Vaccinations & Immunizations

Health Officials Say Myocarditis After COVID-19 Vaccination “Rare”

by Samantha McGrail

Federal health officials recently added new clinical guidance on the potential for myocarditis after COVID-19 vaccination for adolescents and young adults.  The statement, signed by the leaders...

Gilead’s Remdesivir Lowers Risk of Mortality in COVID-19 Patients

by Samantha McGrail

Gilead recently announced that its COVID-19 treatment, remdesivir, lowered the risk for mortality compared with matched controls in patients hospitalized with the virus. The three real-world data...

Biden Invests Over $3B to Boost COVID-19 Antiviral Development

by Samantha McGrail

The Biden Administration will invest over $3 billion to accelerate the discovery, development, and manufacturing of COVID-19 antiviral medicines. The initiative, called the Antiviral Program for...

Pfizer’s Drug Helps COVID-19 Patients Hospitalized with Pneumonia

by Samantha McGrail

New data showed that Pfizer’s tofacitinib elicited a lower cumulative incidence of death or respiratory failure through day 28 compared to placebo in COVID-19 patients hospitalized with...

Novavax COVID-19 Vaccine 100% Effective in Phase 3 Clinical Trial

by Samantha McGrail

Novavax has announced that its COVID-19 vaccine, NVX-CoV2373, demonstrated 100 percent protection against moderate or severe illness and 90.4 percent efficacy overall in a Phase 3 clinical...

FDA Boosts Johnson & Johnson’s COVID-19 Vaccine for Export

by Samantha McGrail

FDA recently updated its letter of authorization for Johnson & Johnson’s COVID-19 vaccine to help facilitate potential export to other countries.  Under the revised letter, FDA...

Pfizer, BioNTech Give US 500M Doses of COVID-19 Vaccine

by Samantha McGrail

Pfizer and BioNTech will provide the US government with 500 million doses of their COVID-19 vaccine; the allotment includes 200 million doses in 2021 and 300 million doses in 2022 at a not-for-profit...

6-in-1 Pediatric Vaccine from Merck, Sanofi Available Across US

by Samantha McGrail

Merck and Sanofi recently announced that their six-in-one combination pediatric vaccine is now available throughout the US.  Vaxelis is the first and only hexavalent combination vaccine available...

Moderna, UNICEF to Supply COVID-19 Vaccine on Behalf of COVAX

by Samantha McGrail

Moderna and UNICEF recently signed a long-term agreement for the supply of COVID-19 vaccine on behalf of the COVAX Facility, part of the agreement announced in May.  UNICEF and its procurement...

Moderna Initiates Rolling Submission for COVID-19 Vaccine

by Samantha McGrail

Moderna recently announced that it initiated the rolling submission process for a Biologics License Application (BLA) for its mRNA COVID-19 vaccine. The company will continue to submit data to support...

Moderna, Aldevron Expand Partnership for mRNA COVID-19 Vaccine

by Samantha McGrail

Moderna and Aldevron recently expanded their partnership to support Moderna’s mRNA COVID-19 vaccine and clinical development therapeutic pipeline.  Aldevron is a provider of plasmid DNA,...

Japan Grants AstraZeneca’s COVID-19 Vaccine Emergency Use

by Samantha McGrail

AstraZeneca’s COVID-19 vaccine, Vaxzevria, was recently granted emergency use in Japan for active immunization of individuals 18 years of age and older.  The Japanese Ministry of Health,...

Moderna’s mRNA COVID-19 Vaccine 100% Effective in Adolescents

by Samantha McGrail

Moderna recently announced that the Phase 2/3 study of its COVID-19 vaccine in adolescents met its primary immunogenicity endpoint, successfully bridging immune response to the adult...

GSK-Medicago COVID-19 Vaccine Elicits High Antibody Responses

by Samantha McGrail

Medicago’s Coronavirus-Like Particle COVID-19 Vaccine Candidate (CoVLP) elicited significant humoral immune response across all age groups when administered in combination with GSK’s...

GSK, Sanofi COVID-19 Vaccine Elicits Strong Antibody Response

by Samantha McGrail

GSK and Sanofi’s COVID-19 vaccine candidate achieved strong rates of neutralizing antibody responses in a Phase 2 clinical trial, according to a recent press release. The Phase 2 trial enrolled...

Top mRNA COVID-19 Vaccines 94% Effective, New CDC Data Shows

by Samantha McGrail

A multisite test-negative design case-control CDC study recently found that the mRNA COVID-19 vaccines from Pfizer and Moderna are highly effective against symptomatic coronavirus. The study analyzed...

Moderna Provides 25M Doses of COVID-19 Vaccine to Australia

by Samantha McGrail

Moderna recently announced a supply agreement with the government of Australia for 25 million doses of its mRNA COVID-19 vaccine and booster variant candidate.  Ten million doses of...

EMA Assesses Blood Clots, Other Side Effects of COVID-19 Vaccines

by Samantha McGrail

EMA’s safety committee recently reviewed a number of risk and safety signals related to various COVID-19 vaccines First, the committee known as PRAC (Pharmacovigilance Risk Assessment Committee)...

Pfizer, BioNTech Seek Full FDA Approval for COVID-19 Vaccine

by Samantha McGrail

Pfizer and BioNTech recently announced the initiation of a Biologics License Application for full FDA approval of their mRNA COVID-19 vaccine With the application, the companies submitted data t from...

Pfizer COVID-19 Vaccine Can be Used in Adolescents, FDA Says

by Samantha McGrail

FDA recently expanded the emergency use authorization for the Pfizer COVID-19 vaccine to include adolescents 12 through 15 years of age. The agency amended the original emergency use authorization...