Moderna recently dosed the first participant in the Phase 3 pivotal registration study of its cytomegalovirus (CMV) mRNA vaccine candidate, mRNA-1647.
The CMVictory study will evaluate the safety and...
FDA recently granted emergency use authorization to Pfizer and BioNTech’s COVID-19 vaccine for children five through 11 years of age.
The agency based its decision on data from a Phase 2/3...
Moderna recently announced that two doses of its COVID-19 vaccine showed a robust neutralizing antibody response in children six to under 12 years of age.
The Phase 2/3 KidCOVE randomized...
Pfizer and BioNTech recently announced that their COVID-19 vaccine booster was 95.6 percent effective in individuals compared to placebo.
The randomized, controlled Phase 3 trial...
FDA recently granted emergency use authorization to both the Moderna and Johnson & Johnson respective COVID-19 vaccine booster doses.
The agency specifically approved Moderna’s booster...
FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) recently recommended a booster dose of Moderna’s COVID-19 vaccine, mRNA-1273, at the 50 microgram...
FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) recently recommended emergency use authorization for a booster dose of Johnson & Johnson’s COVID-19 vaccine.
VRBPAC...
GSK recently welcomed the World Health Organization’s (WHO) recommendation for the broader development of GSK’s RTS, S malaria vaccine to reduce childhood illness and deaths from malaria in...
Moderna recently announced that it will build a state-of-the-art mRNA facility in Africa to produce up to 500 million doses of vaccines annually at the 50 microgram dose level.
The company will invest...
Johnson & Johnson recently announced that Paul Stoffels, MD, current vice-chairman of the executive committee and chief scientific officer of Johnson & Johnson, will retire at the end of...
Johnson & Johnson recently submitted data to the FDA to support its COVID-19 vaccine booster shot in adults 18 and older.
The submission includes results from the Phase 3 ENSEMBLE study, which...
Pfizer and BioNTech recently submitted data to FDA from the Phase 2/3 clinical trial of their COVID-19 vaccine in children five to 11 years of age.
Last week, the companies announced that...
Gilead recently announced that a three-day course of its COVID-19 treatment, remdesivir, elicited an 87 percent reduction in risk for the composite primary endpoint of COVID-19-related hospitalization...
FDA recently amended the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to allow for a single booster dose six months after completing the primary series.
In December 2020,...
Johnson & Johnson recently announced that a booster shot of its COVID-19 vaccine elicited 94 percent protection against coronavirus in a Phase 3 clinical trial.
The largest real-world...
Johnson & Johnson recently announced that its Ebola vaccine regimen, Zabdeno and Mvabea, generated robust antibody immune responses in children and adults.
The Phase 3 EBOVAC-Salone clinical...
Pfizer and BioNTech recently announced that two doses of their COVID-19 vaccine elicited neutralizing antibody responses in pediatric patients in a Phase 2/3 clinical trial.
In the trial,...
Many experts expect immunotherapy to positively impact the treatment landscape for patients with earlier-stage cancers in the neoadjuvant, adjuvant, and perioperative settings, according to a new...
National Resilience recently entered into a multi-year agreement with Moderna to manufacture drug substance mRNA for its COVID-19 vaccine.
Resilience is a manufacturing and technology company...
Pfizer recently initiated a Phase 3 clinical trial evaluating the efficacy, immunogenicity, and safety of a single dose of its respiratory syncytial virus (RSV) vaccine candidate in adults.
The...
