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FDA: J&J Will Need To Monitor Vaccine For Link To Thrombotic Events

Johnson & Johnson will need to monitor its COVID-19 vaccine for any potential link to thromboembolic events if it gets emergency use authorization from FDA and the vaccine is distributed to a larger population beyond those included in the clinical trials, FDA says in briefing materials released ahead of its Friday (Feb. 26) vaccine advisory committee meeting.

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A provision allocating $1.8 billion to assisted living centers and other congregate settings has been cut from the COVID-19 package, infuriating stakeholders who say the federal government is abandoning seniors and their caregivers in their greatest time of need.

States would be given a seven-year authorization to offer 12 months of Medicaid and Children’s Insurance Program coverage to postpartum individuals under the manager’s amendment to the House COVID-19 relief legislation, which is set to be voted on Friday (Feb. 26).

The House passed legislation Thursday (Feb. 25) to effectively scrap a Trump administration rule that didn’t recognize gender identity discrimination under the umbrella of sex discrimination in the Affordable Care Act’s Section 1557.

Lawmakers told the nation’s top physician lobby group they will consider extending the Medicare sequestration moratorium, easing prior authorization requirements and tackling other health care priorities like telehealth and graduate medical slots after Congress passes the pandemic relief package.

The Biden administration is prepared to allocate 3 to 4 million doses of Johnson & Johnson’s one-shot COVID-9 vaccine as early as next week, if the vaccine gets emergency use authorization from FDA, White House COVID-19 Response Team Coordinator Jeff Zients said Wednesday (Feb. 24).

President Joe Biden has directed HHS and the Department of Defense to deliver more than 25 million masks to community health centers and food pantries across the United States to ensure disadvantaged communities have proper protection against COVID-19, the White House announced Wednesday (Feb. 24).

While World Trade Organization members remain deadlocked over the question of whether to waive some intellectual property obligations in response to the pandemic, they largely share a common sense that countries must explore how intellectual property flexibilities can be part of a pandemic response framework, according to a Geneva-based trade official familiar with the discussions.

Leading vaccine makers are using real-world evidence from across the globe, including from Israel and the United Kingdom, to further assess the safety and effectiveness of their COVID-19 vaccines outside of randomized controlled clinical trials.