Read & Download your Issue of Monday – February 22 FNN News

Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18–59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial

• This study investigated CoronaVac (Sinovac Life Sciences, Beijing, China), an inactivated vaccine candidate against COVID-19, containing inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), for its safety, tolerability and immunogenicity.
• In this randomised, double-blind, placebo-controlled, phase 1/2 clinical trial, healthy adults aged 18–59 years were recruited from the community.
• Taking safety, immunogenicity, and production capacity into account, the 3 μg dose of CoronaVac is the suggested dose for efficacy assessment in future phase 3 trials.

Source: The Lancet

The temporal association of introducing and lifting non-pharmaceutical interventions with the time-varying reproduction number (R) of SARS-CoV-2: a modelling study across 131 countries

• Non-pharmaceutical interventions (NPIs) were implemented by many countries to reduce the transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causal agent of COVID-19.
• A resurgence in COVID-19 cases has been reported in some countries that lifted some of these NPIs.
• This study aimed to understand the association of introducing and lifting NPIs with the level of transmission of SARS-CoV-2, as measured by the time-varying reproduction number (R), from a broad perspective across 131 countries.

Source: The Lancet

Cefiderocol versus high-dose, extended-infusion meropenem for the treatment of Gram-negative nosocomial pneumonia (APEKS-NP): a randomised, double-blind, phase 3, non-inferiority trial

• Nosocomial pneumonia due to multidrug-resistant Gram-negative pathogens poses an increasing challenge.
• This study compared the efficacy and safety of cefiderocol versus high-dose, extended-infusion meropenem for adults with nosocomial pneumonia.
• Cefiderocol was non-inferior to high-dose, extended-infusion meropenem in terms of all-cause mortality on day 14 in patients with Gram-negative nosocomial pneumonia, with similar tolerability.
• The results suggest that cefiderocol is a potential option for the treatment of patients with nosocomial pneumonia, including those caused by multidrug-resistant Gram-negative bacteria.

Source: The Lancet

Efficacy and safety of cefiderocol or best available therapy for the treatment of serious infections caused by carbapenem-resistant Gram-negative bacteria (CREDIBLE-CR): a randomised, open-label, multicentre, pathogen-focused, descriptive, phase 3 trial

• New antibiotics are needed for the treatment of patients with life-threatening carbapenem-resistant Gram-negative infections.
• In this study they assessed the efficacy and safety of cefiderocol versus best available therapy in adults with serious carbapenem-resistant Gram-negative infections.
• Cefiderocol had similar clinical and microbiological efficacy to best available therapy in this patient population.
• The findings from this study support cefiderocol as an option for the treatment of carbapenem-resistant infections in patients with limited treatment options.
• Funding

Source: The Lancet

Safety, immunogenicity, and efficacy of a Clostridioides difficile toxoid vaccine candidate: a phase 3 multicentre, observer-blind, randomised, controlled trial

• In the absence of a licensed vaccine, Clostridioides (formerly Clostridium) difficile infection represents a substantial health burden.
• The aim of this study was to evaluate the efficacy, immunogenicity, and safety of a toxoid vaccine candidate.
• In adults at risk for C difficile infection, a bivalent C difficile toxoid vaccine did not prevent C difficile infection.
• Since the C difficile vaccine candidate met the criteria for futility, the study was terminated and clinical development of this vaccine candidate was stopped.

Source: The Lancet

Pfizer vaccine found to give strong immune response to new Covid variants

• People who have received two doses of the Pfizer vaccine have been found to have strong T-cell responses against the Kent and South African variants of Covid, suggesting that the vaccine will continue to protect against serious disease in the coming months.
• In the first study to test immune responses against the variants circulating in populations, researchers found that although antibody responses against the new variants were blunted, they may still be high enough to protect most people from becoming infected, after a second dose of vaccine has been given.

Source: The Guardian

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