The U.S. Department of Health and Human Services announced Friday that it has ordered an additional 2.5 million doses of Bavarian Nordic’s JYNNEOS, an FDA-licensed vaccine indicated for prevention of smallpox and monkeypox, for use in responding to current or future monkeypox outbreaks and as part of U.S. smallpox preparedness.
Deliveries from this latest order of the Bavarian Nordic‘s Jynneos vaccine will begin arriving at the Strategic National Stockpile (SNS) later this year and will continue through early 2023 HHS said in a statement.
“We are working around-the-clock with public health officials in states and large metro areas to provide them with vaccines and treatments to respond to the current monkeypox outbreak,” said HHS Secretary Xavier Becerra. “This order of additional JYNNEOS vaccine will help us push out more vaccine quickly, knowing that we have more doses on the way in the coming months — and is only possible because of our longstanding investment in smallpox and monkeypox preparedness.”
The order announced today is in addition to the 500,000 doses of government-owned vaccine the company is producing in 2022 for use in the current response to monkeypox in the U.S and brings the total vaccine doses to be delivered in 2022 and 2023 to more than 4 million.
The company will produce these doses in liquid frozen form using vaccine already manufactured in bulk under an existing 10-year contract with the Biomedical Advanced Research and Development Authority, within the HHS Office of the Assistant Secretary for Preparedness and Response; that contract was part of ongoing national preparedness efforts against smallpox.
“The medical countermeasures available to help respond to the current outbreak are the result of years of investment and planning made possible through the ongoing work between HHS and private industry,” said Gary Disbrow, director of the Biomedical Advanced Research and Development Authority. “We are pleased that we have been able to work with our partners at Bavarian Nordic to accelerate delivery of vaccines that can help keep people safe and stem the spread of the virus.”
BARDA supported the development of JYNNEOS, which is approved by the FDA to prevent smallpox and monkeypox. The U.S. government owns enough smallpox vaccine — JYNNEOS and ACAM2000 — to vaccinate millions of Americans, if needed.
As of June 24, ASPR’s SNS held approximately 65,000 doses of JYNNEOS in immediate inventory with delivery of an additional 300,000 doses in the coming days. On June 28, HHS announced that it would immediately make available 56,000 doses and soon after would make available 240,000 additional doses. The SNS also has more than 100 million doses of ACAM2000 which was developed with SNS support and is approved by FDA for use in preventing smallpox. The Centers for Disease Control and Prevention currently has an expanded access Investigational New Drug protocol which allows use of ACAM2000 for monkeypox.
In addition, the SNS has over 1.7 million treatment courses of the smallpox antiviral drug TPOXX, which was developed with BARDA support and can be used to treat individuals with monkeypox under an appropriate regulatory mechanism. CDC currently has an expanded access Investigational New Drug protocol which allows its use for monkeypox.
As of June 29, the CDC has received reports of approximately 350 cases of monkeypox in the U.S., primarily among men who have sex with men.
To learn more about monkeypox, visit cdc.gov/monkeypox.
Biden executive order to bolster efforts to secure release of Americans detained abroad
Brittney Griner remains detained in Russia
President Joe Biden on Tuesday signed an executive order that will bolster his administration’s efforts to secure the release of Americans who are detained or being held hostage abroad.
The executive order, which is based on the 2020 Robert Levinson Hostage Recovery and Hostage-Taking Accountability Act, a retired FBI agent who Iranian authorities arrested in 2007, reinforces what a press release describes as “the administration’s tool kit in key ways.”
- Reinforces the U.S. government’s efforts to support families of Americans wrongfully detained or held hostage overseas;
- Authorizes agencies to impose costs and consequences, including financial sanctions, on those who are involved, directly or indirectly, in hostage-taking or wrongful detentions to support expanded and ongoing interagency efforts;
- Directs relevant parts of the U.S. government to bolster their engagement and sharing of relevant information, including intelligence information, consistent with the protection of sources and methods, with families regarding their loved ones’ status and U.S. Government efforts to secure their release or return, as appropriate; and
- Charges experts across the interagency to develop options and strategies to deter future hostage-taking and wrongful detentions.
“It reaffirms the fundamental commitment of the president of the administration to bring home those Americans held hostage (and) wrongfully detained abroad,” said senior administration on Monday during a conference call with reporters.
