Fauci says COVID-19 vaccine trials could end early if results are overwhelmingly positive
Editor's Note Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health told the Kaiser Health News on September 1 that a COVID-19 vaccine could be available earlier than expected if clinical trial results are overwhelmingly positive. An independent Data and…
FDA could fast-track COVID-19 vaccine approval
Editor's Note In an interview with the Financial Times, Food & Drug Administration (FDA) Commissioner Stephen Hahn, MD, on August 30, said the FDA could fast-track approval of a COVID-19 vaccine before late-stage clinical trials are complete if regulators believe the benefits of doing so outweigh the risks. Dr Hahn…
FDA warns against use of protective barrier enclosures without negative pressure during intubation, extubation of COVID-19 patients
Editor's Note In an August 21 letter, the Food & Drug Administration (FDA) warns that the use of passive protective barrier enclosures without negative pressure when treating patients (such as during intubation, extubation) who are known or suspected to have COVID-19 may pose increased health risk to patients and healthcare…
Gallup poll finds disinterest in receiving COVID-19 vaccine
Editor's Note A Gallup poll of US adults conducted from July 20 to August 2 finds that 35% of those surveyed would not be interested in receiving a COVID-19 vaccine when one is approved by the Food & Drug Administration. The survey also finds that 41% of non-white Americans would…
FDA authorizes first COVID-19 diagnostic test for screening asymptomatic people
Editor's Note The Food and Drug Administration (FDA) on July 24 reissued its emergency use authorization (EUA) for LabCorp’s COVID-19 RT-PCR Test to include two new indications for use: Testing for individuals who do not have COVID-19 symptoms or who have no reason to suspect COVID-19 infection. Allowing for pooled…
HHS taps Pfizer for large-scale COVID-19 vaccine production
Editor's Note The Department of Health and Human Services (HHS) and Department of Defense on July 22 announced an agreement with Pfizer to produce and deliver 100 million doses of its COVID-19 vaccine in the US, following manufacture and approval. Pfizer will deliver the doses, once the vaccine receives emergency…
Pfizer could have COVID-19 vaccine by October
Editor's Note Food & Drug Administration (FDA) approval of Pfizer’s COVID-19 vaccine could happen in October, the July 12 Time reports. The company was granted FDA Fast Track designation for the vaccine. Pfizer’s vaccine, being developed with its German biotech partner BioNTech, uses a messenger-RNA, genetics-based approach. Pfizer CEO Albert…
Late-stage COVID-19 vaccine trials to start this summer
Editor's Note The National Institute of Allergy and Infectious Diseases director Anthony Fauci says COVID-19 vaccine candidates will start moving into late-stage clinical trials by the end of July, continuing through the summer and into fall, the July 2 Reuters reports. The director of the National Institutes of Health, Dr…
FDA releases COVID-19 update
Editor's Note The Food and Drug Administration (FDA) on June 10 released a COVID-19 update announcing the following actions taken in its response to the pandemic: The FDA and National Institutes of Health have updated the CURE ID crowd-sourcing app to make it easier for healthcare providers to share their…
FDA reissues EUAs revising types of respirators that can be decontaminated
Editor's Note Citing a response to public health concerns, the Food & Drug Administration (FDA) on June 7 reissued certain emergency use authorizations (EUAs) to specify which respirators are appropriate for decontamination and reuse. The FDA determined that certain respirators should not be decontaminated for reuse by healthcare professionals during…
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