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Tag: GOVADM

  • U.S. FDA proposes shift to annual COVID vaccine shots

    U.S. FDA proposes shift to annual COVID vaccine shots

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    Jan 23 (Reuters) – The U.S. health regulator on Monday proposed one dose of the latest updated COVID-19 shot annually for healthy adults, similar to the influenza immunization campaign, as it aims to simplify the country’s COVID-vaccine strategy.

    The U.S. Food and Drug Administration also asked its panel of external advisers to consider the usage of two COVID vaccine shots a year for some young children, older adults and persons with compromised immunity.The regulator proposed the need for routine selection of variants for updating the vaccine, similar to the way strains for flu vaccines are changed annually, in briefing documents ahead of a meeting of its panel on Thursday.

    The FDA hopes annual immunization schedules may contribute to less complicated vaccine deployment and fewer vaccine administration errors, leading to improved vaccine coverage rates.The agency’s proposal was on expected lines, following its announcement of its intention for the update last month.

    A nurse fills up syringes with the coronavirus disease (COVID-19) vaccines for residents who are over 50 years old and immunocompromised and are eligible to receive their second booster shots in Waterford, Michigan, U.S., April 8, 2022. REUTERS/Emily Elconin

    The Biden administration has also been planning for a campaign of vaccine boosters every fall season.

    Currently, most people in the United States need to first get two doses of the original COVID vaccine spaced at least three to four weeks apart, depending on the vaccine, followed by a booster dose a few months later.

    Pfizer’s primary vaccine doses for children and people involve three shots, with the third a bivalent shot given about two months later.

    If the panel votes in favor of the proposal, Pfizer Inc (PFE.N) and Moderna Inc’s (MRNA.O) bivalent vaccines, which target both the Omicron and the original variants, would be used for all COVID vaccine doses, and not just as boosters.

    Reporting by Leroy Leo in Bengaluru; Editing by Shailesh Kuber and Shinjini Ganguli

    Our Standards: The Thomson Reuters Trust Principles.

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  • U.S. FDA allows abortion pills to be sold at retail pharmacies

    U.S. FDA allows abortion pills to be sold at retail pharmacies

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    WASHINGTON, Jan 3 (Reuters) – The U.S. Food and Drug Administration (FDA) will allow retail pharmacies to offer abortion pills in the United States for the first time, the agency said on Tuesday, even as more states seek to ban medication abortion.

    The regulatory change will potentially expand abortion access as President Joe Biden’s administration wrestles with how best to protect abortion rights after they were sharply curtailed by the Supreme Court’s decision to overturn the landmark Roe v Wade ruling and the state bans that followed.

    Pharmacies can start applying for certification to distribute abortion pill mifepristone with one of the two companies that make it, and if successful they will be able to dispense it directly to patients upon receiving a prescription from a certified prescriber.

    The FDA had first said it would be making those changes in December 2021 when it announced it would relax some risk evaluation and mitigation strategies, or REMS, on the pill, that had been in place since the agency approved it in 2000 and were lifted temporarily in 2021 due to the COVID-19 pandemic.

    The changes included permanently removing restrictions on mail order shipping of the pills and their prescription through telehealth.

    The agency finalized the changes on Tuesday after reviewing supplemental applications from Danco Laboratories and GenBioPro, the two companies that make the drug in the United States.

    “Under the Mifepristone REMS Program, as modified, Mifeprex and its approved generic can be dispensed by certified pharmacies or by or under the supervision of a certified prescriber,” the agency said on its website on Tuesday.

    Mifeprex is the brand name version of mifepristone which, in combination with a second drug called misoprostol that has various uses including miscarriage management, induces an abortion up to 10 weeks into a pregnancy in a process known as medication abortion.

    Abortion rights activists say the pill has a long track record of being safe and effective, with no risk of overdose or addiction. In several countries, including India and Mexico, women can buy them without a prescription to induce abortion.

    “Today’s news is a step in the right direction for health equity,” Planned Parenthood President Alexis McGill Johnson said in a statement.

    “Being able to access your prescribed medication abortion through the mail or to pick it up in person from a pharmacy like any other prescription is a game changer for people trying to access basic health care,” Johnson added.

    NO EQUAL ACCESS

    The regulatory change will, however, not provide equal access to all people, GenBioPro, which makes the generic version of mifepristone, said in a statement.

    Abortion bans, some targeting mifepristone, have gone into effect in more than a dozen states since the U.S. Supreme Court overturned the constitutional right to terminating pregnancies when it scrapped the 1973 Roe v. Wade ruling last year.

    Women in those states could potentially travel to other states to obtain medication abortion.

    The president of anti-abortion group SBA Pro-Life America, Marjorie Dannenfelser, said the latest FDA move endangers women’s safety and the lives of unborn children.

    “State lawmakers and Congress must stand as a bulwark against the Biden administration’s pro-abortion extremism,” she said in a statement.

    FDA records show a small mortality case number associated with mifepristone. As of June 2021, there were reports of 26 deaths linked with the pill out of 4.9 million people estimated to have taken it since it was approved in September 2000.

    Retail pharmacies will have to weigh whether or not to offer the pill given the political controversy surrounding abortion, and determine where they can do so.

