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[01;01] CHRIS DUGGAR, CDC: Ordering began this Monday July 25th. And our first deliveries began yesterday. We have more in the air and on the ground today and more expected to be delivered tomorrow. So for those of you asking, why don’t I see it yet? Keep looking.
And it is active in Vaccine Finder on vaccines dot gov as of today.
But remember, we don’t have a lot of deliveries out there yet. So that, as that inventory grows, you’ll be able to find it if you search actively.
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[0;20] CHRIS DUGGAR, CDC: So our limited Novavax supply, that U.S. government just procured this summer, has been allocated across all of our distribution channels. That’s all 50 states, our islands, territories, our federal retail pharmacy program, and some other federal entities like DOD, Veterans Affairs, and others. It is a one-time pro-rata threshold based on eligible, unvaccinated adults. So not our traditional supply constraint pro rata based on the entire population, but remaining unvaccinated folks. That does mean in areas where they had high coverage, they saw a lower threshold, and our areas with still a fair amount of adults to be vaccinated, are gonna get a bigger piece of the pie.
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[01;32] CHRIS DUGGAR, CDC: Again, just reiterating the Novavax vaccine is shipped and stored at our standard vaccine refrigeration temperatures. Not frozen, please do not freeze this vaccine. I did see the questions.
Once received, it goes into your refrigerator and the maximum shelf life for Novavax is nine months. That’s what they got through EUA. Everything that we’re shipping to you has a February 2023 expiration.
So the lot that we have for distribution expires in February next calendar year.
11:25:26 AM JENNIFER MCQUISTON, CDC: As of July 27th, over 20,000 cases have been detected globally in 77 countries. And here in the United States, there have been over 4,600 cases of monkeypox identified across 48 jurisdictions, including states, Washington DC, and Puerto Rico. This includes an increase in cases recorded over the last two days that reflects historic cases that are now being reported to CDC through electronic data streams
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11:25:58 AM JENNIFER MCQUISTON, CDC: Yesterday, CDC released an epidemic curve for monkeypox that provides a picture of case trends in this country over time. That’s now available on the web and we’re going to update this data on a weekly basis as we go forward. CDC is also releasing a technical report very soon that summarizes early results from CDC’s response to the current monkeypox outbreak and provides data that people can use for research.
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11:26:21 AM JENNIFER MCQUISTON, CDC: We also have additional data on demographics and clinical presentations of reported cases in the U.S. as of yesterday. For those who have available age data that are reported, the median age is 35 years old, with a minimum of 17 and a maximum of 76. I’d like to note that this does not yet include the two cases in children that we reported last week. For those with information available about sex assigned at birth, 99% were assigned male sex at birth and the vast majority reported male to male sexual context. And overall, among those with race and ethnicity data reported, 37% of cases have been among non-hispanic white people, 31% among Hispanic or Latino people, 27% among non-Hispanic Black or African-American people, and 4% among Asian people. The four most common symptoms reported in case report forms include rash, which was reported in 99%, followed by malaise or feeling tired, fever and swollen lymph nodes. Other symptoms reported included, chills, headache, and muscle pain. As we continue to work closely with jurisdictions to improve data reporting, and with health care providers to better understand how patients are being tested and make sure they know how to test them, we expect the number of reported cases are going to go up over the next several days and weeks.
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11:28:38 AM JENNIFER MCQUISTON, CDC: We’re also working closely with HHS and ASPR on the federal vaccine allocation strategy, and as more vaccines become available and we learn more about this outbreak, we continue to update that vaccination strategy. With the additional doses being announced today, we have again updated the plan for allocating doses, to take into account two key factors: the total population of people at risk in a jurisdiction and the number of new cases in each jurisdiction since the last allocation. This update gives greater weight to prioritizing vaccine to areas with the greatest number of people at risk, which includes men who have sex with men, who have HIV, or who are eligible for HIV PrEP, while still considering where we are seeing cases in increase. This strategy, also makes sure that jurisdictions have the doses they need to complete the second dose of this two dose vaccine regimen for those of already been vaccinated over the last month. Our U.S. vaccine strategy continues to be responsive to where we’re seeing cases now and helps us stay ahead of where this outbreak may lead in the future. And as we have said, since the beginning, we’re going to continue to update and adjust the allocation of vaccines and our strategy, as supplies increase, to ensure vaccine doses are available for those who are most in need.
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11:30:31 AM DAWN O’CONNELL, ASPR: As of July 27th, HHS has distributed more than 338,000 doses of the Jynneos monkeypox vaccine to states and jurisdictions and we’re making an additional, as everyone has already mentioned this morning, 786,000 doses available starting tomorrow with continued distribution over the course of the coming weeks. I’d like to share a bit about the distribution of these vaccine doses. First, building from the CDC allocation formula, which Jenny just referenced, HHS was communicating the next round of allocations to jurisdictions today. We will also make this allocation formula publicly available on aspr.hhs.gov today soon after this telebrief. Tomorrow, we will open ordering on our current system so jurisdictions that would like additional vaccines immediately, and can receive them over the weekend, can order them. And then starting Monday, jurisdictions can begin placing orders through a centralized ordering system. This is the same system jurisdictions, used to order COVID treatment. But again, if jurisdictions are ready to place orders before Monday, we’re happy to take those through our current email system. Finally, and this is an important part of what we have learned from the covalent response, as jurisdictions to ramp up their vaccination efforts, HHS will continue to calibrate the vaccine allocation strategy based on data we receive from jurisdictions regarding usage and administration. This will allow us to continue to distribute the vaccines to all jurisdictions across the country, while also ensuring we retain a little bit of flexibility to direct any additional doses to those states in most need. Our goal is to ensure flexibility on the ground by continuously assessing the outbreak, reviewing our inventory, and understanding how the vaccines we’ve already distributed are being administered, and this is also something we currently do in our COVID response.
