Pfizer (NYSE:PFE) and BioNTech (NSDQ: BNTX) plan to formally seek FDA emergency authorization in the coming weeks for the use of their Comirnaty (BNT162b2) vaccine in children 5 to 11. The news came today as the companies announced the submission of initial Phase 2/3 trial data to FDA. The companies last week announced that the […]
Pfizer
Gottlieb: Delta wave could burn out by Thanksgiving
Pfizer board member Dr. Scott Gottlieb has predicted that the COVID-19 Delta surge could mark a high-water mark of the pandemic. “This may be the last major wave of infection,” said Gottlieb, who served as the FDA commissioner from 2017 to 2019. In an interview with CNN, Gottlieb predicted that the pandemic in the U.S. […]
FDA advisory panel recommends boosters only for older and high-risk individuals
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 […]
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 […]