The FDA has given emergency use authorization to Abbott for its AdviseDx, a lab-based COVID-19 antibody blood test.
Pre-purchase agreements to manage risk and new methods of using structural proteins or genetic material have enabled rapid development of COVID-19 vaccines. Historically, medical innovation has been spurred by crisis, and many of the innovations accelerated by the pandemic are likely to remain.
The political climate and supply shortages during the COVID-19 pandemic have ignited interest in reshoring manufacturing of US products, but there are considerable barriers to doing so, and 71% of US manufacturers surveyed by the American Chamber of Commerce in Shanghai said they don't plan to move production out of China. Reshoring pharma production would require significant investment as well as changes in the US tax code, which encourages research and development in the US and production abroad -- particularly in Belgium, Ireland, the Netherlands, Singapore and Switzerland.
Manufacturers of in vitro diagnostics typically don't have much excess manufacturing capacity, so industry leaders had to invest heavily in production and other capabilities to scale up production of COVID-19 tests, especially rapid antigen tests. Planning new facilities takes time, and shortages of parts, personnel and materials have complicated efforts to scale rapidly, but the market could soon be flooded with equipment and raw materials as supply lines catch up with demand.
Much of the world's air freight, including pharmaceuticals, is moved in passenger aircraft, and reduced capacity as passenger travel remains limited is one of the challenges the airline industry must manage as it plans for distribution of a COVID-19 vaccine, says Julian Sutch, who oversees Emirates SkyCargo's pharmaceutical division. Moreover, the volume of dry ice allowed on aircraft is limited, complicating the shipment of vaccines that require extremely cold storage, Sutch says.
Researchers have harnessed a process known as antibody affinity maturation in a study that could pave the way to a universal influenza vaccine. The idea is to train B cells to bind to the stable stalk of hemagglutinin protein on the virus' surface instead of to the HA protein head, which is subject to mutation, and animal studies suggest the approach prompts production of broadly neutralizing antibodies.
When dealing with new infectious diseases like SARS-CoV-2, it can be challenging to determine what safety measures laboratories should implement to protect their staff. The CDC recommends that each lab perform activity- and site-specific risk assessments to come up with safety measures that fit the laboratory's unique needs, writes Reynolds Salerno, CDC director of the division of laboratory systems.
The National Institutes of Health, in collaboration with the Biomedical Advanced Research and Development Authority under the Rapid Acceleration of Diagnostics initiative, will be awarding $98.35 million in contracts to Quanterix, Luminostics, Ellume USA, Flambeau Diagnostics, Ubiquitome and Visby Medical to aid in the development of COVID-19 testing technology.
Needlepoint bipolar ionization, ultraviolet light and MERV-13 filters are among the top strategies for controlling and preventing the spread of viruses in buildings, Phil Zito writes. UV light treatment might require a retrofit and NPBI systems can be pricey, but the systems often can be combined to effectively sterilize indoor air, Zito writes.
The White House has approved more stringent FDA standards for Emergency Use Authorization of COVID-19 vaccines after the FDA published the standards as part of a briefing for an advisory panel of vaccine experts. Vaccine developers will need two months of follow-up data from at least 50% of trial participants after the final dose is administered, meaning there is unlikely to be any EUA before the end of November.