The United Kingdom’s Medicines & Healthcare Products Regulatory Agency (MHRA) granted temporary authorization for emergency use to Pfizer and BioNTech for the companies’ mRNA vaccine BNT162b2, marking the first Western country EUA for a Covid-19 vaccine.
Moderna Inc.’s Covid-19 vaccine could be approved for emergency use within 24 to 72 hours after the U.S. health regulator’s advisory committee meeting, Chief Executive Officer Stéphane Bancel said.
Defying Skeptics, Pfizer and Moderna Gun for Global Covid-19 Vaccine Approval
BioNTech, China, Clinical Trials, Covid-19 Data, COVID-19 Vaccines, Drug Distributors, Emergency Use Authorization, Europe, European Medicines Agency, FDA/Regulatory, Health Canada, McKesson, Medicines and Healthcare products Regulatory Agency (MHRA), Moderna, NPR, Oxford University, Oxford University’s Jenner Institute, Pfizer, Product Pipelines, R&D, Russia, SwissMedic, United KingdomIf all things go well, the Pfizer-BioNTech Covid-19 vaccine will receive EUA from the U.S. Food and Drug Administration around December 10 or within a few days after, and the Moderna vaccine will receive EUA around December 17 or within a few days after.
Covid-19 vaccine sprint as Pfizer-BioNTech, Moderna seek emergency EU approval
BioNTech, Clinical Trials, Coronavirus Disease (COVID-19) Pandemic, COVID-19 inoculations, COVID-19 Vaccines, Europe, European Medicines Agency, Johnson & Johnson, Messenger RNA (mRNA) Vaccines, Moderna, Pfizer, R&D, Rolling Review, United StatesModerna and Pfizer-BioNTech are in a tight race to launch their Covid-19 vaccines in Europe after the companies applied for emergency EU approval on Dec. 1, though there was uncertainty over whether a rollout could begin in 2020.
Europe’s health regulator started a real-time review of Johnson & Johnson’s Covid-19 vaccine candidate after preliminary results showed that the shot triggered the production of antibodies and immune cells against the virus.
Moderna Inc. applied for U.S. emergency authorization for the company’s Covid-19 vaccine after full results from a late-stage study showed mRNA-1273 was 94.1% effective with no serious safety concerns.
Moderna’s Covid-19 Vaccine Heads to FDA for Emergency Use Authorization
BioNTech, COVID-19 cases, Covid-19 Data, COVID-19 Vaccines, Emergency Use Authorization, FDA, Interim Analysis, Messenger RNA (mRNA) Vaccines, Moderna, National Institute of Allergy and Infectious Diseases (NIAID), Pfizer, Placebo, Secondary Endpoints, U.S. Centers for Disease Control and PreventionModerna announced plans to submit the company’s request to the U.S. Food and Drug Administration for an Emergency Use Authorization (EUA) for the Covid-19 vaccine mRNA-1273 on Nov. 30.
Airlines Gear Up to Fly Covid-19 Vaccines to U.S. Distribution Sites
"Operation Warp Speed" Initiative, Advisory Committees, Airlines, Belgium, BioNTech, Business, COVID-19 Vaccines, Distribution, Emergency Use Authorization, FDA, Federal Aviation Administration (FAA), Michigan, Pfizer, U.S. Department of Transportation (USDOT)With both Pfizer-BioNTech and Moderna’s Covid-19 vaccines at the U.S. Food and Drug Administration awaiting potential Emergency Use Authorization (EUA), airlines are preparing their cargo operations to ship the vaccines.
Ten Covid-19 vaccines seen by mid-2021, head of global pharma group says
AstraZeneca, Big Pharma, BioNTech, Biotech, Business, Clinical Trials, Coronavirus Disease (COVID-19) Pandemic, COVID-19 Vaccines, India, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Moderna, Patents, Pfizer, R&D, South Africa, World Trade Organisation (WTO)Ten Covid-19 vaccines could be available by the middle of 2021 if they win regulatory approval, but their inventors need patent protection, the head of the global pharmaceutical industry group said.
Despite the constant need for social distancing, mask-wearing and the isolation and economic uncertainty that resulted from the Covid-19 outbreak, there is still much to be thankful for when families gather around a virtual table to break bread and carve the turkey this year.