The New York Times also reported, “The Centers for Disease Control and Prevention reported on Thursday that the United States has now confirmed more than 4,600 cases of monkeypox, which has already been declared a global health emergency by the World Health Organization. The U.S. case count is among the highest in the world, and the figure is almost certainly an underestimate. Men who have sex with men comprise 99 percent of the confirmed cases so far.”
While the virus is not limited to gay men, fears of stigmatization are already present, and many virologists and epidemiologists are anxious to emphasize that fact, as are gay community leaders.
Monkeypox was first seen in Europe in early May, shortly before it reached epic proportions in New York City, and Washington, DC, in late June, but, also in other large cities such as San Francisco and Chicago; and London Breed, San Francisco’s mayor, was forced to declare a public health emergency.
The approved vaccine was long stuck in a bottleneck in a Danish factory, until recently, when the FDA visited it to give final approval and there were long lines in both New York, and Washington, which forced many health providers to give only one dose of the two dose regimen.
Much like the early days of covid, testing has not been emphasized, and some say the five labs the government has contracted with, still leaves the nation short.
Biden administration efforts
The Biden-Harris administration earlier issued a white paper discussing its humanitarian efforts, but it was not seen by many, and with long lines many likened it to the huge supply problems faced with the covid vaccine that initially had severe supply issues.
While few in the LGBT community have been openly critical of Biden, with one saying, “at least he isn’t advising people to drink bleach like Trump,” but if supplies continue to be limited, that might occur, and with his sunken ratings, this is the last thing he needs before the November midterms.
Previously, Politico announced that Biden was poised to declare monkeypox a health emergency, one that is made by the US Department of Health and Human Services, and much like other national disasters would release “a slew of actions, including accessing new money and appointing new personnel, according to the law that dictates how and when the federal government can declare such an emergency.”
Earlier this month, the Biden Administration announced that it has directed the Health and Human Services director to announce a national health emergency.
The New York Times reported that Xavier Becerra briefing the press said, “We’re prepared to take our response to the next level in addressing this virus, and we urge every American to take monkeypox seriously.”
While some lawmakers have urged the administration for more action, and a list of the steps it has taken to advance help and to increase supply, "AIDS activists, who have been sharply critical of the administration, have been demanding an emergency declaration for weeks. “This is all too late,” said James Krellenstein, a founder of PrEP4All, an advocacy group. “I don’t really understand why they didn’t do this weeks ago.”
For those hoping that this declaration would increase vaccine supply, this is not to be, "Declaring the emergency would not ease that shortage, but the administration may take steps to allow quicker access to tecovirimat, the drug recommended for treating the disease," they added.
What does it do? "The emergency designation would allow the F.D.A. to authorize measures that can diagnose, prevent or treat monkeypox, without having to go through the agency’s usual exhaustive review. The agency relied heavily on this provision to speed tests, vaccines and treatments for the coronavirus."
Declaring an emergency also gives the Centers for Disease Control and Prevention more access to information from health care providers and from states. Generally, federal agencies like the C.D.C. cannot compel states to share data on cases or vaccinations.
Tom Ingelsby, director of the Johns Hopkins Center for Health Security at the Bloomberg School of Public Health, told them, “We’re having a lot of challenges around the country with their rate of rise in terms of new cases,” and while “not a high threat to the general population, . . . it has the potential to spread to additional vulnerable communities.”
In agreement, Dr. Tom Frieden tweeted, “The recent outbreaks of monkeypox, and Marburg show why we better learn the lessons of Covid. Unless we make significant investments in global health and strengthen systems to quickly find and stop new disease threats, we and our children will face the consequences.”
Frieden is the former commissioner of the New York City Department of Health and Mental Hygiene (2002–2009) and is now president and CEO of Resolve to Save Lives, a $225 million, five-year initiative to prevent epidemics and cardiovascular disease, according to his Wikipedia profile.
Monkeypox has symptoms raging from a rash, or sores anywhere on the body, including the genitals, and often with flu-like symptoms, and can include swollen lymph nodes and is often spread through sex, and other intimate actions, such as kissing and physical contact; but, also with sharing infected towels, clothing, bedding, and other materials. But, to note, symptoms can appear, without a linear pattern, therefore making testing essential.
The sores can also be extremely painful, and gay men have been advised to refrain from sex, by some health personnel, and to immediately test if symptoms occur.
Vaccine shortages
Despite the arrival of more vaccines, the US is still critically short of what is needed and according to the Washington Post, “Even with the latest shipments, there are only enough vials of the two-dose Jynneos vaccine to cover about a third of the estimated 1.6 million gay and bisexual men who officials consider at highest risk and who are being urged to get the shots.”
