Florida rations limited supply of monkeypox vaccines as infections go up

DOH spokesman Jeremy Redfern said although the virus is considered low risk for the general public, agency officials expect more people to get sick.

“That being said, due to the lack of monkeypox vaccines from the federal government, we are expecting infections to increase,” Redfern said in an email. “Monkeypox is proving to be extremely painful for those infected, but the fatality rate remains at zero in the US.”

The nationwide increase in monkeypox infections prompted President Joe Biden to declare a public health emergency last week. Data from the U.S. Centers for Disease Control and Prevention show New York is leading the nation with 1,960 infections as of Sunday, followed by California with 1,310 cases. The governors of those states each signed an emergency declaration as cases went up, but the Florida Department of Health has no plans to ask DeSantis to declare an emergency.

“We work with providers, hospitals, and clinics to ensure they are able to properly diagnose a case of monkeypox and report the case to their county health department for further testing,” Redfern wrote.

An emergency declaration allows the state’s government to coordinate with agencies, impose special restrictions and sign contracts outside of state procurement laws.

Florida Gov. Ron DeSantis and Ladapo have downplayed the impact of the monkeypox virus, with DeSantis saying last week — when Florida was fifth in the nation for infections — that politicians and the news media are using the virus to scare people.

Two Democrats vying to unseat the incumbent Republican also demanded that DeSantis take more action. Florida Agriculture Commissioner Nikki Fried said after a Tuesday campaign-related news conference in the parking lot of the governor’s mansion that her office has called on HHS to provide the state with more vaccines. She also urged the DeSantis administration to take the impact of the virus more seriously.

Fried said she recognizes that emergency declaration powers may not be necessary for monkeypox when compared to the ongoing Covid-19 pandemic, but outreach efforts are key at preventing the virus from spreading, usually through direct human contact.

“It’s more so that we can say that this is serious, that we’ve got an issue here, and that we are starting to work with our local governments to provide the resources of vaccines and testing,” Fried said. “The whole thing about monkeypox is knowledge is power.”

Fried will face Rep. Charlie Crist (D-Fla.) in the Aug. 23 primary, and the winner of that race will face off against DeSantis in November. Crist said during a Tuesday interview that DeSantis should be looking for ways to receive more vaccines from HHS rather than just downplaying the issue. With awareness playing such a crucial role in preventing spread, DeSantis should be pulling more levers that he has at his disposal in the event of a problem.

“We know that testing is difficult, and the cases are probably more than we will ever know,” Crist said during a phone interview. “The thing to do here is be engaged, and the governor’s just not engaged here.”

Fried and Crist have also called on the Biden administration to acquire more vaccine doses. The U.S. endured a shortage of the Jynneos vaccine used to treat monkeypox after the first infections were reported in May.

By declaring a national emergency, Biden has started a process the federal government has to follow before it changes a vaccine-use authorization. In Florida, Redfern said the state can direct counties to conserve shots without a declaration, and that the state’s actions were to accommodate for delays in vaccine distribution by the federal government.

“A state of emergency can’t do much to speed up something that is physically unavailable,” Redfern said.

One LGBTQ coalition is already planning its own outreach efforts to alert high-risk Floridians. National Black Justice Coalition Deputy Director Victoria Kirby York said Florida officials have failed to account for the state’s status as one of the most popular tourist destinations in the country, with millions of visitors hitting the beach every summer. She said previous governors, from Crist to Jeb Bush, showed compassion for human beings.

“Governor DeSantis has done nothing but show that every decision he’s making is about a presidential run,” Kirby York said. “It has little or nothing to do with the well-being of the people of Florida.”

The National Black Justice Coalition was one the groups picked by drugmaker Gilead Sciences on Tuesday to receive part of a $5 million grant meant to help promote awareness about monkeypox. Kirby York’s organization refers to the monkeypox virus as MPV due to its racial undertone.

“If we want to stop this, we need to change the trajectory, and start getting into those communities and letting people know,” she said. “You’d think we’d know by now that viruses always start in a community.”

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FBI seizes Rep. Scott Perry’s phone

Perry’s statement didn’t detail what the FBI wanted from his phone, but he has been a figure of interest to congressional investigators probing Trump’s effort to overturn the 2020 election. Perry, a key ally in that effort, pressed Trump to replace Justice Department leaders and install a little-known official, Jeffrey Clark, atop the department. Clark had signaled support for Trump’s effort to call on state legislatures to reconvene and consider appointing “alternate” electors to swing the outcome toward Trump.

