“You may choose to look the other way, but you can never say again that you did not know.”
— William Wilberforce
The European Medicines Agency (EMA) last week added an autoimmune condition known as Guillain-Barré syndrome (GBS) as a possible side effect to the product information on AstraZeneca/Oxford University’s Vaxzevria (or “AZD1222”) experimental adenovirus vectored vaccine. GBS is a neurological disorder that causes pain, numbness, muscle weakness and sometimes paralysis.1 2 3 4 A total of […]
On Aug. 23, 2021, the U.S. Food and Drug Administration (FDA) gave full approval to a Biologics License Application (BLA) submitted by BioNTech Manufacturing GmbH of Mainz, Germany on May 18, 2021 for a biologic drug called COVID Vaccine, mRNA. The FDA gave permission to BioNTech to label the product “Comirnaty” and market it in […]
The European Union has announced that it will be officially launching a digital COVID-19 certificate for all E.U. citizens and residents, as well as for specific categories of travelers by July 1, 2021.1 What is the Digital COVID-19 Certificate? The E.U. Digital COVID Certificate is a mobile app that provides information such as the digital […]
On May 12, 2021, the French National Assembly passed a bill approving the use of a COVID pass sanitaire or “health pass.” The pass, which would be in digital form or paper, would be required as of June 9 to prove an individual has either been fully vaccinated for COVID-19, recently tested negative for SARS-CoV-2 […]
Last week was a bad one for COVID-19 biologics produced by Moderna, Inc. and Johnson & Johnson, Inc. (J&J). News reports began filtering out about new research from the U.S. Centers for Disease Control and Prevention (CDC), which were published on Apr. 5, 2021 in the journal JAMA and revealed that people who receive Moderna’s […]
The European Commission really doesn’t want this to be called a vaccine passport. They’re calling it a digital green pass or certificate, and this would essentially be in the form of a QR code—those funny little square barcodes that we’re all getting so used to seeing around in restaurants and things to scan and find […]
Health officials in Germany have cautioned that the AstraZeneca/Oxford University COVID-19 vaccine (AZD1222) should not be given to people over the age of 65. Germany’s disease control agency, the Robert Koch Institute, only recommends the shot for people between the ages of 18-64 after concluding that there is not enough data available to determine whether the […]
Biopharmaceutical company CureVac NV of Tübingen, Germany has released the interim results of its Phase 1 clinical trial on its experimental CVnCoV vaccine COVID-19. The vaccine, which was given to more than 250 healthy adults 18 to 60 years of age, is based on messenger ribonucleic acid (mRNA) technology.1 2 Unlike traditional vaccines, mRNA vaccines […]
Vaccines Europe, a pharmaceutical industry lobbying group, has issued a memo to its member companies saying it would seek liability protection from the European Union (EU) for corporations manufacturing COVID-19 vaccines. The memo, obtained by the Financial Times, expressed concern about the “inevitable risks” of rushing the development and global marketing of COVID-19 vaccines.1 2 3 […]
There appears to be a consensus opinion among leading public health authorities that a coronavirus vaccine for COVID-19 would take at least 12-18 months to develop, test and be ready for market distribution. The projection assumes that an aggressive development schedule would produce a licensed vaccine proven safe and effective for use in humans no […]