Latest reports are that there will not be more deliveries nationwide until October, but The Post continued, “The shortfall of Jynneos, the only vaccine approved by the Food and Drug Administration to protect against monkeypox, has health officials at every level of government scrambling to come up with strategies. Those in hard-hit communities like New York City and D.C. have opted to give out only one dose for now, against regulators’ advice, while pushing federal officials for larger allotments.”
Previously San Francisco’s KTVU reported that San Francisco had 281 probable and confirmed monkeypox cases. This makes up 33% of cases statewide. Breed said data shows that San Francisco has been hit the hardest and health officials don’t want to wait another day to get people the testing, vaccines and treatment they need.”
They later expected, "to receive 4,220 monkeypox vaccine doses, enabling Zuckerberg San Francisco General Hospital to reopen a vaccination clinic on August 1 that closed July 13 and again this week when supplies ran out.”
Breed has emphasized that "This is not going to be ignored. This is a public health crisis," Breed said in her calls for more vaccines.”
Personal appeals to local Chicago lawmakers resulted in responses that held the Feds accountable for the supply problem, and that they could not give what they didn't have, with some being almost defensive.
We witnessed long lines of men, in nearly 90 degree heat, in Chicago waiting outside the offices of Test Positive Aware Network, (TPAN) for two hours, only to be told that the vaccine had run out and to come back the following week, and that those with a number, an unknown fact to many, would then get vaccinated; which in turn caused one bystander to remark, “This is just like Covid.”
There were also unconfirmed rumors that some social venue vaccination efforts in Chicago, anxious about supplies, vaccinated some people ahead of others.
Scott Gottlieb, a former commissioner of the Food and Drug Administration, and now a senior fellow at the American Enterprise Institute, opined in The New York Times that “Our country’s response to monkeypox has been plagued by the same shortcomings we had with Covid-19. Now if monkeypox gains a permanent foothold in the United States and becomes an endemic virus that joins our circulating repertoire of pathogens, it will be one of the worst public health failures in modern times not only because of the pain and peril of the disease but also because it was so avoidable . . . We don’t have a federal infrastructure capable of dealing with these emergencies.”
According to the Illinois State Rep. Kelly Cassidy’s earlier email newsletter, “CDPH (Chicago Department of Public Health) has distributed over 5,000 doses of the vaccine and reports they are expecting a delivery of an additional 15,000.”
Many say that even this is not enough, and criticize the early decision to vaccinate only those with confirmed or, “likely contacts of monkeypox patients.”
In a recent interview on WAMU’s ‘1A”, epidemiologist Dr. Celine Gounder noted that more studies need to be done on the efficacy of one dose, while many are waiting for the arrival of more vaccines, and with concerns of those who are not having multiple partners, waiting for the vaccine, she analogized to a neighborhood that is on fire and that water must be given only to the houses that are actually burning.
The Biden paper noted that “as additional doses are received from the manufacturer, HHS will make them available to jurisdictions to expand availability to the vaccine for individuals with elevated risk.”
State level efforts
Illinois governor JB Pritzker had urged the Centers for Disease Control and Prevention, “to use the tools available at the federal level to immediately increase the availability of vaccines in at-risk communities, “ Cassidy wrote
Shortly afterward, in a late development, he declared Illinois a public health emergency, and said, ““MPV is a rare, but potentially serious disease that requires the full mobilization of all available public health resources to prevent the spread.”
This will ensure smooth coordination between state agencies and all levels of government, thereby increasing our ability to prevent and treat the disease quickly. We have seen this virus disproportionately impact the LGBTQ+ community in its initial spread. Here in Illinois we will ensure our LGBTQ+ community has the resources they need to stay safe while ensuring members are not stigmatized as they access critical health care.”
Illinois currently has the fourth highest cases in the nation, 888, with Chicago at 460. Overall the US has, at current estimate 14,115.
In its local coverage, NBCChicago.com reported, “officials can [now] more easily secure vaccine shipments and ramp up distribution to ensure the most impacted communities receive treatment as soon as possible."
Funding needed
Of course, going further also requires money, and in a private estimate, some federal officials said, on deep background, that $7 billion is needed to even meet “the scope and urgency of the current situation”, their reporters revealed.
Breaking it down, in an internal memo that Post reporters obtained, there would be $6.9 billion needed to have the vaccine made in the US, and “could also secure $19 million new doses of vaccine for monkeypox, replenish 4 million doses for smallpox preparedness efforts and more.”