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11:35:56 AM DAWN O’CONNELL, ASPR: At this point, 338,000 doses have been made available to the states and jurisdictions and we’re in the process of signing data use agreements to be able to get the administration data back in to our account. So, currently, we know 338,000 have been distributed
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11:39:00 AM XAVIER BECERRA, HHS: In terms of the public health emergency and how it weighs relative to other issues, we’re going to take each one as they come before us and engage based on the criteria for calling a public health emergency. In this particular case of monkeypox, what I can tell you is we continue to monitor the response throughout the country on monkeypox. As I’ve said, we’ve made vaccines, tests, and treatments well beyond the numbers that are currently needed available to all jurisdictions who manage their public health systems and are the ones that work with clinicians to make both – I mean all three, tests, treatments, and the vaccines available. And we will weigh any decision on declaring the public health emergency based on the response we’re seeing throughout the country. Bottom line is, we need to stay ahead of this and be able to end this outbreak.
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11:43:29 AM DAWN O’CONNELL, ASPR: So just a few particulars about what the secretary just weighed in on. We, in addition to the 1.2 fill-finished vaccines, which we now have fully in the U.S. as of thanks to the FDA work this week, we also have 16.1 million doses in bulk drug substance that our manufacturer was holding in storage for us. We intended that to be used for a lyophilization program for our smallpox preparedness, but we immediately began putting all of doses that we thought were necessary that we could afford to fill finish into our monkeypox response. So right now, of that bulk drug substance, we have ordered 5.5 million doses to be fill-finished over the course of the next several months. That equals that 6.9 million total that I mentioned. But that also leaves 11.1 million doses that we also could fill-finish, pending additional funding from Congress. So, I think this goes into what was mentioned, previously, about the need for supplemental funds. We’ve got an additional 11.1 million doses, pending pending supplemental funding, that we could access and put towards the monkeypox response.
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11:45:27 AM XAVIER BECERRA, HHS: Dan, thanks for the question. If you heard me at the beginning, I said we want to stay ahead of the virus and end the outbreak. It’s a combination. You can’t just stay ahead, you’ll be running forever. You want to end it. And so– but you can’t end it if you’re falling behind. So our task is to stay ahead of this. That’s why we have procured more than a million vaccines already, even though there are only been less than 5,000 cases. That’s why we have made 60 to 80,000 tests available at testing sites, for testing, of up to 68,000 a week available. Even though the number of tests being performed is only a fraction of that number. That’s why we have 1.7 million treatments or those who have contracted monkeypox, even though we only have, as I said, less than 5,000 cases report. So we want to continue to stay ahead of us. We don’t control public health in the 50 states and the territories and in the tribal jurisdictions. We rely on our partnership to work with them. They need to work with us. And those numbers I gave you work to stay ahead, so long as everyone is doing their part. That’s why I said, we all got a responsibility here. All the communities that are could be impacted, including those that are most at risk, have every reason to understand monkeypox and do everything they can to stay ahead. And so it’s the prevention, it’s the treatment, it’s the education, and the outreach. We’re going to do everything we need to do. We believe that we’ve done what helps our state and local healthcare partners stay ahead of this and we’ll continue to monitor because we cannot let this get out of control and we will do everything on our part to be a good partner to our state and local governments, who ultimately are the ones that determine how healthcare is administered in their jurisdictions.
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11:50:01 AM XAVIER BECERRA, HHS: Well, I’d almost turn that question back to you Ariel and ask how many vaccines do you think we need at the stage? Now, there are 330 million Americans. We could try to vaccinate all 330 million, but as we’ve seen with COVID, which is far deadlier, there’s not a person who’s died from from monkeypox, we’ve lost over a million people from COVID, we still haven’t seen every American get vaccinated with a vaccine that has proven itself to be effective in keeping people alive. So on monkeypox, if there are so far less than 5,000 cases reported, but we’ve already made available to jurisdictions throughout the country more than 330,000 vaccines, and today we’re announcing that another 786,000 are available, how many more vaccines would you say we need today? If the response is, we’re not going to expect any type of prevention work by the communities at risk, by the state and local officials, then chances are, we’re going to have to go to the really high numbers of vaccines. But if everyone does their work, and remember, containing a virus requires a lot of preventative work as well. We did masks, that’s why we did social distancing with COVID, we know what we need to do pretty well on on monkeypox. And so, to the question, can we not only stay ahead of this virus but end this outbreak? Absolutely. And we believe that we have done everything we can at the federal level to work with our state and local partners, and communities affected, to make sure we can stay ahead of this and end this outbreak. But everybody’s got to take the oar and row. Everybody’s got to do their part. We don’t control– as you can see from our lack of data that we’ve gotten from jurisdiction on what they’re doing with their vaccines, we don’t have the authority to tell them what to do. We need them to work with us. And so I would say that if you’re asking the students in the classroom who did their homework? I will raise my hand and say, that at HHS, we’ve done our homework.