the staff of the Ridgewood Blog
Oxford UK, according to Johns Hopkins Center for Health Security, less than a week after suspending Phase 3 clinical trials for its candidate SARS-CoV-2 vaccine due to a serious adverse event, AstraZeneca announced that the trials have resumed in the UK. According to a press release issued by AstraZeneca, the trials resumed after the UK government’s Medicines Health Regulatory Authority (MHRA) evaluated the evidence and determined that it was safe to continue testing the vaccine. The press release states that AstraZeneca and the University of Oxford are not permitted to “disclose further medical information” regarding the adverse event, presumably including the associated safety data reviewed by MHRA or the results of their analysis. It appears that the Phase 3 trials in other countries remain on hold.
The CEO of Pfizer, Inc., announced that the company could be ready to begin distributing its candidate SARS-CoV-2 vaccine to the American public by the end of 2020. In support of this effort, Pfizer received approval to expand its Phase 3 clinical trial from 30,000 participants to 44,000 in order to more quickly collect necessary safety and efficacy data. A press release published by Pfizer indicates that expanding the study would “further increase trial population diversity” and allow for the inclusion of children aged 16 years and older and those with various pre-existing health conditions. Pfizer (and collaborator BioNTech) expects to have preliminary findings by the end of October.
Experts have criticized both AstraZeneca and Pfizer for their lack of transparency with respect to their candidate vaccines and associated clinical trials. These experts argue that the companies should publish more information, both in terms of trial study design and data analysis in order to build confidence among the public in advance of future availability. This could be particularly important in light of the recent pause in AstraZeneca’s trials and speculation regarding the nature of the participant’s serious adverse event.
Remdesivir is one of the few treatments available for COVID-19 with an Emergency Use Authorization (EUA) from the US FDA. Reports during the summer warned of shortages of remdesivir for hospitals in need, but officials from the US Department of Health and Human Services have recently noted that purchases of the antiviral have slowed. State and territory public health systems accepted only 72% of their allocation, and hospitals purchased only two-thirds of that supply. It appears that overall demand for the drug in hospitals has decreased since the US summer resurgence. Additionally, while the FDA expanded the authorization to include any hospitalized patient, some facilities are limiting its use to more severely ill patients. Despite the decreased demand, some hospitals continue to stockpile remdesivir in anticipation of a surge during the fall and winter months.