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F.D.A. Authorizes Updated Covid Booster Shots for Children 5 to 11


12 Oct 2022

Federal regulators on Wednesday broadened access to updated coronavirus booster shots to include children as young as 5, hoping to bolster protection against the now-dominant version of the virus.


Long COVID


09 Aug 2022

What Is Long COVID? Many people recover fully within a few days or weeks after being infected with SARS-CoV-2, the virus that causes COVID-19. But others have symptoms that linger for weeks, months, or even years after their initial diagnosis. Some people seem to recover from COVID-19 but then see their symptoms return, or they develop new symptoms within a few months. Even people who had no symptoms when they were infected can develop symptoms later. Either mild or severe COVID-19 can lead to long-lasting symptoms. Long COVID, long-haul COVID, post-COVID-19 condition, chronic COVID, and post-acute sequelae of SARS-CoV-2 (PASC) are all names for the health problems that some people experience within a few months of a COVID-19 diagnosis. Symptoms of long COVID may be the same or different than symptoms of COVID-19. Long COVID can also trigger other health conditions, such as diabetes or kidney disease.


Studying Long COVID Might Help Others With Post-Viral Fatigue Ailments


08 Aug 2022

For people with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), “fatigue” doesn’t just mean being a little tired. It means a brain like molasses, a body exhausted and weak, and legs like jelly. If you are just tired, a typical remedy is to get some exercise or move around a bit to get blood flowing. But for people with ME/CFS, exercise does just the opposite. Physical or mental exertion can debilitate them, requiring recovery time that lasts for days, months, or years. Resting does not help. This symptom, known as post-exertional malaise, is one of the defining features of the disease, and it is poorly understood.


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.




Articles


SARS-CoV-2 Vaccines


26 Feb 2021

Shortly after SARS-CoV emerged at the turn of the 21st century, the spike (S) protein (particularly in its prefusion [native] conformation) was identified as the immunodominant antigen of the virus. Evaluation of patients with SARS-CoV-2 revealed that binding and neutralizing antibodies primarily target the receptor-binding domain of the S1 subunit.




SARS-CoV-2 Variants of Concern in the United States—Challenges and Opportunities


17 Feb 2021

. SARS-CoV-2, like other RNA viruses, constantly changes through mutation, with new variants occurring over time. Generally, when new variants become more common, they do so because of some selective advantage to the virus.




The US Regulatory System and COVID-19 Vaccines The Importance of a Strong and Capable FDA


15 Feb 2021

For many in public health and medicine, the coronavirus disease 2019 (COVID-19) pandemic in the US has been a frustrating journey from one disappointment to the next: late access to testing, insufficient staff and inadequate funding for contact tracing, jumbled communications, and, at the end of 2020, a chaotic launch of vaccination efforts.




COVID-19 Vaccination in Pregnant and Lactating Women


08 Feb 2021

Pregnant women with severe or critical coronavirus disease 2019 (COVID-19) infection are at increased risk for preterm birth and pregnancy loss.




Durability of Responses after SARS-CoV-2 mRNA-1273 Vaccination


04 Feb 2021

We recently reported the results of a phase 1 trial of a messenger RNA vaccine, mRNA-1273, to prevent infection with SARS-CoV-2; those interim results covered a period of 57 days after the first vaccination.




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