ALTIMMUNE COVID-19 VACCINE CANDIDATE PREVENTS SARS-COV-2 DISEASE IN STUDIES

US-based Altimmune has reported that additional preclinical data on its single dose intranasal Covid-19 vaccine candidate, AdCOVID, showed 100% protection against lethal challenge from the SARS-CoV-2 virus, and reduction in viral replication.

The preclinical studies were undertaken at University of Alabama at Birmingham and Saint Louis University, both of which serve as the collaborating institutions of the clinical-stage biopharmaceutical firm.

According to the data derived through the K18-hACE2 transgenic mouse model, a single intranasal dose of AdCOVID not only offered complete protection against SARS-CoV-2 virus, but that all animals had also survived and showed no weight loss.

Initial analysis of immunogenicity indicated mean antibody levels of about 1 mg/mL. This in turn showed that the serum IgG antibody response against the spike protein was strong and similar to that reported by the company earlier.

EU COUNTRIES SUSPEND USE OF COVID-19 VACCINE ASTRAZENECA

Several countries in Europe have suspended the University of Oxford/AstraZeneca Covid-19 vaccine completely or partially after several suspected deaths were reported due to blood clotting following vaccination.

The countries that have banned the use of the vaccine following similar reports of blood clots include Denmark, Norway, Iceland, Austria, Italy, Bulgaria, Romania, Estonia, Lithuania, Luxembourg and Latvia.

The Indo-Asian News Service reported that Bulgaria Prime Minister Boyko Borissov has ordered the suspension of the vaccine "until an accurate and clearly confirmed diagnosis comes from the European Medicines Agency".

In response to the statement, the company said that a review of safety data for more than 17 million people vaccinated with AstraZeneca showed no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia in any age group or gender.

PFIZER REPORTS REAL-WORLD EVIDENCE FOR COVID-19 VACCINE IN ISRAEL

The Israel Ministry of Health (MOH), Pfizer and BioNTech have reported real-world evidence showing significantly reduced incidence rates of Covid-19 in fully vaccinated people.

The Pfizer-BioNTech Covid-19 vaccine (BNT162b2) is based on the latter’s mRNA technology and authorised for emergency use in over 60 countries.

The latest data build upon and reinforce earlier evidence from the MOH showing the vaccine’s effectiveness in preventing symptomatic SARS-CoV-2 infections, Covid-19 cases, hospitalisations, severe and critical hospitalisations and deaths.

According to the latest information, protection is more robust two weeks after the second vaccine dose. Also, the vaccine showed at least 97% effectiveness in preventing symptomatic disease, severe and critical disease and death.

In addition, the analysis showed a 94% vaccine effectiveness against asymptomatic disease.

Pfizer noted that this real-world evidence could be important to all nations as they advance their inoculation campaigns a year after the WHO declared Covid-19 a pandemic.

NOVAVAX’S VACCINE SHOWS GREATER EFFICACY AGAINST COVID-19 VARIANT

Novavax has reported that data from a pivotal Phase III trial of its vaccine candidate, NVX–CoV2373, in the UK showed an efficacy of 96.4% against mild, moderate and severe disease caused by the original Covid-19 strain.

A protein-based vaccine candidate, NVX-CoV2373 is engineered from the genetic sequence of SARS-CoV-2.

The Phase III trial enrolled over 15,000 subjects aged between 18 and 84 years.

Data showed that the vaccine’s efficacy was 96.4% against the original virus strain and 86.3% against the B.1.1.7/501Y.V1 variant circulating in the UK.

The primary efficacy endpoint showed an overall vaccine efficacy of 89.7%. Of 106 cases detected, ten were in the vaccine arm while 96 in the placebo arm.

The randomised, observer-blinded, placebo-controlled South Africa Phase IIb clinical trial of NVX-CoV2373 had two cohorts.

One cohort analysed efficacy, safety and immunogenicity in 2,665 healthy adult subjects while the second cohort analysed safety and immunogenicity in 240 medically stable, HIV-positive adults.

EMA APPROVES FOURTH COVID-19 VACCINE, J&J’S SINGLE-SHOT CANDIDATE

The European Medicines Agency (EMA) has recommended conditional marketing authorisation for Johnson & Johnson (J&J) subsidiary Janssen’s Covid-19 vaccine.

Janssen’s Covid-19 vaccine is the fourth to be recommended for use in adults in the EU; it follows vaccines produced by Pfizer/BioNTech, Moderna and AstraZeneca/Oxford.

Like the AstraZeneca/Oxford vaccine, it is an adenovirus product and relies on Janssen’s proprietary AdVac platform.

The J&J vaccine is the first approved jab that is designed to be effective after a single dose. The other approved vaccines require two doses spaced over a number of weeks for optimal immunisation.

The recommendation came after a thorough evaluation by the EMA’s Committee for Medicinal Products for Human Use of clinical trial data submitted by J&J in December.

The committee determined that the data for the vaccine was robust and met the criteria for efficacy, safety and quality.

In the Phase III ENSEMBLE study, which was carried out in the US, South Africa, as well as countries across Latin America, Janssen’s Covid-19 vaccine was found to be 67% effective at preventing symptomatic Covid-19 and 85% effective at preventing severe disease.

LILLY’S COMBINATION THERAPY LOWERS HOSPITALISATION, DEATH IN COVID-19 TRIAL

Eli Lilly and Company has reported that new data from BLAZE-1 Phase III study of bamlanivimab (LY-CoV555) 700mg and etesevimab (LY-CoV016) 1400mg combination showed significant reduction in Covid-19 linked hospitalisations and deaths in high-risk patients.

The randomised, double-blind, placebo-controlled trial analysed bamlanivimab 2,800mg plus etesevimab 2,800mg versus placebo, and bamlanivimab 700mg plus etesevimab 1,400mg versus placebo.

Results showed four events in patients receiving bamlanivimab plus etesevimab while 15 events in patients receiving placebo, indicating an 87% risk reduction.