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CDC on monkeypox: ‘We anticipate an increase in cases in the coming weeks’

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The head of the Centers for Disease Control said she expected the reported cases of monkeypox to increase.

Rochelle Walensky, director of the Centers for Disease Control & Prevention, warned on Friday the spread of monkeypox, an outbreak that has occurred primarily among gay and bisexual men, would increase in the coming weeks.

“Now as we closely monitor cases, I would like you all to understand that we anticipate an increase in cases in the coming weeks,” Walensky said in a conference call with top Biden administration health officials and reporters.

The increase, Walensky said, is due to three factors: 1) The CDC streamlining its reporting process to allow states to report new cases more quickly and accurately; 2) With more cases in the United States, an increase in the resulting exposure of these cases in the coming weeks; and 3) A significant increase in the number of people seeking laboratory tests and the number of specimens being submitted for testing.

Monkeypox cases in the United States, Walensky said, have reached 1,470 reported cases documented across 44 jurisdictions as of July 14.

Younger gay and bisexual men are primarily affected: The median age is 36 with a range of 18 to 76 years of age, and the vast majority of cases happen among those who identify as men who have sex with men based on demographic information local health departments provided to CDC, Walensky said.

The Biden administration on the same day Walensky disclosed the new data announced an order for another 2.5 million doses of Bavarian Nordicā€™s JYNNEOS vaccine to respond to the current monkeypox outbreak.

The vaccines, however, won’t arrive soon: According to the Department of Health & Human Services, they’re coming in 2023 as part of the plan for the U.S. governmentā€™s available supply of vaccine to reach 7 million by mid-2023, which would be several months after the outbreak has begun.

The Biden administration has been faulted for moving too slowly in responding to monkeypox in criticism reminiscent of inaction during the coronavirus and HIV/AIDS epidemics, including being too slow to distribute vaccines and make testing available. Monkeypox is transmitted by skin-to-skin contact, unlike the other two diseases, and isn’t fatal.

Walensky during the call acknowledged “the demand for vaccines from jurisdictions is higher than our current available supply,” but pushed back on other criticisms as “points of confusion where we’ve been hearing from the public, our partners and media.” The availability of tests, for example, is and has been meeting capacity, Walensky said.

“We have the testing capacity needed,” Walensky said. “We expanded the nation’s monkeypox testing capacity this week, and now have four commercial labs with combined capabilities along with CDC laboratory Response Network ā€¦ we’ve gone from being able to test 6,000 samples a week to 70,000 samples per week. Having commercial lab testing for monkeypox will also make it more convenient for providers to access tasks by using existing providers to lab relationships, and we have not yet received anywhere near that demand of tests as our capacity now permits.”

Also during the call health officials announced efforts to work on delivery of 786,000 doses currently located in Denmark, which they said will be available pending FDA clearance by the end of July. The inability of the Biden administration to move the vaccines from Europe in a timely fashion has been a source of criticism of the FDA.

Peter Marks, director of the Center for Biologics Evaluation & Research at the FDA, pushed back on that criticism in response to a question from the Washington Blade, insisting the FDA had taken a timely approach to obtaining those vaccines.

“First of all ā€¦ quite contrary to missing a chance for approval, FDA actively reached out using contacts with the Biomedical Advanced Research & Development Authority to actually move up the submission that was necessary and all of the other events that were necessary to get those doses to be able to be used from what was originally going to be this fall,” Marks said. “And we did that actually, pretty shortly after we realized there was a monkeypox outbreak.”

Marks also said the United States was unable to rely on the European Union’s certification of the vaccines because the FDA relies on its own safety protocols for approval of medication for use domestically.

“We do not in the United States recognize ā€” we don’t have mutual recognition of vaccine inspections for initial licensure from other countries, and that’s because we have our quality standards that have to be maintained,” Marks said. “And we have with all due diligence to make sure that the necessary procedures were undertaken, so that these will be available before the end of July but these doses were originally not scheduled to be approved until sometime in the fall, and that was moved up.”

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The White House

USCIS announces it now only recognizes ‘two biological sexes’

Immigration agency announced it has implemented Trump executive order

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An American flag flies in front of a privately-run U.S. Immigration and Customs Enforcement detention center in the Southeast U.S. on July 31, 2020. U.S. Citizenship and Immigration Services has announced it now only recognizes "two biological genders, male and female." (Washington Blade photo by Yariel ValdƩs GonzƔlez)

U.S. Citizenship and Immigration Services on Wednesday announced it now only “recognizes two biological sexes, male and female.”

A press release notes this change to its policies is “consistent with” the “Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government” executive order that President Donald Trump signed shortly after he took office for the second time on Jan. 20.

ā€œThere are only two sexes ā€” male and female,ā€ said DHS spokesperson Tricia McLaughlin in a statement. “President Trump promised the American people a revolution of common sense, and that includes making sure that the policy of the U.S. government agrees with simple biological reality.”

“Proper management of our immigration system is a matter of national security, not a place to promote and coddle an ideology that permanently harms children and robs real women of their dignity, safety, and well-being,ā€ she added.

The press release notes USCIS “considers a personā€™s sex as that which is generally evidenced on the birth certificate issued at or nearest to the time of birth.”

“If the birth certificate issued at or nearest to the time of birth indicates a sex other than male or female, USCIS will base the determination of sex on secondary evidence,” it reads.

