Via Teleconference
(August 9, 2022)
MR. FENTON: Hi, I'm Bob Fenton, the White House National Response Coordinator for monkeypox. And welcome to the White House National Monkeypox Response Briefing.
Today, the Biden-Harris administration is making key announcements in our fight to combat the monkeypox outbreak and protect communities most at risk.
This has been a top priority of President Biden and the entire administration. And today's announcements reinforce our whole-of-government approach to scaling and accelerating our response.
You'll hear today from HHS Secretary Becerra, FDA Commissioner Califf, CDC Director Walensky, and myself. We also have next to me Dr. Demetre Daskalakis, Deputy Coordinator of the White House Monkeypox Response; and Dr. Peter Marks from FDA; and Dawn O'Connell, HHS Assistant Secretary for Preparedness and Response here to answer some questions.
With that, I'll turn it over to Secretary Becerra.
SECRETARY BECERRA: Well, thanks very much. Let me begin with what I've said before: Every American should take monkeypox seriously, and every American must do their part to help us beat back monkeypox.
On May 18, the first case of monkeypox was reported in the U.S. Today, we have some 8,900 cases that have been reported.
At the time that that first case was reported, within two days, we at HHS began to ship out vaccines to the various states that were asking for help. Today we've made more than 1.1 million vaccine doses available throughout the country, and we've delivered more than 620,000 of those doses. We've also deployed more than 15,000 courses of the TPOXX treatment and have increased the country's capacity to administer tests on a weekly basis to some 80,000.
Last week, I declared a public health emergency to address the monkeypox outbreak. Today, we take another important step. I've exercised my authority under Section 564 of the Food, Drug, and Cosmetic Act to allow the FDA to take further measures to safely increase the availability of vaccines to prevent monkeypox.
Dr. Califf, the FDA Commissioner, will go into greater detail on FDA's issuance of an emergency use authorization for the Jynneos vaccine and what today's FDA action means for patients, providers, and states and jurisdictions.
This is very welcome news in our fight against monkeypox.
Today's action will boost and strengthen our response further. It safely accelerates and multiplies our supply of effective vaccines by up to fivefold.
Today's action also reaffirms HHS and this administration's commitment to using all available resources and capabilities to end the monkeypox outbreak and provide the best possible care to those suffering from the virus.
So, with that, let me now turn it over to Commissioner Califf.
DR. CALIFF: Thank you, Mr. Secretary. Since the early days — earliest days of the outbreak, the FDA has been fully committed to combating the outbreak on multiple fronts, working closely with our federal public health partners to ensure the availability of medical countermeasures.
Today is the latest example of all components of the federal government coming together to address an everchanging and evolving outbreak.
As I noted last week, given the continued spread of the monkeypox virus at a rate outpacing the availability of our current vaccine supply, the agency began exploring viable scientific options that would allow for greater access to the currently available vaccine.
After conversations over the past several days with key federal partners, the infectious disease community, and Bavarian Nordic, today the FDA has issued an emergency use authorization — or EUA — allowing healthcare providers to use an alternative dosing regimen of the Jynneos vaccine. This will increase the total number of doses available for use by up to fivefold.
The EUA also allows for use of the vaccine in individuals younger than 18 years of age determined to be at high risk of monkeypox infection. In these individuals, Jynneos is administered by subcutaneous injection.
As many of you saw, last week, the FDA and CDC were able to quickly adapt and address the needs of dozens of young children following a monkeypox exposure at a childcare facility in Illinois.
As part of the alternative approach under the EUA, one fifth of the current vaccine does would be administered intradermally, rather than subcutaneously, as the vaccine was originally approved.
Data from a clinical study of the vaccine published prior to its approval in 2019 evaluated a two-dose series given intradermally compared to subcutaneously.
Individuals who received the vaccine intradermally received a lower volume — one fifth — than individuals who received the vaccine subcutaneously.
The results of this study demonstrate that intradermal administration produced a similar immune response to subcutaneous administration, meaning individuals in both groups responded to vaccination in a similar way.
While the study, which is published in a peer-reviewed journal, found that intradermal administration resulted in some mild to moderate side effects like redness, firmness, itchiness, and swelling at the injection site, these were all manageable.
Additionally, Jynneos has been tested in individuals who have immunocompromising conditions and has been found to be safe and effective in the trials that were performed to support approval.
