US Real-World Evidence On COVID-19 Vaccine Safety Is Inadequate, Former HHS Official Says
US government does not have an adequate system to monitor vaccine safety in real time, Nicole Lurie, former assistant secretary for emergency preparedness says. Low-income countries sometimes do not receive same COVID product that FDA reviewed, a former agency official notes.
You may also be interested in...
CBER Reorganization Aims To Fight Recruitment Challenges, Tackle Upcoming Gene Therapy Wave
A growing focus on real-world evidence and an expected infusion of user fee funding are among the reasons for the new office branches at US FDA’s biologics center.
US FDA’s Confidentiality Policies Seen As Big EUA Shortcoming
System needs to be changed to enable US FDA to share COVID-19 application data and inspection reports with other regulatory authorities, stakeholders urge. Merck’s Julie Gerberding and former FDA Commissioner Hamburg criticize company announcement of data via press release prior to submission.
CDC Data More Positive on Myocarditis Benefit-Risk Than FDA’s Assessment of Pfizer’s Vaccine
Updated modeling on heart events in young adults presented to CDC’s vaccine advisors points towards much lower rates of the adverse event from mRNA vaccines than some of FDA’s modeling.