Johnson & Johnson (J&J) has announced that its phase 3 COVID-19 vaccine trial is fully enrolled, with approximately 45,000 participants involved in the late-stage study.

The phase 3 ENSEMBLE trial is being conducted in collaboration with the US Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID).

In a statement, J&J said that it expects that the number of participants now enrolled in the study will be sufficient to generate the data needed to determine the safety and efficacy of its COVID-19 vaccine.

This is due in large part to the high levels of COVID-19 cases among the general populations in the locations where the phase 3 trial is being conducted – this includes the US, where cases have now surpassed a total of 17 million.

J&J is expecting interim data from the phase 3 trial to be available by the end of January 2021, although this depends on the number of COVID-19 cases observed across the study itself.

Depending on the outcome of the study, J&J said it could submit an emergency use authorisation to the US Food and Drug Administration (FDA) in February, with additional health regulatory applications set to be made ‘in parallel’.

J&J had previously announced that it would decrease the size of the ENSEMBLE trial after cases surged across the US.

As cases grow, participants will be more likely to come into contact with the virus, allowing J&J to evaluate its vaccine in a smaller population of volunteers.

J&J advanced its COVID-19 vaccine candidate into phase 3 testing in September 2020 following positive interim results from a phase 1/2a clinical study of the shot. The pivotal late-stage study is investigating the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19.

French biotech company Valneva has started phase 1/2 trials of its potential COVID-19 vaccine across four National Institute for Health Research (NIHR) testing sites in the UK.

The phase 1 and 2 trials will initially test Valneva’s VLA2001 vaccine on 150 volunteers at sites in Birmingham, Bristol, Newcastle and Southampton, with the aim of determining if the vaccine produces a safe and effective immune response against COVID-19.

Valneva’s vaccine candidate is made of inactivated whole virus particles of SARS-CoV-2, which causes COVID-19, with high S-protein density. This is combined with two adjuvants – alum and CpG 1018 – to boost antibody levels.

Following the early trial launch, Valneva is expecting the initial primary endpoint read-out two weeks after completion of the two-dose immunisation regimen.

After analysis of this data, including the selection of an optimal dose of VLA2001, additional trials are expected to begin in the second quarter of 2021.

The UK government previously pre-ordered 60 million doses of Valneva’s vaccine candidate, with these doses potentially becoming available by the end of 2021.

In August 2020, the government also announced a multi-million-pound joint investment in a manufacturing facility in Livingston, West Lothian to support manufacturing capacity for Valneva’s COVID-19 vaccine.

CureVac has launched a new phase 3 study of its COVID-19 vaccine in healthcare workers at the University Medical Center Mainz in Germany.

The Tübingen, Germany-headquartered company will enrol more than 2,500 participants aged 18 years or above in this phase 3 study.

The study will evaluate the safety and efficacy of CureVac’s investigational CVnCoV vaccine, which will be administered as a two-dose regimen.

The phase 3 study in healthcare workers was initiated on 22 December 2020 and builds on CureVac’s ongoing non-interventional study, which is investigating the distribution of COVID-19 in employees at University Medical Center Mainz.

The epidemiological study is focused on how and at what rate SARS-CoV-2-specific antibodies arise and can be detected in hospital employees, as well as the frequency of virologically confirmed COVID-19 cases in this cohort.

The University Medical Center Mainz study complements CureVac’s recently initiated global phase 2b/3 trial, which is evaluating CVnCoV in over 35,000 participants.

In CureVac’s phase 1 study of CVnCoV, the investigational mRNA-based vaccine induced strong binding and neutralising antibody responses, as well as early indications of functional T cells.

In November 2020, CureVac announced that CVnCoV has up to 24 hours of stability when stored at room temperature.

CureVac also said that data for its potential COVID-19 vaccine, CVnCoV, suggests the vaccine remains stable and within defined specifications for at least three months when stored at a standard refrigerator temperature of +2°C to +5°C (+41°F).

The EMA has launched a rolling review the vaccine candidate, based primarily on positive non-clinical data demonstrating that the vaccine produces a ‘robust’ immune response.
This rolling review will enable the EMA to accelerate the assessment of J&J’s vaccine by allowing the agency to review data as and when it becomes available.

When the EMA’s human medicines committee (CHMP) determines that it has sufficient data, J&J can then submit a formal application for approval of the vaccine within the European Union.

J&J is also in talks with other global health regulatory authorities as it preps regulatory review processes for the COVID-19 vaccine to be used during the pandemic response period.

The investigational candidate uses J&J’s AdVac vaccine platform, which was also used to develop the company’s approved Ebola vaccine regimen, as well as additional investigational vaccines for the Zika virus, RSV and HIV.

In September 2020, J&J advanced the vaccine into phase 3 testing, following positive interim results from a phase 1/2a trial of the shot.

In an interim analysis of results from the ENSEMBLE phase 1/2a trial, J&J’s vaccine demonstrated a promising safety profile and immunogenicity after a single dose.

Moderna has announced that it expects to have between 100 million and 125 million doses of its COVID-19 vaccine available globally in the first quarter of 2021.

The company added that 85 million to 100 million of those doses will be allocated to the US, with 15 million to 25 million doses set to be available elsewhere.

Moderna announced that initial data from an interim analysis of its phase 3 COVE study suggested that its COVID-19 vaccine, mRNA-1273, is 94.5% effective.

The preliminary data was based on analysis of 95 confirmed COVID-19 cases within the study – 90 of which occurred in the placebo group and five within the vaccinated arm.

The updated data analysis is based on 196 cases, of which 185 cases of COVID-19 were observed in the placebo group versus 11 cases in the mRNA-1273 group, reflecting a point estimate vaccine efficacy of 94.1%.

In August, Moderna also signed a deal with the US government for 100 million doses of mRNA-1273 for $1.5bn. Under the terms of the agreement – as part of the government’s Operation Warp Speed – the US will also have the option to purchase an additional 400 million doses of the vaccine.

The UK government has also agreed to purchase seven million doses of the Moderna’s potential COVID-19 vaccine candidate – enough to vaccinate around 3.5 million people.

So far, the UK has secured access to COVID-19 vaccine candidates from AstraZeneca, BioNTech/Pfizer, Novavax, Valneva, GlaxoSmithKline/Sanofi Pasteur and Janssen, as well as Moderna.

The US government has purchased an additional 650,000 doses of Lilly’s neutralising COVID-19 antibody bamlanivimab, the company has announced.

Bamlanivimab scored an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) in November for the treatment of high-risk, mild-to-moderate COVID-19 patients.

The US government has paid $812.5m for the additional doses. Following the new purchase agreement, the total number of bamlanivimab doses secured by the US government totals 950,000.

In an interim analysis conducted from the phase 2 BLAZE-1 clinical trial, bamlanivimab cleared the novel coronavirus by day 11 in most patients with mild-to-moderate COVID-19 symptoms.

Patients with a high risk of disease progression included in this study also saw their risk of hospitalisation and hospital visits drop when treated with bamlanivimab compared to the placebo group.

Lilly has reiterated that bamlanivimab is only indicated under emergency use for patients with mild-to-moderate COVID-19 symptoms.

It is not indicated or authorised for use in patients who have been hospitalised with COVID-19, and may actually be associated with worse clinical outcomes when administered to hospitalised patients who require high flow oxygen or mechanical ventilation.

Another COVID-19 antibody cocktail, developed by Regeneron, also holds an EUA in the US for the treatment of mild-to-moderate high-risk COVID-19 patients. As part of the US’ Operation Warp Speed initiative, Regeneron signed an agreement for the initial supply of 300,000 doses of the antibody cocktail.