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Officials Wrestle With Whether to Allow New Monkeypox Vaccination Strategy

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WASHINGTON — It sounded like a simple solution to the shortage of monkeypox vaccine: Merely by changing the way doses are injected, the federal government could vaccinate five times as many people with the supply it has in hand.

But the approach — injecting one-fifth of the current dose into the skin instead of a full dose into underlying fat — is not actually all that simple, experts say. And some federal officials are concerned about changing the method without more research, even though Dr. Robert M. Califf, the head of the Food and Drug Administration, described the proposal on Thursday as promising.

Some outside experts, too, are urging caution. “From a basic science perspective, this should work,” said Dr. Jay K. Varma, the director of the Cornell Center for Pandemic Prevention and Response. “But, of course, there are lots of things in life, in science, that we think should work, and then when we actually do them, they don’t.”

Stretching out doses of the vaccine, Jynneos, could help the federal government resolve a predicament partly of its own making. Even though it invested more than $1 billion developing the two-dose vaccine to use against both monkeypox and smallpox, the government only has 1.1 million shots on hand, partly because it was slow to order bulk vaccine stocks to be processed into vials.

That supply is enough to cover 550,000 people, but about three times as many doses are needed to cover the 1.6 million to 1.7 million Americans who, according to the Centers for Disease Control and Prevention, are at high risk of monkeypox. For now, the virus has been spreading primarily through skin-to-skin contact during sex among gay and bisexual men, the C.D.C. has said.

Some federal officials are hoping that by injecting a smaller dose of the vaccine between skin layers, called an intradermal shot, the Biden administration could tamp down the outbreak before it spreads more widely.

But some experts argue that this approach has not been sufficiently studied. They also warn that some vaccinators will need training to properly deliver the shots, which could slow vaccination efforts. Otherwise, the government could end up wasting doses, not saving them.

Intradermal injection involves carefully guiding a needle into skin layers, a thin space with immune cells. If a vaccinator goes too deep and inserts the dose into fat, the patient might not receive enough vaccine, experts say. But if the needle is not inserted far enough, some of the vaccine could leak back out.

“If you’re giving a lower dose and you don’t inject it properly into the skin — you might inject it into the wrong place — you may not be giving a protective vaccine,” said Dr. Phil Krause, who retired as a senior F.D.A. vaccine regulator last year and worked on the agency’s licensing of Jynneos. “If you ask this to be done nationwide in millions of doses, it’s a lot easier for there to be mistakes made in the administration of the vaccine.”

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On the other hand, the method has a track record. It has been used in polio vaccination campaigns when doses have been limited, as well as for rabies and for tuberculosis skin tests.

“It’s not a brand-new concept,” said Dr. Anthony S. Fauci, President Biden’s chief medical adviser. “We were thinking about this as a strategy in the event of a paucity of vaccines years ago.”

Vaccinators have used special bifurcated needles in smallpox inoculation campaigns that have allowed them to perform intradermal injections more uniformly and cheaply.

Dr. John Beigel, an associate director of clinical research at the National Institutes of Health, said a government-sponsored study of Jynneos published in 2015 compared the intradermal approach with the standard injection method and found that it triggered a comparable level of neutralizing antibodies, a measure of the strength of the immune response. The intradermal method caused more redness, swelling and itching, but the standard injection was more painful.

Dr. Beigel said that switching to the intradermal method was a better option for preserving vaccine than administering just a single shot, as some jurisdictions are now doing, because research has shown that one shot does not prompt nearly as strong of an immune response.

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“One dose is not likely to be effective,” he said, adding that the intradermal method “is an acceptable way to go.”

Although the 2015 trial involved hundreds of participants, some experts note that it was a single study that was limited in what it measured. Researchers at the N.I.H. had been planning to test the intradermal strategy for Jynneos in a trial that was set to begin in a few weeks. But results were not expected until the late fall or early winter, and that plan is up in the air for now.

Dr. H. Clifford Lane, the clinical director of Dr. Fauci’s National Institute of Allergy and Infectious Diseases at the N.I.H., said that while researchers could glean insight by following people who get vaccinated, a traditional clinical trial would provide a clearer picture.

“I can understand doing it as long as it’s very clear why it’s being done,” he said of the intradermal strategy. “The question is: How can we stretch the current supplies without significantly compromising efficacy?”

Another question is how well the vaccine will actually work: It was licensed in 2019 for use against both monkeypox and smallpox after studies showed it provoked a stronger immune response than an earlier vaccine. That drug itself was approved because it compared favorably to an even earlier vaccine, federal officials said.

Monkeypox is rarely fatal and no deaths have been reported in the United States. Symptoms typically resolve within two to four weeks. But with the outbreak spiraling from eight reported cases in late May to 7,510 now, the administration is scrambling to try to improve the vaccination rate and the availability of tests and treatments.

