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Monkeypox

Newsom declares State of Emergency for state response to Monkeypox

To date, the state has distributed more than 25,000 vaccine doses and will make additional allocations in the coming days and weeks

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California Governor Gavin Newsom (Blade file photo via Office of the Governor)

SACRAMENTO – Governor Gavin Newsom today declared a State of Emergency to bolster the state’s vaccination efforts as California responds to the monkeypox outbreak.

The proclamation enables the California Department of Public Health and other public health officials to coordinate a whole-of-state government response to monkeypox, seek additional vaccines and lead outreach and education efforts on accessing vaccines and treatment.

“California is working urgently across all levels of government to slow the spread of monkeypox, leveraging our robust testing, contact tracing and community partnerships strengthened during the pandemic to ensure that those most at risk are our focus for vaccines, treatment and outreach,” said Newsom. “We’ll continue to work with the federal government to secure more vaccines, raise awareness about reducing risk, and stand with the LGBTQ community fighting stigmatization.”

State Senator Scott Wiener (D-San Francisco) who has been advocating for immediate state action and was instrumental in the efforts to get the City and County of San Francisco to declare a state of emergency released the following statement applauding Newsom for declaring a State of Emergency due to Monkeypox:

“The monkeypox outbreak is an emergency, and we need to use every tool we have to control it. I’m deeply grateful to Governor Newsom for recognizing the peril we face, and thus declaring a state of emergency. This declaration will help expand vaccination, testing, and other critical strategies around the outbreak. I look forward to working with the Governor and his Administration to combat this dangerous health situation.”

Last month, California public health leaders urged federal partners to make more vaccine doses available to the state as quickly as possible so that the state can expand eligibility to both confirmed and probable exposures, as well as to individuals who are at high-risk of contracting the virus.

To date, the state has distributed more than 25,000 vaccine doses and will make additional allocations in the coming days and weeks. Los Angeles County has received a separate allocation of vaccine. In all, the state has received more than 61,000 doses. The state is also supporting overall vaccination efforts in collaboration with locals, including helping provide staffing and mobile clinics. The state allocates doses to local health departments based on a number of factors, including the number of reported monkeypox cases in an area and estimate of at-risk populations.  

As of July 28, the state had expanded its testing capacity to process more than 1,000 tests a week. The state’s public health laboratory leaders have been working with local public health, academic, and commercial laboratories to ensure testing capacity is increasingly available and coordinated with the public health response. CDPH is also expanding treatment options.

Access to the antiviral prescription drug tecovirimat (TPOXX) used to treat monkeypox is limited, but the treatment can now be administered at more than 30 facilities and providers across the state the State Health Department noted in a press release.

Equality California, the nation’s largest statewide LGBTQ+ civil rights organization, released the following statement from Executive Director Tony Hoang: 

“Equality California applauds the leadership of Governor Newsom to ensure that Californians are protected from the fast growing monkeypox outbreak in our state. While anyone of any sexual orientation can get Monkeypox, the fact is that, Monkeypox continues to disproportionately affect gay, bisexual and queer men here in California and across the country. 

Equality California is committed to continue working with government officials, public health leaders and other LGBTQ+ organizations to increase awareness and education while fighting stigmas.” 

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Monkeypox

Monkeypox vax strategy shift by Biden Administration amid shortages

As the estimated number of monkeypox cases in the United States reaches 8,900, top health officials announced the new move on Tuesday

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Los Angeles Blade file photo

WASHINGTON – 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 and children — where single digit monkeypox cases have been reported — 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 emulate 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 — real world studies are needed — 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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Monkeypox

Out NY Congressman introduces bill to make monkeypox testing free

The bill requires private health insurers as well as Medicare & Medicaid to cover the costs of monkeypox testing at no expense to patients

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Rep. Sean Patrick Maloney (D-NY) (Blade file photo by Michael Key)

WASHINGTON – Rep. Sean Patrick Maloney (D-N.Y.), amid the ongoing monkeypox affecting gay and bisexual men, introduced legislation in the U.S. House seeking to make testing for the 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 that the measure, called the No Cost for Monkeypox Testing Act, would make testing amid the current monkeypox outbreak be accessible to all who requested it.

