Vaccines

The company’s vaccine candidate, MenABCWY, which is indicated for adolescents was given a Prescription Drug User Fee Act (PDUFA) goal date for later this year.

In just a month, the XBB.1.5 variant went from causing 1% to over 40% of new COVID-19 infections.

New booster shots, antigen testing, and a shrinking incubation period: these were the top COVID-19 stories of 2022.

TP-05, a novel, oral therapeutic recently reported topline results from its phase 1 study.

In addition to avoiding additional infection, illness, and death, the COVID-19 vaccination program likely saved the US $1.25 trillion in medical costs.

The European Commission has approved their first dengue vaccine, Takeda’s TAK-003, as climate change and urbanization contribute to a worldwide rise in dengue incidence.

Today, Pfizer-BioNTech filed submitted an Emergency Use Authorization (EUA) to administer their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster in children under 5 years of age.

A germline-targeting HIV vaccine candidate elicited broadly neutralizing antibodies in 97% of recipients.

The investigational shot from Pfizer and Valneva demonstrated higher antibody levels in the three-dose vaccination schedule versus the two-dose vaccination schedule.

Takeda’s investigational dengue vaccine TAK-003 is currently under evaluation for preventing any dengue virus serotype in individuals 4-60 years old.

Priorix and M-M-R II are fully interchangeable vaccines to protect against measles, mumps, and rubella, the CDC’s Advisory Committee on Immunization Practices said.

Sanofi and GlaxoSmithKline are the latest companies to bring their COVID-19 booster vaccine to the marketplace with the European Commission’s approval of VidPrevtyn Beta.

New clinical findings suggest the Pfizer-BioNTech bivalent booster elicited more neutralizing antibody titers for all tested emerging Omicron sublineages, compared to their original COVID-19 vaccine.

Dynavax reported results from its phase 1 study looking at its (Tdap-1018 CpG Adjuvanted) Tetanus/Diphtheria/Pertussis booster vaccine.

The intranasal, live-attenuated vaccine CodaVax-RSV was granted FDA Fast Track designation. Clinical trials are expected to launch soon.

“In the long run, what we will have is a virus that will become endemic in our population," said Donald J. Alcendor, MD. "The idea of thinking we can chase variants with boosters is a failed effort. We must realize that.”

Polio outbreak has CDC Advisory Committee on Immunization Practices considering a novel oral vaccine 20 years after shelving its predecessor.

A late-breaking IDWeek 2022 study found high seroprotection was achieved among people living with HIV after receiving 3 doses of a hepatitis B vaccine.

What makes Novavax’s COVID-19 booster different? The adjuvanted vaccine “has kept recognizing variants that arise,” says Novavax executive director Germán Áñez, MD.

Breakthrough COVID-19 infections were rare in fully vaccinated individuals, but the average breakthrough occurred just under 50 days after complete vaccination.

Overall, 91.5% of the hospitalized adults with COVID-19 were unvaccinated and 8.5% of patients were fully vaccinated.

The phase 2, randomized, placebo-controlled, dose-finding trial evaluated the mRNA-based cytomegalovirus vaccine, which features a lipid nanoparticle formulation.

Preliminary results from a phase 2/3 trial suggest Pfizer-BioNTech’s Omicron BA.4/BA.5 bivalent COVID-19 booster vaccine provides better protection for younger and older adults.

The Moderna vaccine can be administered to children as young as six years old and the Pfizer-BioNTech vaccine for kids as young as five years old.

Pediatric populations are disproportionately affected by influenza. The first cell-based quadrivalent flu vaccine offers potential for greater vaccine effectiveness.