As of now, the outbreak is almost entirely limited to men who have sex with men, with those who have multiple partners considered at particular risk. But five cases involving children have been reported so far On Friday, the Illinois Department of Public Health announced that an adult working at a day care center had tested positive for monkeypox and that children and other staff members there were being screened.

Thursday’s declaration of a public health emergency allowed the federal government to speed up investigations of monkeypox and approve grants, but did not invoke the F.D.A.’s emergency powers. Changing the injection mode would require a second kind of emergency declaration, giving the Food and Drug Administration more leeway to issue emergency use authorizations.

Federal regulators can issue emergency authorizations of products when they believe the potential benefits outweigh potential risks. Early in the coronavirus pandemic, the Trump administration issued the same type of emergency declaration, allowing the F.D.A. to make Covid-19 vaccines available to Americans many months before regulators issued full approvals.

Dr. Califf, the F.D.A. commissioner, said on Thursday that regulators would continue to ensure the vaccine was delivered in a safe and effective manner. He said regulators would probably decide in the next few days whether to go with the intradermal strategy, but that it was “looking good right now” — a comment that some outside experts said seemed to get ahead of deliberations by career regulators.

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Emily Cochrane and Tracey Tully contributed reporting.

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A journalist since 1994, he also founded DMGlobal Marketing & Public Relations. Glover has an extensive list of clients including corporations, non-profits, government agencies, politics, business owners, PR firms, and attorneys.

Politics

Abrams for Governor Releases New Memo Highlighting Motivating Impact of Abortion Among Georgia’s Democratic Voters

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Internal campaign polling shows that abortion is a bigger motivator for Georgia Democrats than it is for Georgia Republicans 

(ATLANTA) –  Abrams for Governor campaign manager, Lauren Groh-Wargo, released a new memo detailing the motivating impact of abortion among voters in Georgia’s 2022 elections. The memo showcases how the victory of abortion rights supporters in Kansas is a great sign for Democrats in Georgia and across the country.

Additionally, yesterday, the campaign released a new TV ad, Signed, featuring women in Georgia calling attention to the dangers of Brian Kemp’s extreme abortion ban.

“Georgia’s women and those who love them have the ability to fight for reproductive freedom, liberty from interference into private medical decisions, and the full scope of health care. The gubernatorial race is already close, the incumbent is below 50%, and Kemp’s extreme and unpopular attacks on women are disqualifying to a substantial majority of voters,” said Lauren Groh-Wargo. “The time to act is now – this race can be won, provided that we invest in the people of Georgia and ensure that they can hear about how Stacey Abrams will deliver for Georgians, stop Kemp’s far right, extreme agenda, and how Kemp’s radical tenure has already and will continue to endanger women across the state.”

Recent polling from the Atlanta Journal-Constitution shows that Kemp’s radical anti-abortion laws are wildly unpopular with Georgia voters — with Georgia voters opposing the overturning of Roe 39%-54%, Kemp’s six-week ban 36%-54%, and a total ban on abortion 21%-72%. Abrams for Governor’s internal polling is consistent with what the AJC poll shows when it comes to the motivational impact of abortion on this election. Georgia Democrats are almost completely unified in telling pollsters that abortion is important and motivational to them in 2022.

Overall Abrams for Governor’s internal research has shown:

  1. Abortion is a bigger motivator for GA Democrats than it is for GA Republicans.
  2. Independent voters in GA are overwhelmingly pro-choice and Kemp’s record of criminalizing abortion is very damaging among them.
  3. A measurable block of GA Republican voters defect from Kemp’s hard-right orthodoxy on abortion and oppose Kemp’s anti-choice agenda.

Abortion access and women’s liberty are on the ballot this year in Georgia. In his first year, Governor Kemp’s priority was signing one of the country’s most extreme and dangerous abortion laws, a law that prevents women from getting life-saving healthcare. His cruel bill sets women up to be investigated and criminalized if they miscarry; threatens to jail doctors who provide life-saving care; and forces rape and incest victims to file police reports to access care. His law bans abortion before most women know they are pregnant, stripping women of their freedom and dictating the personal medical decision of women and their families. This election is a contrast between having a governor who will fight to protect women’s reproductive freedom versus a Governor bent on controlling women’s bodies for his political gain.

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What U Need Is… Join the BWOPA and Partners Statewide Listening Session / Conversation on Reparations Now!

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Biden Is an Uneasy Champion on Abortion. Can He Lead the Fight in Post-Roe America?

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WASHINGTON — The Supreme Court’s decision to end the constitutional right to an abortion in the United States after nearly 50 years has set in motion a generational struggle over Republican efforts to ban the procedure in states across the country.

