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Paxlovid will no longer be authorized for emergency use after March 8; V-safe, the CDC's vaccine safety monitoring system, is once again open.

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Republicans and Democrats reached an agreement on topline spending levels for fiscal year 2024 but still must hammer out action on various health care issues, including stopping $16 billion cuts to Medicaid disproportionate share hospital payments.

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The CDC launched the National Wastewater Surveillance Program to detect traces of infectious diseases as COVID-19 hospitalizations increase for the third week in a row.

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A CDC advisory committee recommends providers wear masks during routine check-ups to prevent the spread of respiratory infections; FDA advises providers to ensure they administer the correct vaccination dosage to youth.

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Newly elected House Speaker Mike Johnson (R-La.) confronts a looming deadline to fund the federal government. Essential hospital advocates come to Washington, D.C., for the association's fall legislative fly-in, Policy Assembly.

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HHS will offer $600 million in funding for the production of new at-home COVID-19 tests and $45 million in grants to support long COVID-19 clinics; FDA amended the emergency use authorization of the Novavax COVID-19 vaccine to include its updated vaccine that targets XBB.1.5.

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FDA approves Moderna and Pfizer-BioNTech's updated COVID-19 vaccines, and HHS announces $1.4 billion for Project NextGen.

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In a recent letter to House leaders, America's Essential Hospitals voiced its support of a legislative proposal that would avert $16 billion in cuts to Medicaid disproportionate share hospital funding but cautioned against other onerous policies, including for site-neutral payment.

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quality

CDC notifies health care providers about a monoclonal antibody and two vaccines that can prevent respiratory syncytial virus infection.

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policy

In its response to a bipartisan group of senators, America's Essential Hospitals urges lawmakers to resist drug industry attacks on the 340B Drug Pricing Program and to protect the program's benefits to essential hospitals and marginalized patients.

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policy

Starting Oct. 1, Medicaid and the Children’s Health Insurance Program will cover only COVID-19 vaccines that have been fully approved by the Food and Drug and Administration.

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policy

Moderna seeks FDA authorization for an updated vaccine, Invivyd announces a pathway to potential emergency use authorization for the monoclonal antibody adintrevimab, and the CDC tracks a new subvariant, EU.1.1.

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The FDA's Vaccines and Related Biological Products Advisory Committee advises manufacturers to develop a monovalent vaccine targeting XBB, the globally dominant subvariant, in time for the fall.

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A CDC study confirms that a third mRNA vaccine is safe for children; FDA grants marketing authorization for the Cue at-home COVID-19 test.

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The House Committee on Energy and Commerce approved a measure to eliminate $16 billion of cuts to Medicaid disproportionate share hospital funding as part of a package that also includes measures for pricing transparency and site-neutral payments.

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The Food and Drug Administration approves Paxlovid to treat COVID-19 in adults; a National Institutes of Health study sheds new light on long COVID-19.

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FDA amends the Pfizer vaccine authorization for immunocompromised children aged 6 months to 4 years old, while the Biden administration ends its vaccine requirement for federal employees.

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CDC simplifies vaccine recommendations for all age groups; a new HHS program supports COVID-19 vaccines and treatments for uninsured Americans.

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Individuals ages 65 and older are eligible for a second bivalent dose; HHS will end vaccine administration flexibility granted during the public health emergency.

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President Biden signs a bill ending the COVID-19 national emergency; FDA grants emergency use authorization to a vilobelimab treatment.

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FDA releases guidance on transitioning to normal operations for medical device authorization after the public health emergency ends and continues to monitor the effect of viral mutation on test performance.

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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.

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policy

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.

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policy

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.

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policy

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.

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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.

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policy

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.

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policy

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.

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policy

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.

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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.

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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. 

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policy

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.

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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.

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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.

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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.

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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.

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

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policy

On Sept. 30, Congress passed and President Joe Biden signed legislation to fund the federal government through Dec. 16. The legislation also continues several federal health programs through that same date and extends U.S. Food and Drug Administration user fees for five years.

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CDC updates guidance on infection control for health care personnel and staff shortages, as well as its global pandemic response strategy.

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Bipartisan legislation to fund the government through mid-December saw progress with a deal to reauthorize FDA user fee programs, but obstacles remain to a final bill before the Sept. 30 end of the current fiscal year.

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CDC reports lower in-hospital mortality rates from the omicron variant, providers have until Sept. 30 to report period 3 Provider Relief Fund spending.

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

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The Biden administration requests an additional $47 billion in emergency funding in the continuing resolution, including $22.4 billion to fight COVID-19; Congress must reauthorize the FDA user fee program by Sept. 30.

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No-cost, at-home COVID-19 tests no longer will be offered through the United States Postal Service, CDC releases a fall vaccination plan, and FDA warns prescribers about Paxlovid drug interactions.

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Pfizer applies for emergency use authorization for its omicron-specific booster vaccine, the National Healthcare Safety Network will take over hospital data reporting, and CMS tells hospitals to brace for the public health emergency's end.

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CDC updated its COVID-19 safety guidelines, FDA warned of false negative test risks, and bebtelovimab will transition to the commercial marketplace.

