Late this week, the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) made recommendations related to COVID-19 vaccine booster doses for specified populations. On Thursday, the VRBPAC unanimously recommended Moderna half-dose booster vaccines for adults over 65 years of age and other adults considered at high risk at least…
Read More »On Thursday, the U.S. Food and Drug Administration (FDA) announced its Antimicrobial Drugs Advisory Committee (AMDAC) will meet on November 30 to review a request for an emergency use authorization (EUA) for molnupiravir, an investigational antiviral drug to treat COVID-19. The drug, created by Merck and Ridgeback, is intended to treat mild-to-moderate COVID-19 in adults…
Read More »In the first authorization of its kind, the U.S. Food and Drug Administration (FDA) this week announced it has authorized the marketing of three new electronic nicotine delivery systems (ENDS) products through the FDA’s Premarket Tobacco Product Application (PMTA) pathway. The FDA granted marketing approvals to R.J. Reynolds Vapor Company for its Vuse Solo ENDS…
Read More »This week, the U.S. Food and Drug Administration (FDA) announced the issuance of final guidance, “Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods.” The guidance provides for voluntary short-term sodium reduction targets for food manufacturers, chain restaurants, and food service operators for 163 categories…
Read More »On Thursday, Pfizer and BioNTech announced they have submitted a formal request to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) of its COVID-19 mRNA vaccine among children ages 5-11. Up to 28 million children nationwide could become eligible upon authorization. Recall, Pfizer and BioNTech received full FDA approval for its…
Read More »This week, the Biden-Harris Administration announced it would invest $1 billion to support the development and availability of at-home rapid tests for COVID-19. The Administration announced the infusion of funding will quadruple the number of at-home tests available for Americans by December. The increase in tests is anticipated to help improve access to at-home testing…
Read More »A new study released this estimates that more than 140,000 children in the U.S. have lost a parent or grandparent caregiver to COVID-19 between April 1, 2020, and June 30, 2021. The study, published in the journal Pediatrics, indicates that the risk of primary caregiver loss was 1.1 to 4.5 times higher among children of…
Read More »This week, the U.S. Department of Health and Human Services (HHS) issued a final regulation governing the Title X Family Planning Program, effectively reversing restrictions on patient referrals to certain reproductive health services established by the Trump Administration in 2019. Recall, the rules put into place by the Trump Administration barred Title X providers from…
Read More »The U.S. Department of Health and Human Services (HHS) this week announced awarding approximately $2.21 billion in Ryan White HIV/AIDS Program funding to local governments, states, and community-based organizations in fiscal year 2021. The funding, issued by the Health Resources and Services Administration (HRSA), supports a comprehensive system of HIV primary medical care, medication, and…
Read More »The U.S. Department of Health and Human Services (HHS) this week, as part of President Joseph R. Biden, Jr.’s Executive Order 14008 related to climate change, released its Climate Adaptation and Resilience Plan to bolster resilience of its operations and assets from the accelerating impacts of climate change. With the release of its plan, HHS…
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