The Jan. 6 select panel subpoenaed Perry in May, but he has brushed off the summons.

The Justice Department’s interest in Perry may relate to the Jan. 6, 2021, attack on the Capitol, but it may also intersect with the probe of Trump’s handling of White House records. The Jan. 6 committee revealed in April that Perry and Trump’s last chief of staff, Mark Meadows, communicated by the encrypted messaging app Signal about matters connected to the 2020 election — and it’s unclear whether either man retained those messages.

Similarly, the select committee received testimony that Meadows burned certain papers after meeting in the White House with Perry. Meadows was a founding member of the pro-Trump Freedom Caucus, of which Perry is now the chair.

The FBI’s confiscation of Perry’s phone is not without recent precedent. Authorities seized the phone of Sen. Richard Burr (R-N.C.) in 2020 as part of an investigation into his stock-trading practices, though the Justice Department later ended its probe without pursuing any charges against him. But Burr still stepped down from his chairmanship of the Senate Intelligence Committee amid the controversy and announced he would not seek reelection to his Senate seat.

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Trump’s sway with GOP on the ballot in another key governor’s race

Here is the latest from Tuesday.

Trump tries to remake Wisconsin in his own image

The race between Kleefisch and Michels has been a contentious one, with the two candidates battling it out for the right to face Democratic Gov. Tony Evers in a key November race.

Kleefisch was seen as an early favorite for the GOP nod until Michels’ late entry into the race. Michels’ self-funding, combined with the former president’s backing, turned the race competitive.

Trump’s intervention mirrored other previous Republican gubernatorial primaries, in which the former president looked to upend in-state GOP power structures, like when he unsuccessfully campaigned against Gov. Brian Kemp in Georgia. In Arizona last week, Trump’s pick for governor, former TV anchor Kari Lake, beat out Karrin Taylor Robson, who had the support of both outgoing GOP Gov. Doug Ducey — the co-chair of the Republican Governors Association — and Pence. (Ducey eventually endorsed Lake.)

Trump is also targeting Wisconsin state Assembly Speaker Robin Vos, backing a primary challenger running against one of the most influential state legislative leaders in the country. Trump has been angered by Vos’ refusal to push for “decertifying” the 2020 election results — a legally impossible notion that has nevertheless gained traction on the right — even as Vos has led the state legislature in funding an investigation into the state’s elections.

Trump is also squaring off with the local GOP in Connecticut’s Senate race. There, the state party backed former state House Minority Leader Themis Klarides, a moderate who said she did not vote for Trump in 2020, while Trump swooped in with a late endorsement of RNC Committeemember Leora Levy.

Minnesota fills a vacant House seat

Minnesota voters in a red-leaning district are deciding who will fill the final months of the late GOP Rep. Jim Hagedorn’s term, in a test of the political environment following the Supreme Court’s Dobbs decision on abortion in June.

Republican former state Rep. Brad Finstad is favored over the Democratic nominee, former Hormel Foods CEO Jeff Ettinger, in a district Trump carried by 9 points in 2020.

But the final margins in the race could be an early sign of how voters’ reaction to the Supreme Court’s ruling is translating to candidates. Last week, Kansas voters overwhelmingly rejected a state constitutional amendment that would have cleared the way for new abortion restrictions there. But it remains an open question how strongly voters will consider abortion as they make their picks for elected offices.

Minnesota election officials warned that final results for the special election will be delayed, due to complications involved with running the special election under the old district lines while also running the primary under the new, redistricted lines for the next term in Congress.

Elsewhere in Minnesota, voters will likely finalize a matchup between Democratic Gov. Tim Walz and former Republican state Sen. Scott Jensen, who is only facing nominal opposition in his primary.

The GOP is also likely to elevate Kim Crockett, an activist who has questioned elections in her state, to face Democratic Secretary of State Steve Simon.

Vermont prepares to send its first woman to Washington

Vermont is the lone state to never yet send a woman to Congress, but voters are taking a big step toward changing that Tuesday. The leading contenders for the Democratic nomination in the state’s open at-large House seat to replace Rep. Peter Welch — who is expected to lock up the Democratic nod for Senate on Tuesday — are both women.

Lt. Gov. Molly Gray and state Senate President Becca Balint are squaring off for the nomination. Sen. Bernie Sanders (I-Vt.) is backing Balint, while the retiring Sen. Patrick Leahy (D-Vt.) supports Gray.

The winner of the Democratic primary will be heavily favored in November.