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HHS agreed to purchase 66 million Moderna bivalent COVID-19 vaccine doses, while the CDC reported fewer vaccine reactions for those older than 50 who receive a second mRNA booster shot.

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As the World Health Organization declares monkeypox a global health emergency, CDC updates clinical guidance, and HHS plans to allocate additional vaccine doses.

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FDA approves the Novavax COVID-19 vaccine for those 18 and older as the Biden-Harris administration releases an action plan to take on the BA.5 subvariant.

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FDA approves the Pfizer COVID-19 vaccine for use in individuals ages 12 to 15 and authorizes state-licensed pharmacists to prescribe Paxlovid.

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policy

The strategy aims to deploy vaccines rapidly in the most affected communities, facilitate testing, and engage stakeholders to mitigate spread.

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FDA advises vaccine manufacturers to incorporate an omicron variant component into booster doses; Pfizer requests FDA approval of antiviral pill Paxlovid.

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CDC recommends the Moderna vaccine for kids ages 6 to 17; an FDA committee will consider modifying COVID-19 vaccine composition to reflect virus mutations.

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CDC recommends that children ages 6 months to 5 years receive a COVID-19 vaccine; Pfizer study data shows Paxlovid failed to alleviate COVID-19 symptoms.

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state-action

The Florida Department of Health does not recommend COVID-19 vaccines for "healthy children" and will not facilitate statewide vaccine distribution; health care providers still may order vaccines directly from the federal government.

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policy

An FDA advisory committee deliberates the safety of Novavax's COVID-19 vaccine and will consider amendments to Pfizer's and Moderna's authorization requests later this month.

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FDA extended the shelf life of select lots of bebtelovimab and updated the authorization for Evusheld to include information about hypersensitivity risks.

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Pfizer and BioNTech release promising data on a three-dose COVID-19 vaccine for children six months to younger than 5; CDC expands booster shot eligibility to include everyone 5 years old and older.

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HHS urges governors to start planning for the end of the COVID-19 public health emergency; FDA authorizes a Pfizer booster vaccine for children ages 5 to 11.

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FDA limits authorized use of the Janssen COVID-19 vaccine after reports of thrombosis with thrombocytopenia syndrome following vaccination; a new analysis estimates vaccines are associated with $2.6 million in savings due to a reduction in Medicare hospitalizations.

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A new omicron subvariant, BA.2.12.1, constitutes more than 30 percent of U.S. genomic sequences; Moderna files for emergency use authorization for a vaccine for children younger than 6.

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Moderna releases promising preliminary data on its variant-specific COVID-19 booster shot; CDC launches a Center for Forecasting and Outbreak Analytics.

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President Joe Biden announces a national research plan on prolonged illness developed after COVID-19; FDA limits authorization of sotrovimab to treat COVID-19.

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Research shows mRNA vaccines effectively prevent ventilation and death from COVID-19; Pfizer and Moderna seek authorization for an additional booster dose.

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CDC announces a new community-level framework that assesses COVID-19 risk; the Biden administration unveils a new COVID-19 mitigation plan for people with disabilities.

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National emergency extended; new study highlights conditions and symptoms developed after COVID-19 infection; CDC updates vaccine guidance with clarifications for immunocompromised people.

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policy

President Joe Biden signed a continuing resolution to keep the government funded through March 11; Biden invited all members of Congress to attend the annual State of the Union address on March 1.

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The Senate voted 50–46 to confirm Robert Califf, MD, as commissioner of the Food and Drug Administration (FDA); The FDA has not had a confirmed commissioner for more than a year. Senators continue work to pass a short-term continuing resolution to fund the government past Feb. 18.

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policy

Authorization for the Pfizer COVID-19 vaccine for children six months to four years old is delayed; FDA authorizes the monoclonal antibody bebtelovimab.

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Pfizer and BioNTech apply for emergency use authorization for their pediatric COVID-19 vaccine; CDC recommends the Moderna COVID-19 vaccine; Medicare will cover over-the-counter COVID-19 tests.

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FDA approves the Moderna COVID-19 vaccine and limits a monoclonal antibody authorization; OSHA withdraws its vaccine mandate emergency temporary standard.

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The Biden administration will distribute 400 million no-cost N95 masks; CDC studies highlight the importance of boosters in protecting against COVID-19.

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House lawmakers noted upcoming federal funding legislation could be an opportunity for additional COVID-19 relief. A Senate committee examines COVID-19 variants and the federal response. Both chambers released draft schedules for their 2022 work.

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policy

FDA expands authorization for the Pfizer COVID-19 booster; FDA authorizes two antiviral pills; CMS updates guidance on vaccine mandate compliance.

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policy

The legislation delays looming Medicare payment cuts and creates an expedited pathway for debt limit relief; Senate Democrats this week are expected to release legislative text for a $2 trillion debt limit increase — sufficient to last through the 2022 midterm election.

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policy

FDA authorizes the Pfizer COVID-19 vaccine booster for individuals as young as 16; the agency also authorizes a monoclonal antibody for COVID-19 prevention.

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FDA and CDC endorse expanded eligibility for Pfizer and Moderna COVID-19 booster vaccine doses; Pfizer seeks authorization for its COVID-19 antiviral pill.

