22 February 2021
Pfizer and BioNTech have submitted new data to the US Food and Drug Administration (FDA) that showed their Covid-19 vaccine was stable when stored between -25°C and -15°C (-13°F to 5°F), which is temperatures of pharmaceutical freezers. This data will be used to support a proposed update to the companies’ US emergency use authorisation (EUA) prescribing information to allow the vaccine to be stored at these temperatures for two weeks as an alternative to a ultra-low temperature freezer of -80°C.
Johnson & Johnson (J&J) has submitted an emergency use listing to the World Health Organization (WHO) for its single-dose Janssen Covid-19 vaccine candidate. The data package submitted includes interim efficacy and safety results from a Phase III ENSEMBLE clinical trial. This means J&J has completed its rolling data submission to the WHO.
Chugai Pharmaceutical has concluded a license agreement with Roche to develop and market AT-527, a new oral drug for Covid-19, in Japan. Global Phase II clinical studies of AT-527 are currently ongoing in mild to moderate Covid-19 patients. AT-527 was created by Atea Pharmaceuticals in the US, but it is being jointly developed with Roche. As a result of this deal, Chugai now has exclusive rights to develop and market AT-527 in Japan.
According to Nikkei, Fujifilm Holdings will restart clinical trials of Avigan, its antiviral drug for treating Covid-19, in Japan. The drug’s approval was delayed because of inconclusive trial data, according to a Japanese health ministry panel in December 2020. The new study will involve approximately 270 patients and Fujifilm will seek approval again in October 2021.