Novavax Inc. now says it plans to submit an emergency use authorization (EUA) to the FDA for its highly efficacious COVID-19 vaccine, NVX-CoV2373, sometime in the fourth quarter, backing off previous plans of a second-quarter and then a third-quarter filing.
Positive phase III top-line results for Valneva SA’s chikungunya virus vaccine candidate, VLA-1553, show the study met its primary endpoint of inducing neutralizing antibody titers, setting it up for possible accelerated approval.
Jiangsu Gdk Biotechnology Co. Ltd. will further develop its vaccine pipeline after it started trading on the Shanghai Stock Exchange Star Market on Aug. 2, where it raised ¥1.21 billion ($187 million) through an initial public offering of 22 million shares. The company plans to use the proceeds from the listing to establish a manufacturing plant to produce its quadrivalent influenza vaccine and invest in R&D for other vaccine candidates, as well as replenish working capital and repay bank loans.
LONDON – The U.K. has set up the first randomized controlled trial of COVID-19 vaccines in pregnant women, to assess different dosing schedules. The aim is to find the balance between longer intervals that are known to spur a greater immune response, against shorter intervals that provide faster protection.
Just weeks after announcing plans to invest billions in an mRNA therapeutics research center, Sanofi SA has acquired Translate Bio Inc. for $3.2 billion, building on a development partnership focused around the technology.
The world has been running an ultramarathon since the COVID-19 pandemic began, but despite the ups and downs of cases and deaths, the wins and losses of clinical efforts, every day is another step forward toward herd immunity and the finish line.
PERTH, Australia – Australia will be phasing out the Astrazeneca COVID-19 vaccine by October and will rely on Pfizer Inc./Biontech SE and Moderna Inc. vaccines to ramp up lagging vaccination rates.
Medigen Vaccine Biologics Corp. released results from a phase III trial of its enterovirus 71 (EV71) vaccine that showed efficacy of 100% against a virus that causes hand, foot and mouth disease and continues to emerge on a regular basis across Asia.
New three-year safety and efficacy data on Takeda Pharmaceutical Co. Ltd.'s dengue vaccine candidate, TAK-003, showed it to be 62% more effective than placebo in preventing virologically confirmed infections with the virus and 83.6% more effective than placebo in preventing hospitalizations caused by the mosquito-borne viral disease and due to any of the four dengue virus serotypes in patients ages 4 to 16.
New phase IIb clinical trial data show the antigen R-21, a malaria vaccine candidate created by the University of Oxford that uses Novavax Inc.'s Matrix-M adjuvant, demonstrated 77% efficacy in children.
