As the spread of Monkeypox climbs across the country, the Biden Administration has been moving to stop the spread of the virus and the misinformation to prevent the confusion that afflicted COVID-19 in its early days.
To that end, the Department of Health and Human Services, along with other partners Aug. 4, hosted a media telebriefing to inform the public on the latest updates on the Biden Administration monkeypox outbreak response efforts.
In his opening remarks, Department of Health and Human Services or HHS secretary Xavier Becerra said there are about 6,600 cases of monkeypox reported in America. Last week, by comparison there were less than 5,000 cases. Also last week, HHS designated about 1.1 million vaccine doses that would be sent throughout the country. As of Aug. 4, HHS has delivered more than 600,000 Jynneos vaccine doses to state, local, tribal and territorial partners throughout the country.
On testing, HHS has the capacity to administer some 80,000 tests per week. On treatments, for those who are infected, HHS has deployed about 14,000 treatments of tecovirimat or TPOXX, a treatment shown to help those infected with monkeypox. HHS has roughly 1,700,000 treatments available in the strategic national stockpile.
Education and Outreach
During the week of Aug. 1, President Joe Biden announced Robert Fenton as the new White House national monkeypox response coordinator. To stay ahead of the virus, Becerra said this “whole of government” response will help contain the spread and outbreak of monkeypox. Becerra announced he has declared a public health emergency on monkeypox. HHS is prepared to take its current response to the next level in addressing this virus and urges everyone to take monkeypox seriously and to take responsibility to help tackle this virus.
President Biden appointed Robert Fenton, White House national monkeypox response coordinator. Dr. Demetre Daskalakis, M.D., is the White House national monkeypox response deputy coordinator. Fenton said this virus is a unique outbreak that is spreading faster than previous outbreaks and the Biden administration is taking steps to make more treatments available to more people. Key actions announced will allow the administration to further accelerate these efforts.
The public health emergency will allow HHS to explore additional strategies to get vaccines and treatments out to impacted communities. It will allow HHS to get more data on jurisdictions so it can effectively track and attack this outbreak.
Administrator Dawn O’Connell of HHS gave an update on vaccine strategy noting, in total, HHS has made more than 1.1 million doses of Jynneos available to its state jurisdiction partners under the national vaccine strategy. And HHS has secured 6.9 million doses in total. Of those, HHS has shipped more than 602,000 doses to states and jurisdictions — an increase of 266,000 since last week. Also since last week, HHS announced the allocation of 786,000 doses of Jynneos, significantly increasing the supply of monkeypox vaccine available to states and jurisdiction. HHS plans to open the next round of ordering Aug. 15. States and jurisdictions that have used 90% or more of their current allocation will be allowed to order additional doses sooner than Aug. 15. HHS will receive another 150,000 doses in the strategic national stockpile in September and it anticipates continued delivery of additional doses in October, November and December.
Dr. Demetre Daskalakis, deputy coordinator on monkeypox response, has been embedded in the monkeypox response since the earliest days of this outbreak. The infectious disease doctor has dedicated more than 20 years in HIV treatment and prevention, and has special focus on the LGBTQAI+ population.
Daskalakis noted while monkeypox is not exclusively a sexually transmitted virus, the white house response team recognized early on that this virus is spreading more rapidly and differently than observed in prior outbreaks. That’s why the CDC and the Federal Government worked quickly to develop testing and vaccine development, availability and production as well as engagement with the LGBTQAI+ community, with the goal of sharing critical information on symptoms of monkeypox and the best practices to stop the spread.
Robert Califf, M.D., commissioner of the Food and Drug Administration, said The FDA has been working with the vaccine manufacturer to accelerate the availability of additional doses as quickly as possible.
The FDA has identified a potential solution that would allow a significant increase in the number of doses available to administer. Under consideration is an approach called “dose sparing” for the current doses of Jynneos (which requires two subcutaneous injections). It would allow health care providers to use an existing one-dose vial of the vaccine to administer a total of up to five separate doses. This approach would change the method of administration for Jynneos, which is currently administered subcutaneously (under the skin). Under the proposed approach, a fifth of the current vaccine dose would be administered intradermally (within the layers of the skin). Dr. Califf said this is done by inserting the needle within the skin and creating a small pocket there into which the vaccine goes. He added this is not unusual and is done in other situations routinely. There are some advantages to intradermal administration including an improved immune response to the vaccine.
Califf noted overall safety and efficacy and the high-quality regulatory standards the public expects will not be sacrificed for this approach. All scientifically feasible options are being explored. He added if you have the opportunity to get the Jynneos vaccine, consider getting the first dose immediately. The FDA is expected to share more information on the dose sharing approach in the days ahead. He also said that the drug TPOXX may be effective on monkeypox but no proof of that yet exists. Further, collecting data will be critical and clinical trials are being planned, which are essential to lead to its full approval.
The Aug. 4 declaration is a Public Health Emergency declaration. A separate declaration under section 564 of the Federal Food Drug and Cosmetic Act, sometimes called an EUA declaration, could be made which would help the FDA speed the issuance of emergency authorizations. Dr. Califf is hopeful about the intradermal approach and he said it’s likely that within a few days the FDA will make a decision on it. At that point a EUA declaration would be needed to make it available because it’s not the standard, previous route of administration.
CDC director Dr. Rochelle Walensky, said the populations at highest risk are both those who are living with HIV and those who are high risk for HIV. With those two populations together, CDC estimates that about 1.2 to 1.7 million people are at highest risk for monkeypox right now.
With this emergency comes the challenge of reaching populations that aren’t in major cities for vaccination, treatment and education. Further, with awareness that the public might stigmatize the Public Health Emergency with the LGBTQ community, messaging is important.
Around those issues, Dr. Demetre Daskalakis, deputy coordinator on monkeypox response, posited that between making vaccines available and receiving more, making efforts to reach beyond populations in large cities — including to community based organizations that don’t only serve large cities, engaging in the LGBTQ space with LGBTQ centers and specifically focusing on providers of both social service and medical service and having trusted messengers, containment of this virus is possible.
“From an LGBTQ perspective this is a clear statement of the value of the lives and people in the LGBTQ community,” said Daskalakis. “Along with accelerating some of the work we are doing it also represents a commitment by the Biden administration to the community.”