Although the need for COVID-19 boosters remains a tense debate among policymakers and scientific experts worldwide, the U.S. FDA is basing its Oct. 14-15 Vaccines and Related Biologics Products Advisory Committee meeting on the premise that vaccine boosters are needed.
FDA preemption of state liability law has proven controversial on a number of occasions, a fact of life resurrected by a case arising out of the Supreme Court of the State of Mississippi. The court declared that the FDA must invoke the rulemaking process for its regulation of medical product labels.
LONDON – The EMA set out the reasons for why it is diverging from the FDA on booster doses of Pfizer Inc.’s/Biontech SE’s COVID-19 vaccine, despite having reviewed the same data.
Software-as-a-medical device (SaMD) came into its own during the pandemic as digital health applications enabled patients to receive care from home through telemedicine, apps and remote patient monitoring. At the 2021 Medtech Conference, a panel of regulators, advocates and digital health executives discussed how the last 18 months may permanently change the regulation of these devices, the steps manufacturers can take to secure the footholds they gained, and how the U.S. CMS can enable digital health to achieve its promise.
LONDON – The EMA has changed its stance on booster doses of the Pfizer Inc./Biontech SE COVID-19 vaccine and said they “may now be considered” at least six months after the second dose for people ages 18 and over.
Xencor Inc. and Janssen Biotech Inc., already partners on the development of bispecific antibodies against CD28 for prostate cancer, have reached a second agreement licensing to Janssen exclusive development and commercialization rights to Xencor's phase I bispecific antibody, plamotamab, for the treatment of B-cell malignancies, both as a monotherapy and in combination regimens.
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.