But inside the West Wing, President Biden has made it clear that he is uncomfortable even using the word abortion, according to current and former advisers. In speeches and public statements, he prefers to use the word sparingly, focusing instead on broader phrases, like “reproductive health” and “the right to choose,” that might resonate more widely with the public.

Mr. Biden, a practicing Catholic who has drawn on his faith to shape his political identity, is now being called on to lead a fight he spent decades sidestepping — and many abortion rights advocates worry that he may not be the right messenger for the moment.

Once an outright critic of abortion rights and later a committed but quiet defender of them, Mr. Biden has a history that gives activists pause.

“This is not necessarily the guy that I am sure most activists wanted in the seat when this happened,” said Jamie L. Manson, the president of Catholics for Choice, referring to the court’s decision overturning Roe v. Wade. “It’s unfortunate because he has so much power and we need him to really get out of his comfort zone.”

For five decades, Mr. Biden has talked openly about the power of his religion, portraying himself as an advocate for workers and a warrior for social justice. His faith also had guided him toward what he once called a “middle of the road” approach to abortion — essentially, not voting to limit abortion, but not voting to fund it either.

And like other Democrats of his generation, Mr. Biden used the existence of Roe v. Wade’s protections to avoid pushing for legislation that might have enshrined the ruling in federal law.

Now, a growing chorus of women’s groups, progressive Democrats and abortion rights activists see the decision to overturn Roe as an indictment of that middle-ground approach, saying Democrats like Mr. Biden have tiptoed too carefully around the issue for years.

The Supreme Court’s decision, they say, must be met with an equally fierce legal, political and rhetorical response. And after a decisive vote this past week to defend abortion rights in deeply conservative Kansas, many Democrats see this as the moment to run more assertively on the issue.

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Mr. Biden’s advisers say that his views on abortion have changed over time and that he is deeply committed to abortion rights. Laphonza Butler, the president of Emily’s List, a group that helps elect Democratic women who support abortion rights, said she was satisfied that Mr. Biden and his team were “using every tool at their disposal” to fight for the cause.

But the president’s history on abortion — informed by his religion and the Democratic Party’s years of careful political calculations — has left him struggling to live up to the expectations of those in his party who want a new strategy and a new energy.

“Yes, there are limits to executive branch power, there are limits to what the president can do,” said Andrea Miller, the president of the National Institute for Reproductive Health. “But this just feels like you’ve got to push the boundaries right now. This is a time to pull out all the stops. This is a time to take risks.”

In 2007, Mr. Biden wrote in his memoir “Promises to Keep” that his position on abortion had “earned me the distrust of some women’s groups.” In the book, he recounted a 1973 conversation with a veteran senator who said his cautious approach was a “tough” one.

“‘Yeah, everybody will be upset with me,’ I told him, ‘except me. But I’m intellectually and morally comfortable with my position,’” Mr. Biden wrote in the book.

Now, he finds himself championing abortion rights. In June, just days after the court’s ruling, he appeared miffed when a reporter noted that some activists did not believe he was the right person to lead the fight against Republican efforts to ban the procedure.

“I’m the only president they got,” he said.

Mr. Biden has often said that his views on abortion — and the proper role for government to play in regulating it — are the result of his faith. In 1982, when he voted in favor of a constitutional amendment pushed by Republicans to allow individual states to overturn Roe v. Wade, he said: “I’m probably a victim, or a product, however you want to phrase it, of my background.”

The Catholic Church considers human life to begin at conception and says that “the intentional killing of a human being living in the womb” is always immoral. Church teachings generally allow for “indirect” abortions when a medical procedure needed for another lifesaving reason results in the death of a fetus. But many Catholics disagree with the church’s official position. In a Pew Research Center survey released last month, 60 percent of Catholics in the United States said abortion should be legal in all or most cases.

Other Democratic politicians have faced difficult moments navigating their stands on the issue. The leaders of the American Catholic Church have publicly rebuked Catholic politicians like John F. Kerry, the former Massachusetts senator, and Speaker Nancy Pelosi for their stances.

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By his own admission, Mr. Biden is a deeply religious person who rarely misses a chance to attend Mass.

Last year in St. Ives, a seaside town in Cornwall on the southern tip of England, Mr. Biden, who was attending the annual Group of 7 meeting with world leaders, slipped into the back pews of the Sacred Heart and St. Ia Church for Mass with about 50 other parishioners. The Rev. Philip Dyson had been given a heads-up just minutes before the arrival of the president and his wife.

“I did find him gracious and humble and a gentleman,” Father Dyson said, recalling the brief conversation after the Mass. The priest would not talk about whether he offered communion to the president during the service. Some Roman Catholic bishops believe politicians who support abortion should be denied communion.

“It’s controversial, and it’s between him and the Lord,” Father Dyson said.

John Carr, the director of the Initiative on Catholic Social Thought and Public Life at Georgetown University, said that abortion had been the one part of Mr. Biden’s faith that had been a source of conflict for the president and his allies over the years.

