FDA Authorizes Pfizer COVID Vaccine for Kids 12-16

FDA Authorizes Pfizer COVID Vaccine for Kids 12-16

May 10, 2021 — The FDA on Monday granted emergency use authorization for the Pfizer coronavirus vaccine to be given to children 12-to-15 years old.   The much-expected decision increases the likelihood that schools in the United States will fully reopen in the fall — a goal of both the Biden and Trump administrations. … Read more

J&J Seeks Emergency Approval of COVID Vaccine

J&J Seeks Emergency Approval of COVID Vaccine

Feb. 5, 2021 — The world’s first single-dose COVID-19 vaccine, from Johnson & Johnson, has been submitted to the U.S. Food and Drug Administration for emergency use approval. Preliminary findings from a large international study suggest the vaccine isn’t quite as strong as the two current FDA-approved vaccines from Pfizer and Moderna, which are … Read more

FDA Authorizes use of Moderna COVID-19 Vaccine

FDA Authorizes use of Moderna COVID-19 Vaccine

Dec. 18, 2020 — As expected, the FDA granted Moderna an emergency use authorization for its COVID-19 vaccine, doubling the number of vaccine doses expected to be available in the coming days for distribution nationwide. There is one final step — the CDC’s Advisory Committee on Immunization Practices will need to recommend its use, … Read more

COVID-19 Vaccines On the Way: What to Know

COVID-19 Vaccines On the Way: What to Know

Paul Offit, MD, director, Vaccine Education Center, and professor of pediatrics, Children’s Hospital of Philadelphia; professor of vaccinology, Perelman School of Medicine, University of Pennsylvania. Naor Bar-Zeev, PhD, associate professor of international health and vaccinology and deputy director, International Vaccine Access Center, Johns Hopkins Bloomberg School of Public Health, Baltimore. JAMA Live Stream: Dec. … Read more

FDA: Pfizer COVID Vaccine Effective After One Dose

FDA: Pfizer COVID Vaccine Effective After One Dose

TUESDAY, Dec. 8, 2020 (HealthDay News) — New data released Tuesday by the U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee suggest that Pfizer’s two-dose COVID-19 vaccine works well protecting recipients against COVID-19. The committee is scheduled to meet on Thursday to consider the Pfizer/BioNTech COVID-19 vaccine for emergency use … Read more

FDA Authorizes Arthritis Drug Combo for COVID-19

FDA Authorizes Arthritis Drug Combo for COVID-19

Nov. 19, 2020 — The FDA on Thursday granted emergency use authorization for the arthritis drug baricitinib to be used in combination with remdesivir to treat hospitalized adults and children with suspected or confirmed COVID-19. The combination is meant for patients who need supplemental oxygen or mechanical ventilation. Baricitinib plus remdesivir was shown … Read more

Doctors Wary of Rushed COVID Vaccine

Doctors Wary of Rushed COVID Vaccine

Sept. 28, 2020 — Only 17% of doctors say they will get a COVID-19 vaccine if it is authorized before all clinical trials have been completed, according to results of a Medscape poll. The poll asked doctors and nurses how likely they were to order or use treatments or vaccines if the FDA grants … Read more

Is Key Safety Data at Risk in Race for COVID Vaccine?

Is Key Safety Data at Risk in Race for COVID Vaccine?

Grace Lee, MD, professor of pediatric infectious diseases, Lucile Salter Packard Children’s Hospital, Stanford University, Stanford, CA. William Schaffner, MD, professor, preventive medicine, health policy, infectious diseases, Vanderbilt University Medical Center, Nashville. Tom Frieden, MD, president and CEO, Resolve to Save Lives, New York City. Hearing, U.S. Senate Committee on Health, Education, Labor and Pensions: … Read more

No Proof Convalescent Plasma Works Against COVID

No Proof Convalescent Plasma Works Against COVID

Sept. 2, 2020 — There’s no evidence to support the use of convalescent plasma to treat COVID-19 patients, and doctors should not consider it a standard of care until more research is completed, a U.S. National Institutes of Health expert panel said Tuesday. “There are insufficient data to recommend either for or against the use … Read more

FDA Halts Approval for Plasma to Treat COVID-19

FDA Halts Approval for Plasma to Treat COVID-19

Aug. 20, 2020 — U.S. Food and Drug Administration’s emergency approval of blood plasma as a COVID-19 treatment was put on hold last week after senior federal health officials said data supporting the therapy was too weak. More data is under review and the approval could still be issued in the near future, according to … Read more