Johnson & Johnson (NYSE:JNJ) announced that it submitted an FDA emergency use authorization (EUA) application for its COVID-19 vaccine candidate. New Brunswick, N.J.-based J&J’s Janssen Biotech subsidiary submitted the application for its investigational single-dose Janssen COVID-19 vaccine candidate, based on safety and efficacy data from its Phase 3 Ensemble clinical trial that met all of its […]
COVID-19 vaccine
4 ways COVID-19 variants could change the battle against the pandemic
Highly-transmissible COVID-19 variants have likely been circulating undetected for months in places like the U.K., South Africa and Brazil. They then seemed to burst onto the scene, fueling large outbreaks that dwarfed preceding ones. While the variants aren’t well understood, they suggest that SARS-CoV-2 is mutating in ways that confer an evolutionary advantage. They thus […]
BREAKING: J&J’s Phase 3 COVID-19 vaccine study results raise more alarms about new variants
Johnson & Johnson (NYSE:JNJ) announced results from its COVID-19 vaccine trial that show decreased effectiveness against new virus variants. The vaccine candidate from Johnson & Johnson’s Janssen Pharmaceutical Companies was 66% effective overall in preventing moderate to severe COVID-19 28 days after vaccination. But it proved less effective in South Africa, where a new variant of […]
Johnson & Johnson gearing up for COVID-19 vaccine data announcement
Johnson & Johnson (NYSE:JNJ) is poised to announce new data related to its Ad26 COVID-19 vaccine early next week. In an earnings call yesterday, management hinted that they expect results from the vaccine to be positive but stopped short at revealing details. “We think it’s very important to follow the data — to follow the science,” […]
Sanofi to provide COVID-19 vaccine manufacturing for rival Pfizer
Sanofi (NYSE:SNY) announced today that it entered into an agreement to support the manufacturing and supply of the Pfizer/BioNTech COVID-19 vaccine. Pfizer and BioNTech’s vaccine is one of two to receive FDA emergency use authorization in the U.S. and it also has clearance in Europe, having received both nods in December 2020. The deal between Sanofi provides BioNTech access […]
MedTech 100 roundup: Another peak for the industry
Medtech stocks have been on the rise in 2021, and the past week saw the trend continue with yet another all-time best mark. MassDevice‘s MedTech 100 index reached 107.4 points on Jan. 20, topping the all-time best of 106.81 points set on Jan. 8. That mark represents a 16% jump from the pre-pandemic high of 92.32 […]
Johnson & Johnson vaccine trial results expected soon
Trial results for the COVID-19 vaccine candidate developed by Johnson & Johnson (NYSE:JNJ) are reportedly expected to be released soon. The Hill reported last week that former FDA Commissioner Scott Gottlieb said the single-dose vaccine from J&J appears to have a “good profile for a vaccine,” indicating the potential for a third authorized candidate, following those […]
7 takeaways from Biden’s ‘full-scale, wartime’ plan to combat the COVID-19 pandemic
President Joe Biden kept to his word to announce plans to “establish clear federal leadership” to tackle the coronavirus pandemic on his first full day in office. The White House issued a 200-page document on Wednesday, detailing “full-scale, wartime” plans to harness the nation’s manufacturing and distribution capabilities to boost vaccine production, end shortages of […]
Amazon offers to help Biden administration with vaccine distribution
Amazon (NSDQ:AMZN) issued a letter to recently inaugurated President Joe Biden offering assistance with COVID-19 vaccine distribution. President Biden, who was sworn into office yesterday, was addressed in the letter from Amazon announcing its availability to help with his intent to distribute 100 million COVID-19 vaccine doses in his first 100 days in office. Get the full story […]
New COVID-19 variants could diminish vaccine efficacy
COVID-19 is mutating. And while early data suggest vaccines will be effective against more infectious COVID-19 variants that emerged in the U.K., South Africa and Brazil, the mutations could have a measurable impact on vaccine efficacy. There’s perhaps a 50/50 chance that such new variants could lead to a “numerically meaningful drop” in vaccine efficacy, […]
Facial swelling and COVID-19 vaccines: 4 facts
Patients with dermal fillers have a small potential risk of developing facial swelling after obtaining mRNA vaccines. To date, the FDA has noted the problem in three clinical trial recipients of the COVID-19 vaccine from Moderna(NSDQ:MRNA). The agency hasn’t observed facial swelling in the Phase 3 clinical trial for the COVID-19 vaccine from Pfizer (NYSE:PFE) […]