Coronavirus

CDC Recommends Pfizer- BioNTech COVID-19 Vaccine for Children

by Samantha McGrail

The CDC Advisory Committee on Immunization Practices (ACIP) recently recommended Pfizer and BioNTech’s pediatric COVID-19 vaccine for children five to 11 years of age. The organization now...

Feds Purchases More Doses of Lilly’s COVID-19 Antibody Treatment

by Samantha McGrail

The US government recently purchased additional doses of Eli Lilly and Company’s combination COVID-19 antibody treatment. Under the agreement, Eli Lilly and Company will supply 614,000 doses of...

Moderna Doses the First Participant in Study of CMV mRNA Vaccine

by Samantha McGrail

Moderna recently dosed the first participant in the Phase 3 pivotal registration study of its cytomegalovirus (CMV) mRNA vaccine candidate, mRNA-1647. The CMVictory study will evaluate the safety and...

FDA Authorizes Thermo Fisher’s COVID-19 New Test Collection Method

by Samantha McGrail

FDA recently granted emergency use authorization to Thermo Fisher Scientific to run new saliva sample collection methods on its COVID-19 tests. The company’s molecular diagnostics Spectrum...

FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Children

by Samantha McGrail

FDA recently granted emergency use authorization to Pfizer and BioNTech’s COVID-19 vaccine for children five through 11 years of age. The agency based its decision on data from a Phase 2/3...

Two Doses of Moderna’s COVID-19 Vaccine Effective in Children

by Samantha McGrail

Moderna recently announced that two doses of its COVID-19 vaccine showed a robust neutralizing antibody response in children six to under 12 years of age.  The Phase 2/3 KidCOVE randomized...

Pfizer, BioNTech COVID-19 Vaccine Booster Dose 95.6% Effective

by Samantha McGrail

Pfizer and BioNTech recently announced that their COVID-19 vaccine booster was 95.6 percent effective in individuals compared to placebo.    The randomized, controlled Phase 3 trial...

CDC Unanimously Recommends J&J, Moderna COVID-19 Vaccine Booster

by Samantha McGrail

CDC recently recommended Johnson & Johnson and Moderna’s COVID-19 vaccine booster shots for all eligible individuals who receive any FDA authorized vaccine.  The organization...

FDA Authorizes Moderna, J&J Booster COVID-19 Vaccine Dose

by Samantha McGrail

FDA recently granted emergency use authorization to both the Moderna and Johnson & Johnson respective COVID-19 vaccine booster doses.  The agency specifically approved Moderna’s booster...

FDA Recommends Booster Dose of Moderna’s COVID-19 Vaccine

by Samantha McGrail

FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) recently recommended a booster dose of Moderna’s COVID-19 vaccine, mRNA-1273, at the 50 microgram...

FDA Recommends Authorization For J&J’s COVID-19 Vaccine Booster

by Samantha McGrail

FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) recently recommended emergency use authorization for a booster dose of Johnson & Johnson’s COVID-19 vaccine. VRBPAC...

AstraZeneca’s COVID-19 Antibody Prevents and Treats COVID-19

by Samantha McGrail

AstraZeneca recently announced that its COVID-19 antibody, AZD7442, reduced severe COVID-19 or death compared to placebo in non-hospitalized patients with mild-to-moderate symptomatic...

Moderna to Build State-of-the-Art mRNA Facility in Africa

by Samantha McGrail

Moderna recently announced that it will build a state-of-the-art mRNA facility in Africa to produce up to 500 million doses of vaccines annually at the 50 microgram dose level. The company will invest...

J&J’s Chief Scientific Officer Paul Stoffels Announces Retirement

by Samantha McGrail

Johnson & Johnson recently announced that Paul Stoffels, MD, current vice-chairman of the executive committee and chief scientific officer of Johnson & Johnson, will retire at the end of...

J&J Submits Data to FDA to Support COVID-19 Vaccine Booster

by Samantha McGrail

Johnson & Johnson recently submitted data to the FDA to support its COVID-19 vaccine booster shot in adults 18 and older. The submission includes results from the Phase 3 ENSEMBLE study, which...

AstraZeneca Requests FDA EUA for COVID-19 Antibody Combination

by Samantha McGrail

AstraZeneca recently submitted a request to FDA for an emergency use authorization for its long-acting COVID-19 antibody combination, AZD7442. AstraZeneca optimized AZD7442 using its YTE half-life...

Francis Collins Resigns as Director of the NIH After 12 Years

by Samantha McGrail

Francis S. Collins, MD, PhD, will be stepping down as director of the National Institutes of Health (NIH) by the end of 2021. Collins is the longest-serving presidentially appointed NIH director,...

Regeneron’s COVID-19 Antibody Cocktail Helps Hospitalized Patients

by Samantha McGrail

Regeneron recently announced that its COVID-19 antibody cocktail, REGEN-COV, significantly reduced viral load in patients hospitalized with the coronavirus. The trial enrolled 1,197 patients to...

Pfizer Submits Data to FDA For COVID-19 Vaccine in Children

by Samantha McGrail

Pfizer and BioNTech recently submitted data to FDA from the Phase 2/3 clinical trial of their COVID-19 vaccine in children five to 11 years of age.   Last week, the companies announced that...

Pfizer Launches Trial of COVID-19 Treatment for Post-Exposure

by Samantha McGrail

Pfizer recently announced the start of a Phase 2/3 study to evaluate its COVID-19 treatment in combination with ritonavir to prevent coronavirus disease. The randomized, double-blind EPIC-PEP study...