After working 24/7 to develop a COVID-19 vaccine in a historic timeframe and scale up manufacturing at an unprecedented rate, some vaccine manufacturers are now facing what appears to be a concerted Russian misinformation campaign akin to those used in the last two U.S. presidential campaigns, as well as in Great Britain and possibly in France.
Pfizer Inc. and Biontech SE submitted new data to the FDA showing its COVID-19 vaccine’s stability can be maintained at temperatures often found in pharmaceutical freezers and refrigerators: -13°F to 5°F (-25°C to -15°C). That’s cold but not nearly as cold as the mRNA-based vaccine’s emergency use authorization label calls for, which is storage in an ultra-cold freezer at temps of between -112 to -76 degrees Fahrenheit (-80 and -60 degrees Celsius).
LONDON –The Russian COVID-19 vaccine Sputnik V now has validation from the Western science establishment, after The Lancet published full interim results of the phase III trial on Feb 2. The peer-reviewed paper confirms the 91%-plus efficacy that the vaccine’s developer, Gamaleya National Center of Epidemiology and Microbiology, claimed in its own announcement of the results in December.
The Sanofi SA-Glaxosmithkline plc COVID-19 vaccine program is taking a step backward to recalibrate as weak interim phase I/II data showed an insufficient response in patients age 50 and older. The step is a large one, delaying a potential launch until mid-2021 at the earliest and the end of next year at the latest.
LONDON – Efficacy data for Russia’s Sputnik V COVID-19 vaccine held steady at 91.4% in the second interim analysis, conducted after 39 confirmed cases of COVID-19 infection in 18,794 volunteers, seven days after they received the second dose.
In a world more familiar with the 30% to 70% efficacy rates of seasonal flu vaccines, news of 95% efficacy rates for two of the major late-stage COVID-19 vaccines in development seems thrilling. But do such robust-sounding numbers, the product of relatively early analyses, really merit the enthusiasm they’ve garnered?
LONDON – A second COVID-19 vaccine has reported positive results in an interim phase III analysis, with Russia’s Sputnik V showing 92% efficacy. The news comes two days after the first readout from a phase III COVID-19 vaccine trial reported 90% efficacy for Pfizer Inc. and Biontech SE’s BNT-162b2.
CAJICA, Colombia – The Russian vaccine candidate Sputnik V, developed by Moscow’s Gamaleya National Research Institute of Epidemiology and Microbiology to prevent the SARS-CoV-2 virus that causes COVID-19, is undergoing phase III trials in Venezuela under complete secrecy.