“He is a product of Catholic social teaching and Democratic orthodoxy,” said Mr. Carr, who has participated in several small-group discussions with Mr. Biden about religion and politics. “When the two go together, he’s really comfortable with the way he talks, the way he acts. Where he is the least at home is where the two conflict.”

Allies of the president note that since the Supreme Court ruling, Mr. Biden has issued two executive orders aimed at protecting the right to travel for health care and the right to access medications. This past week, the Justice Department filed a lawsuit in Idaho, accusing the state of illegally restricting abortion when the procedure is needed to stabilize a woman’s health.

“The president’s faith is not the problem that we have,” said Representative Katherine M. Clark, Democrat of Massachusetts and the assistant speaker. “The problem is an extremist G.O.P. that says, ‘We don’t respect your faith, your medical history, your circumstance.’”

But for most of his career, Mr. Biden has been viewed with suspicion by abortion rights advocates because of his history on the issue.

In 1984, Mr. Biden voted to praise the “Mexico City Policy,” a decision by the Reagan administration to prevent funding of abortion services abroad. It was a position that would be anathema for a Democratic president today. Over the years since, Republican presidents have routinely reinstated the policy, and Democrats have eliminated it. Mr. Biden rescinded it eight days after taking office.

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For years, Mr. Biden also declined to join other Democrats in opposing the Hyde Amendment, a federal ban on funding for abortion. It was not until 2019 that he reversed himself. Facing intense backlash from within his party, he said he could “no longer support an amendment” that makes it harder for low-income women to get access to an abortion. Although he followed through by submitting budgets without Hyde’s restrictive language, lawmakers added it back in.

As vice president, Mr. Biden fought to exempt Catholic institutions from the Affordable Care Act requirement to provide coverage for contraception. The provision was fiercely opposed by American Catholic bishops, and Mr. Biden tried to make the bishops’ case.

He lost in the end, though the contraception mandate was later struck down by the Supreme Court.

Kathleen Sebelius, who served as secretary of health and human services under President Barack Obama, said that Mr. Biden wanted to “just avoid a battle with the church.”

“I think that’s sort of where he started the conversation,” she said. But she recalled that Mr. Biden eventually acknowledged the impact that denying contraceptive coverage would have for people who worked at Catholic institutions.

“He started in one place, and then gradually moved to a very different place,” she said.

On other issues where Democratic Party positions clashed with Catholic teaching, like support for same-sex marriage, Mr. Biden was quicker to change his position, said Mr. Carr, noting what he called the president’s “passion and eloquence” on L.G.B.T.Q. issues.

But he said abortion had always seemed more difficult for the president.

“Biden has never sought power to make abortion more available,” Mr. Carr said. “It’s just not part of who he is.”

The president admitted as much in an interview on NBC’s “Meet the Press” in 2007.

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“I’m a practicing Catholic,” he said. “And it is the biggest dilemma for me in terms of comporting my religious and cultural views with my political responsibility.”

Two days before the Supreme Court’s ruling overturning Roe v. Wade, abortion rights advocates met at the White House with some of Mr. Biden’s top aides and with Vice President Kamala Harris, who has become a forceful voice of the administration on the issue of abortion.

Everyone knew what was likely to happen, after Politico’s publication weeks earlier of a draft opinion in the abortion case of Dobbs v. Jackson Women’s Health Organization. But some of the people around the table left unhappy with the administration’s plans to respond to the ruling.

“It was a very frustrating meeting where we were looking to the White House for guidance,” Ms. Manson, of Catholics for Choice, said. “And instead, what we got was a recap of all the conversations they had had with all of us.”

Others at the meeting described it differently, saying the administration had spent weeks preparing for the Dobbs ruling in a series of productive meetings with activists.

But the frustration clearly underscored the tension between Mr. Biden and abortion rights activists, many of whom have said publicly that the president’s past positions make it hard for them to trust that he is all-in on the fight.

Mr. Biden’s aides note that he has used the word “abortion” a handful of times since the ruling. And in a statement on Saturday condemning a new Indiana law banning almost all abortions, the White House used the term in reiterating support for reproductive rights.

But some veterans of the abortion rights movement say they remain wary of a president who is uncomfortable with using the word. Others say they are willing to judge Mr. Biden by his actions.

Mini Timmaraju, the president of NARAL Pro-Choice America, said there was value in Mr. Biden’s approach, which can appeal to a broader audience. But she said the president should not avoid using direct, forceful language at a moment when people are scared.

“He’s done that,” she said. “And he’s going to need to get more comfortable with that because this is the modern-day Democratic Party. He’s getting there, from what I can see.”

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Katie Rogers contributed reporting from Washington, and Maggie Haberman from New York.

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