Five days after an FDA advisory committee recommended a booster dose of Pfizer Inc.-Biontech SE’s COVID-19 vaccine, Comirnaty, for people 65 and older or those who are at high risk of a serious infection, the CDC’s Advisory Committee on Immunization Practices (ACIP) struggled Sept. 22 with what a U.S. booster program would look like if only one booster is available when three different COVID-19 vaccines are being used in the country.
Fresh data from Johnson & Johnson show COVID-19 protection dramatically increased with a booster shot of its single-dose vaccine, adding momentum to the U.S. drive for boosters.
As members of the White House COVID-19 Response Team talk about COVID-19 boosters as if they are a fait accompli for Americans even before the FDA completes its evaluation of the data, the controversy continues to roil around the need for another vaccine dose.
A closely watched phase IIb test of JNJ-9220, an investigational HIV vaccine regimen developed by Johnson & Johnson's Janssen Vaccines & Prevention BV, has been stopped because the regimen provided insufficient protection against HIV infection. Though safe, the candidate's efficacy was just 25.2%, according to statisticians who analyzed data from the study, called Imbokodo. Further analysis of the study will continue, and the study was deemed to have provided sufficient data for further immunological correlates research, according to J&J.
Johnson & Johnson has announced new data supporting use of its COVID-19 vaccine as a booster shot, after separate trial data from the U.K. showed effects of several vaccines waned after six months.
The FDA has granted full approval to Pfizer Inc.’s COVID-19 vaccine in a move that is hoped will convince unvaccinated citizens that the shot is safe and effective. The mRNA vaccine, which will be branded as Comirnaty and was first developed by Germany’s Biontech SE, has been available since Dec. 11 last year under an emergency use authorization (EUA) and is the first to receive the FDA’s full endorsement.
Plans for offering COVID-19 vaccine booster shots in the U.S. took a big step forward Aug. 18, as Health and Human Services (HHS) public health and medical experts laid out their intention to offer booster shots across the country for people 18 and older beginning the week of Sept. 20 and starting eight months after an individual's second dose.
LONDON – Mestag Therapeutics Ltd. has closed a hefty $45 million seed round to advance development of antibodies targeting activated fibroblasts, in the treatment of cancer and immune diseases.
More than a decade after the Biologics Price Competition and Innovation Act became law and nearly six years after the first biosimilar launched in the U.S., the country’s first potential interchangeable is on deck awaiting an FDA decision.
A proposed $26 billion global settlement could end the state-by-state opioid litigation in the U.S. for Johnson & Johnson (J&J) and three drug distributors. The attorneys general from several states announced the proposed agreement July 21 with J&J, Amerisource Bergen Drug Corp., Cardinal Health Inc. and McKesson Corp.
