The FDA has asked Emergent BioSolutions to stop manufacturing a new drug substance for Johnson & Johnson's COVID-19 vaccine at its Baltimore plant while the agency investigates a contamination issue that resulted in the destruction of millions of doses last month. J&J said it will work with the agency and Emergent to address any issues uncovered in the investigation.
The CDC could decide by Friday if restrictions will be added to the Johnson & Johnson vaccine after six women reported blood clotting issues after receiving the shot, according to National Institute of Allergy and Infectious Diseases Director Anthony Fauci. The US paused use of J&J's vaccines last week.
All US individuals ages 16 and older can now receive a COVID-19 vaccine, according to the CDC, which said those with underlying medical conditions that raise the risk for serious complications should be given priority. Nearly 211.6 million COVID-19 vaccine doses had been administered in the US as of Monday, with more than 85.3 million people now fully vaccinated.
The FDA has updated regulations for certain medical devices, including three radiology software products -- picture archiving and communications systems, medical image storage devices and medical image communication devices. The rules are effective immediately.
Calls for proposals for fall 2021 conferences are open now through May 21. If there is an issue you want to see addressed or new perspective you would like to share, now is your chance to submit proposals for our highest-level educational events. Learn More