Nordic Life Science 1
PH A SE I I GLOBA L REP OR T Nine leading vaccine
developers have signed a pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. THE CEOS OF ASTRAZENECA, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck (known as MSD outside the United States and Canada), Moderna, Novavax, Pfizer and Sanofi have announced what they call historic pledge outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines. The vaccine makers said they will stand with science at a time when the world is looking to science – in particular to a vaccine – to help bring us to the end of the pandemic. The companies pledge to always make the safety and well-being of vaccinated individuals their top priority, continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes, only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA, and to work to ensure a sufficient supply and range of vaccine options, including those suitable for global access. The statement is perhaps particularly important in the US, where President Trump has pushed for a vaccine before the presidential election. “There’s absolutely a desperate need for this vaccine,” said Judith Feinberg, the Vice Chair for Research in Medicine at West Virginia University in Morgantown to the New York Times. “I love the fact that the nine big vaccine manufacturers today said they would not do anything premature – I think there’s enormous pressure to do something premature.” ANTI-GBM ANTIBODY DISEASE, also known as Goodpasture’s disease, is a severe autoimmune disease where the immune system mistakenly develops IgGantibodies directed against the glomerular basement membrane (GBM), resulting in an acute immune attack causing severe kidney injury and, in some patients, also injuring the lungs. The results indicate that imlifidase treatment may lead to increased renal survival in patients with anti-GBM antibody disease due to rapid clearance of IgG antibodies. The study enrolled 15 subjects. At inclusion, ten of the patients were dialysis-dependent, including five who were oliguric/anuric, while five patients were dialysis-independent but had eGFR levels below 15 ml/ min. Six hours after imflidase no patient had anti-GBM antibody levels above the normal range. At six months, ten patients were dialysis-independent. Four patients were dialysis-dependent, while one patient had died. Søren Tulstrup, CEO, Hansa Biopharma PHOTO BIONTECH