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U.S. declares monkeypox a public health emergency

Number of cases of disease among MSM climbs

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Secretary of Health & Human Service Xavier Becerra declared on public health emergency on monkeypox.

The United States has designated monkeypox a public health emergency as the number of cases of the disease, which has primarily affected men who have sex with men, continues to climb.

The news was first reported by the New York Times. Secretary of Health & Human Services Xavier Becerra announced he’d declare monkeypox a public health emergency in a conference call on Thursday with reporters.

“I will be declaring a public health emergency on monkeypox,” Becerra said. “We’re prepared to take our response to the next level in addressing this virus, and we urge every American to take monkeypox seriously and to take responsibility to help us tackle this virus.”

Robert Fenton, the recently appointed White House National Monkeypox Response Coordinator, said amid criticism the Biden administration has been too slow in responding to monkeypox the new declaration would open up opportunities in confronting the outbreak.

“The public health emergency will allow us to explore additional strategies to get vaccines and treatments more quickly out in the affected communities, and it will allow us to get more data from jurisdictions so we can effectively track the suffering,” Fenton said.

During the call, Becerra said an estimated 6,600 cases of monkeypox have been reported throughout the country, and more than 600,000 vaccines have been delivered to localities. The United States, Becerra said, now has the capacity to administer 60,000 tests for monkeypox each week.

The Biden administration has faced criticism for not moving quickly enough to collect and distribute and for not more explicitly naming gay and bisexual men as being primarily affected by the disease. The New York Times reported this week the Department of Health & Human Services failed to act early on bulk stocks of vaccine.

“The government is now distributing about 1.1 million doses, less than a third of the 3.5 million that health officials now estimate are needed to fight the outbreak,” the Times reported. “It does not expect the next delivery, of half a million doses, until October. Most of the other 5.5 million doses the United States has ordered are not scheduled to be delivered until next year, according to the federal health agency.”

Sen. Richard Burr (R-N.C.), top Republican on the Senate Health, Education, Labor & Pensions Committee, has been among the critics of the Biden administration’s approach to the outbreak.

Although the Biden administration has issued a rudimentary plan on monkeypox, Burr said in a statement the Department of Health & Human Services hasn’t laid out an effective plan to Congress.

โ€œI have asked HHS repeatedly for their strategic plan to combat monkeypox and have yet to receive an answer,” Burr said. “On July 13, I sent a letter to Secretary Becerra asking detailed questions about the outbreak and the Biden administrationโ€™s response. In the three weeks since that letter was sent, monkeypox cases have increased by more than 470 percent to 6,617 reported cases today. Still, the administration continues to stonewall Congress.”

White House Press Secretary Karine Jean-Pierre defended the Biden administration’s early approach to the monkeypox Thursday under questioning from CNN during the regular briefing with reporters.

“Within two days of the first confirmed case of monkeypox in the U.S., we began deploying vaccine to states and jurisdictions and prepositioning tens of thousands of additional doses in the Strategic National Stockpile,” Jean-Pierre said. “The initial science led us to believe…based on recent past monkeypox outbreaks, that those doses would be sufficient to meet the needs of the country as what we knew at that time.”

Jean-Pierre added, however, infections diseases are dynamics and inherently predictable and the Biden administration “quickly moved” to order tens of thousands of new doses when officials saw that happening with monkeypox.

Asked by CNN whether President Biden think his administration acted urgently in its approach to monkeypox, Jean-Pierre replied, “What we’re saying to you is that I laid out how dynamic and how rapidly changing this virus has been.”

“So yes, the President has confidence in HHS, and let’s not forget, we just brought on the monkeypox coordinators, the response team, which is also going to make a difference,” Jean-Pierre added.

Jennifer Kates, director of global health & HIV policy for the Kaiser Family Foundation, was among those praising the announcement from the Biden administration.

“Monkeypox is quickly spreading throughout the United States, with significant health implications for those it impacts most โ€“ so far, primarily gay and bisexual men and other men who have sex with men โ€“ and limited supplies of treatments and vaccines,” Kates said. “This latest move by the federal government is an important one for providing new flexibilities and allowing federal, state, and local health officials to take additional actions to address the outbreak. “

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Over 100 LGBTQ-themed books in a Florida school district labeled with advisory warning

They warn: โ€œthis book has been identified by some community members as unsuitable for students.โ€

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Advisory Notice (via Twitter)

A southwest Florida district put parental โ€œadvisory noticeโ€ on over 100 books, many of which are race or LGBTQ-themed.ย 