Voters pick candidates in a handful of key House districts

Some of the biggest November House battlegrounds have relatively sleepy primaries on Tuesday. In Minnesota, Democratic Rep. Angie Craig and Republican Tyler Kistner are both preparing for a general election rematch, after Craig narrowly beat Kistner in 2020. And two reach seats for Republicans in Connecticut — to challenge Democratic Reps. Jahana Hayes and Joe Courtney — have no-drama, unopposed primaries Tuesday as well.

One contest to watch is the Democratic primary to replace the retiring Rep. Ron Kind (D-Wis.). Three Democrats — Deb McGrath, Brad Pfaff and Rebecca Cooke — are competing for the nomination to face Republican Derrick Van Orden, whom Kind beat by about 3 points in 2020, in a district that the GOP views as one of its best pickup opportunities of the year.

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Biden administration authorizes emergency monkeypox vaccine strategy

The EUA also allows individuals under 18 who are at high risk for monkeypox infection to receive the vaccine through the originally approved subcutaneous method.

White House National Monkeypox Response Coordinator Robert Fenton said the move is “a game changer when it comes to our response and our ability to get ahead of the virus,” during a briefing with reporters. “It’s safe, it’s effective, and it will significantly scale the volume of vaccine doses available for communities across the country,” he said.

But the strategy has sparked concerns among public health experts and health advocates who say there is not enough data about how much protection it will provide against the virus, that it could be harder to administer, and that it will generate further confusion in the middle of a growing public health crisis.

Some see the approach as the direct result of a series of missed opportunities and failures by the Biden administration to contain the virus by not ramping up testing earlier and securing and distributing vaccines more quickly.

“In an attempt to avoid the political embarrassment of having to admit that we’re out of doses, they’re coming up with a scheme that is very, very risky from a public health perspective,” says James Krellenstein, managing director of the advocacy group PrEP4All.

“Personally, I give it 80 or 90 percent chance that the thing works. But it’s a 20 or 10 percent chance it doesn’t work, and that’s a very, very large risk in a public health emergency,” Krellenstein said.

The Biden administration declared the monkeypox outbreak a public health emergency on Aug. 4, less than three months after the first case was recorded in the U.S., giving the federal government access to increased funding and staff for the outbreak.

On Tuesday, HHS declared monkeypox an emergency under a different statute that gives the FDA the power to authorize the new vaccine protocol.

So far, a total of 8,934 cases have been confirmed in every state except Wyoming, as well as in the District of Columbia and Puerto Rico, according to the Centers for Disease Control and Prevention.

Almost all of the cases with available data have been among men, according to the CDC, and 94 percent have been among men who have reported having sex or intimate contact with men. The disease is endemic in Africa but has not previously spread this widely in the United States. It causes flu-like symptoms as well as a rash that can be painful or itchy. No one in this country has died since the current outbreak, which has now hit scores of countries across the globe, began.

Last month, CDC Director Rochelle Walensky acknowledged the government did not have enough vaccines to meet demand as the outbreak widened.

There are currently 441,000 doses of the Jynneos vaccine in the Strategic National Stockpile, according to the Department of Health and Human Services, meaning 2.2 million doses could be available using the new approach of splitting doses.

The FDA is basing the updated emergency use authorization on a seven-year-old study funded by the National Institutes of Health that found using a smaller amount of the vaccine injected between the skin’s layers could generate a similar immune response to a full dose injected below the skin.

Administration officials held two separate phone calls on Monday with state health officials and health advocates and experts to brief them on the new strategy before announcing it, according to people on the calls.

There are valid concerns about there not being enough vaccines, said one attendee who requested anonymity to speak candidly about the calls. “But are we experimenting?” the person added.

“There’s really no clinical data on hard clinical outcomes on how well these vaccines protect against monkeypox, including these different dosing strategies,” said Philip Chan, an associate professor in the Department of Medicine at Brown University who specializes in HIV prevention.

Walensky also acknowledged on Tuesday that the government is still gathering data on the vaccine’s efficacy.

“While additional vaccine effectiveness studies are underway, we at CDC are very much recommending that people who get vaccinated continue to take steps to protect themselves from infections — especially if they have only had a single dose — by avoiding close skin-to-skin contact, including intimate contact with somebody who has monkeypox,” she said. “We don’t yet know how well these vaccines work.”

Infectious disease experts stressed that it isn’t that they fear that the new strategy won’t work at all, but they want to make sure the federal government collects more data to make sure it is working — and reaching the people who need it.

