FDA approves intradermal injection for monkeypox vaccine
People who are at high risk for monkeypox can now get vaccinated for the virus via intradermal injection after the U.S. Food and Drug Administration authorized the technique.
The FDA issued an emergency use authorization Tuesday for intradermal administration of the two-dose Jynneos vaccine for smallpox and monkeypox.
The technique differs from the standard vaccination method, which involves an injection into muscle tissue, by administering the vaccine just under the surface of the skin, typically on the forearm.
ADDITIONAL INFORMATION ON MONKEYPOX: California Department of Public Health | SF Department of Public Health | Santa Clara County Department of Public Health
State and federal public health officials suggested intradermal vaccinations will provide similar immunity to monkeypox and will expand the amount of available vaccine doses by a factor of five, because intradermal injections require only one-fifth of the dosage needed for administration in a person's shoulder or other muscle tissue.
FDA Commissioner Dr. Robert Califf said in a statement that the nationwide spread of monkeypox has magnified the country's inability to keep up with demand for the vaccine.
"The FDA quickly explored other scientifically appropriate options to facilitate access to the vaccine for all impacted individuals," Califf said. "By increasing the number of available doses, more individuals who want to be vaccinated against monkeypox will now have the opportunity to do so."
State health officials praised the decision but said they still expect demand for the vaccine to outpace supply for the foreseeable future.
The dearth of vaccine doses has led health officials to recommend administration of the first of the vaccine's two doses to as many eligible people as possible to ensure those who are high risk have at least some protection.
Those who have already been vaccinated will eventually receive their second dose, but it may be longer than the vaccine's standard four-week waiting period between doses.
"To date, over 109,000 doses of Jynneos vaccine have been received in California," California Department of Public Health Director and state Public Health Officer Dr. Tomas Aragon said in a statement Thursday.
"We anticipate another allocation from the federal government next week, and we will continue our work with local health jurisdictions to expand vaccine availability," he said.
As of Thursday, roughly 2,000 cases of monkeypox have been reported statewide, 516 of which have been reported in San Francisco and 112 in Alameda County.
In the greater Bay Area, monkeypox cases have also been reported in Napa, Contra Costa, San Mateo, Monterey, Santa Cruz, Santa Clara, Solano, Sonoma and Marin counties.
Local officials in the Bay Area have chafed at the vaccine rollout, arguing that the federal government should have done more to maintain the national stockpile of the Jynneos vaccine.
San Francisco Supervisor Rafael Mandelman, one of two LGBTQ members of the board, made a comparison last month during a hearing on monkeypox between the federal government's ongoing response and the early days of the HIV/AIDS epidemic of the 1980s.
Confirmed and suspected monkeypox cases have overwhelmingly been reported in gay and bisexual men both in San Francisco and statewide, but health officials have stressed the virus is not specific to any sexual orientation and is mostly being spread by skin-to-skin contact rather than more intimate activities like kissing or sexual activity.
"We have nearly 6 million, maybe more, men who have sex with men and trans folks living in the United States," Mandelman said. "This is all assuming that this monkeypox outbreak stays within the queer community. There's no reason to believe that at some point it doesn't spread out."
Sen. Scott Wiener, D-San Francisco, noted Tuesday during the first meeting of the state Legislature's Senate Select Committee on Monkeypox that nearly 20 million doses of the vaccine in the Strategic National Stockpile expired over the last decade and were not replaced.
"You would think that would be a recipe for very quickly controlling an outbreak," Wiener said. "Unfortunately, due to some very severe public health failures over a number of years and three different presidential administrations, that has not happened and we have shot ourselves in the foot."
Gov. Gavin Newsom declared a state of emergency for monkeypox last week, helping state and local government agencies collaborate to conduct outreach regarding monkeypox vaccines and treatment, seek more vaccine doses and rapidly open vaccination and testing facilities.
Aragon and state Health and Human Services Secretary Dr. Mark Ghaly said in a letter last month that the state needs a conservative estimate of 600,000 to 800,000 vaccine doses just to support those who are at high risk of contracting the virus.
San Francisco has received roughly 23,000 vaccine doses and had administered roughly 12,000 as of Tuesday, according to the city's Director of Health Dr. Grant Colfax.
However, Colfax said the city needs 150,000 doses to vaccinate all of the city's high-risk residents.
State health officials have urged residents to take steps to reduce their risk of contracting monkeypox, including avoiding physical contact or sharing clothing or bedding with those who have a rash or lesions consistent with monkeypox.
Monkeypox can initially develop like the flu, with symptoms including a fever, headache, muscle aches, exhaustion and enlarged lymph nodes. Painful lesions or a rash can also appear.
Monkeypox generally lasts up to two to four weeks, can resolve on its own without treatment and is rarely fatal. To date, just 48 reported monkeypox patients have been hospitalized, according to the CDPH.
"While we move forward with this latest authorization, we continue to urge Californians to be aware of the risks associated with MPX, including best practices to prevent transmission," Aragon said.
Information from the CDPH on who is eligible to get tested for monkeypox and who is eligible to get vaccinated can be found at https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/Monkeypox.aspx.