Coronavirus

CDC Advisors Recommend Johnson & Johnson COVID-19 Vaccine

by Samantha McGrail

Johnson & Johnson recently announced that the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended its single-shot COVID-19 vaccine under the recent FDA emergency use...

GSK Antibody Helps Combat Respiratory Failure from COVID-19

by Samantha McGrail

GSK recently announced results from a Phase 2 proof-of-concept trial evaluating its investigational monoclonal antibody treatment, otilimab.  The OSCAR study evaluated the efficacy and safety of...

Moderna Ships Doses of Variant-Specific COVID-19 Vaccine to NIH

by Samantha McGrail

Moderna recently announced that it has shipped doses of its variant-specific COVID-19 vaccine candidate to the National Institutes of Health (NIH) for a Phase 1 clinical trial. NIAID will conduct the...

Pfizer, BioNTech Submit COVID-19 Vaccine Stability Data to FDA

by Samantha McGrail

Pfizer and BioNTech recently announced the submission of new data to FDA demonstrating the stability of their COVID-19 vaccine when stored at higher temperatures.  Specifically, the...

Additional Moderna Investments to Boost COVID-19 Vaccine Output

by Samantha McGrail

Moderna recently announced that it is making new capital investments to increase global manufacturing capacity of its COVID-19 vaccine, mRNA-1273.  The company will make investments to increase...

Pfizer to Study COVID-19 Vaccine in Pregnant Women

by Samantha McGrail

Pfizer and BioNTech recently announced that the first participants have been dosed in a global Phase 2/3 study to further evaluate their COVID-19 vaccine in healthy pregnant women. The randomized,...

FDA Issues New Guidance for COVID-19 Vaccine Developers

by Samantha McGrail

FDA recently issued three guidance documents for COVID-19 vaccine developers and other medical product creators covering to address the current and potential future emergence of variants of...

FDA Authorizes Johnson & Johnson’s Single-Dose COVID-19 Vaccine

by Samantha McGrail

FDA has issued an emergency use authorization for a third COVID-19 vaccine to Johnson & Johnson, which will be distributed in the US for use in individuals 18 years of age and older.  The...

Flu Vaccine Patterns Hint To Effective COVID-19 Vaccination Efforts

by Emily Sokol, MPH

Promise of the world returning to normal hinges on COVID-19 vaccine rollout. Talk of herd immunity has given people hope that large gatherings, indoor dining, and sporting events will once again become a part of everyday life, or at least...

FDA Analysis Finds J&J’s COVID-19 Vaccine Safe, Effective

by Samantha McGrail

A recent FDA analysis found that Johnson & Johnson’s COVID-19 vaccine met requirements for emergency use authorization.  The data submitted to FDA by the pharmaceutical company was from...

HHS Releases New Actions to Expand COVID-19 Testing Across the US

by Samantha McGrail

HHS recently announced new actions to expand COVID-19 testing capacity across the US as part of President Joe Biden’s National Strategy for the COVID-19 Response and Pandemic Preparedness. The...

WHO Grants Emergency Use to AstraZeneca’s COVID-19 Vaccine

by Samantha McGrail

The World Health Organization (WHO) recently granted AstraZeneca’s COVID-19 vaccine emergency use listing (EUL) for active immunization to prevent coronavirus in individuals 18 years of age and...

AstraZeneca, Biologika to Increase Output of COVID-19 Vaccine

by Samantha McGrail

AstraZeneca and IDT Biologika recently partnered to boost manufacturing and supply capacity for COVID-19 Vaccine AstraZeneca in the second quarter of 2021.  The companies will also launch a joint...

Eli Lilly Enhances Local Access to COVID-19 Antibody Therapies

by Samantha McGrail

Eli Lilly and Company recently partnered with local health systems to enhance access to crucial COVID-19 antibody therapies.   The partnership will work to launch dedicated infusion center...

CVS Health Boosts Access to COVID-19 Vaccines Across 11 States

by Samantha McGrail

CVS Health recently announced that it is expanding access to COVID-19 vaccines to eligible populations at a limited number of CVS Pharmacy locations across 11 states.  In total, there will be...

Siemens Healthineers Receives CE Mark for COVID-19 Antigen Test

by Samantha McGrail

Siemens Healthineers recently announced that it received the CE mark to use anterior nose swab sampling for its COVID-19 antigen test. The CLINITEST Rapid COVID-19 Antigen Test is a point-of-care...

FDA Approves Eli Lilly’s Combination COVID-19 Antibody Treatment

by Samantha McGrail

FDA recently issued an emergency use authorization to Eli Lilly & Company for its combination COVID-19 antibody treatment.  The authorization states that providers can administer the...

Roche to Launch Self-Administered COVID-19 Antigen Test

by Samantha McGrail

Roche recently announced that it received the CE mark for its new self-administered COVID-19 antigen test, which will be available in countries accepting the CE mark by the middle of this...

GSK, CureVac to Develop Next Generation mRNA COVID-19 Vaccines

by Samantha McGrail

GSK and CureVac recently announced a $180.5 million collaboration to jointly develop next-generation mRNA COVID-19 vaccines. The companies will contribute resources and expertise to research, develop,...

HHS Expands Workforce Authorized to Administer COVID-19 Vaccines

by Samantha McGrail

HHS recently issued a fifth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to add categories of qualified persons authorized to prescribe,...