The World Health Organization (WHO) has listed the COVID-19 mRNA vaccine for emergency use, making the Pfizer/BioNTech vaccine the first to receive emergency validation from WHO since the outbreak began a year ago. The WHO’s Emergency Use Listing (EUL) opens the door for countries to expedite their own regulatory approval… Read More
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided authorisation for emergency supply of the Oxford University AstraZeneca COVID-19 vaccine for the active immunisation of individuals 18 years or older. The authorisation recommends two doses administered with an interval of between four and 12 weeks. This regimen was shown… Read More
The UK government has accepted the recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA) to authorise the emergency use of the ChAdOx1 nCoV-19 coronavirus vaccine in the UK. The Joint Committee on Vaccination and Immunisation (JCVI) will also publish its latest advice for the priority groups to receive… Read More
The FDA has issued an Emergency Use Authorization (EUA) to Moderna, for its COVID-19 vaccine, which was co-developed with scientists at the NIH National Institute of Allergy and Infectious Diseases (NIAID) and Moderna. This partnership has enabled NIH and Moderna to develop a COVID-19 vaccine within a year that will… Read More
Moderna has announced that the FDA has authorised the emergency use of mRNA-1273, its vaccine against COVID-19 in individuals 18 years of age or older. The vaccine is now authorised for distribution and use under an Emergency Use Authorisation (EUA). Delivery to the US government will begin immediately. Moderna will… Read More
Researchers from the University of Oxford have published further data from the Phase I/II clinical trials of the ChAdOx1 nCoV-19 coronavirus vaccine, evidencing the decision to move to a two-dose regimen in ongoing Phase III trials, and how ChAdOx1 nCov-19 is induces broad antibody and T cell functions. These findings… Read More
The University of Queensland (UQ) and CSL have said that the Phase I trial of the UQ-CSL v451 COVID-19 vaccine has shown that it elicits a robust response towards the virus and has a strong safety profile. There were no serious adverse events or safety concerns reported in the 216… Read More
Genetic evidence is second only to clinical trials as a way to tell which treatments will be effective in a disease. Existing drugs that target the actions of the genes reveal which drugs should be repurposed to treat COVID-19 in clinical trials, experts say. Genes involved in two molecular processes… Read More
Pfizer and BioNTech have announced that the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) have voted to recommend the use of the Pfizer-BioNTech COVID-19 vaccine in people 16 years of age and older under the Emergency Use Authorization (EUA) issued by the Food… Read More
The US Food and Drug Administration (FDA) has authorised the use of the Pfizer BioNTech mRNA vaccine, BNT162b2, against COVID-19 in individuals 16 years of age or older. The vaccine is authorized under an Emergency Use Authorization (EUA) while Pfizer and BioNTech gather additional data and prepare to file a… Read More
Sanofi and GSK have announced a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in older adults. Phase I/II study interim results showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years, but a low immune response… Read More
Fusion Antibodies, pre-clinical antibody discovery, engineering and supply experts, and Queen’s University Belfast, have been awarded a £453,000 grant from Invest Northern Ireland to further expand their COVID-19 targeted research and development efforts. Within the framework of their Northern Ireland Coronavirus Antibody Development Alliance (NICADA), the two organisations will use… Read More
Moderna has announced that the first adolescent participants have been dosed in the Phase II/ III study of mRNA-1273, its vaccine candidate against COVID-19, in adolescents ages 12 to less than 18. The study is being conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of… Read More
Novavax has appointed Margaret McGlynn, to its board as an independent director. She has extensive pharmaceutical industry, vaccine and non-profit experience to her role on the Novavax Board of Directors. “Margie’s deep experience in vaccine commercialisation and understanding of global public health will be invaluable as we move closer to… Read More
The new CPhI report looks ahead to a post-pandemic 2021 with pharma manufacturing capacity and payment structures shifting as new sourcing strategies emerge. It explores the potential implications in 2021 of impending vaccine approvals, a new administration in the White House and a return to dual supply chain strategies. The report… Read More
A new report on the public’s attitudes towards coronavirus vaccines has revealed that around half of those surveyed (51%) may be willing to get vaccinated next year. Findings from a survey of 13,500 people across 15 countries* in November suggest that fewer would be willing if a vaccine were to… Read More
