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White House scrambles to ship tens of thousands of monkeypox vaccine doses

The Biden administration is stepping up its efforts to slow the spread of monkeypox by distributing tens of thousands of vaccine doses after being criticized for its early response to an outbreak in the US that primarily affects gay men.

The plan, announced Tuesday, includes rapidly expanding access to doses of Bavarian Nordic’s Jynneos vaccine — which has been limited until now — to prevent monkeypox in areas of highest transmission and need.

The announcement came just hours after proponents sent a message letter to the White House, which has denounced the government’s response to monkeypox and says 1 million doses of the Jynneos vaccine already in US possession are held in Denmark pending an inspection of the facility.

Although the vaccine itself has been approved for use by US regulators, the doses were produced in Denmark on a production line that is still awaiting Food and Drug Administration (FDA) approval, officials said earlier this month.

The letter from PrEP4ALL and Partners for Health said in part: ‘We must not allow the same failures in vaccine production and distribution that hampered the global COVID-19 response to fail to contain the current monkeypox outbreak. to keep.’

“If this is a test run to be prepared for a pandemic, we’ll fall,” said James Krellenstein, co-founder of PrEP4ALL. Washington Post

“We have over a million doses of an FDA-approved vaccine to prevent monkeypox,” he said. “And the US government can’t figure out how to get it out of the freezers in Denmark — doses it possesses — when there’s rampant spread in the gay community.”

Lines formed last week at a monkey pox vaccine clinic in New York that quickly ran out of 1,000 doses of Jynneos offered to high-risk men

Lines formed last week at a monkey pox vaccine clinic in New York that quickly ran out of 1,000 doses of Jynneos offered to high-risk men

The White House plan, announced Tuesday, includes a rapid expansion of access to doses of Bavarian Nordic's Jynneos vaccine — which has been limited until now

The White House plan, announced Tuesday, includes a rapid expansion of access to doses of Bavarian Nordic’s Jynneos vaccine — which has been limited until now

The Biden administration’s new plan will immediately allocate 56,000 doses of Jynneos from a national stockpile to states and territories, with 1.6 million doses available by the end of the year, officials said.

State and local health departments can also order stocks of Emergent BioSolutions’ older ACAM2000 vaccine, which is in much larger stock but has more side effects and cannot be used by everyone, including those who are immunocompromised.

The United States has more than 100 million doses of ACAM2000 in stock, officials said earlier this month, but the vaccine is not recommended for people with HIV.

The United States has officially recorded 306 cases of monkeypox, a viral infection linked to smallpox that causes painful skin lesions — but health officials fear the true number could be higher.

Although the virus is endemic to parts of Africa, the current outbreak has affected countries where the virus does not normally spread, raising fears that it could become more widespread.

The map above shows where cases of monkey pox have been detected in America.  On the right, the third column of the table shows the number of cases registered in the past two days

The map above shows where cases of monkey pox have been detected in America. On the right, the third column of the table shows the number of cases registered in the past two days

Workers sit outside DC Health's first monkeypox vaccination clinic, which administers the first Jynneos vaccine doses to be distributed in the US capital on Tuesday

Workers sit outside DC Health’s first monkeypox vaccination clinic, which administers the first Jynneos vaccine doses to be distributed in the US capital on Tuesday

Even after Tuesday’s announcement, some proponents expressed concern that vaccines wouldn’t reach those who need them most, including men who have sex with other men, a higher-risk group.

David Harvey, executive director of the National Coalition of STD Directors, told the Post that the latest announcement was a “confusing mess” that failed to explain the vaccine distribution formula.

“There are profound questions about how they will allocate limited vaccines to which jurisdictions, and states and local communities need a coordinated federal plan,” Harvey told the outlet.

“We need to reach people at risk for monkey pox and conduct widespread vaccine efforts for gays and other men who have sex with men.”

The White House said in a statement that the vaccine doses will be distributed to “areas of highest transmission and need, using a tiered allocation system.”