“It is critical that we eliminate cost as a barrier to testing for monkeypox to ensure we can identify cases and prevent further spread,” Maloney said. “This 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.”

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.

Secretary of Health & Human Services Xavier Becerra said Tuesday the federal government has the capacity to conduct an estimated 80,000 tests each week.

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Monkeypox

Biopharma giant commits millions to address monkeypox

Gilead is giving GLAAD, the HRC, NBJC and NCLR $350,000 each – $1.4 million total – to fund public education efforts

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Courtesy of Gilead Sciences, Inc.

FOSTER CITY, Ca. – Gilead Sciences Inc., one of the largest biopharma companies in the world, will provide millions of dollars to address the ongoing monkeypox outbreak, including nearly $2 million for LGBTQ and human rights organizations. 

The Foster City, Calif.-based company announced Tuesday that it is committing up to $5 million to address monkeypox, nearly $2 million of which is reserved for LGBTQ and human rights organizations. Another $3 million will fund a global outbreak emergency grant program. 

Gilead will partner with GLAAD, the Human Rights Campaign (HRC), National Black Justice Coalition (NBJC), National Center for Lesbian Rights (NCLR) and NMAC to address public education and policy surrounding monkeypox.

Monkeypox has become a growing threat, especially to gay and bisexual men, since the virus – which has historically only circulated in central and western Africa – started to spread globally. It officially reached the U.S. in May

The U.S. Department of Health and Human Services officially declared the disease a public health emergency last week, freeing up emergency funding and improving the distribution of vaccines and treatments. The move came after criticism from LGBTQ advocates and health experts who said the Biden administration wasn’t acting quickly enough

Vaccines have remained scarce as the U.S. pushes near 9,000 confirmed cases, 94% of which occur in men who have sex with men, according to the U.S. Centers for Disease Control and Prevention. 

The outbreak has also hit people living with HIV particularly hard. In an interview with the Los Angeles Blade, Korab Zuka, Gilead’s vice president of public affairs, referenced a New England Journal of Medicine study that found 41% of 528 monkeypox infections diagnosed between April 27 and June 24 were in people living with HIV. Gilead is a leader in HIV treatments. 

Gilead is giving GLAAD, the HRC, NBJC and NCLR $350,000 each – $1.4 million total – to fund public education efforts, according to Zuka. The money will be used to create a comprehensive communications campaign, including videos, graphics and other informational resources focused on vaccines, prevention and treatment. 

“As we saw with HIV, COVID-19, and now [monkeypox], disinformation continues to challenge the LGBTQ+ community,” Sarah Kate Ellis, president and CEO of GLAAD, said in a statement. She added: “When communities receive accurate, timely information, they are empowered to take appropriate action, leading to long-lasting, positive health outcomes.”

The drugmaker awarded the NMAC, a nonprofit focused on health equity and racial justice to end the HIV epidemic in America, $500,000 to lead the public policy response, according to Zuka. The funding will help the organization inform public policy “to drive a more comprehensive, swift and coordinated community response,” said a news release. 

In a statement, the group’s executive director, Paul Kawata, said the NMAC would use its “extensive contacts at the federal level” and “work with both the White House and Congress to provide the necessary resources to deal with this outbreak.”

“Our top priorities will include making sure that vaccine access is equitable for all communities at risk and that any outreach plans will include ways to deal with vaccine hesitancy in a culturally competent way,” he said. 

The remaining funds will be used to create a global outbreak emergency fund, which will provide grants of up to $50,000 to Gilead’s existing grantee organizations working in regions with active monkeypox outbreaks, according to officials. Zuka said the money would be distributed through an application process based on need.

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