Following the record surge in COVID-19 cases during the Omicron-driven wave, some 58 percent of the U.S. population overall and more than 75 percent of younger children have been infected with the coronavirus since the start of the pandemic, according to a U.S. nationwide blood survey released on April 26.
Pfizer Inc. and the company’s partner BioNTech SE said on April 26 that they had submitted an application to the U.S. health regulator for the authorization of a booster dose of their COVID-19 vaccine for children aged 5 to 11 years.
Gilead’s Veklury Becomes First FDA-Approved COVID-19 Treatment for Young ChildrenAntivirals, Children, COVID-19 Therapeutics, FDA, Gilead, Hospitalized COVID-19 Patients, National Institute of Allergy and Infectious Diseases (NIAID), Pharmacokinetic Data, R&D, Remdesivir, Safety Data, Therapeutics, World Health Organization, Young children
The U.S. Food and Drug Administration approved Gilead Sciences’ antiviral therapy Veklury (remdesivir) as the first treatment for COVID-19 in young children.
Pfizer/BioNTech say booster dose increases protection against Omicron in kids aged 5-11BNT162b2 (Pfizer and BioNTech), CDC, Children 5-11 Years, Clinical Trials, COVID-19 booster shots, COVID-19 shots, COVID-19 Vaccines, FDA, Immunocompromised, Immunogenicity Data, Neutralizing Antibodies, Omicron (B.1.1.529) (South Africa), R&D, SARS-CoV-2 virus
A third dose of the COVID-19 vaccine from Pfizer (PFE.N) and BioNTech (22UAy.DE) produced significant protection against the Omicron variant of the coronavirus in healthy children ages 5 to 11, the companies said on April 14.
Vaccination after COVID improves immunity; ivermectin fails in major trialAntiparasitics, Blood Plasma, Children, Convalescent Plasma, CoronaVac (Sinovac Biotech), COVID-19 immunity, COVID-19 Studies, Delta Variant (B.1.617.2; India), Hospitalized COVID-19 Patients, Ivermectin, JAMA Pediatrics, Janssen COVID-19 Vaccine (J&J), Lancet Infectious Diseases, mRNA-1273/Moderna COVID-19 Vaccine (Moderna), Omicron (B.1.1.529) (South Africa), R&D, Therapeutics, Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
Although people who recover from COVID-19 usually gain some immune defenses against reinfection, they get additional protection from vaccines, especially against severe disease, according to two studies published on March 31 in The Lancet Infectious Diseases. Additionally, two gold-standard trials published in The New England Journal of Medicine on March 30 help settle questions about two controversial therapies touted by many early in the pandemic with decidedly mixed results – failure for the antiparasite drug ivermectin and success for antibody-rich blood plasma from COVID-19 survivors.
The U.S. Food and Drug Administration extended the Prescription Drug User Fee Act date for Merck’s supplemental Biologics License Application (sBLA) for Vaxneuvance, a pneumococcal conjugate vaccine intended for preventative use in infants and children.
Children ages 5 to 11 who received the Pfizer/BioNTech COVID-19 vaccine were 68% less likely to be hospitalized during the Omicron wave in the United States than unvaccinated children, according to a study published on March 30.
UCB’s Fintepla (fenfluramine) oral solution CIV was approved in the United States for the treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age and older. Additionally, the FDA granted pediatric exclusivity for the product.
New York Mayor Eric Adams is set to lift the city’s COVID-19 vaccine mandate for performers and professional athletes as early as this week, Politico reported on March 23, a rule that has come under growing criticism by local sports teams.
With Robust Results, Moderna to Request Vaccine EUA for Kids Under 6BNT162b2 (Pfizer and BioNTech), CDC, Children, Clinical Trials, COVID-19 Vaccines, Data, Emergency Use Authorization (EUA), Immunogenicity Data, Moderna, mRNA-1273/Moderna COVID-19 Vaccine (Moderna), Omicron (B.1.1.529) (South Africa), R&D
Moderna reported positive interim results from the Phase II/III KidCOVE trial of the company’s mRNA COVID-19 vaccine for children six months to under two years and also two to six years of age.