Eli Lilly has announced that its neutralising antibody bamlanivimab significantly reduced the risk of COVID-19 infection among residents and staff in care homes.

The results come from the phase 3 BLAZE-2 COVID-19 prevention trial, which enrolled residents and staff at care homes and assisted living facilities across the US.

At baseline, 965 participants tested negative for the SARS-CoV-2 virus, which causes COVID-19, while 132 participants tested positive for the virus.

Those who tested positive at baseline were included in exploratory analyses for assessing treatment with bamlanivimab, while participants who tested negative were randomised to receive either 4,200mg of the antibody or placebo.

After eight weeks of follow-up, the participant group that was treated with bamlanivimab demonstrated a significantly lower frequency of symptomatic COVID-19 cases compared to placebo.

The results suggest that bamlanivimab-treated participants have up to an 80% lower risk of contracting COVID-19 compared to residents in the same facility who did not receive the antibody.

Lilly has also entered a collaboration agreement with GlaxoSmithKline (GSK) and Vir Biotechnology to evaluate their respective COVID-19 antibodies.

As part of the deal, Lilly will test a combination of its neutralising antibody bamlanivimab with GSK/Vir’s monoclonal antibody VIR-7831.

The BLAZE-4 trial will evaluate the two antibodies in low-risk patients with mild-to-moderate COVID-19.

The two neutralising antibodies bind to different epitopes of the SARS-CoV-2 spike protein, Lilly said in a statement.

Bamlanivimab is directed against the SARS-CoV-2 spike protein and is designed to block viral attachment and entry into human cells, while VIR-7831 has the potential to both block viral entry into health cells and clear infected cells.

Pfizer and BioNTech have agreed to supply up to 40 million doses of their COVID-19 vaccine to COVAX, the international vaccines-sharing facility.

COVAX is the vaccine pillar of the WHO’s ACT Accelerator – a collaborative initiative co-led by the World Health Organization (WHO) that aims to accelerate development, production and equitable access to COVID-19 tests, treatments and vaccines.

Although specific details of the deal are scarce, the WHO said in a statement that rollout of the doses will begin with the ‘successful negotiation and execution of supply agreements’.
COVAX is aiming to secure two billion vaccines in 2021 – the global initiative now has agreements in place to access just over this amount, according to the WHO.

This includes a deal with AstraZeneca (AZ) for 170 million doses of its Oxford University-partnered vaccine, as well as a ‘memorandum of understanding’ with Johnson & Johnson (J&J) for 500 million of its single-dose jab.

Another deal, agreed with the Serum Institute of India, will see COVAX receive 200 million doses of either the AZ/Oxford vaccine or the Novavax vaccine. COVAX also has a statement of intent from Sanofi and GlaxoSmithKline (GSK) for 200 million doses of a candidate vaccine that the companies are developing.

The WHO also announced that it is set to exercise an option to receive the first 100 million doses of the AZ/Oxford vaccine, manufactured by the Serum Institute.

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).

Regeneron has announced that its antibody cocktail REGEN-COV can be used as a passive vaccine to prevent COVID-19 in people who are at high risk of infection.

The ongoing phase 3 trial is evaluating the cocktail, which contains the two monoclonal antibodies casirivimab and imdevimab, for the prevention of COVID-19 in high-risk populations.

The first exploratory analysis of 400 evaluable participants found that passive vaccination with REGEN-COV resulted in 100% prevention of symptomatic COVID-19 infections.

On top of that, the cocktail led to approximately 50% lower overall rates of infection – with infections occurring with REGEN-COV therapy all being asymptomatic.

Regeneron added that the infections observed in the placebo group had more than 100-fold higher peak viral loads compared to REGEN-COV-treated patients.

While appropriately 40% of COVID-19 infections in the placebo group lasted three to four weeks, infections in the REGEN-COV group lasted no more than one week.

“Even with the emerging availability of active vaccines, we continue to see hundreds of thousands of people infected daily, actively spreading the virus to their close contacts,” said George Yancopoulos, president and chief scientific officer, Regeneron.

“The REGEN-COV antibody cocktail may be able to help break this chain by providing immediate passive immunity to those at high risk of infection, in contrast to active vaccines which take weeks to provide protection,” he added.

A report in The Mail on Sunday in January said that Valneva is preparing to begin manufacturing doses of the vaccine for commercial use at its site in Livingston, Scotland.

The UK government has since confirmed this, adding in a statement that Valneva has started manufacturing doses of the vaccine at the Livingston facility.

Valneva’s chief executive officer Thomas Lingelbach also said that the COVID-19 vaccine, known as VLA2001, could be made available in Britain between July and September.

The UK government has invested a ‘multi-million sum’ in a facility based in Livingston, Scotland to support manufacturing doses of VLA2001, with over 100 new highly skilled, local jobs already being supported by this site.

Following the upfront investment, the expanded Livingston facility could also potentially supply up to 100 million doses of VLA2001 to the UK and other countries, according to the Department for Business, Energy & Industrial Strategy.

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.

VLA2001 uses the same manufacturing platform used by Valneva to create its licensed Japanese encephalitis vaccine, Ixiaro.

A clinical trial that will combine AstraZeneca (AZ)/Oxford University’s COVID-19 vaccine with Russia’s Sputnik V COVID-19 vaccine could begin in February, according to the chairman of Russian pharma company R-Pharm.

R-Pharm chairman Alexei Repik told Reuters that human trials of the combined vaccination are expected to start in early February, a month after AZ confirmed that it will explore a combination of its Oxford-partnered vaccine with Sputnik V.

On 11 December 2020, AZ announced “a clinical trial programme to assess the safety and immunogenicity of a combination of AZD1222, developed by AstraZeneca and Oxford University, and Sputnik V, developed by Russian Gamaleya Research institute”.

Repik added that the trials are set to be conducted in Azerbaijan, Argentina, Saudi Arabia, the UAE, Belarus, Russia and other locations.

The clinicaltrials.gov database, which lists information from clinical studies from around the world, gives an estimated study start date of 16 March, with participants set to receive a first dose of the AZ/Oxford vaccine followed by the Russian vaccine on day 29 of the study.

In November 2020, Russia announced that data for Sputnik V showed that the vaccine is 91.4% effective on day 28 after the first dose.

The updated analysis evaluated the vaccine’s efficacy after 39 COVID-19 cases in total were observed in the trial – eight of which occurred in the vaccinated group compared to 31 in the placebo arm.

The efficacy evaluation was conducted among participants 28 days after receiving the first dose, and seven days after the second dose, with the analysis demonstrating a 91.4% efficacy rate.

The vaccine, developed by the Gamaleya Institute, consists of two strains of adenoviruses, which usually cause the common cold and are used as ‘vectors’ to carry the gene for the SARS-CoV-2 spike protein.

Like Sputnik V, the AZ/Oxford vaccine also uses an adenoviral vector and contains genetic material of the SARS-CoV-2 virus spike protein.