Cárdenas, L.A. Congressional Delegation: More Monkeypox Virus Vaccines Needed
As County Caseload Explodes, Vaccine Supply Through FDA’s Alternative Dosing Regimen Still Falls Short of Projected Demand
LOS ANGELES – Today, Congressman Tony Cárdenas (CA-29) and 10 members of the Los Angeles County area Congressional Delegation sent a letter to U.S. Health and Human Services Secretary Xavier Becerra highlighting the urgent need to increase the supply of the monkeypox virus vaccine. This comes as the L.A. County Department of Public Health reported more than 100 new cases over the weekend and that its vaccine supply is expected to run out in the next two weeks, forcing them to pause pre-registration for appointments.
“We are encouraged by the Biden administration’s recent actions declaring monkeypox a public health emergency and issuing an emergency use authorization to help expand JYNNEOS vaccine supply. While these are critical steps in the public health response to MPV, we strongly urge the Department of Health and Human Services, in coordination with the White House, to take further steps to procure and distribute additional JYNNEOS vaccine doses to ensure areas that have been hardest hit, including Los Angeles, have adequate vaccine supply,” the members wrote in the letter.
Congressman Adam Schiff (CA-28) first wrote to Secretary Becerra on July 20 urging the federal government to bolster its monkeypox virus (MPV) response, including by increasing the manufacturing and distribution of vaccines, supporting more health care provider and community outreach, and developing a long-term strategy to ensure access to testing, vaccination, treatment, and provider education for years to come.
On August 9, after public health experts and elected officials like Congressman Schiff raised the alarm about the United States’ limited supply of MPV vaccine doses, the FDA announced it had granted Emergency Use Authorization for the JYNNEOS vaccine to be administered intradermally, increasing the number of doses available through the existing supply. However, clinical data available about the alternative dosing regimen is limited to a single 2015 study, and will require urgent and comprehensive outreach to health care providers on how to use the more specialized administration method.
Furthermore, while the existing vaccine supply and alternative dosing regimen could fully vaccinate 1 million people, the CDC estimates about 1.7 million people are currently at the highest risk for MPV infection – and as cases continue to climb and the virus spreads beyond the communities already impacted, the highest-risk population will inevitably grow. In Los Angeles County, more than 100 new cases were reported just last weekend, and the Department of Public Health has nearly exhausted its current vaccine dosages. Therefore, the members are encouraging the federal government to look beyond the emergency use authorization and take additional steps to increase its overall vaccine supply.
“As of August 12, 2022, Los Angeles County – the most populous county in the United States with over 10 million residents – has received only 43,290 doses of the JYNNEOS vaccine. Supply is not meeting demand, and as the virus continues to spread demand will inevitably increase. While we are encouraged by the potential to expand the number of available doses through implementation of intradermal administration, this approach alone will not suffice,” the members added.
The August 17 letter is cosigned by Representatives Adam Schiff (D-Burbank), Maxine Waters (D-Los Angeles), Lucille Roybal-Allard (D-Downey), Grace Napolitano (D-Norwalk), Linda Sánchez (D-Whittier), Judy Chu (D-Monterey Park), Karen Bass (D-Los Angeles), Mark Takano (D-Riverside), Nanette Barragán (D-San Pedro), and Jimmy Gomez (D-Los Angeles).
Click here to read the letter or read the full text below:
Dear Secretary Becerra,
We write to express our ongoing concerns regarding limited access to JYNNEOS vaccine doses as the monkeypox virus (MPV) continues to spread throughout our districts in and around Los Angeles County, California. We are encouraged by the Biden Administration’s recent actions declaring monkeypox a public health emergency and issuing an emergency use authorization (EUA) to help expand JYNNEOS vaccine supply. While these are critical steps in the public health response to MPV, we strongly encourage the Department of Health and Human Services (HHS), in coordination with the White House, to take further steps to procure and distribute additional JYNNEOS vaccine doses to ensure areas that have been hardest hit, including Los Angeles, have adequate vaccine supply.
The Food and Drug Administration (FDA) took a critical step in working to expand vaccine supply by authorizing intradermal administration of the JYNNEOS vaccine for emergency use. This alternative dosing regimen has the potential to increase our nation’s JYNNEOS vaccine supply by five-fold. However, it is imperative that the federal government acknowledge the reality that a successful transition to intradermal administration depends heavily on several unknown factors.
First, the efficacy of the JYNNEOS vaccine through intradermal administration for the prevention of MPV is based on a single 2015 study. While the available clinical data is encouraging, it is limited in scope. Further, expanding supply of the JYNNEOS vaccine through intradermal administration relies on the success of rapid, comprehensive provider education and training on how to administer the vaccine through a more specialized method. The federal government will also need access to real-time epidemiological data to properly inform ongoing vaccine allocations among cities and states. These hurdles are in addition to existing barriers that have inhibited vaccine access since the start of the outbreak, including stigmatization and financial burden.
The CDC estimates that there are currently 1.6 million to 1.7 million people who are at highest risk for MPV infection. Under the new alternative dosing regimen, the remaining 400,000 vials of JYNNEOS vaccine that have not yet been distributed could provide, at maximum, approximately 2 million doses. This projection is enough to fully vaccinate only 1 million Americans – but, even then, does not take into consideration logistical hurdles and human error that will ultimately impact vaccine supply. The federal government must also be prepared for the likelihood that MPV will begin spreading at higher rates among communities outside of those already impacted. As the virus begins to circulate in other parts of our communities, the number of people considered high risk will inevitably grow.
As of August 12, 2022, Los Angeles County – the most populous county in the United States with over 10 million residents – has received only 43,290 doses of the JYNNEOS vaccine. Supply is not meeting demand, and as the virus continues to spread demand will inevitably increase. While we are encouraged by the potential to expand the number of available doses through implementation of intradermal administration, this approach alone will not suffice. We strongly encourage the Biden administration take additional steps to increase vaccine supply and ensure future vaccine allocations are distributed as soon as possible with an emphasis on hardest-hit areas.
Thank you for your attention to this matter. We look forward to working with you on this critical issue.
Sincerely,
Members of Congress
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