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NYC plans to delay second doses of monkeypox vaccine

New York City is set to delay rolling out second doses of the monkeypox vaccine because it has too few doses, health officials say amid warnings the U.S. outbreak is already out of control.

The city’s Department of Health warned Friday it would likely be unable to meet this deadline because it has received too few doses from the federal government.

Guidance states patients should receive their second dose of the jab four weeks after the first to ensure best protection.

New York — which is at the epicenter of the outbreak — has switched track to prioritize getting first doses to as many patients as possible. It is also releasing the 1,000 doses it initially held back for second shots.

Dr Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC), sought to calm fears over a vaccine shortage telling STAT News that New York City was among those set to receive yet more deliveries.

Dr Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, said it was ‘not recommended’ to delay second doses.

Dr Rochelle Walensky, who heads up the Centers for Disease Control and Prevention (CDC), sought to calm fears saying more doses were scheduled to be delivered to New York City imminently

Dr Peter Marks, from the Food and Drug Administration, said it was not recommended to extend the dosing period

Dr Rochelle Walensky, who heads up the Centers for Disease Control and Prevention (CDC), sought to calm fears saying more doses were scheduled to be delivered to New York City imminently. Dr Peter Marks, from the Food and Drug Administration, said it was not recommended to extend the dosing period

America is currently rolling out the Jynneous vaccine, which is given as a two-dose course with the second shot administered four weeks after the first.

But several countries — including the UK and Canada — have already expanded this bracket as they prioritize getting first doses into arms.

The tweaking of dosing schedules has echoes of the Covid pandemic, where many countries — but not the U.S. — widened the gap between doses in order to reach more people faster.

Monkeypox outbreak likely ‘out of control’ in America, officials say 

Monkeypox may already be out of control in the United States, a former U.S. Food and Drug Administration commissioner has warned.

Speaking in a CBS interview Sunday, Dr Scott Gottlieb warned that the window for getting on top of the disease ‘probably has closed’.

He said the national tally — at 1,800 cases — was likely ‘just a fraction’ of the actual number because of poor testing coverage.

And that monkeypox had likely already spread outside of gay and bisexual men, but that this was yet to be detected.

Monkeypox has now been spotted in almost every U.S. state — except Mississippi in the south, Wyoming, Montana and North Dakota, and in Maine and Vermont.

Of the tally, eight cases have been spotted so far in women nationally, and none in children and adolescents.

No studies have been carried out on how effective the Jynneous vaccine is with a longer gap between doses.

But manufacturers point to trial results showing it is as effective as ACAM2000 — the other monkeypox vaccine — from two weeks after the first dose to show a longer dosing interval may be possible.

Dr Amesh Adalja, an infectious diseases expert at Johns Hopkins University in Baltimore, Maryland, raised no concerns over extending the time between doses when asked by DailyMail.com.

‘There’s nothing magical about the dosing interval and individuals can be caught up when supply is more abundant,’ he said.

‘The priority is getting some level of immunity in those at highest risk for exposure.’ 

New York City launched its monkeypox vaccine roll out on June 23 for gay or bisexual men who have multiple sexual partners every two weeks.

The first recipients will be eligible for their second jab in just three days time.

Revealing the delay Friday, the city said: ‘Given the rapid increase in cases, the Health Department has decided that providing first doses to offer protection to more at-risk New Yorkers is the best strategy until we receive adequate vaccine supply.

‘In many instances, this means that individuals may not get a second dose by the 28-day interval between doses as indicated in the Food and Drug Administration (FDA) prescribing label.’

They added: ‘Until there is sufficient supply in the city, all vaccine doses will be treated as first doses, and we will only begin scheduling second dose appointments once we have enough vaccine to do so.

‘The Department will communicate to people who have received first doses about when second doses are available and how to receive them.’

Monkeypox vaccines are in very high demand in New York City, with appointments for the 9,300 doses released Friday all booked within minutes. Washington D.C., the other rolling out the jabs, is also seeing appointments run out rapidly.

Nationally, more than 1,800 cases have been detected across all but seven states — Alaska, Maine, Montana, Mississippi, North Dakota, Vermont and Wyoming.

In New York the 489 cases have all been detected among men, with 60 percent identifying as either gay or bisexual.

But a top expert has warned that the tropical disease has likely already spilled over into other groups — but is yet to be detected.

No fatalities from the disease have been recorded in the U.S. to date, but young men who make up the bulk of the patients are at very low risk.

There are mounting concerns, however, over the risk of fatalities should the disease reach pregnant women and older adults — who are more at risk.

‘The negligible fatality rate won’t necessarily persist if the virus escapes its current network: mostly young, mostly healthy adult men,’ Donall McNeil, a journalist who sounded the alarm on Covid, Zika and other virus outbreaks, wrote for Common Sense.

‘In Africa, children and pregnant women are the most likely to die from monkeypox,’ he added.

Dr Scott Gottlieb warned on Sunday that the virus had likely spread to other groups besides gay or bisexual men, but was yet to be detected

Dr Scott Gottlieb warned on Sunday that the virus had likely spread to other groups besides gay or bisexual men, but was yet to be detected

Walensky told STAT in an interview that anyone getting the vaccines would need two doses to get the ‘higher level of protection’.

She said: ‘We’re not asking New York — or anybody — to hold back doses right now because… we’re pretty confident that what’s going to come in is going to be able to cover those second doses.’

Marks also warned against delaying second doses of the vaccine.

‘We do not recommend to go off the recommended schedule here,’ he said during a press conference at the Department of Health and Human Services.

‘A single dose of this vaccine will not provide the kind of protection over time that is necessary if people continue this risky behavior.

‘So, the two-dose regimen is the best that we can do to make sure that we actually have people get the protection that the vaccine is intended to provide.’

Monkeypox may already be out of control in the United States, a former U.S. Food and Drug Administration commissioner has warned.

Speaking in a CBS interview Sunday, Dr Scott Gottlieb, former commissioner of the FDA, warned that the window for getting on top of the disease ‘probably has closed’.

He said the national tally — at 1,800 cases — was likely ‘just a fraction’ of the actual number because of poor testing coverage.

And that monkeypox had likely already spread outside of gay and bisexual men, but that this was yet to be detected.

Monkeypox has now been spotted in almost every U.S. state — except Mississippi in the south, Wyoming, Montana and North Dakota, and in Maine and Vermont.

Of the tally, eight cases have been spotted so far in women nationally, and none in children and adolescents.

Speaking on CBS’ ‘Face the Nation’, Gottlieb said: ‘I think the window for getting control of this and containing it probably has closed. If it hasn’t closed, it’s certainly starting to close.’

On the current tally, he added: ‘We’re probably detecting just a fraction of the actual cases because we had, for a long time, a very narrow case definition on who got tested and by and large, we’re looking in the community of men who have sex with men and at STD clinics.

‘So, we’re looking there, we’re finding cases there, but it’s a fact that there’s cases outside that community right now. 

‘We’re not picking them up because we are not looking there.’ 

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Read more at DailyMail.co.uk