COVID-19

Premas Biotech announced that its joint venture Oravax will initiate testing of their oral virus-like particle (VLP) vaccine candidate against Omicron variant of SARS-CoV 2 virus through preclinical, in vitro and challenge studies to assess its efficacy for the new mutant strain. Premas Biotech, Oramed Pharmaceuticals, MyMD Pharmaceuticals, and certain other shareholders formed Oravax Medical to bring an oral COVID-19 vaccine to the market.

SARS-CoV-2 has affected more than 200 million people causing more than 5 million deaths worldwide as per the WHO statistics. The rise in mutant variants of SARS-CoV-2 virus has led to concerns regarding vaccine effectiveness. Delta (B.1.617.2) variant is the predominant strain in India. The vaccination programme in India is driven largely by the Covishield vaccine (ChAdOx1 nCoV-19).

A large analysis of health records from 87 health care centers across the United States found that people taking a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs), particularly fluoxetine, were significantly less likely to die of COVID-19 than a matched control group.

Zydus Cadila has received an order to supply one crore doses of ZyCoV-D, the world’s first Plasmid DNA Vaccine, to the Government of India at Rs. 265 per dose and the needle-free applicator being offered at Rs. 93 per dose, excluding GST. The pricing has been decided in consultation with the Government of India.

Celltrion Group announced that the European Medicine’s Agencys Committee for Medicinal Products for Human Use (CHMP) issued a positive scientific opinion recommending marketing authorisation for regdanvimab (CT-P59), a monoclonal antibody treatment for adults with COVID-19 that do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. The CHMP positive opinion is a scientific recommendation to the European Commission (EC), which authorises marketing approval in the European Union.

Clotting problems and resulting complications are common in COVID-19 patients. Researchers at the Medical University of Vienna have now shown that a member of the anticoagulant group of drugs not only has a beneficial effect on survival of COVID-19 patients, but also influences the duration of active infection with the SARS-CoV-2 coronavirus. The results were recently published in the journal Cardiovascular Research.

Premas Biotech, a developer of novel biotherapeutic and vaccine candidates announced that Oravax Medical Inc., a US based company that Premas Biotech is a partner in, has received clearance from the South African Health Products Regulatory Authority to commence patient enrollment in a first in human, Phase 1 clinical trial, for its oral COVID-19 vaccine; and preparations to begin the trials are now underway.

Pfizer Inc and BioNTech SE announced that the U.S. Food and Drug Administration has authorized for emergency use the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred to as 5 to <12 years). For this age group, the vaccine is to be administered in a two-dose regimen of 10-µg doses given 21 days apart. The 10-µg dose level was carefully selected based on safety, tolerability and immunogenicity data. This is the first COVID-19 vaccine authorized in the U.S. for individuals 5 through 11 years of age.

Antibodies in the airways quickly wane after SARS-CoV-2 infection, but vaccination results in a strong increase in antibody levels, especially after two doses, according to a new study from Karolinska Institutet in Sweden published in the journal JCI Insight. The results suggest that having a second dose of vaccine also after recovering from COVID-19 may be important for protecting against re-infection and to prevent transmission.