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COVID-19 Boosters This Fall to Include Omicron Antigen, but Questions Remain About Its Value


11 Jul 2022

Probably many people who watched or participated in the June 28 virtual US Food and Drug Administration (FDA) advisory committee meeting about updating COVID-19 vaccines could agree on 1 point, made by the agency’s Peter Marks, MD, Ph.D: “It is science at its hardest.” More New Online Views 8,944 Citations 0 25 Medical News & Perspectives July 8, 2022 COVID-19 Boosters This Fall to Include Omicron Antigen, but Questions Remain About Its Value Rita Rubin, MA Article Information JAMA. Published online July 8, 2022. doi:10.1001/jama.2022.11252 related articles icon Related Articles Probably many people who watched or participated in the June 28 virtual US Food and Drug Administration (FDA) advisory committee meeting about updating COVID-19 vaccines could agree on 1 point, made by the agency’s Peter Marks, MD, PhD: “It is science at its hardest.” The SARS-CoV-2 Omicron variant is shown as green dots budding from a vero mammalian kidney epithelial cell 36 hours after infection. The SARS-CoV-2 Omicron variant is shown as green dots budding from a vero mammalian kidney epithelial cell 36 hours after infection. Steve Gschmeissner/sciencesource.com The FDA convened its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss whether to add an Omicron component to boosters for the fall. In order to have enough doses by early October, “we will need to very rapidly move to let companies know what that selection will be,” Marks reminded the panelists. (How many doses will be enough isn’t clear—as of June 30, only 51.1% of fully vaccinated US adults aged 18 years or older had received 1 booster shot, while only 27% of fully vaccinated adults aged 50 years or older, for whom a second booster is recommended, had received 2, according to government data.)


COVID-19 Vaccines for Kids Under 5: What Parents Need To Know


19 Jun 2022

After multiple delays, very young children are finally eligible for COVID-19 vaccination. In mid-June, the Food and Drug Administration (FDA) granted emergency use authorization (EUA) to Pfizer’s COVID-19 vaccine for children ages 6 months to 5 years, as well as to Moderna's vaccine for kids ages 6 months to 6 years. The Centers for Disease Control and Prevention (CDC) soon after recommended the vaccines, which should become available early next week.


Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age


17 Jun 2022

Today, the U.S. Food and Drug Administration authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age. For the Moderna COVID-19 Vaccine, the FDA amended the emergency use authorization (EUA) to include use of the vaccine in individuals 6 months through 17 years of age. The vaccine had been authorized for use in adults 18 years of age and older. For the Pfizer-BioNTech COVID-19 Vaccine, the FDA amended the EUA to include use of the vaccine in individuals 6 months through 4 years of age. The vaccine had been authorized for use in individuals 5 years of age and older.


Using AI to Advance Understanding of Long COVID Syndrome


07 Jun 2022

The COVID-19 pandemic continues to present considerable public health challenges in the United States and around the globe. One of the most puzzling is why many people who get over an initial and often relatively mild COVID illness later develop new and potentially debilitating symptoms. These symptoms run the gamut including fatigue, shortness of breath, brain fog, anxiety, and gastrointestinal trouble.


The E.U. will no longer recommend that masks be required for air travel.


11 May 2022

The European Union will no longer recommend that member states require face masks on planes and in airports, two E.U. agencies announced on Wednesday, ending a guideline that had been in place for nearly two years as countries across the bloc lift Covid restrictions.




Articles


Long-Term Dysfunction of Taste Papillae in SARS-CoV-2


06 Sep 2023

Abstract BACKGROUND We sought to determine whether ongoing taste disturbance in the post-acute sequelae of coronavirus disease 2019 is associated with the persistent virus in primary taste tissue. CONCLUSIONS Our data show a temporal association in patients between functional taste, taste papillae morphology, and the presence of SARS-CoV-2 and its associated immunological changes. (Funded by Intramural Research Program/National Institute on Aging/National Institute of Allergy and Infectious Diseases/National Institutes of Health; ClinicalTrials.gov numbers NCT03366168 and NCT04565067.)




Uninsured and Not Immune — Closing the Vaccine-Coverage Gap for Adults


20 Jul 2023

The U.S. Covid-19 vaccination strategy was simple: get safe and effective vaccines into arms as quickly as possible by making them free and accessible. This strategy worked: more than 670 million Covid-19 vaccine doses had been administered to more than 270 million Americans by the end of the national public health emergency.




Strategic Masking to Protect Patients from All Respiratory Viral Infections


06 Jul 2023

The end of the public health emergency in the United States is a richly symbolic milestone in the course of the SARSCoV-2 pandemic. During the height of the pandemic, the virus killed millions of people worldwide, upended lives, and radically altered health care. One of the most visible changes in health care was the introduction of universal masking, a measure designed to reduce SARS-CoV-2 transmission in health care facilities by applying source control and exposure protection to everyone in the facility. With the end of the public health emergency, however, many health care centers in the United States are now stopping universal masking and reverting to requiring masking in only limited circumstances (e.g., when health care workers are caring for patients with potentially contagious respiratory infections).




Development of a Definition of Postacute Sequelae of SARS-CoV-2 Infection


25 May 2023

Key Points Question What symptoms are differentially present in SARS-CoV-2–infected individuals 6 months or more after infection compared with uninfected individuals, and what symptom-based criteria can be used to identify postacute sequelae of SARS-CoV-2 infection (PASC) cases? Findings In this analysis of data from 9764 participants in the RECOVER adult cohort, a prospective longitudinal cohort study, 37 symptoms across multiple pathophysiological domains were identified as present more often in SARS-CoV-2–infected participants at 6 months or more after infection compared with uninfected participants. A preliminary rule for identifying PASC was derived based on a composite symptom score. Meaning A framework for identifying PASC cases based on symptoms is a first step to defining PASC as a new condition. These findings require iterative refinement that further incorporates clinical features to arrive at actionable definitions of PASC.




11 clinical trials that will shape medicine in 2023


23 Dec 2022

2022 has been a rollercoaster year for biopharma, as it has faced an industry-wide slowdown and late-stage clinical trial failures, as well as breakthroughs and regulatory approvals. COVID-19 has continued to disrupt nearly all aspects of clinical trial infrastructure, from patient recruitment to supply chains, but despite this, 2023 promises to bring many new readouts from different branches of medicine (Table 1). Nature Medicine asked 11 leading experts for their top clinical trials to watch in the coming year




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