A great number of books in Collier County Public Schools, either digital or physical, now have warning labels writing โ€œAdvisory notice to parents,โ€ according to an NBC report,

The label, tweeted by nonprofit free-speech-promoting group PEN American, states, โ€œThis Advisory Notice shall serve to inform you that this book has been identified by some community members as unsuitable for students. This book will also be identified in the Destiny system with the same notation. The decision as to whether this book is suitable or unsuitable shall be the decision of the parent(s) who has the right to oversee his/her childโ€™s education consistent with state law.โ€ย 

Stephana Ferrell, co-founder of the Florida Freedom to Read Project, which means to fight book banning, told NBC that she had a call from Elizabeth Alves, the associate superintendent of teaching and learning for Collier County Public Schools. In the call, Alves told her that the district added the labels starting in February.ย 

These measures, which Alves described as a โ€œcompromise,โ€ happened after the districtโ€™s legal representative talked with the Florida Citizens Alliance, a conservative group which initiated a โ€œPorn in Schools Reportโ€ project last year. The report included a list of books that โ€œpromote gender self-identification and same-sex marriageโ€ as well as titles that include โ€œindecent and offensive material,โ€ as the group explained. 

Chad Oliver, the Collier County Public Schools spokesperson, on the other hand offered a different story. 

Oliver sent an email to NBC News and said, “Based upon advice from the General Counsel, we placed advisory notices on books about which parents and community members had expressed concern and in accordance with the recently passed Parents’ Bill of Rights Law (HB 241).” 

The law referred by Oliver is also known as the โ€œDonโ€™t Say Gayโ€ law.

According to PEN America, there are 110 labeled books in total, and the list greatly overlaps with the one Florida Citizens Alliance inquired about with Collier County Public Schools.ย 

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Rep. Sean Patrick Maloney introduces bill to make monkeypox testing free

Health insurers would be required to cover costs

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Rep. Sean Patrick Maloney has introduced legislation to make monkeypox testing free to the public. (Blade file photo by Michael Key)

Rep. Sean Patrick Maloney (D-N.Y.), amid the ongoing monkeypox affecting gay and bisexual men, has introduced legislation in the U.S. House seeking to make testing for disease free to the public.

Maloney, one of seven openly gay members of Congress and chair of the Democratic Congressional Campaign Committee, said in a statement the measure, called the No Cost for Monkeypox Testing Act, would testing amid the monkeypox outbreak would be accessible to all.

โ€œIt is critical that we eliminate cost as a barrier to testing for monkeypox to ensure we can identify cases and prevent further spread,โ€ Maloney said. โ€œThis legislation takes the lessons we learned from past public health emergencies and protects those at risk of contracting monkeypox by making tests accessible to everyone.โ€

The legislation would require private health insurers as well as Medicare and Medicaid to cover the costs of monkeypox testing at no expense to the patients, either through deductibles, co-payments, and co-insurance.

The bill introduction comes the week after the Biden administration declared the monkeypox outbreak a public health emergency and the same it has issued new guidance to enhance to the accessing of existing vaccines doses amid criticism federal officials were too slow in distributing shots.

The Washington Blade has placed a request in with the Centers for Disease Control seeking comment on the legislation. Secretary of Health & Human Services Xavier Becerra said Tuesday the federal government has the capacity to conduct an estimated 80,000 tests each week.

Maloney has been representing New York’s 18th congressional district, but after redistricting is now seeking re-election in the 17th district. Amid controversy over a potential showdown between Maloney and Rep. Mondaire Jones (D-N.Y.), who’s Black, another openly gay member of Congress and the current representative of that district, Jones has since opted to run for re-election in the New York’s 10th congressional district. Maloney is now running unopposed in the 17th.

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Biden administration shifts monkeypox vaccine approach amid shortage

Health experts sees new guidance as mixed bag

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The Biden administration has changed its guidance on monkeypox vaccines to enhance availability amid the shortage.

The Biden administration, amid criticism it was slow to act on the monkeypox outbreak and still not meeting the demand for vaccines as the number of cases continues to grow, has announced a shift in guidance for implementation of the shot in an effort to enhance availability.

As the estimated number of monkeypox cases in the United States reaches 8,900, top health officials announced the new move on Tuesday as part of a decision by Secretary of Health & Human Services Xavier Becerra to issue a determination under Section 564 of the Federal Food, Drug and Cosmetic Act to justify emergency use authorization of vaccines. The announcement follows up on the Biden administration’s announcement last week declaring the monkeypox outbreak a public health emergency.

