE study is the prevention of symptomatic COVID-19 disease, with key secondary endpoints including the prevention of severe COVID-19 disease and prevention of infection with SARS-CoV-2, which causes COVID-19, regardless of symptoms.

Results from an interim analysis of the phase 1 study of mRNA-1273, published in July, demonstrated that participants who received two doses of the vaccine had rapid and strong immune responses against SARS-CoV-2, the novel virus which causes COVID-19.

The Russian Direct Investment Fund (RDIF) has submitted its COVID-19 vaccine Sputnik V to the World Health Organization (WHO) for an emergency use listing and prequalification.

In August, Russia became the first country in the world to grant regulatory approval to a COVID-19 vaccine.

The approval came before large-scale phase 3 safety trials of the vaccine had been completed. Following the regulatory authorisation, Russian President Vladimir Putin maintained that the shot is safe for use despite concerns raised by health experts across the world.

Sputnik V – a name which refers to the first artificial earth satellite launched by the Soviet Union – was developed by Moscow’s Gamaleya Institute and marketed by RDIF.

It is based on a platform of human adenoviral vectors, which is designed to deliver a gene from the SARS-CoV-2 virus into the body and trick it into producing protective antibodies against the infection.

A WHO emergency use listing is designed to enable potential vaccines to become available globally at a faster rate, while a prequalification indicates the quality, safety and efficacy of a vaccine.

If Sputnik V is granted these qualifications, the vaccine will go on to be included in the list of medical products that meet leading quality, safety and efficacy standards, according to RDIF chief exec Kirill Dmitriev.

“The Russian Federation was the first in the world to register a vaccine against the coronavirus, Sputnik V, which was created on a safe, effective and well-studied platform of human adenoviral vectors,” said Dmitriev in a statement.