August 4th 2023
The lawsuit comes as the RSV market is likely to get more crowded, with a pending approval for Pfizer's pediatric indication later this month and a BLA submission from Moderna recently filed.
August 2nd 2023
The vaccine targets an additional 8 unique serotypes that disproportionally affect the adult population.
January 9th 2023
Evusheld, the only FDA-approved COVID-19 pre-exposure prophylactic, is anticipated to be ineffective against the emerging XBB.1.5 variant.
September 8th 2022
Texas judge Reed O’Connor ruled that requiring employers to cover the medical expense of HIV PrEP is a violation of religious freedom.
May 18th 2022
The FDA lifted a clinical hold on investigational lenacapavir for HIV treatment and pre-exposure prophylaxis. All clinical studies evaluating injectable lenacapavir can now resume.
Developing a COVID-19 Antiviral for Treatment and Prevention
Dr. Simon Portsmouth of Shionogi discusses the trial results of their once-daily oral COVID-19 antiviral, S-217622, as well as the significance of the therapy as vaccine efficacy wanes in the age of Omicron.
PrEP User Adherence to Regular HIV Testing Recommendations
In Germany, HIV pre-exposure prophylaxis users are recommended to receive regular HIV, STI, and renal function testing. How frequently are PrEP users getting tested?
Large Study Confirms mRNA COVID-19 Vaccine Side Effects are Mild and Temporary
A large surveillance study of 2 symptom-reporting databases found side effects after Moderna or Pfizer-BioNTech COVID-19 vaccination were frequently nonserious and resolved within 1-2 days.
Seeking Solutions for Endocarditis in People Who Inject Drugs
“People don’t recognize that at least 1 in 5 of the deaths from opioids may result from endocarditis,” said National Institute of Drug Abuse (NIDA) director Dr. Nora Volkow, adding that endocarditis is “100% preventable.”
Convalescent Plasma May Safely Treat Children at High Risk of Severe COVID-19
Convalescent plasma safely raised antibody levels in children at high risk of severe or fatal COVID-19, successfully neutralizing the virus but unlikely to provide lasting protection.
Moderna COVID-19 Vaccine Boosters May Provide Significant Omicron Antibodies
Two different doses of the company's mRNA vaccine were found to increase antibodies by up to 83-fold.
Digital Pill Accurately Tracks HIV PrEP Adherence
A novel digital pill was 98% effective in tracking daily HIV PrEP adherence.
Vaccination Against HPV Decreases Cervical Cancer, Especially in Young Women
HPV vaccination decreases cervical cancer incidence and mortality, but it is most effective in young women and girls.
Moderna Provides Stronger, Durable Vaccine Efficacy Over 4 Months
New cohort data from VA medical centers provide more evidence of a correlate between antibody levels and vaccine effectiveness for mRNA vaccines.
CDC Updates Guidelines: Doctors Should Talk to All Sexually Active People About HIV PrEP
The CDC updated its HIV PrEP guidelines, including a recommendation that doctors talk to all sexually active adults about HIV prevention and prescribe PrEP to anyone who asks for it.
Merck Pauses Enrollment in Phase 3 Clinical Trials for Islatravir HIV PrEP
Merck announced an enrollment pause in 2 of their stage 3 clinical trials for once-monthly oral islatravir for HIV PrEP. Enrolled participants will continue receiving study medicine.
HIV PrEP Use Among Heterosexual Adults Is Negligible, CDC Reports
Only 1 in 3 heterosexually active adults is aware of HIV PrEP, and this is even lower among Hispanic/Latinx men and women.
FDA May Authorize Pfizer-BioNTech COVID-19 Booster for All Adults This Week
A new report suggests FDA and CDC deliberations may result in booster doses of the mRNA vaccine becoming available by this weekend.
US Private Employer COVID-19 Vaccine Mandates Will Begin January 4
The Biden administration is also setting mandates for health care workers in facilities receiving federal aid.
CDC Committee Recommends Pfizer-BioNTech COVID-19 Vaccine for Children 5-11 Years Old
The ACIP considered the benefits of the newly emergency-authorized vaccine versus the risks of COVID-19 in children aged 5-11 years old.
A Third of New HIV Cases Occurred in “Low-Risk” Gay and Bisexual Men Not Indicated for PrEP
29% of cisgender men who have sex with men acquired HIV despite being designated as “low risk.”
Moderna Vaccine Reports Robust COVID-19 Antibody Response in Children
Unpublished data from the company's ongoing pediatric trial show children aged 6 to <12 years old have an antibody response greater than that of young adults.
COVID-19 Experts Weigh in on Heterologous Booster Doses
The FDA and CDC have authorized and recommended 3 different booster doses, to be used in "mix-and-match" strategy among eligible adults. What does this mean for immunity?
FDA Expected to Authorize Heterologous COVID-19 Vaccine Boosters
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.
In Rural Areas, Injection Drug Users Have Less Knowledge, More Stigma About PrEP
People who inject drugs in rural areas had a less accurate understanding of HIV PrEP, largely due to stigma surrounding sexual orientation and drug use.
CYPRESS Trial: RSV Vaccine for Older Adults Elicits Robust Immune Response
The findings have supported the launch of a phase 3 trial called EVERGREEN, which is now underway.
PROVENT Trial: AZD7442 as Long-Acting Pre-Exposure Prophylaxis Protects Against Symptomatic COVID-19
In the primary efficacy analysis, the risk of developing symptomatic COVID 19 was reduced by 77% with AZD7442.
Pfizer-BioNTech Submits Pediatric COVID-19 Vaccine Data to FDA
The companies will be seeking emergency authorization for a lighter-dose mRNA vaccine for children aged 5 to <12 years old.
CDC Panel Reviews COVID-19 mRNA Vaccine Booster Dose Safety Data
A presentation of available third-dose data suggest the adverse event rate is consistent with that observed with second doses.
Johnson & Johnson Report Promising COVID-19 Vaccine Booster Efficacy, Long-Term Data
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.
Pfizer COVID-19 Vaccine Shows Continued Efficacy, Safety at 6 Months
Though efficacy waned over months, protection from symptomatic and severe COVID-19 remained significant, with no new adverse event risks observed.
US COVID-19 Vaccine Distribution Disproportionate to Death Burden
A neighborhood-level assessment of major cities show areas impacted the most by historic COVID-19 deaths are significantly less vaccinated.
Johnson & Johnson HIV Vaccine Reports Low Efficacy in African Women Trial
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.
Pfizer COVID-19 Vaccine Raises Adverse Event Risk, Though Not as Much as COVID-19
An Israel study estimates vaccinated persons' risk of side effects including myocarditis, relative to the risk brought on by SARS-CoV-2 infection.
Pfizer-BioNTech Submit COVID-19 Booster Vaccine for FDA Approval
The submission comes day after BNT162b2 became the first fully approved COVID-19 vaccine by the FDA.
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