Vaccines

With these results, the company plans to submit their investigational vaccine, MRNA-1345, for regulatory approval in the first half of 2023.

Preclinical testing suggests that a newly developed SARS-CoV-2 vaccine could protect against current and future variants.

The agency licensed the new indication for Sanofi’s Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed [Tdap]) shot for immunization during the third trimester of pregnancy.

RSV cases spiked to unprecedented levels this season. Why were these infections so frequent and severe? Why has vaccine development taken so long?

Good news: across 23 countries, trust in COVID-19 vaccines increased 5.2% from 2021 to 2022. However, vaccine hesitancy remains in key populations.

The 24-valent investigational pneumococcal conjugate vaccine, VAX-24, met its primary endpoints in a phase 1/2 trial.

A new Infectious Diseases Society of America (IDSA) board member and vice president offers some insights on the leadership’s goals and direction for 2023.

“This was a total surprise,” said study lead author John Tsang, PhD.

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.