    A spokesperson for CVS Health (CVS.N) said the drugstore chain owner was reviewing the updated REMS “drug safety program certification requirements for mifepristone to determine the requirements to dispense in states that do not restrict the dispensing of medications prescribed for elective termination of pregnancy.”

    A spokesperson for Walgreens (WBA.O), one of the largest U.S. pharmacies, said the company was also reviewing the FDA’s regulatory change. “We will continue to enable our pharmacists to dispense medications consistent with federal and state law.”

    Reporting by Ahmed Aboulenein; Additional reporting by Eric Beech in Washington, Shivani Tanna, Rahat Sandhu, and Kanjyik Ghosh in Bengaluru; Editing by Himani Sarkar

    Our Standards: The Thomson Reuters Trust Principles.

    Ahmed Aboulenein

    Thomson Reuters

    Washington-based correspondent covering U.S. healthcare and pharmaceutical policy with a focus on the Department of Health and Human Services and the agencies it oversees such as the Food and Drug Administration, previously based in Iraq and Egypt.

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  • Democrats seek vote reform, gay marriage, debt ceiling in ‘lame duck’ Congress

    Democrats seek vote reform, gay marriage, debt ceiling in ‘lame duck’ Congress

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    WASHINGTON, Nov 14 (Reuters) – Democrats in the U.S. Congress aim to pass bills protecting same-sex marriage, clarifying lawmakers’ role in certifying presidential elections and raising the nation’s debt ceiling when they return from the campaign trail on Monday.

    President Joe Biden’s party got a boost over the weekend when it learned it would keep control of the Senate for the next two years, while control of the House of Representatives is still up in the air as votes are counted after Tuesday’s midterm election.

    But Democrats escaped a feared midterm drubbing and will look to make the most they can of their current thin majorities in both chambers before the new Congress is sworn in on Jan. 3, a period known as the ‘lame duck’ session.

    House Speaker Nancy Pelosi and Treasury Secretary Janet Yellen both signaled that addressing the nations’ looming debt ceiling would be a priority during the session.

    Some Republicans have threatened to use the next hike in the $31.4 trillion debt ceiling, expected in the first quarter of 2023, as leverage to force concessions from Biden. Yellen in a Saturday interview with Reuters warned that a failure to act would pose a “huge threat” to America’s credit rating and the functioning of financial markets.

    Pelosi, who would lose her position as speaker if Republicans win a majority in the House, told ABC News on Sunday that the best way to address the debt ceiling was “to do it now.”

    “My hope would be that we could get it done in the lame duck,” Pelosi said. “We’ll have to, again, lift the debt ceiling so that the full faith and credit of the United States is respected.”

    Biden told reporters over the weekend he would wait to speak to Republican leadership before deciding any priorities, adding he planned to “take it slow.”

    Congress has a long to-do list in the coming weeks. It faces a Dec. 16 deadline to passing either a temporary funding bill to keep government agencies operating at full steam until early next year, or a measure that keeps the lights on through Sept. 30, the end of the current fiscal year. Failure to enact one of those would result in partial government shutdowns.

    [1/5] Members-elect from the upcoming 118th congress arrive at the U.S. Capitol building for orientation in Washington, U.S., November 14, 2022. REUTERS/Leah Millis

    The House already has passed legislation legalizing gay marriage and the Senate was poised, as soon as this week, to approve its slightly different version of the “Respect for Marriage Act.” The bill is intended to ensure that the U.S. Supreme Court does not end gay marriage rights, which conservative Justice Clarence Thomas mused was possible when the court in June ended the national right to abortion.

    Another high-priority item is a bipartisan bill reforming the way Congress certifies presidential elections, intended to avoid a repeat of the violence of the Jan. 6, 2021, assault on the Capitol by supporters of former President Donald Trump who wanted to stop lawmakers from certifying Biden’s win.

    Democratic leaders also aim to pass legislation speeding permits for energy projects and provide more financial and military support for Ukraine in its fight against Russia’s invasion.

    Some Republicans have expressed reluctance to provide more financial support for Ukraine.

    Progressive Democrats have bridled at the prospect of the government stepping up the energy permitting process, thus encouraging the flow of fossil fuels to market even as Biden attempts to meet stringent goals to reduce the impact of climate change.

    Biden has suggested permitting reform could be included in the National Defense Authorization Act, the annual bill funding the military that usually gets strong bipartisan support.

    But keeping the Senate majority for the next two years means that there will be less pressure on Senate Majority Leader Chuck Schumer to confirm as many of Biden’s nominees for federal judgeships as possible before the end of the year.

    There are 57 judicial nominees pending before the Senate, with 25 already approved by the Judiciary Committee and awaiting action by the full chamber.

    The Senate has already confirmed 84 of Biden’s judicial nominees, allowing him to essentially keep pace with the near-record number of appointments Trump made during four years as he worked to move the judiciary rightward.

    Reporting by Moira Warburton and Richard Cowan; Additional reporting by David Lawder in New Delhi, Nandita Bose in Phnom Penh and Trevor Hunnicutt, Doina Chiacu and Susan Heavey in Washington; Editing by Scott Malone, Alistair Bell and Daniel Wallis

    Our Standards: The Thomson Reuters Trust Principles.

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