Becerra said in a conference call with reporters the 564 determination and change in approach to vaccines would “boost and strengthen” the Biden administration’s response to monkeypox, which has overwhelmingly affected gay and bisexual men, and “safely accelerates and multiplies our supply of effective vaccines by up to fivefold.”

“Today’s action also reaffirms HHS and this administration’s commitment to using all available resources and capabilities to end the monkeypox outbreak and provide the best possible care to those suffering from the virus,” Becerra added.

The new vaccine approach, which may may be considered minor to non-medical observers, would change injections of the JYNNEOS vaccine from the subcutaneous route (delivery of the vaccine under the fat layer underneath the skin) to the intradermal route (delivery of the vaccine into the layer of skin just underneath the top layer). In theory, that would allow for greater accessibility of monkeypox vaccines as it increases the number of doses from each vial of vaccine.

The change was made amid criticism the Biden administration failed to meet the demand for vaccines during the outbreak and geographic inequity as certain metropolitan areas of the country have more access to vaccines than other places.

As The New York Times reported last week, the Biden administration has faced criticism for not moving quickly enough in acquiring and distributing vaccines, including bulk stocks already owned by the U.S. government manufactured in Denmark by Bavaria Nordic now being given to other clients.

“The government is now distributing about 1.1 million doses, less than a third of the 3.5 million that health officials now estimate are needed to fight the outbreak,” the Times reported. “It does not expect the next delivery, of half a million doses, until October. Most of the other 5.5 million doses the United States has ordered are not scheduled to be delivered until next year, according to the federal health agency.”

Biden officials, nonetheless, touted the numbers of vaccines and tests in response to monkeypox as a positive, acknowledging the 1.1 million vaccines being made available as well as delivery of more than 620,000 of those doses, deployment more than 15,000 courses of the monkeypox treatment and increasing the country’s capacity to administer tests on a weekly basis to around 80,000. Meanwhile, officials also promoted the change in approach in vaccines as means to allow greater accessibility to the shots.

Rochelle Walensky, director of the Centers for Disease Control & Prevention, promoted during the conference call the use of intradermal injections and said they’re “often used for TB skin tests and have been used for other types of vaccines.”

Although Walensky conceded some health care providers “may not be as familiar with intradermal administration” as they are with subcutaneous injection, she said CDC would make additional guidance materials available, including a clinician alert message to the Association of State & Territorial Health Officials, outreach to key clinician partners and an education resource video. The change in guidance, Walensky said, is for vaccine implementation in adults, but children โ€” where single digit monkeypox cases have been reported โ€” would continue to receive vaccination in the traditional subcutaneous approach.

But health experts aren’t responding with overwhelming praise to the decision to change the guidance on vaccine implementation from subcutaneous injections to intradermal injections, expressing concerns the new approach may be insufficient.

Jennifer Kates, director of global health & HIV policy at the Kaiser Family Foundation, was among those saying the change in guidance on vaccine approach was a mixed bag and told the Blade more data is needed to evaluate the effectiveness.

“As we saw with COVID, using these authorities in the context of public health emergencies is an important strategy,” Kates said. “In this case, this step will significantly expand access to vaccines for those most at risk. However, there remain questions about the effectiveness of this approach โ€” real world studies are needed โ€” and challenges to translating vaccines into vaccinations.”

Peter Marks, director of the Center for Biologics Evaluation & Research (CBER) at the Food & Drug Administration, was asked during the conference call with reporters to respond to concerns the change in guidance was insufficient and downplayed the novelty of implementing the vaccines through the intradermal route as “not at all new.”

“In fact, the reason why the Bavaria part of this equation comes from the fact that in Germany, this vaccine was given intradermally originally, in an effort to replicate the original version of the smallpox vaccine,” Marks said. “It’s been given to thousands of people intradermally, so this isn’t the first time it’s been done.”

Walkensky said the intradermal vaccine approach has been implemented amid policies among localities to implement a one-dose approach to the JYNNEOS vaccine through the subcutaneous route. (The D.C. government is one of the jurisdictions that had enacted a one-dose approach amid a vaccine shortage.) There is not data, Walkensky said, to support that approach and “in fact, if anything, there are data saying that that is not protective enough.”

“So by using this alternative strategy of intradermal dosing, not only do we have more doses, but we actually allow people to get two doses in a way that shows immunologic response that’s superimposable from the subcutaneous dosing,” Walkensky said. “So we have more doses, and in fact, we have the ability to doubly vaccinate people so that they get the protection that they need.”

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