CANSINO BIOLOGICS TO START CLINICAL TRIALS OF INHALED COVID-19 VACCINE 

Chinese company CanSino Biologics is set to commence clinical trials of a Covid-19 vaccine that can be administered through inhalation.

CNBC reported that, in collaboration with the Beijing Institute of Biotechnology (BIB), CanSinoBIO is developing the inhalation vaccine.

The news channel quoted CanSino Biologics co-founder and chief executive Xuefeng Yu as saying that an inhaled vaccine could be more effective compared to injected ones as SARS-COV-2 enters the human body through the airways.

Yu added that, theoretically, an inhaled vaccine can activate antibodies or T cells in the airways and offer extra protection.

In the event of protection layer failure and the entry of the virus deep into the body, other parts of the immune system could still work against the virus.

NIH-FUNDED TRIAL TO ASSESS REPURPOSED DRUGS FOR COVID-19 TREATMENT

The National Institutes of Health (NIH) is set to fund the Phase III ACTIV-6 clinical trial to analyse various prescription and over-the-counter medications that are currently available for self-administration to treat Covid-19 symptoms.

With an initial investment of $155m from NIH, the large, randomised, placebo‑controlled trial will provide evidence-based treatment options for most adult Covid-19 patients with mild-to-moderate symptoms and do not require hospitalisation.

As per the ACTIV-6 protocol, up to seven FDA-approved drugs for other conditions will be explored through an approach called drug repurposing.

The safety and effectiveness of these drugs will be assessed in treating mild to moderate Covid-19.

The trial will enrol up to 13,500 Covid-19-positive subjects aged 30 or above with two or more mild-to-moderate disease symptoms for seven days.

ASTRAZENECA GETS US CLEARANCE FOR PROPOSED ALEXION ACQUISITION

The US Federal Trade Commission has granted clearance to AstraZeneca for its proposed acquisition of Alexion Pharmaceuticals for approximately $39bn or $175 a share.

The latest development comes after completing clearances in Canada, Brazil, Russia and others, while other regulatory clearances remain incomplete in countries including the UK, EU and Japan.

AstraZeneca executive director and chief financial officer Marc Dunoyer said: “These clearances further advance us towards closing our acquisition of Alexion.

“We remain focused on the next chapter for AstraZeneca and Alexion, building on our combined expertise in immunology and precision medicines and our shared ambition to bring more innovative medicines to patients worldwide.”

Last December, AstraZeneca announced the proposed acquisition of Alexion to boost its scientific presence in immunology by adding the latter’s advanced complement-technology platforms and robust pipeline.

On concluding the acquisition, anticipated in the third quarter of this year, a specialised business unit, known as ‘Alexion, The AstraZeneca Rare Disease Unit’, will be set up in Boston, US.

FDA REVOKES EUA FOR LILLY’S COVID-19 ANTIBODY THERAPY BAMLANIVIMAB

The US Food and Drug Administration (FDA) has revoked the emergency use authorization (EUA) granted to Eli Lilly’s investigational therapy bamlanivimab (LY-CoV555) 700mg alone for treating mild-to-moderate Covid-19 in adults and certain paediatric patients.

A recombinant, neutralising human IgG1 monoclonal antibody bamlanivimab is directed against SARS-CoV-2 spike protein. It can potentially inhibit viral attachment and entry into human cells, thereby neutralising the virus that causes Covid-19.

The latest development comes after Lilly requested the FDA to revoke the authorisation due to the SARS-CoV-2 variant issue in the US and the full availability of bamlanivimab and etesevimab together.

According to an ongoing analysis of emerging scientific data, a surge in viral variants that are resistant to bamlanivimab alone resulted in a high risk for treatment failure.

Therefore, the FDA determined that bamlanivimab’s benefits when administered alone no longer prevail over the risks for its authorised use and revoked EUA.

Last November, Lilly received FDA EUA for bamlanivimab alone for treating mild-to-moderate Covid-19 in adults and paediatric patients.

SINOVAC’S COVID-19 VACCINE PREVENTS 67% SYMPTOMATIC INFECTIONS IN STUDY

The Chilean Ministry of Health has reported that the Chinese pharmaceutical company Sinovac Covid-19 vaccine CoronaVac demonstrated to be up to 67% effective in preventing symptomatic infections in a study.

Named ‘Effectiveness of the inactivated CoronaVac vaccine against SARS-CoV-2 in Chile’, the study showed that after 14 days of administering the second dose, CoronaVac was 85% effective in preventing hospitalisation.

It also had 89% effectiveness in preventing intensive care unit admission and 80% effectiveness in preventing death caused by the virus.

Xinhua quoted Chilean Health Minister Enrique Paris as saying that the vaccine being used by Chile is showing effectiveness.

“We have to continue vaccinating and we cannot relax self-care measures.”

The study included approximately 10.5 million individuals aged 16 years or above.

EMA STARTS REVIEW OF GSK AND VIR’S MONOCLONAL ANTIBODY FOR COVID-19

The European Medicines Agency (EMA) has started a review of GlaxoSmithKline (GSK) and Vir Biotechnology’s investigational dual-action SARS-CoV-2 monoclonal antibody VIR-7831 (GSK4182136) for treating Covid-19 patients.

VIR-7831 is an investigational dual-action antibody designed for increasing concentration in the lungs to guarantee optimal penetration into SARS-CoV-2 affected airway tissues.

The antibody treatment is intended for adults and adolescents aged 12 years and above weighing at least 40kg who do not need supplementary oxygen and are at high risk of progressing to severe Covid-19.

EMA’s Committee for Human Medicinal Products (CHMP) is conducting the review and will offer recommendations across the EU for national authorities to make evidence-based decisions for the early use of the medicine before obtaining formal marketing authorisation.