Vaccinations & Immunizations

FDA Amends EUA For Pfizer-BioNTech’s COVID-19 Vaccine Booster

by Samantha McGrail

FDA recently amended the emergency use authorization for Pfizer and BioNTech’s COVID-19 vaccine booster to include individuals 5– 11 years of age at least five months after completing the...

FDA Approves Eli Lilly and Company’s Type 2 Diabetes Injectable

by Samantha McGrail

FDA recently approved Eli Lilly and Company’s Mounjaro (tirzepatide) injection to improve blood sugar control in adults with type 2 diabetes as an addition to diet and...

Roche, Global Fund to Build Diagnostic Capacity of HIV, Tuberculosis

by Samantha McGrail

Roche’s Global Access Program and the Global Fund to Fight AIDS, Tuberculosis, and Malaria, recently partnered to build and strengthen diagnostic capacity and pandemic preparedness in...

J&J Appoints Thibaut Mongon CEO of New Consumer Health Company

by Samantha McGrail

Johnson & Johnson recently appointed Thibaut Mongon as chief executive officer and Paul Ruh as chief financial officer designate of its future consumer health company.   With over 20...

Janssen Pharmaceuticals Terminates Collaboration in Hepatitis B, HPV

by Samantha McGrail

The Janssen Pharmaceutical Companies of Johnson & Johnson recently terminated its collaboration with Bavarian Nordic, which developed potential vaccines against the hepatitis B virus and human...

FDA Limits Use of Johnson & Johnson COVID-19 Vaccine

by Samantha McGrail

FDA recently limited the authorized use of Johnson & Johnson's COVID-19 vaccine to include individuals 18 years of age and older for whom other authorized or approved vaccines are not...

Pfizer’s COVID-19 Treatment Reduces Disease by 37% Post-Exposure

by Samantha McGrail

Pfizer recently announced that its COVID-19 treatment, Paxlovid reduced disease by 32% and 37% in adults for 5–10 days, respectively, compared to placebo.   The Phase 2/3 EPIC-PEP study...

FDA Expands Approval of COVID-19 Treatment, Remdesivir

by Samantha McGrail

FDA recently expanded the approval for COVID-19 treatment, Veklury (remdesivir), to include pediatric patients 28 days of age and older weighing at least seven pounds.  The agency's decision...

Pfizer Reports Positive Phase 2 Data for Lyme Disease Vaccine

by Samantha McGrail

Pfizer and Valneva recently reported positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15. The Phase 2 trial, VLA15-221, is the first clinical study with VLA15 that enrolled...

Moderna Appoints Arpa Garay as Chief Commercial Officer

by Samantha McGrail

Moderna recently announced that Arpa Garay will join the company as chief commercial officer, effective May 31, 2022. Garay joins Modera from Merck & Co, where she became an expert in oncology,...

FDA Issues EUA to First COVID-19 Test Using Breath Samples

by Samantha McGrail

FDA recently issued an emergency use authorization (EUA) for the first COVID-19 test that detects chemical compounds in breath samples associated with SARS-CoV-2 infection.   Qualified,...

Major Milestones in Medicine, Drug Development in Recorded History

by Alivia Kaylor

Because the past few centuries have witnessed several revolutionary scientific advances, research into the mechanisms responsible for infectious diseases and the development of drugs and vaccines has led to the eradication of...

Moderna Doses Participants in Study of Two Influenza mRNA Vaccines

by Samantha McGrail

Moderna recently dosed the first patients in a Phase 1/2 study of its influenza mRNA vaccine candidates, mRNA-1020 and mRNA-1030.  The randomized, observer-blind trial will evaluate the safety,...

WHO Recommends Johnson & Johnson’s COVID-19 Vaccine for Booster Use

by Samantha McGrail

The World Health Organization (WHO) recently updated the emergency use listing (EUL) for Johnson & Johnson’s COVID-19 vaccine, recommending it as a booster in individuals 18 years of age and...

Merck Expands Broad Access to HPV Vaccines Globally

by Samantha McGrail

Merck recently reaffirmed its commitment to enable broad equitable access to its human papillomavirus (HPV) vaccines.  Under the initiative, Merck will expand its vaccines manufacturing facility...

FDA Approves Second Dose of Moderna’s COVID-19 Vaccine

by Samantha McGrail

FDA recently amended the emergency use authorization of Moderna's COVID-19 vaccine to allow for a second booster dose at the 50 microgram level in adults 50 years of age and older.  The...

Moderna Will Expand mRNA Vaccine Pipeline Through 2 New Programs

by Samantha McGrail

Moderna will expand its mRNA vaccine pipeline through two new development programs, including a combination respiratory vaccine candidate and a program against four endemic human coronaviruses...

Pfizer Submits for EUA of Additional COVID-19 Vaccine Booster

by Samantha McGrail

Pfizer and BioNTech recently submitted an application to FDA for emergency use authorization (EUA) of an additional COVID-19 vaccine booster dose for adults 65 years and older.   The...

Novavax Launches 2 Global Vaccine Programs As Educational Tools

by Samantha McGrail

Novavax recently launched its global, unbranded vaccine programs, 'We Do Vaccines' and 'Know Our Vax' as educational efforts to help protect people's health in the fight against the...

Moderna Doses First Patient in HIV mRNA Vaccine Clinical Trial

by Samantha McGrail

Moderna recently dosed the first participant in an HIV trimer mRNA vaccine (mRNA-1574) clinical trial.   The open-label Phase 1 trial will evaluate the safety and immunogenicity of...