Returning to vaccine supply shortages: “Some experts also are advocating that people be encouraged to take a less desirable vaccine, ACAM2000, which was approved for the related virus of smallpox but not for monkeypox.”
“There are not enough shots” to pursue a strategy of relying solely on Jynneos, said a federal official working on the monkeypox response, who spoke on the condition of anonymity because they were not authorized to comment, warning of a possible “vaccine cliff” in coming weeks,” added the Post..
Dosage variance and advice to address shortages
“Some experts have called on U.S. officials to instead encourage Americans to get vaccinated with ACAM2000, which was approved for smallpox, a related virus, and that the United States had previously stockpiled in case of a potential outbreak. That vaccine relies on injecting people with a live, if weakened, virus, which carries additional risks. It also is administered in a series of rapid punctures that can draw blood and lead to scarring. The vaccine is available as needed, although public health officials have been wary of relying on it.”
ACAM2000 is not recommended for those with compromised immune systems, and with many people still living with HIV in the gay male population, the risks are enormous.
“No one’s crazy about it. You shouldn’t be crazy about it. But you should give people the choice,” said Ezekiel Emanuel, a bioethicist who has advised the Biden administration on coronavirus and attended a White House briefing this week on monkeypox,” according to the Post.
Earlier reports at the end of July from the City of Chicago said that there was an increase in vaccines and that, “Those 33,000 doses will come from the nearly 800,000 doses that were cleared by the Biden administration . . . to arrive over the next several weeks.”
Even more alarming is this: “Even with the latest shipments, there are only enough vials of the two-dose Jynneos vaccine to cover about a third of the estimated 1.6 million gay and bisexual men who officials consider at highest risk and who are being urged to get the shots.”
One shot or two? Or half?
Previously, “U.S. officials said that they have now secured 1.1 million Jynneos vaccine doses, including 786,000 doses finally cleared by regulators after being delayed in Denmark for more than a month, and which will “be in the hands of people who need them over the course of the next several weeks,” Becerra said in a later press conference. Federal regulators reiterated Friday that the vaccine should be given to most people as a two-dose regimen, meaning that U.S. officials have enough shots to cover about 550,000 people.”
As we have seen, that is being ignored in some areas, and while the studies are yet to be done, using one shot, there is some evidence to suggest that they can be effective as 2 doses, but this has also provoked a fierce debate among researchers and physicians, and as Goudner said, in the absence of studies, there is a feeling that many providers are taking what they can get.
In a recent development, in order to ensure adequate vaccine supplies, there has been a move to fractional shots, "which allows providers to use only one-fifth of the current dosage. The vaccines may now be administered intradermally or between layers of skin, rather than in the fat layer under the skin," noted the Times in a recent update.
“The 500,000 additional doses that the U.S. ordered in June is anticipated to be delivered this year,” a Bavarian Nordic spokesperson wrote in an email, declining to respond to specific questions about timing or the company’s commitments to other countries.”
Giving some hope was “Sarah Lovenheim an HHS spokeswoman [who] said officials had expedited the doses announced this week and were working to accelerate future shipments, too.
“We’ll seize every opportunity to speed up the path to secure more doses ahead of schedule, as possible,” Lovenheim said.
Another problem is that there has been a change in delivery systems that health care officials across the nation have said is burdened by "missteps and confusion", reported the Times; and, the distribution system VTrcks, noted for its efficiency and linkage to state systems has not been used for this vaccine, and instead is using email, instead of a distribution system and orders have been severely delayed, and in one instance a shipment to Ft. Lauderdale, Fla, was reported as being sent to Oklahoma, then Mississippi, and then Florida.
While HHS has switched to a different system it is still not linked to state immunization databases.
“Peter Hotez, dean for the National School of Tropical Medicine at the Baylor College of Medicine, said he was open to the idea of “dose sharing” as a temporary fix, suggesting that people could get one dose of Jynneos and one dose of ACAM2000.”
“We don’t have much of a window to fix this,” Hotez said. “Once it gets into the rodent population, it becomes a fixture here, like it’s been in Central and West Africa.”
Updated August, 20, 2022 at 4:25 p.m. CDT
Please note that this is an evolving story, and will be updated as needed.
It’s sad that we can compare a democratic president to Reagan’s myopic attitude to the early aids crisis
ReplyDeleteThere is no bright line comparison, yet, with Reagan, but people are watching, and many state and local leaders are worried. Thanks for writing.
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