In granting a temporary unapproved use of an approved product, the FDA is still ensuring the vaccine meets high standards for safety, effectiveness, and manufacturing quality that the American public has come to expect.
We'll continue to work with the federal public health partners to provide the latest information to impacted communities to make informed decisions to protect themselves.
If you have the opportunity to get the Jynneos vaccine, I urge you to consider getting your first dose immediately.
With that, I will turn it over to Bob.
MR. FENTON: Thank you, Dr. Califf. What Dr. Califf just laid out is a gamechanger when it comes to our response and our ability to get ahead of the virus.
It's safe, it's effective, and it will significantly scale the volume of vaccine doses available for communities across the country.
As Secretary Becerra mentioned, we've distributed over 670,000 vials of vaccine already to jurisdictions across the country.
And we have 400,000 vials in the Strategic National Stockpile that have been allocated to jurisdictions, ready to be ordered when jurisdictions use 90 percent of their current supply.
With today's announcement, those 400,000 vials have the potential to provide up to 2 million doses to Americans.
We encourage jurisdictions to utilize the alternative dosing method as quickly as possible, and we'll be your partner in this step every step of the way.
While intradermal administration of vaccine has been used for tests like the tuberculosis skin test, we know that some healthcare professionals and providers may not be as familiar with intradermal administration.
That's why the CDC is launching a robust outreach, training, and education plan starting today to support a transition to intradermal administration of vaccine.
You'll hear Dr. Walensky speak in more detail about this shortly.
Our goal is to get jurisdictions, healthcare providers, and the public informed about this alternative approach immediately and get it put into practice so we can get more doses out to more individuals faster.
We also will be reviewing the current allocation and distribution timeline for vaccines moving forward in light of today's announcements to make sure that jurisdictions have sufficient vaccine supply to meet demand and also make sure that jurisdictions aren't receiving more vaccine than they can store or use in a given time period.
Across the administration, we will continue our work to accelerate vaccine production and distribution.
Just last week, we announced that 150,000 vials of vaccine — now totaling 750,000 doses — will arrive in the United States in September, two months ahead of schedule. And we will still proceed with the procurement of 5.5 million vials of vaccine, totaling potentially over 25 million doses that we will have in the United States supply on top of what we currently have.
So, as I said in today's announcement, this marks a significant acceleration in our efforts to make more vaccines widely available to at-risk communities. And we look forward to working with jurisdictions, providers, and individuals on the ground to help quickly adopt the intradermal dosing approach.
Now I'll turn it over to Dr. Walensky to provide more detail on the CDC's outreach and training plan for intradermal administration of vaccine.
DR. WALENSKY: Thank you, and good afternoon. We are excited to support FDA and the administration in this strategy to make more monkeypox vaccine doses available to those who need them now.
I'd like to briefly share how CDC will be providing resources and education to healthcare providers, public health workers, and the community on this new vaccine strategy.
As Dr. Califf described, this strategy would change the method of administration for the Jynneos vaccine from subcutaneous to intradermal to allow vaccine providers to use an existing one-dose vial of the vaccine to administer a total of up to five separate doses. Intradermal injections are often used for TB skin tests and have been used for other types of vaccines before.
Some healthcare providers may not be as familiar with intradermal administration, where you deliver the vaccine into the layer of skin just underneath the top layer, compared to the more traditional subcutaneous administration, which goes into the fat layer underneath the skin.
For this reason, CDC will be providing information and educational materials to vaccine providers to help ensure this new strategy can be implemented quickly and as seamlessly as possible.
CDC's interim clinical considerations provide guidance for the use of the Jynneos vaccine as an intradermal regimen for adults, as well as the standard, or subcutaneous, regimen for children.
CDC's interim clinical considerations will also include an overview of both available vaccines; planning considerations for health departments, including health equity; vaccine administration, schedule and dosing regimens, dosing intervals, contraindications and precautions; as well as pre- and post-vaccination counseling.
CDC will also be conducting a series of webinars and training opportunities to educate clinicians on how to appropriately administer the Jynneos vaccine.
Our outreach and education will build upon the in-depth, close communication with clinicians and public health partners CDC has had throughout this outbreak.
Since the start of the monkeypox outbreak, CDC has hosted three "COCA" calls — or Clinician Outreach and Community Activity calls — with 6,000 to 10,000 participants on each call and which were then shared with over 64,000 COCA subscribers and 100 COCA partners comprised of national medical and public health organizations.
