The Biden administration announced today that it will begin sharing its store of AstraZeneca’s COVID-19 vaccine following safety reviews. Once the vaccine clears federal safety reviews, 60 million doses of the vaccine are expected to be made available, according to a Tweet from senior White House advisor Andy Slavitt. “BREAKING: U.S. to release 60 million Astra Zeneca […]
coronavirus
Here at MassDevice — medtech's online business journal — we're covering news about the coronavirus (COVID-19) pandemic daily. Here is the latest about coronavirus and the medical device industry, regulatory changes related to the pandemic, new tests for the virus, vaccine development, and much more.
More than 5 million skipped getting second COVID-19 vaccine dose
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 […]
Israel investigating heart inflammation cases in Pfizer COVID-19 vaccine recipients
Israel’s Health Ministry is researching “tens” of cases of myocarditis, or heart inflammation, in people who have received the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX). More than five million people in the country have received the vaccine. The agency, however, has not yet established a causal relationship between the events and the vaccine. Get the […]
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 […]
MedTech 100 roundup: New heights reached again
One week after recording its all-time best performance, the medtech industry again topped itself, storming even further ahead. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — has been on the rise since April began, with last week’s mark of 112.25 (April 16) representing an all-time best, topping the […]
FDA releases scathing inspection report regarding Emergent BioSolutions plant
An FDA report cites multiple failures in an Emergent BioSolutions plant tapped to produce vaccines for Johnson & Johnson and AstraZeneca. The vaccine plant had been forced to discard up to 15 million doses of Johnson & Johnson’s COVID-19 vaccine in a single manufacturing batch. Emergent Biosolutions recently paused production of the vaccine during the FDA inspection and […]
FDA just made pooled COVID testing easier
COVID-19 molecular tests have already been authorized for individual use will have an easier time getting an FDA nod for pooled testing. The FDA said today it will add tests by manufacturers who validated their nasal specimen test for pooling to its list of tests available for use with pooled nasal specimens. This could expand […]
Benefits of J&J COVID-19 vaccine outweigh risks, EU regulator says
The European Medicines Agency confirmed that the benefits of the COVID-19 vaccine from Johnson & Johnson (NYSE:JNJ) outweigh risks of blood clots. At a meeting today, EMA’s safety committee (PRAC) concluded that there is a link between unusual blood clots with low blood platelets with the COVID-19 vaccine made by J&J’s Janssen Pharmaceuticals unit. PRAC determined that […]
Abbott stock down on mixed bag Q1
Abbott (NYSE:ABT) shares are down today on first-quarter results that were mixed compared to the consensus forecast. The Abbott Park, Ill.–based company posted profits of $1.8 billion, or $1 per share, on sales of $10.5 billion for the three months ended March 31, 2021, more than doubling its bottom-line on sales growth of 35.3%. Adjusted […]
FDA nixes EUA for Lilly’s bamlanivimab
On April 16, Lilly announced that it was requesting FDA to revoke the emergency use authorization (EUA) for the monoclonal antibody bamlanivimab (LY-CoV555) when used alone. Hours after, the agency agreed to rescind the EUA on the grounds that bamlanivimab is potentially ineffective against some SARS-CoV-2 variants. Bamlanivimab, however, won’t be disappearing as a COVID-19 […]
A quick history of the tech behind J&J, AstraZeneca’s COVID-19 vaccines
Regulatory authorities in the U.S. and Europe have either paused or constrained the use of COVID-19 vaccines from AstraZeneca (LON:AZN) and Johnson & Johnson (NYSE:JNJ), causing some to wonder why the adenoviral-vector vaccines have been potentially linked to similar blood clotting events. Researchers have observed blood clotting events associated with adenoviral vectors since the late-1990s […]