NEW VACCINE APPROACH ON TAP FOR MONKEYPOX
County ratifies state of emergency; FDA approves dividing doses to stretch supply
monkeypox cases continue to increase, the San Diego County Board of Supervisors Tuesday unanimously ratified a local public health state of emergency declared last week by Dr. Wilma Wooten, the region’s public health officer.
The number of local cases neared the 100 mark in San Diego’s latest report Monday, with 98 cases through Sunday, double the 46 listed in San Diego one week earlier. In California, more than 1,300 monkeypox cases have been reported.
And demand for the monkeyration pox vaccine has grown along with the number of cases.
On Tuesday, Biden administration officials announced a new strategy to split vaccine doses in hopes of inoculating up to five times as many people against the virus.
The plan, unveiled days after the federal government’s declaAs of a public health emergency, would allow public health officials to stretch their limited supply of monkeypox vaccine doses by changing how those shots are administered. Rather than inject doses of Jynneos subcutaneously, a traditional way of delivering vaccines into the fatty tissue under the skin, the doses would instead be injected under the top layer of the skin. This approach, known as an intradermal injection, uses a thinner needle and less vaccine but leads to a small bubble forming on the surface of the skin that can scar.
Health and Human Services Secretary Xavier Becerra issued a declaration Tuesday that would allow for emergency use of the existing monkeypox vaccine, a move swiftly followed by the Food and Drug Administration granting emergency authorization for officials to inject the shots differently for adults. The move also allows minors to receive the monkeypox vaccine, which is only approved by the FDA for adults, through the traditional approach if they are deemed at high risk of infection.
The change in injection method would maximize the immune reaction generated by
the vaccine and allow U.S. officials to only administer one-fifth of the original dose, officials said, stressing that the approach would not compromise safety or efficacy.
“It’s safe, it’s effective, and it will significantly scale the volume of vaccine doses available for communities across the country,” Robert Fenton, coordinator of the nation’s monkeypox response, told reporters Tuesday.
FDA Commissioner Robert Califf has compared the new method, which he first described publicly last week, to tests for tuberculosis and other injections routinely performed by health care workers.
But the change in vaccine dosing would be a largescale, real-time experiment as officials race to stave off a monkeypox outbreak that has infected nearly 9,500 people in the United States. The announcement has drawn support as well as skepticism among public health experts eager to combat the virus, with some questioning its practicality and effectiveness.
If successful, the new vaccine plan would allow the Biden administration to transform about 441,000 existing doses of Jynneos — the only FDA-approved vaccine for monkeypox — into more than 2 million potential shots, officials said Tuesday. Although U.S. officials received more than 1.1 million doses of Jynneos this year, demand has rapidly outpaced supply and more doses are not expected for weeks.
The Biden administration has faced sustained criticism from patients, local public health officials and some lawmakers for not ordering more doses of the monkeypox vaccine earlier in the response. Federal officials consider at least 1.6 million gay and bisexual men at highest risk for the virus and are urging them to get the shots.
The change is not without risk. People who receive the pared-down version of the Jynneos vaccine, which is intended as a two-dose regimen, may end up needing additional shots if the new vaccine strategy leads to an insufficient level of protection against the virus. Local officials may also struggle to administer the new strategy, which could require additional training and supplies like new needles to safely deliver the shots.
“Actually being able to get the shots in the arms as fast as possible is our primary issue,” said Kody Kinsley, North Carolina’s top public health official.
He noted that many vaccine administrators familiar with injecting shots into muscles would need to be retrained and that public health officials are struggling to maintain the necessary staffing to meet demand.
The Centers for Disease Control and Prevention plans to release guidance for health care workers on how to administer the new vaccine strategy as part of an outreach campaign.
David Harvey, executive director of the National Coalition of STD Directors, said sexual health clinics are severely underfunded and not well-positioned to administer more doses under the new plan. He also questioned whether the new approach would work.
“We have grave concerns about the limited amount of research that has been done on this dose and administration method, and we fear it will give people a false sense of confidence that they are protected,” Harvey said in a written statement.
Administration officials worked through the weekend on the logistics of the new strategy, drawing on prior studies into splitting vaccine doses, which is often referred to as “dose-sparing.” The FDA in its Tuesday announcement cited a 2015 study of the two-dose vaccine that found similar immune responses after intradermal shots, although with more redness and itchiness at the injection site.
Of the 98 cases reported in San Diego County, all have been men, ranging in age from 21 to 62.
“There have been two hospitalizations and thankfully no deaths,” Wooten said.
Board of Supervisors Chair Nathan Fletcher emphasized that monkeypox, while currently spreading predominantly in the gay community, is just as capable of spreading among any group of people through intimate contact.
“It is important to remember the monkeypox virus can infect anyone, regardless of sexual orientation, age or gender,” Wooten added during her presentation.
On Thursday, the county health department will hold a virtual town hall on monkeypox, featuring a range of experts, including Wooten; Dr. Ankita Kadakia, deputy public health officer; Dr. Eric McDonald, county chief medical officer; and Dr. Winston Tilghman, director of the county’s HIV STD and Hepatitis Branch.
The event, scheduled to start at 6 p.m., will allow participants to submit questions in advance at sandiegocounty.com/monkeypoxsd or during the meeting. Participants can join the meeting confidentially at tinyurl.com/MonkeypoxTownhall or call (669) 900-6833 to participate by phone.