COVID-19

Japan has suspended the use of around 1.63 million doses of the Moderna vaccine due to contamination, which the health ministry confirmed resulted from “foreign materials” in an unused batch of roughly 560,000 vials, according to BBC reports.   According to the news site, Takeda Pharmaceutical, which sells and distributes the vaccine in Japan, said Moderna had put […]

Moderna has completed the rolling submission process for its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for the full licensure of the its Covid-19 vaccine for active immunisation to prevent Covid-19 in individuals 18 years of age and older. As part of the completed BLA submission, Moderna has requested Priority Review designation.   “This BLA submission for our Covid-19 vaccine, […]

The US Food and Drug Administration (FDA) has approved the Biologics License Application for the Pfizer-BioNTech Covid-19 vaccine. It will now be marketed as Comirnaty for the prevention of Covid-19 disease in individuals 16 years of age and older.  It is the first COVID-19 vaccine to be granted approval by the FDA.  The vaccine continues to be available under emergency use authorisation (EUA), including for individuals […]

Valneva has begun a rolling submission for initial approval of its Covid-19 vaccine candidate, VLA2001, with the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. VLA2001 is a whole virus, inactivated, adjuvanted vaccine candidate and is the only vaccine candidate of this type currently in clinical trials in Europe.  VLA2001 is currently being […]

New data has been published on the durability of the Moderna Covid-19 vaccine in generating neutralising antibodies against variants. The manuscript was published in Science.   “We are pleased with these new data showing that people vaccinated with two doses of the Moderna Covid-19 vaccine maintained antibodies through six months, including against variants of concern such as the Delta variant. Along with our partners, we […]

Following a thorough review of evidence carried out by the Medicines and Healthcare products Regulatory Agency (MHRA) and recommendation by the Commission on Human Medicines (CHM), the UK government’s independent expert scientific advisory body, the MHRA has approved Ronapreve as the first monoclonal antibody combination product indicated for use in the prevention and treatment of acute Covid-19 […]

A pilot study has begun to assess the antibody response to a third dose of an authorised Covid-19 mRNA vaccine in kidney transplant recipients who did not respond to two doses of the Moderna or Pfizer-BioNTech Covid-19 vaccine. The Phase II trial is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the […]

CureVac and GSK have published preclinical data investigating immune responses as well as the protective efficacy of CureVac’s first-generation vaccine candidate, CVnCoV, and second-generation vaccine candidate, CV2CoV, against SARS-CoV-2 challenge in non-human primates.   The study, conducted in collaboration with Harvard Medical School, assessed cynomolgus macaques vaccinated with 12µg of either the first or second-generation […]

Moderna has announced that the U.S. Food and Drug Administration (FDA) has approved an update to the emergency use authorisation for the Moderna Covid-19 vaccine (mRNA-1273) to include a third dose for immunocompromised individuals. The third dose will available to people 18 years of age or older in the United States who have undergone solid […]

Mount Sinai researchers have made headway in treating a rare but serious aftereffect of Covid-19 in children, known as multisystem inflammatory syndrome in children or MIS-C. The study was published in Nature Communications. The researchers reported that RNA sequencing of blood samples from the Mount Sinai Covid-19 Biobank led to the discovery that specific infection-fighting […]