US Declares Monkeypox a Public Health Emergency

The Biden administration declared monkeypox a public health emergency, aiming to accelerate vaccine and treatment capabilities, as well as awareness efforts amid rising cases nationwide.

Announced Thursday during a press briefing by HHS Secretary Xavier Becerra, monkeypox cases in the United States have risen to 6600, a rise from the less than 5000 cases reported last week. A total of 1.1 million Jynneous vaccines have been designated for distribution across the country, of which 602,000 have been delivered to states and jurisdictions, noted Becerra; a further 150,000 doses will be expedited to arrive to the strategic national stockpile in September from the previously scheduled delivery date in October.

States that have used 90% or more of their current vaccine allocation will be allowed to order additional doses before the next round of ordering on August 15.

FDA Commissioner Robert Califf, MD, added that in addition to working closely with the vaccine manufacturer to increase the availability of vaccine doses, a dose sparing approach is being considered that would allow health care providers to use an existing 1-dose vial of the vaccine to administer a total of up to 5 separate doses intradermally, as opposed to the current subcutaneous delivery.

However, as the current public health emergency declaration falls under section 319 of the Public Health Service Act, a separate declaration under section 564 of the Federal Food, Drug, and Cosmetic Act would be needed to allow for intradermal administration of the Jynneous vaccine.

“There are some advantages to intradermal administration including an improved immune response to the vaccine. It's important to know that the overall safety and efficacy profile will not be sacrificed with this approach,” said Califf. “We're feeling very good about the intradermal approach and within the next few days we'll make a final decision about it.”

Regarding treatment, approximately 14,000 tecovirimat (TPOXX) doses have been deployed, with roughly 1,700,000 available in the strategic national stockpile.

Recently appointed White House National Monkeypox Response Coordinator Robert Fenton noted that along with scaling up vaccine, treatment, and testing capabilities, the public health emergency declaration will allow for improved data sharing from jurisdictions to effectively track and contain the outbreak.

A total of 51 jurisdictions have signed data use agreements with the CDC that will make vaccine administration data available, as well as detailed metrics on testing and hospitalizations.

“We've worked to put resources into the hands of people at highest risk of contracting monkeypox to allow them to protect themselves directly through social media and through trusted partners and communities across the country,” said CDC director Rochelle Walensky, MD, MPH. “The public health emergency is going to mobilize additional boots on the ground to help educate people about actions they can take to limit their exposure as vaccines become more widely available.”

The declaration follows similar actions by health officials in New York, California, and Illinois, as well as the World Health Organization, which declared the disease a public health emergency of international concern, its highest-level warning, on July 23.

A total of 1.6 to 1.7 million people are estimated to be at highest risk for monkeypox, said Walensky, which includes men who have sex with men (MSM) that are HIV positive or who are taking pre-exposure prophylaxis (PrEP) to reduce their chance of contracting HIV.

Although not exclusively a sexually transmitted virus, Demetre Daskalakis, MD, White House National Monkeypox Response Deputy Coordinator, who also serves as director of HIV prevention at CDC, said that early signs on the virus show that it spreads more rapidly and differently than seen in prior outbreaks.

Daskalakis mentioned several actions that he is undertaking with Fenton to disseminate critical information on monkeypox symptoms and preventive best practices to the general public and LGBTQIA+ community:

• Provide technical assistance to state and local health departments to develop and ramp up nonstigmatizing messaging as they prepare for large gatherings in the coming weeks and months
• Develop monkeypox-related training content for sexually transmitted infection and sexual health providers
• Provide technical assistance, outreach, and training on contact tracing to providers and groups doing this work in jurisdictions across the country
• Reaching out directly to networks of providers to encourage broader use of testing to better understand the scope and transmission of the virus
• Work with partners to deliver up-to-date information on monkeypox prevention and resources, including behaviors or actions that those in the gay, bisexual, and other MSM communities can use to limit their risk
• Listen to community partners, leaders, and affected individuals to gain insight and feedback on how to improve and scale the response in a community responsive way

“These are just some of the actions we're taking to aggressively respond to and combat this virus, and work in partnership with individuals, local leaders, public health officials, and the LGBTQIA+ community on the ground across the country,” said Daskalakis.