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Pfizer and BioNTech ask the FDA to authorize their COVID-19 booster vaccine for everyone age 18 and older; FEMA COVID-19 funding will continue until April 2022.

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policy

FDA authorizes the Pfizer COVID-19 vaccine for use in children ages 5 to 11 and delays approval of the Moderna vaccine in adolescents ages 12 to 17. The agency recommends providers avoid purchasing or using imported medical gloves from certain companies that might be in violation of laws and rules.

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policy

FDA and CDC recommend Moderna and Janssen booster vaccines, along with heterologous booster doses; the Biden administration releases a plan to vaccinate children.

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policy

The Vaccines and Related Biological Products Advisory Committee endorses booster shots of the Moderna and Janssen COVID-19 vaccines. Meanwhile, FDA delays authorization of the Moderna COVID-19 vaccine for emergency use in adolescents ages 12 to 17 after reports of cardiac side effects.

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policy

HHS guidance clarifies how HIPAA applies to COVID-19 vaccination status requests; CDC urges pregnant people to get vaccinated amid a surge in hospitalizations.

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policy

FDA on Sept. 22 authorized a third booster dose of the Pfizer-BioNTech COVID-19 vaccine for select groups. A CDC panel subsequently recommended the booster shots, and CMS announced coverage for all Medicare beneficiaries and nearly all Medicaid and Children's Health Insurance Program beneficiaries.

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policy

An FDA advisory committee recommends a Pfizer COVID-19 vaccine booster for a limited population; CDC announces $2.1 billion dedicated to infection control and prevention.

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policy

An FDA committee will review Pfizer's COVID-19 vaccine booster application; Moderna is applying for booster approval. CDC data show COVID-19 hospitalizations on the rise among children.

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A CDC advisory committee voted Aug. 30 to recommend the Pfizer-BioNTech COVID-19 vaccine; the agency warns against using ivermectin to treat or prevent COVID-19.

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policy

FDA approves the Pfizer-BioNTech COVID-19 vaccine. HHS plans to promote a booster shot of the mRNA vaccines beginning in September. CMS and CDC work to develop an emergency regulation requiring COVID-19 vaccination for nursing home staff.

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policy

FDA and CDC recommend a third mRNA COVID-19 vaccine dose for immunocompromised people; CDC recommends COVID-19 vaccines for pregnant and breastfeeding people.

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The Occupational Safety and Health Administration extends to Aug. 20 the comment period for the COVID-19 health care emergency temporary standard. The Centers for Disease Control and Prevention and the Food and Drug Administration say fully vaccinated individuals do not need COVID-19 booster shots.

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policy

Novavax's COVID-19 vaccine demonstrated 90.4 percent efficacy in clinical trials; CDC urges vaccination upon hospital discharge.

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President Biden announces a National Month of Action to vaccinate 70 percent of U.S. adults by July 4; Moderna applies for FDA approval of its vaccine.

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FDA lengthens the refrigerator storage time for the Pfizer COVID-19 vaccine. A new CDC site aggregates state and local COVID-19 funding opportunities. The Department of Health and Human Services allocates $4.8 billion to the HRSA COVID-19 Uninsured Program.

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A CDC brief updates transmission methods; Pfizer applies for FDA approval of its vaccine; CMS increases the Medicare payment for monoclonal antibodies.

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CDC and FDA lift the pause on Janssen vaccine administration after blood clot reports. Data show COVID-19 patients have long-term health needs.

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Everyone in the United States ages 16 and older is now eligible for a COVID-19 vaccine; CDC's advisory committee will meet April 23 to discuss the Janssen vaccine pause.

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policy

HHS and CDC launch a nationwide grassroots vaccine promotion network; CDC issues new guidance on travel, cleaning, and disinfection.

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FDA alerts providers about monoclonal antibody–resistant SARS-CoV-2 variants; a new study examines vaccine rates in counties where residents experience a high number of social risk factors.

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policy

FDA granted an emergency use authorization for the one-dose Janssen COVID-19 vaccine and an at-home COVID test; a multi-agency FAQ document addresses COVID-19 health coverage.

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policy

Janssen applied for emergency use authorization of its COVID-19 vaccine; a CDC report shows reporting gaps in ethnic and racial data of vaccine recipients.

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Essential Insights

Leaders from University Health, in San Antonio, share how partnerships, preregistration, and constant adaptation shaped their COVID-19 vaccine distribution effort.

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policy

CDC announces target groups for phases 1b and 1c of COVID-19 vaccine allocation; a new brief recommends strategies for building vaccine trust.

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policy

FDA issues an emergency use authorization for the Moderna vaccine and an at-home antigen test; a CDC committee votes on allocation recommendations.

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FDA authorizes the Pfizer COVID-19 vaccine for emergency use; HHS expands hospital COVID-19 data reporting requirements to include therapeutic data.

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CDC recommends groups to prioritize in vaccine distribution and revises antigen testing guidance.

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policy

Moderna applied for emergency use authorization for its COVID-19 vaccine; CDC issued ethical vaccine application principles and updated face mask guidance for health care workers.

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