Another senior administration official added the executive order “reinforces U.S. government efforts to support the families of Americans wrongfully detained or held hostage overseas by directing parts of the federal government to bolster their engagement with such families and their sharing of relevant information, including intelligence information, with families regarding their loved one’s status, and the government’s efforts to secure their release or their return.”
“This EO (executive order) reflects the administration’s commitment not just to the issues generally, but to the families in particular and it has been informed by the government’s regular engagements with them and other stakeholders who have and continue to undertake important constructive advocacy efforts on behalf of their loved ones,” they said. “President Biden and those across the administration will now draw on this EO to advance our efforts and we hope to do so in an active conversation with family members and outside stakeholders.”
The executive order also creates a “D” indicator in the State Department’s travel advisories that notes the countries in which American citizens are at risk for “wrongful detention.” Burma, China, Iran, North Korea, Russia and Venezuela are the first six countries named.
“We’re committed to provide us citizens with comprehensive safety and security information about foreign countries so they can make informed travel decisions before they before they head overseas,” said another senior administration official during Monday’s conference call. “The United States opposes wrongful detention and the practice of using individuals as political bargaining chips everywhere. These practices we know represent a threat to the safety of all US citizens traveling and living abroad.”
Biden signed the executive order against the backdrop of WNBA star Brittney Griner’s continued detention in Russia.
Officials at Moscow’s Sheremetyevo Airport in February detained Griner — a Phoenix Mercury center and two-time Olympic gold medalist who is a lesbian and married to her wife, Cherelle Griner, — after customs inspectors allegedly found hashish oil in her luggage.
The State Department has determined that Russia “wrongfully detained” her.
Griner’s trial, which began on July 1, continues, even though she has pleaded guilty to charges that she smuggled drugs into the country. The White House is under increased pressure from Griner’s wife and family, teammates and LGBTQ activists to secure her release.
A senior administration official on Monday’s call did not directly respond to a question about how the executive order will help secure Griner’s release.
“There are a number of ways in which it would affect cases like that case in the wrongful detainee category,” said the official. “The executive order directs those across the executive branch to share consistent accurate information with the families of those who are deemed wrongfully detained, to ensure that they receive support and assistance throughout the ordeal, and to work with parts of our government to try to impose costs on those responsible.”
Jill Biden addresses LGBTQ donors at Equality PAC fundraiser
First lady Jill Biden expressed solidarity with members of the LGBTQ community Monday at a D.C.-based fundraiser hosted by the Equality PAC, urging action amid fears same-sex marriage is under threat in the wake of the U.S. Supreme Court ruling overturning Roe v. Wade.
“Right now we’re fighting the battles we thought we had already won,” Jill Biden said. “And we don’t need to guess where the extremists are going next because they’ve already told us in the Dobbs decision.”
The Equality PAC is a congressional political action committee led by the openly gay and lesbian members of the U.S. House. Among the notables seen in attendance who spoke at the fundraiser were Reps. Mark Takano (D-Calif.) and David Cicilline (D-R.I.), who co-chair the caucus. The event was held at the Long View Gallery.
“Progress isn’t a line,” Jill Biden said. “It sometimes feels like an ocean, pushing forward and pulling back. But with time and persistence, the shore of injustice does wear away.”
Jill Biden touted President Biden’s actions on behalf of the LGBTQ community, pointing out he signed an executive order against anti-LGBT discrimination, ended the transgender military ban, and appointed LGBTQ federal officials. She also mentioned an executive order President Biden signed in June, which included new prohibitions on widely discredited conversion therapy.
The first lady closed the event urging action and expressing solidarity, although she momentarily tripped over the LGBTQ acronym.
“I want you to know that I will be there beside you every step of the way. It won’t be easy,” she said. “The legacy of the LGD – the LGBTQI community is a hope that has never been crushed.”
Takano also spoke at the event and said Equality PAC raised a total of $217,000 at the event and more than $10.8 million this cycle, envisioning wins for Democrats on Election Day despite expectations of Republican gains.
“We are going to keep our majority and I dare say we’re going to expand it,” Takano said.
CDC on monkeypox: ‘We anticipate an increase in cases in the coming weeks’
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 Nordic’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. government’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 … 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 … 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 — 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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