The USCIS Policy Manuel defines “secondary evidence” as “evidence that may demonstrate a fact is more likely than not true, but the evidence does not derive from a primary, authoritative source.”

“Records maintained by religious or faith-based organizations showing that a person was divorced at a certain time are an example of secondary evidence of the divorce,” it says.

USCIS in its press release notes it “will not deny benefits solely because the benefit requestor did not properly indicate his or her sex.”

ā€œThis is a cruel and unnecessary policy that puts transgender, nonbinary, and intersex immigrants in danger,” said Immigration Equality Law and Policy Director Bridget Crawford on Wednesday. “The U.S. government is now forcing people to carry identity documents that do not reflect who they are, opening them up to increased discrimination, harassment, and violence. This policy does not just impact individuals ā€” it affects their ability to travel, work, access healthcare, and live their lives authentically.” Ā 

“By denying trans people the right to self-select their gender, the government is making it harder for them to exist safely and with dignity,” added Crawford. “This is not about ā€˜common senseā€™ā€”it is about erasing an entire community from the legal landscape. Transgender, nonbinary, and intersex people have always existed, and they deserve to have their identities fully recognized and respected. We will continue to fight for the rights of our clients and for the reversal of this discriminatory policy.ā€Ā 

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The White House

Trump threatens Maine’s Democratic governor over trans athlete ban

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President Donald Trump (Washington Blade photo by Michael Key)

President Donald Trump threatened to withhold federal funding from Maine after the state’s Democratic Gov. Janet Mills refused to say that she would enforce his administration’s ban on transgender women and girls competing in sports.

Their brief but heated exchange during a meeting of the National Governors Association at the White House on Friday kicked off when Mills agreed only to abide by “state and federal law” and Trump told her, ā€œWe are the federal law. You better do it because youā€™re not going to get any federal funding if you don’t.”

“See you in court,” Mills responded.

ā€œGood,” Trump agreed, “I’ll see you in court. I look forward to that. That should be a real easy one. And enjoy your life after governor, because I don’t think you’ll be in elected politics.”

Two days after Trump’s issuance of the executive order”Keeping Men Out of Women’s Sports” on Feb. 5, the governing body responsible for overseeing high school sports in Maine said trans athletes would still be allowed to compete because the ban was in conflict with provisions of the Maine state Human Rights Act.

The president previewed his proposal to condition federal funding on states’ compliance with the policy during a meeting on Thursday of the Republican Governors Association.

Earlier on Friday, Mills vowed in a statement that ā€œIf the President attempts to unilaterally deprive Maine school children from the benefit of Federal funding, my Administration and the Attorney General will take appropriate and necessary legal action to restore that funding and the academic opportunity it provides.”

Echoing her comments, the state’s Democratic Attorney General Aaron Frey said in a statement Friday morning that “Any attempt by the President to cut federal funding in Maine unless transgender athletes are restricted from playing sports would be illegal and in direct violation of court orders.”

ā€œFortunately, though, the rule of law still applies in this country, and I will do everything in my power to defend Maineā€™s laws and block efforts by the President to bully and threaten us,” he said.

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The White House

Trump bars trans women and girls from sports

The administration reversed course on the Biden-Harris policy on Title IX

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President Donald Trump (Washington Blade photo by Michael Key)

President Donald Trump on Wednesday issued another executive order taking aim at the transgender community, this time focusing on eligibility for sports participation.

In a signing ceremony for ā€œKeeping Men Out of Womenā€™s Sports” in the East Room of the White House, the president proclaimed “With this executive order, the war on womenā€™s sports is over.”

Despite the insistence by Trump and Republicans that trans women and girls have a biological advantage in sports over cisgender women and girls, the research has been inconclusive, at best.

A study in the peer reviewed Sports Medicine journal found ā€œno direct or consistent researchā€ pointing to this conclusion. A different review in 2023 found that post-pubertal differences are ā€œreduced, if not erased, over time by gender affirming hormone therapy.ā€

Other critics of efforts to exclude trans student athletes have pointed to the small number of people who are impacted. Charlie Baker, president of the National Collegiate Athletic Association, testified last year that fewer than 10 of the NCAA’s 522,000+ student athletes identify as trans.

The Trump-Vance administration has reversed course from the Biden-Harris administration’s policy on Title IX rules barring sex-based discrimination.

ā€œIf youā€™re going to have womenā€™s sports, if youā€™re going to provide opportunities for women, then they have to be equally safe, equally fair, and equally private opportunities, and so that means that youā€™re going to preserve womenā€™s sports for women,” a White House official said prior to the issuance of the order.

Former President Joe Biden’s Title IX rules, which went into effect last year, clarified that pursuant to the U.S. Supreme Court’s ruling in Bostock v. Clayton County (2020), sex-based discrimination includes that which is based on the victim’s sexual orientation or gender identity.

The White House official indicated that the administration will consider additional guidance, regulations, and interpretations of Title IX, as well as exploring options to handle noncompliance by threatening federal funding for schools and education programs.

White House Press Secretary Karoline Leavitt told reporters that Trump ā€œdoes expect the Olympic Committee and the NCAA to no longer allow men to compete in womenā€™s sports.ā€

One of the first legislative moves by the new Congress last month was House Republicans’ passage of the “Protection of Women and Girls in Sports Act,” which would ban trans women and girls from participating in competitive athletics.

The bill is now before the U.S. Senate, where Republicans have a three-seat majority but would need 60 votes to overcome the filibuster.

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