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FDA allows new delivery of monkeypox vaccine to make more doses available

USA TODAY logo USA TODAY 8/9/2022 Karen Weintraub, USA TODAY
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Monkeypox vaccine shots will soon be delivered differently and in a way that allows 5 doses to be obtained from a current single dose.

The Food and Drug Administration Tuesday issued an emergency use authorization for the Jynneos monkeypox vaccine so it can be available for adults as a so-called intradermal injection, which penetrates only the top layer of skin.

In a Tuesday afternoon call with news media, members of the Biden Administration urged state and local officials who still have doses of Jynneos available to immediately switch to intradermal injections to conserve vaccines.

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The federal government has purchased and already allocated more than 600,000 Jynneos doses. States and localities can order additional vaccine once they have used 90% of the stock allocated to them.

Using the new approach, the 441,000 doses of vaccine that have not yet been distributed will be able to provide 2.2 million shots, according to Dawn O’Connell, assistant secretary for preparedness and response in the department of Health and Human Services.

The extra doses are intended to bring more control to an outbreak that has now caused at least 8,900 monkeypox infections in the United States alone.

“In recent weeks the monkeypox virus has continued to spread at a rate that has made it clear our current vaccine supply will not meet the current demand,” FDA Commissioner Dr. Robert Califf said in a prepared statement. “By increasing the number of available doses, more individuals who want to be vaccinated against monkeypox will now have the opportunity to do so.” 

Previous studies have shown that an intradermal injection triggers the same immune response as the deeper, subcutaneous shot, which is delivered to the fat layer under the skin.

Minors at high risk for monkeypox will continue to receive the vaccine by subcutaneous injection, because it's easier to deliver deeper shots into small arms and because the shallower shots have not been studied in children, said Dr. Peter Marks, who heads the FDA division that reviews vaccines. "We feel very comfortable with the safety of the approach," he said.

The federal government has ordered another 5 million vials of vaccine, which will begin arriving in September and should now provide as many as 25 million shots. Shots are available at no cost to the recipient and have generally been distributed at government-sponsored vaccination clinics.

Communities that have limited recipients to one dose of the vaccine should now begin giving out second doses, delivered intradermally, according to Califf and Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention.

There is no data to suggest that a single Jynneos dose will be protective long-term against the virus, Walensky said in urging people to get the additional dose. A second dose is generally given 28 days after the first.

"We feel pretty strongly that two doses are necessary in part because we simply don't have any evidence out 6, 8, 3 months later after a single dose that people will be adequately protected and we don't want to give people a false sense of security," Marks said.

Decreasing sexual partners, even after vaccination also reduces infection risk, Walensky said.

"We don't yet know how well these vaccinations work," Walensky said, noting that studies have only looked at immune response to the shots, because there weren't widespread monkeypox outbreaks to test them in. The National Institutes of Health in collaboration with the CDC are preparing to launch that research.

The Biden administration's Aug. 9 determination that monkeypox constitutes a public health emergency enabled the FDA to authorize the intradermal delivery as well as vaccines for children.

Vaccines are still being targeted at the people most likely to have been exposed to monkeypox, including men who have sex with men.

Since the outbreak came to widespread public attention in late April, most of the 30,000 infected worldwide have been men who have sex with men. So far, about 13 people have died globally, none in the United States.

As it spreads, the virus is expected to affect other communities as well, which is why it's important to contain it, officials have said. 

Monkeypox is passed through close physical contact with someone carrying the infection, including, but not exclusively during sex. It's not clear whether someone can be contagious before they develop weeping – and often very painful – lesions, though the pus is believed to be the main route of transmission.

More than 15,000 courses of a 5-day antiviral called Tpoxx has also been made available to monkeypox patients through the federal government, HHS Secretary Xavier Becerra said Tuesday.

The government has cut out much of the red tape that had been required to distribute Tpoxx although it still takes about an hour per prescription, said Dr. Peter Silver, senior vice president, chief quality officer and associate chief medical officer at Northwell Health in New York.

Tpoxx seems to speed up the time it takes for the lesions to heal, though most people recover without needing targeted medication, Silver said. Of about 100 patients seen by Northwell in two Manhattan and one Long Island clinics, as of late last week, only 11 have required Tpoxx and 7 required hospitalization, mostly to treat the pain of the lesions, he said. 

Testing is faster than it was, but still can take 3- to 5 days for results, he said, adding that Northwell is assessing an in-house test to speed the process. 

Vaccines have been available, but "demand is greater than supply," he said.

People with monkeypox are considered to be contagious and advised to isolate until the lesions have scabbed over and been replaced by new skin, which can take 3 to 4 weeks.

A man holds a sign urging increased access to the monkeypox vaccine during a protest in San Francisco, July 18, 2022. © Haven Daley, AP A man holds a sign urging increased access to the monkeypox vaccine during a protest in San Francisco, July 18, 2022.

In a letter sent Monday to the leader's of Biden's monkeypox response team, members of the Harvard School of Public Health called for a more aggressive response to the outbreak. 

Monkeypox "may infect queer and trans communities first, but these communities will not be the last. We demand action now," the letter read.

Then it proposed 11 policy solutions, which the authors said were identified by the queer and trans community, scholars, and activists "that the Biden administration should implement to center health equity and improve its response" to monkeypox.

Those include involving people of color at the highest levels of decision-making on monkeypox strategy, providing better access to testing, vaccination and treatment, including offering free condoms at clubs and bars where queer and trans communities congregate, becoming more involved in the global response, increasing resources at  community sexual health clinics and LGBTQ health centers and supporting development of at-home tests to detect monkeypox.

Public health experts and advocates have been critical of the administration's response to date, saying that while steps have been taken in the right direction, they came far too slowly, allowing the virus to spread.

Monkeypox, a far less lethal cousin of smallpox, has spread around the world since late April after being transmitted within Nigeria for about five years. 

Despite its name, the virus' natural host is rodents, not monkeys and it is endemic in parts of Africa. The size and scale of the current outbreak suggests it could become a permanent fixture in many other countries as well.

The earliest symptoms often include a fever, swollen glands and muscle aches, followed by a rash that can be extremely painful.

Prior to this outbreak, most of the transmission came directly from animals rather than among people.

Contact Karen Weintraub at kweintraub@usatoday.com.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

This article originally appeared on USA TODAY: FDA allows new delivery of monkeypox vaccine to make more doses available

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