“As additional supplies become available, we will expand our efforts further, making vaccines available to a larger population,” Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, told reporters.

Those at highest risk of monkey pox are men who have sex with men. The demand for the vaccine is growing. Last week, a clinic in New York began offering the vaccine and soon ran out of available injections.

Previously, health officials have focused on offering the vaccine to individuals with direct contact with a person who has had a confirmed case of monkey pox.

Last Thursday, New York City's health department — armed with 1,000 doses of Jynneos from the federal government — announced it would open a temporary clinic

Last Thursday, New York City’s health department — armed with 1,000 doses of Jynneos from the federal government — announced it would open a temporary clinic

The new strategy will expand that definition to include presumed exposures, said Jennifer McQuiston, deputy director of CDC’s Division of High Consequence Pathogens and Pathology.

These include those who have been in close contact with someone diagnosed with monkeypox, those who know their sexual partner has been diagnosed with monkeypox, and gay men who have recently had multiple sex partners in a location where monkeypox was known to exist or in a area where monkey pox spreads.

Monkeypox ‘not a global emergency,’ says WHO

The World Health Organization said the escalating monkeypox outbreak in more than 50 countries requires close monitoring but does not justify declaring it a global health emergency.

In a statement Saturday, a WHO emergency committee said many aspects of the outbreak were “unusual” and acknowledged that monkeypox – which is endemic in some African countries – has been neglected for years.

“While some members expressed differing views, the committee decided by consensus to advise the Director-General of WHO that it should be determined at this stage that the outbreak does not constitute a global emergency,” the WHO said in a statement.

The WHO nevertheless pointed to the “emergency” of the outbreak and said controlling its spread would require an “intensive” response.

The commission said the outbreak “should be closely monitored and assessed after a few weeks.”

But it would recommend a reassessment before then if certain new developments emerge – such as cases involving sex workers; spread to other countries or within countries that have already had cases; increased severity of cases; or an increasing rate of spread.

“It’s almost like we’re expanding the definition of who a contact might be,” McQuiston said. If people have been to a party or other place where monkeypox is known to spread, we recommend that they get a vaccine, she said.

The goal of the first phase of the strategy is to slow the spread of the disease, government officials said.

Most monkeypox patients only experience fever, body aches, chills and fatigue. People with more serious illness may develop rashes and lesions on the face and hands that can spread to other parts of the body.

There have been no US deaths and officials say the risk to the US public is low. But they are taking steps to reassure people that medical measures have been taken to address the growing problem.

One of the steps was to expand who is recommended to get vaccinated. Vaccines are usually given to build immunity in people before they are ever infected.

But if given within days or even a few weeks of initial infection, some vaccines can reduce the severity of symptoms.

A two-dose vaccine, Jynneos, has been approved for monkeypox in the U.S. The government has many more doses of an older smallpox vaccine — ACAM2000 — which they say could also be used, but that vaccine is thought to carry a greater risk of side effects. and is not recommended for people with HIV.

So it’s the Jynneos vaccine that officials have been trying to use as a primary weapon against the monkeypox outbreak. So far, the government has deployed more than 9,000 doses of vaccine.

Last Thursday, the New York City health department — armed with 1,000 doses of Jynneos from the federal government — announced it would open a temporary clinic to offer the vaccine to all gay, bisexual, and other men who have sex with men who have multiple or anonymous sex partners in the past two weeks.

But all appointments quickly filled up that day, and the last round of appointments was Monday.

“Until we have more supply, we cannot release additional vaccination appointments,” Patrick Gallahue, a spokesman for the city’s health department, said in an email.

On Monday, the District of Columbia’s health department took a similar step. The department started taking appointments at 1 p.m. Monday but had to stop after 20 minutes, Mangla said.

The department only had 200 doses of Jynneos and it was clear the department didn’t have the vaccine stock or staff to sign up new people, he said.

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