Vaccines

The CDC found 2 doses of Pfizer-BioNTech reduced COVID-19 severe outcomes and hospitalization by 93% in adolescents 12-18 years old.

The decision comes after supporting data from a "mix and match" trial last week, and may align with emergency authorizations for the Moderna and Janssen booster doses.

The VRBPAC committee unanimously voted in favor of the Janssen (Johnson & Johnson) COVID-19 vaccine for use under EUA as a booster dose in individuals 18 years and older at least 2 months after a single dose primary vaccination.

The VRBPAC meeting precedes deliberation from the FDA on amending the company's emergency authorization to include booster doses for adult patients.

While receiving a booster of one’s original COVID-19 shot leads to an immune boost, this was heightened among individuals who received a different booster than their primary vaccine.

The FDA suggested that Johnson & Johnson had not conducted an appropriately thorough test to prove its vaccine requires a six-month booster.

Qatar has the highest mRNA vaccine coverage in the world, but their vaccinated population is experiencing significant waning in vaccine efficacy, leading to breakthrough infections.

Monica McArthur, MD, PhD, discusses why to-be-authorized COVID-19 vaccine doses for children may not be tiered for patient risk as they were for adults.

The findings have supported the launch of a phase 3 trial called EVERGREEN, which is now underway.

An expert explains the science of vaccine- and infection-induced immunity, and how it informs the timeline of COVID-19 outbreaks this year.

The companies will be seeking emergency authorization for a lighter-dose mRNA vaccine for children aged 5 to <12 years old.

A presentation of available third-dose data suggest the adverse event rate is consistent with that observed with second doses.

Preprint data from a real-world evidence assessment, as well as preliminary reports from a 2-dose trial, support the company's pursuit for FDA authorization of a second COVID-19 vaccine dose.

Though efficacy waned over months, protection from symptomatic and severe COVID-19 remained significant, with no new adverse event risks observed.

A neighborhood-level assessment of major cities show areas impacted the most by historic COVID-19 deaths are significantly less vaccinated.

New Imbokodo findings show a 4-dose regimen was only about 25% effective in preventing HIV in at-risk women, hindering progress for the vaccine.

An Israel study estimates vaccinated persons' risk of side effects including myocarditis, relative to the risk brought on by SARS-CoV-2 infection.

The submission comes day after BNT162b2 became the first fully approved COVID-19 vaccine by the FDA.

David Weber, MD, MPH, explains what portion of the population may buy into the newly approved Pfizer-BioNTech vaccine.

The full approval for BNT162b2 will afford physicians greater prescribing capability, and will likely drive workplace vaccine mandates.

The Biden administration reportedly hopes for FDA-authorized booster doses for the adult general population in the next month.

The US is targeting a possible Fall rollout of publicly available doses, yet experts debate their current necessity.

An England study shows the Pfizer-BioNTech and AstraZeneca vaccines remain effective in reducing symptomatic disease risk.

Emergency authorization may be complete before the end of August, ensuring more protection for patients burdened with certain chronic diseases.

The report of promising phase 2 findings align with word that an FDA submission will be delayed until later this year.

Last influenza season was notably quiet during peaking COVID-19 cases. Experts explain what may influence risk of dueling epidemics this year.

The prophylaxis showed non-inferiority across shared serotypes with an available 13-valent vaccine in its indication-supporting data.

The designation moves the companies' PDUFA date up to January 2022, when BNT162b2 may become the first regulated COVID-19 vaccine.

The announcement aligns with an FDA and CDC statement against the need for booster doses.

Experts suggest the vaccine, if regulated by the FDA, would benefit the US as a booster dose to combat waning immunity against emerging variants.