The Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously supported emergency use authorization to administer the Pfizer-BioNTech Comirnaty vaccine as a booster to those 65 years of age and older individuals at high risk of developing severe COVID-19. The panel, however, resoundingly rejected a plan to administer the vaccine as a booster to individuals […]
Pfizer
Report: U.S. set to buy hundreds of millions of Pfizer’s COVID-19 vaccine to share
The Biden administration reportedly plans to purchase and share with the world hundreds of millions of doses of Pfizer’s COVID-19 vaccine. The Washington Post reported today that the U.S. has plans to make another large purchase of COVID-19 vaccines, although details of the deal have not been made clear. Neither the White House nor Pfizer have […]
COVID-19 vaccine booster tensions mount between White House, CDC and FDA
Facing the second-biggest wave of COVID-19 infections and waning popularity, President Biden has promised to launch an initiative to begin providing vaccine boosters starting September 20. But the plan hinges upon FDA and CDC support, and some officials at the agencies remain unconvinced that boosters are immediately necessary. Two departing senior FDA vaccine officials recently co-wrote […]
Overcoming vaccine delivery device design’s top challenges
Vaccine delivery has long been a hot topic and only got hotter in the ongoing push to vaccinate against COVID-19 around the world. Most would probably associate vaccines with the standard “jab” injection with a syringe. Over the past year and more, companies have touted ideas for other avenues. Inovio has a “smart” delivery device for […]
FDA approves Pfizer-BioNTech COVID-19 vaccine
The FDA today issued approval for Pfizer and BioNTech’s COVID-19 vaccine, making it the first to receive full approval in the U.S. The approval covers the prevention of COVID-19 in individuals 16 years of age and older. In addition, the vaccine remains available under FDA emergency use authorization (EUA) for people who are 12 years […]
Novavax stock surges after striking EU COVID-19 vaccine deal
Novavax (NSDQ:NVAX) saw its stock jump more than 20% in afternoon trading after the European Commission agreed to purchase up to 200 million doses of its vaccine. The Gaithersburg, Md.–based vaccine maker announced in March that its NVX-CoV2373 vaccine was 96.4% effective against the original SARS-CoV-2 strain in a U.K. trial. The efficacy in a later trial […]
MedTech 100 roundup: Industry climbs with earnings season in full swing
Better-than-expected quarterly earnings are providing a further boost to medtech industry stocks. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week (July 30) at 118.86 points. Two weeks ago aside — when the index shot up to 145.88 points and quickly tumbled down — this mark […]
Pfizer highlights COVID-19 and flu vaccine strategy in Q2 earnings call
With vaccines generating a significant portion of Pfizer’s (NYSE:PFE) revenue in the first six months of 2021, the company shed light on its vaccine plans in its most recent quarterly earnings call. While the company recently won FDA approval for its potential blockbuster pneumococcal 20-valent vaccine, its mRNA vaccine strategy understandably took center stage during […]
Pfizer-BioNTech to provide U.S. with another 200M shots for kids, boosters
Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that the U.S. government has purchased another 200 million doses of their COVID-19 vaccine. Media outlets including CNN and the Financial Times cited a Biden administration official saying the additional doses are needed to vaccinate children under 12, pending FDA authorization, plus the potential need for additional booster shots against variants. In […]
MedTech 100 roundup: Industry shatters all-time best with remarkable rise
The medtech industry’s steady growth provided optimism in recent weeks, but an unforeseen leap sees it hitting new heights now. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week (July 16) at 145.88 points, a remarkable 27.1% rise week-over-week, registering by far the greatest increase the […]
Pfizer agrees to pay $345M in EpiPen pricing lawsuit
Pfizer (NYSE:PFE) agreed to pay $345 million to settle claims of overpayments for EpiPens due to alleged anti-competitive and unfair practices. Reuters reported that a filing disclosed in federal court in Kansas City, Kan., revealed the settlement set to resolve claims from consumers who say they overpaid for EpiPens with the alleged anti-competitive and unfair practices by […]
