While the developments are exciting, they’re also scary for some.
What Is a DSMB?
Johnson & Johnson did not disclose the specific adverse event.
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The Moderna and AstraZeneca vaccines are both among several vaccines in development with funding from the NIH.
Keeping names secret helps protect DSMB members from corporate or government pressure.
The Data Monitoring Committee (DMC) consists of a chairperson and four additional members.
One member is a respected statistician with extensive experience in vaccine trials."
What’s Next?
Both meetings were open to the public and broadcast on YouTube.
The FDA does not have to take the recommendation of the advisory committee, but usually does.
During the advisory committee hearings, more specific safety and effectiveness data reviewed by the DSMBs is made public.
On January 31, 2022, Moderna received full approval from the FDA for its vaccine.
The vaccine, which will be marketed asSpikevax,is authorized for adults ages 18 and older.
Some health and government leaders are adding extra reviews to help alleviate public fears.
For the most recent updates on COVID-19, visit ourcoronavirus news page.
National Institute of Allergy and Infectious Diseases.Research using human subjects.
National Institute of Allergy and Infectious Diseases.Promising interim results from clinical trial of NIH-Moderna COVID-19 vaccine.
Pfizer.Pfizer and Biontech conclude phase 3 study of COVID-19 vaccine candidate, meeting all primary efficacy endpoints.
Food and Drug Administration.FDA approves first COVID-19 vaccine.
Food and Drug Administration.FDA authorizes Pfizer-BioNTechCOVID-19 vaccine for emergency use in children 5 through 11 years of age.
PR Newswire.Coronavirus (COVID-19) update: FDA takes key action by approving second COVID-19 vaccine.
National Medical Association.NMA forms COVID-19 task force take the politics out of vaccine development.
Spokane Regional Health District.Western States Scientific Safety Review Workgroup approves second COVID-19 vaccine.