Michael Osterholm, the director of the Center for Infectious Disease Research and Policy at the University of Minnesota, noted that while changing the delivery of the vaccine could work to offer protection to more individuals, it’s practically far more difficult to do.

“Intradermal administration is often considered more art than science,” said Osterholm, who has spoken with Biden administration officials about how best to roll out the vaccine. “The worst thing that can happen is you have a major vaccine failure. … How reliable will the intradermal vaccination delivery system actually be? How well does it work in immunocompromised people?”

He said these are questions he wants to see studied as the policy moves forward. “We need answers to this to provide to people who are getting vaccinated so we give them full information on what this vaccine can and can’t do,” he added.

Researchers at the National Institute of Allergy and Infectious Diseases are working on a study that would look at the efficacy of administering the Jynneos vaccine between the skin, but those results won’t be ready for months.

Others agree that there is evidence this approach can protect people, but more data is needed as the government implements the new plan.

“As this is happening, they should be doing studies simultaneously or pragmatic trials to understand what efficacy they can expect from this,” said Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security at the Bloomberg School of Public Health. “Yes, okay, let’s move forward with this, but make sure that we’re gathering data that it actually works.”

Separately, health advocates working in the community of men most affected by the disease have serious concerns about how the lower dose will be received, particularly in New York City where a one-dose strategy has already been implemented to stretch vaccine supplies, against FDA guidance.

The FDA noted in its emergency use authorization that “there are no data available to indicate that one dose of Jynneos will provide long-lasting protection, which will be needed to control the current monkeypox outbreak.”

“It is already leading to a lot of confusion,” said Joseph Osmundson, a clinical assistant professor of biology at NYU who has been part of ongoing conversations with federal health officials about the monkeypox response. “And I don’t know that confusion is the right way to drive vaccine uptake in an already marginalized community.”

It’s not a small consideration as vaccine confidence has once again become a nationwide health issue during the pandemic.

“My primary worry — even if this turns out to be equally equivalent, which I think odds are it will — will people trust it enough to get the vaccine?” asked Krellenstein.

Demetre Daskalakis, deputy coordinator of the administration’s national monkeypox response, said the rate of vaccination for Covid-19 among men in the high-risk group bodes well, as long as public health officials are getting the message out to them.

“I think we’re going to see that we will likely still run out of vaccines before we run out of arms,” he said.

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Zelenskyy says ‘we will return’ to Crimea after blasts rock Russian base – POLITICO

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Ukraine’s President Volodymyr Zelenskyy declared Tuesday that the war with Moscow “began with Crimea and must end with Crimea,” after explosions rocked a Russian air base on the peninsula, killing one and injuring others.

“Today, there is a lot of attention on the topic of Crimea. And rightly so. Because Crimea is Ukrainian, and we will never give it up,” Zelenskyy said in a Telegram video. “This Russian war against Ukraine and against all of free Europe began with Crimea and must end with Crimea — with its liberation. Today it is impossible to say when this will happen. But we are constantly adding the necessary components to the formula of liberation of Crimea … I know that we will return to the Ukrainian Crimea.”

But Zelenskyy stopped short of directly addressing the blasts, and Russia has denied they were attacks, instead blaming “violations of fire safety rules” and the accidental detonation of stored ammunition, according to Russian media.

“Only violations of fire safety rules are considered as a key cause of the explosion of several munitions. There are no signs or evidence that it was done deliberately,” Russian news agency TASS cited a source in the defense ministry as saying.

Moscow annexed Crimea from Ukraine in 2014 and used it to help launch its full-scale invasion of its neighbor in February. But if Ukraine did strike the base, it would mark an escalation in the war as the first known major attack on a Russian military site in Crimea.

From a strategic perspective, striking jets at an airbase in Crimea would support a significant Ukrainian counter-offensive toward the southern city of Kherson but also begs questions of how Russia will respond. Only last month, former President Dmitry Medvedev made apocalyptic warnings of Russian retaliation if Crimea were attacked. Trying to play down the sense of a big set-back on Tuesday, Russian authorities denied the loss of any planes.

Ukraine’s defense ministry noted sarcastically on Facebook that it could not verify the cause of the explosions, “but once again draws attention to fire safety rules and the ban on smoking in uncertified places.” It added: “We can’t rule out that the occupiers will ‘accidentally’ find some characteristic ‘insignia’, ‘visiting card’ or even ‘DNA’.”

It also wrote on Twitter: “The Ministry of Defense of Ukraine would like to remind everyone that the presence of occupying troops on the territory of Ukrainian Crimea is not compatible with the high tourist season.”

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