Health

Smallpox monkey vaccination scheme demonstrates new dosing regimens for cities and countries


WASHINGTON – The White House, under pressure to contain a growing outbreak of smallpox in monkeys, announced on Thursday that it has sent 1.8 million doses of the vaccine to jurisdictions that have agreed to use an injection protocol. new strain, as public health officials prepare for Gay Pride events and the return of college campuses, which they fear could accelerate the spread of the virus.

The Biden administration did not receive an additional dose of monkeypox vaccine. Instead, they are trying to stretch the existing stockpile by promoting a different management approach that uses 1/5 per shot. Federal health officials say that only works when injected into the skin rather than injecting the entire dose into the underlying fat.

The White House plan is an effort to encourage cities and states to switch to what’s known as the intradermal approach. Those who have already done so, and using 90% of their current vaccine supply, will be able to order additional doses starting Monday, officials said.

Robert J. Fenton Jr., the White House monkeypox response coordinator, told reporters on Thursday: “Adding more shots to the arm is how we control the outbreak.

But not all jurisdictions have switched to intradermal medication — New York City, the epicenter of the outbreak in the United States, has yet to initiate such a shift. And the protocol has raised concerns from some scientists, activists and the vaccine maker, Bavarian Nordic.

In a letter last week to President Biden’s health secretary, Xavier Becerra, the company expressed “some reservations” about the system, citing “very limited safety data” and concerns that the patient may not receive the second dose needed. On Thursday, the company said it had reached an agreement with a US-based contract manufacturer to supply bottled doses of the vaccine, called Jynneos, to ease shortages. current shortage.

The administration’s vaccine distribution plan has drawn criticism from activists, who say the better response would be to work with cities and states on a more flexible plan for vaccination. mixed dose. In that proposed regimen, some shots would be injected into the skin – most likely by large medical centers equipped to do so – and some would be given in a more traditional way, by suppliers are not trained or equipped to switch.

“What they’re doing now is, first of all, unscientific,” said Joseph Osmundson, a virologist at New York University. “Assume that 100% of the dose will be injected intradermally is incorrect.”

James Krellenstein, founder of PrEP4All, an advocacy group for the care of HIV patients, called Thursday’s announcement of the vaccine dose distribution “a complete procedure”. Activists also say the new protocol could exacerbate existing racial disparities and signal to people of color that they can get lower doses, despite approval from regulatory authorities. medical authority.

Jennifer Barnes-Balenciaga, a black transgender woman, said: “Once it starts to be fair, it’s not like, ‘We’re going to give you the dose that everyone’s been getting before,’ ‘ but, ‘We’ll give you a shorter dose. who is helping lead RESPND-MI, an epidemiological study of smallpox in monkeys.

Officials also said they will distribute 50,000 doses of Tpoxx, an antiviral drug used to treat smallpox in monkeys, to cities and states so providers have available treatments. treat. Doctors and patients have complained that Tpoxx is difficult to reach — and many patients don’t receive it until more than a week after the onset of symptoms.

Last week, after an article in The New York Times detailed the difficulties doctors and patients face when buying drugs, Representative Carolyn B. Maloney, chair of the Committee on Oversight and Reform , urged Mr. Becerra to make the drug more accessible. .

Thursday’s announcement comes as the country has recorded more than 13,000 cases of monkeypox, an infectious disease that can be extremely painful, though rarely fatal, and spreads mainly in men who have sex with men.

There are concerns that upcoming events could continue to flare up.

Universities and colleges are bracing for monkeypox when students return, amid concerns that the virus could spread in dormitories or at parties. Two major Pride events – Black Pride in Atlanta and Southern Decadence in New Orleans – are scheduled for Labor Day weekend.

On Wednesday, organizers of Southern Decadence in New Orleans, one of the country’s biggest Pride celebrations, announced they would be canceling Bourbon Street Extravaganza, a free concert, out of concern. about smallpox in monkeys.

Dr Rochelle Walensky, director of the Centers for Disease Control and Prevention, said the administration will provide guidance via text message to colleges and universities and will work with local officials to Perform vaccinations at major events. She made it clear that the government is not trying to prevent the attendance of gay life celebrations.

“These events are important opportunities for people to connect with their communities and enjoy themselves,” says Dr. Walensky. “And they are also an opportunity to deliver public health messages and resources to hard-to-reach populations.”

The New York Times reported earlier this month that the Jynneos vaccine shortage was partly due to an early failure by the Department of Health and Human Services to require bulk bottling of the vaccine for distribution. Bavarian Nordic said the deal it announced Thursday, with Grand River Aseptic Manufacturing, will “accelerate the shipment of vials to the US while freeing up capacity for other countries”.

Gay rights activists have been extremely critical of the government’s response, especially when it comes to vaccinations, as well as local and state health officials, who say the practice. Vaccine deployment has been confusing and ineffective.

In New York City, Dr. Ashwin Vasan, the health commissioner, said in an interview Thursday that more time is needed to train people on the method and talk to community partners about it. convert. He also cited equity concerns, saying that providers at public health organizations may have little training in the method and some may be less willing to take a dose of 1 /5.

“I think everyone is under pressure,” Dr. Vasan said. “I think every jurisdiction feels like this is a quick transition. It is done quickly. And I hope that our partners will understand that especially in the largest, most complex city in the country, with one of the most complex delivery systems in the country, we will take our time. yourself and do it right. “

There is little data on whether Jynneos is safe and effective. The vaccine has been approved in current doses based on small studies showing that it seems to produce an immune response comparable to an older smallpox vaccine. Even little evidence supports the use of one-fifth of the intradermal dose of Jynneos to prevent smallpox in monkeys.

There’s only been one study done directly on the use of Jynneos in the skin, and while it didn’t document a reduction in effectiveness, it noted more local side effects such as swelling and redness. Dr Peter Hotez, a vaccine expert at Baylor School of Medicine in Houston, said he wants the government to do an additional pilot study of intradermal dosing before switching the midstream vaccination strategy.

“Gather more data on a few thousand individuals, not only on immunological parameters, but also on safety, to confirm He said. But overall, he feels that intradermal medication is an “innovative approach” to solving the supply problem.

According to Dr. Bruce Weniger, an expert in intradermal injection techniques and a former CDC scientist, this approach has been used to extend the supply of vaccines for other diseases. During a public health emergency, he said, officials must make recommendations based on what seems reasonable from prior, possibly limited evidence and experience.

He added: “Avoiding recommendations because there is no perfectly aggregated data is one way of avoiding it. “On the other hand, clinical trials that are done easily and quickly can show” how well a 1/5th dose would fit into the full dose.

Federal scientists were poised to begin just such a trial in the fall, but a vaccine dose shortage prompted the administration to proceed without that outcome.



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