The percentage of people who failed to get the second dose of Pfizer or Moderna COVID-19 vaccines is growing, according to recent CDC data. Some five million people, or almost 8% of people who got the first vaccine dose, missed getting the second. In mid-March, 3% of people were overdue for their second dose. People […]
Centers for Disease Control & Prevention (CDC)
FDA, CDC lift pause on J&J COVID-19 vaccine
The FDA and CDC have lifted the pause placed on the Johnson & Johnson (NYSE:JNJ) COVID-19 vaccine after reports of blood clots caused concern. On April 13, the FDA and CDC issued a joint statement recommending the pause in the administration of the J&J (Janssen) COVID-19 vaccine after, among 6.8 million doses delivered in the […]
Feds halt J&J COVID-19 vaccine due to blood clot concern
The FDA and CDC issued a joint statement today recommending the pause in the administration of the Johnson & Johnson COVID-19 vaccine. As of yesterday, more than 6.8 million doses of the J&J single-dose vaccine had been administered in the U.S. Among recipients of those doses, six cases of a rare and severe type of blood […]
Biden to put $12B toward COVID testing
The Biden administration today pledged $10 billion for school COVID-19 screenings and $2.25 billion for screenings and diagnostic testing among underserved populations. The money is part of the $1.9 trillion American Rescue Plan Act that Biden signed into law last week. The Department of Health and Human Services will divvy up the $10 billion among […]
House Dems subpoena Azar, Redfield on questions of political pressure at CDC
A Congressional committee subpoenaed top Trump administration officials today, demanding documents they allege could show “extensive” pandemic-related political interference at the CDC. In a letter to Health and Human Services secretary Alex Azar and Centers for Disease Control and Prevention director Dr. Robert Redfield, House Democrats said an investigation showed that efforts to interfere with […]
The top 5 MassDevice stories of the week — December 11, 2020
The medtech industry continues to plug along as major news comes in about vaccines, the incoming presidential administration and more. This week’s top stories include the latest on COVID-19, Joe Biden and some additional FDA clearances, plus a major royalties spat. Want to hear more about the week’s top medtech news on MassDevice? Tom Salemi will […]
Biden makes picks for HHS secretary, CDC director
President-elect Joe Biden has made selections for leaders of the U.S. Dept. of Health & Human Services and the Centers for Disease Control & Prevention. Biden chose California Attorney General Xavier Becerra as his nominee for HHS secretary. The 12-term veteran of U.S. Congress had previously advocated for healthcare issues as AG in California and […]
Siemens, CDC team on standardizing COVID-19 antibody assays
Siemens Healthineers (ETR:SHL) announced today that it is collaborating with the CDC and the JRC on a project to standardize COVID-19 assays. The collaboration with the CDC and Europe’s Joint Research Centre (JRC) is slated to develop a novel process for standardizing the SARS-CoV-2 antibody tests as they differ among manufacturers and currently can’t e analytically […]
How decontamination could solve the COVID-19 mask shortage problem
With cold and flu season rapidly approaching, public health officials worry about a resurgence of COVID-19 and personal protective equipment shortages. Protecting frontline workers will likely include decontaminating face masks. A spike in COVID-19 cases this fall and winter could leave healthcare facilities with renewed shortages of personal protective equipment — particularly masks. Hundreds of […]
FDA eases mask regulations, seeks to boost decontamination of used masks
The FDA yesterday further relaxed regulations on medical and surgical masks and face shields to ease shortages during the coronavirus pandemic, and invited companies that decontaminate masks to submit proposals for emergency authorizations. In a new guidance, the agency also gave its blessing to healthcare providers to use improvised masks during the public health emergency […]
Report: FDA promise of 1 million coronavirus tests this week unattainable
The FDA grossly overestimated the number of coronavirus diagnostic tests that would be available this week as well as U.S. laboratories’ capacity to process them, according to a report in the New York Times. FDA commissioner Stephen Hahn told reporters on Monday that the agency’s decision allowing private labs to make their own tests would […]
