FDA announces that children aged 6 months through 4 years old who completed primary monovalent COVID-19 vaccination are now eligible to receive a bivalent booster dose, while agency advisers vote in favor of full Paxlovid approval.

FDA announced March 10 that it will withdraw and revise several COVID-19 guidance documents, including emergency use authorization of surgical masks, as circumstances surrounding the virus evolve.

A bivalent vaccine that protects against SARS-CoV-2 and influenza will not be available this year, while a CDC advisory committee says there is not enough evidence to recommend more than one annual COVID-19 booster for immunocompromised people.

FDA authorizes the first at-home nasal test that detects influenza A and B as well as COVID-19; Moderna reaches a $400 million agreement with the National Institutes of Health.

National Institutes of Health research finds that Black and Hispanic Americans face greater long COVID-19 risks, the CDC says that primary series vaccination protects children ages 3–5 for four months, and Novavax will deliver an additional 1.5 million doses.

The CDC updated the 2023 immunization schedule for children and adolescents to include the COVID-19 primary vaccine series, and the FDA cleared for commercial distribution a device that detects 15 respiratory viral and bacterial infections.

FDA no longer requires a positive COVID-19 test to receive a Paxlovid or Lagevrio prescription; CDC reports that bivalent boosters protect against XBB and XBB.1.5 SARS-Co-V-2 subvariants.

FDA's Vaccines and Related Biological Products Advisory Committee votes to replace the original monovalent COVID-19 vaccine, Evusheld no longer is authorized under emergency use, and the CDC launches a COVID-19 testing locator.

An FDA committee will vote on the future of the COVID-19 vaccine, while CDC unveils two trackers for COVID-19, flu, and RSV–related hospital and emergency department visits.

In a new podcast series by a physician at association member NYC Health + Hospitals, Beth Feldpush, DrPH, the association's senior vice president of policy and advocacy, unpacks the complex patchwork of payments that keep essential hospitals afloat. 

The National Institutes of Health launches the Home Test to Treat program; FDA and CDC report a COVID-19 vaccine safety concern for those ages 65 and older.

FDA and CDC say Evusheld is unlikely to neutralize the XBB.1.5 subvariant, and a CDC report indicates COVID-19 vaccination in children and adolescents is highest among Asian and Hispanic youth. 

Registration is open now for the two Climate Change and Cardiovascular Disease Collaborative webinars on Jan. 12, at noon ET, and Feb. 9, at noon ET.

FDA approves the use of Actemra, a monoclonal antibody treatment, as COVID-19 cases caused by the XBB.1.5 subvariant of SARS-CoV-2 spike.

Americans again can request four no-cost, at-home COVID-⁠19 tests per address; FDA's vaccine committee will meet in January to develop a long-term strategy.

CDC expands its recommendation for bivalent COVID-19 vaccines for children ages 6 months to 5 years old as health agencies confront low vaccination rates among children.

FDA pauses its emergency use authorization of bebtelovimab, which does not protect against prevalent SARS-CoV-2 subvariants; CDC updates its guidance for managing COVID-19 in congregate living settings to align with previous guidance.

New COVID-19 vaccine initiatives seek to address access inequalities, and NIH launches a website where Americans can self-report COVID-19 test results anonymously to provide data to public health departments.

Pfizer-BioNTech and Moderna data indicate that bivalent vaccines provide greater protection than the original monovalent vaccine against the emerging BQ.1.1 omicron subvariant, while the CDC reports low COVID-19 vaccination numbers among children.

A JAMA Network open study highlights disparities in access to Test-to-Treat sites; the Biden administration holds a White House COVID-19 Equity Summit.

A new report from the Department of Veterans Affairs indicates that Paxlovid can reduce risk of long COVID-19; new data show Pfizer bivalent COVID-19 booster vaccines substantially increase immune responses compared with monovalent vaccines.

President Joe Biden urges Americans to get their updated COVID-19 vaccine, which protects against the original SARS-CoV-2 variant and BA.4 and BA.5 subvariants.

A CDC committee recommends the inclusion of COVID-19 vaccines in the 2023 immunization schedule; the administration releases a biodefense strategy.

CDC recommends for younger age groups updated Pfizer and Moderna COVID-19 booster vaccines that target the BA.4 and BA.5 subvariants of SARS-CoV-2.

Effective Oct. 13, Health and Human Services Secretary Xavier Becerra renewed the COVID-19 public health emergency determination.

HHS links COVID-19 vaccinations to fewer COVID-19 hospitalizations and deaths, and NIH details its plan to study long COVID-19 effects.

FDA now urges COVID-19 test developers to take traditional premarket review pathways, and HHS will cover the cost of 60,000 bebtelovimab doses.