Avazo-Healthcare warned by the FDA about its coronavirus disease 2019 (COVID-19) testing kits; Pfizer, BioNTech get first COVID-19 vaccine approval; risk for Guillan-Barré syndrome from flu vaccine deemed insignificant.
In a warning letter, the FDA has instructed Avazo-Healthcare to take immediate action and cease the sale of 2 coronavirus disease 2019 (COVID-19) antigen test kits and several serology test kits, citing they do not have market approval or authorization for direct-to-consumer sales. The FDA is also accusing the limited liability corporation of failing to notify the federal agency that it would be introducing the tests for distribution. The letter also included a warning to rectify potential false claims that the company’s cannabidiol products can prevent, mitigate, and treat COVID-19.
An emergency authorization was handed down from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency for Pfizer and BioNTech’s COVID-19 vaccine, reported The New York Times. A total of 800,000 doses could be ready for distribution next week, and 40 million doses have been pre-ordered. The fast-tracked approval came about due to Britain being allowed to circumnavigate the European Union’s typical regulatory process in public health emergencies. The FDA is set to meet on December 10 and 17 to discuss approving the Pfizer/BioNTech and Moderna vaccines for use in the United States.
According to study results published in The Journal of Infectious Diseases, the risk for this rare disease, in which the immune system attacks nerves, is statistically insignificant in light of the benefits the flu vaccine bestows on older Americans. Just 1 case of Guillain-Barré was seen in the risk (days 8-21 and 1-42 post vaccination) and control (days 43-84 post vaccination) windows of the study, which saw close to 22 million patients receive the high-dose influenza vaccine during the 2018-2019 flu season.