Vaccinations & Immunizations

FDA Approves Johnson & Johnson’s Schizophrenia Injectable

by Samantha McGrail

FDA recently approved Johnson & Johnson’s long-acting atypical antipsychotic, Invega Hafyera, the first and only twice yearly injectable to treat schizophrenia in adults.  Providers...

Moderna Submits Initial Data to FDA for COVID-19 Vaccine Booster

by Samantha McGrail

Moderna recently submitted initial data to the FDA to evaluate a booster dose of its COVID-19 vaccine, mRNA-1263, at the 50 microgram dose level.  The company will submit data to the European...

Pfizer, BioNTech COVID-19 Vaccine Expands to Latin America

by Samantha McGrail

Pfizer and BioNTech recently signed a letter of intent with Eurofarma Laboratoriors SA, a Brazilian pharmaceutical company, to manufacture its COVID-19 vaccine, Comirnaty, in Latin...

J&J COVID-19 Vaccine Booster Elicits Strong Antibody Responses

by Samantha McGrail

Johnson & Johnson recently announced that a booster dose of its COVID-19 vaccine generated a rapid and robust increase in spike-binding antibodies, nine-fold higher than 28 days after...

Pfizer-BioNTech COVID-19 Vaccine Gets Full FDA Approval

by Samantha McGrail

FDA has granted full approval to Pfizer and BioNTech’s COVID-19 vaccine for individuals 16 years of age and older.  This vaccine, previously known as the Pfizer-BioNTech COVID-19...

New CEO to Take Over for Gorsky at Johnson & Johnson

by Samantha McGrail

Johnson & Johnson will have a new CEO in 2022. Current chairman and CEO Alex Gorsky is transitioning to the role of executive chairman and will be replaced as CEO by Joaquin Duato, according to a...

UPMC Expands Access to Monoclonal COVID-19 Antibody Treatments

by Samantha McGrail

The University of Pittsburgh Medical Center (UPMC) recently announced expanded access to its potential COVID-19 antibody treatments in outpatient and inpatient settings for eligible...

FDA OKs 3rd COVID-19 Vaccine Dose for the Immunocompromised

by Samantha McGrail

FDA amends the emergency use authorizations for both the Pfizer-BioNTech and Moderna COVID-19 vaccines to allow for an additional dose in immunocompromised individuals. The agency determined that the...

Novavax’s COVID-19 Vaccine Booster Neutralizing Antibody Levels

by Samantha McGrail

Novavax recently announced that a single booster dose of its COVID-19 vaccine, NVX-CoV2373, elicited a 4.6-fold increase in functional antibody titers six months after an initial two-dose...

FDA Broadens Authorization for Eli Lilly’s COVID-19 Treatment

by Samantha McGrail

FDA recently broadened the emergency use authorization for Eli Lilly and Company’s COVID-19 treatment, baricitinib, to allow for treatment without remdesivir. Under the new authorization,...

51% of Retail Pharmacy Customers Used Wellness Services in 2020-21

by Samantha McGrail

Over half of retail pharmacy customers (51 percent)  have used health and wellness services over the past year, according to the J.D. Powers 2021 US Pharmacy Study.  This number is up from...

Sanofi, Translate Enter Pharma Acquisition Deal for mRNA Vaccines

by Samantha McGrail

Sanofi and Translate Bio recently entered into a $3.2 billion pharma acquisition deal to accelerate the development of mRNA vaccines and therapeutics.  Under the terms of the acquisition,...

AstraZeneca’s COVID-19 Vaccine 82% Effective Against Variants

by Samantha McGrail

AstraZeneca recently announced that its COVID-19 vaccine, Vaxzevria, was 82 percent effective against hospitalization or death caused by the Beta/Gamma SARS-CoV-2 variants.  The results,...

J&J COVID-19 Vaccine Elicits Antibody Responses Against Variants

by Samantha McGrail

Johnson & Johnson recently announced that its COVID-19 vaccine elicited strong antibody and T-cell immune responses as long as eight months after vaccination. The results, published in the New...

Moderna Doses First Patient in Study of Flu mRNA Vaccine Candidate

by Samantha McGrail

Moderna recently announced that the first patient has been dosed in the Phase 1/2 study of its quadrivalent seasonal flu mRNA vaccine candidate. mRNA-1010 is Moderna’s first seasonal flu vaccine...

Gavi Signs Agreement for Sinopharm, Sinovac COVID-19 Vaccine Doses

by Samantha McGrail

Gavi recently signed an advance purchased agreement with Sinopharm and Sinovac for their respective COVID-19 vaccines. The purchase agreements for Sinopharm’s “BBIBP-CorV” and...

FDA Updates J&J COVID-19 Vaccine Label to Include Rare Disorder

by Samantha McGrail

FDA recently updated the label on Johnson & Johnson’s COVID-19 vaccine to warn of the possible side effect of Guillain-Barre syndrome, according to multiple news outlets.  Of the 100...

J&J COVID-19 Vaccine Neutralizes Activity Against Delta Variant

by Samantha McGrail

Johnson & Johnson recently announced that a single shot of its COVID-19 vaccine generated robust and persistent activity against the SARS-CoV-2 Delta variant and other prevalent viral...

Moderna’s COVID-19 Vaccine Elicits Activity Against All Variants

by Samantha McGrail

Moderna recently announced that its COVID-19 vaccine produced neutralizing titers against all coronavirus variants tested in a Phase 1 clinical trial.  Specifically, Moderna COVID-19 Vaccine...

ViiV Healthcare, Halozyme to Develop Long-Acting HIV Treatment

by Samantha McGrail

ViiV Healthcare and biopharmaceutical company Halozyme Therapeutics recently announced a global collaboration and license agreement to develop long-acting HIV treatment.  Under the agreement,...