The Biden-Harris administration today announced a global distribution list for 55 million doses of America’s COVID-19 vaccine supply. Biden pledged to allocate 80 million doses of the COVID-19 vaccine supply belonging to the U.S. by the end of June to aid the global fight against the pandemic. Earlier this month, the administration announced the plan […]
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.
Biden administration invests $3B to accelerate development of next-gen COVID-19 treatments
President Joe Biden’s administration will spend $3 billion in American Rescue Plan money to accelerate the discovery, development and manufacturing of antiviral medicines against COVID-19, HHS announced today. Not only will the Antiviral Program for Pandemics seek to boost the availability of medicines to prevent serious COVID-19 illness and save lives, but it will pursue […]
CureVac’s interim vaccine efficacy is 47% in Phase 2b/3 study
Germany-based CureVac (NSDQ:CVAC) announced that its mRNA vaccine was 47% effective against COVID-19 in a second interim analysis of a pivotal study involving approximately 40,000 participants in 10 countries. The rise of COVID-19 variants played a role in the disappointing results. At least 13 COVID-19 variants were present in the study population who contracted the […]
U.S. government buys 200M more doses of Moderna’s COVID-19 vaccine
Moderna (NSDQ:MRNA) announced today that the U.S. government purchased an additional 200 million doses of its COVID-19 vaccine. The government’s purchase agreement with Moderna also includes the option to purchase other COVID-19 vaccine candidates to come out of the company’s pipeline. Get the full story at our sister site, Pharmaceutical Processing World.
Novavax’s COVID-19 vaccine demonstrates 90% efficacy
Novavax (NSDQ:NVAX) announced today that its COVID-19 vaccine demonstrated 90.4% efficacy in protecting against COVID-19. Gaithersburg, Md.–based Novavax’s recombinant nanoparticle protein-based COVID-19 vaccine demonstrated 100% protection against moderate and severe disease, with 90.4% efficacy overall as it met the primary endpoint in the Prevent-19 pivotal Phase 3 trial. Get the full story at our sister site, […]
J&J must reportedly throw out 60M COVID-19 vaccine doses from Emergent plant
Another large amount of doses of Johnson & Johnson’s COVID-19 vaccine produced at an embattled manufacturing plant reportedly have to be thrown out. The New York Times reported that the FDA told J&J that about 60 million doses of the single-dose vaccine produced at Emergent BioSolutions’ Baltimore plant can’t be used because of possible contamination. Get the full […]
Biden to promise world 500 million COVID-19 vaccine doses
President Joe Biden has struck a deal with Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) to provide 500 million COVID-19 vaccine doses to roughly 100 countries over two years. The two companies today confirmed the news, saying that the U.S. government will purchase at a not-for-profit price 200 million doses in 2021 and 300 million in early 2022. Doses […]
Amazon wins EUA to sell its COVID-19 test directly to consumers
Amazon subsidiary STS Lab Holdco received FDA emergency use authorization (EUA) for the direct-to-consumer sale of its COVID-19 test. The FDA authorized the test with indications as a direct-to-consumer product for testing individual anterior nasal swab specimens self-collected at home with the Amazon COVID-19 test collection kit DTC by any individual 18 years or older, […]
U.S. to buy nearly 2 million courses of Merck’s COVID-19 antiviral treatment
Merck (NYSE:MRK) announced today that it agreed to supply the U.S. government with its molnupiravir (MK-4482) for treating COVID-19. Molnupiravir, developed through a collaboration between Merck and Ridgeback Biotherapeutics, is currently under evaluation in a Phase 3 clinical trial for the treatment of non-hospitalized patients with laboratory-confirmed COVID-19 infection and at least one risk factor […]
Pfizer expands COVID-19 vaccine trial involving children under 12
Pfizer (NYSE:PFE) and its German partner BioNTech (NASDAQ: BNTX) will proceed with a COVID-19 vaccine trial involving as many as 4,500 children. The trial will significantly reduce the 30-mg dose that adults and adolescents receive. Investigators will administer a 10-µg dose to children aged 5 to 11 and give those aged six months to five years […]
Biden administration wants to boost funding for new pharma manufacturing processes
The Biden administration today released findings from 100-day supply chain assessments, determining the need to boost pharmaceutical manufacturing. According to a fact sheet, the administration plans to take immediate action to “address vulnerabilities and strengthen resilience” with its effort to take on near-term supply chain disruptions for four products: semiconductor manufacturing and advanced packaging; large […]
