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Eric Deeble, USDA [00:17:35]
We are wrapping up now the third round of experiments in BSL 3 facilities, in order to help us better understand how this disease manifests in animals, and how we can address it.
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Eric Deeble, USDA [00:17:59]
I will mention that we are also sampling beef that is derived from culled dairy cows, through our national residue monitoring program, to make sure that we have as much visibility into H5N1 in the herd as possible.
To date, we have detected no H5N1 in these samples, but out of an abundance of concern, both for public health, public safety, trading relationships and opportunities, we’re going to continue to do this for the foreseeable future.
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Eric Deeble, USDA [00:18:41]
A couple of things that folks often are interested in is the way in which this disease has spread and whether or not say the fall migration and birds moving back through the environment pose a risk to dairy cattle in the same way that they do to avian flock, typically poultry houses.
And the answer is no. We have quite definitive evidence that H5N1 is spreading between states through cattle movement, which I mentioned earlier, and then spread between dairies, and sometimes, within dairies and sometimes to other dairies through the movements of individuals and equipment.
We don’t know everything that we would like to about this disease, and we’re continuing to study it as vigorously as we can. We’re particularly interested at this point at the manner in which the disease is transmitted from individual cow to individual. We know that it is not respiratory. We do know that it is associated with milk. We believe that milking equipment, and other environmental surfaces or milking practices are implicated, but it is challenging to get the definitive answer that we want, even as we continue to explore that we do know the best way to address that.
And that is to make sure that folks understand the risk to their herd, and are able to implement biosecurity, in order to mitigate the risk of the spread.
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Lizette Durand, CDC [00:39:30]
CDC is also collaborating with state health departments on H5N1 seroprevalence studies to determine if there is asymptomatic infection among people who have worked with sick cows.
Sero prevalence studies can help to answer important public health questions about whether there is evidence of asymptomatic infections and what behaviors are associated with greater or lower risk to infection.
The Michigan health department released negative results from first round of data collection last month, additional data collection is ongoing.
Colorado has completed enrollment in their study, and CDC is testing specimens in our lab.
Additionally, a CDC team of epidemiologists, veterinarians and health communications specialists worked with the Ohio department of health to conduct a serosurvey that will assess past exposures to H5 viruses among a national network of veterinarians and other veterinary professionals. Next slide, please.
As I mentioned on the previous slide, CDC collaborated with the Ohio department of health at the American Association of Bovine Practitioners or AABP annual conference to conduct a sero survey.
The study enroll at about 150 attendees who have worked closely with cattle in the past three months.
As DSM has publicly indicated, it has submitted an OMOR for bemotrizinol to the FDA. In general, after an OTC Monograph Order Request (OMOR) is submitted, the FDA will determine if the OMOR is acceptable for filing. If the FDA accepts the OMOR for filing, the FDA will review the OMOR. The FDA would then typically issue a proposed order addressing the substance of the OMOR within a timeframe agreed to under the OMUFA Goals Document. The public will have a minimum of 45 calendar days to submit comments on the proposed order (although FDA may provide for a longer comment period). After reviewing and considering the comments, the FDA would issue a final order, including to update the relevant OTC monograph(s), if appropriate.
The FDA continues to encourage industry to submit data to address the data gaps for those monograph ingredients FDA has indicated need additional data. This will enable the FDA to confirm the ‘generally recognized as safe and effective’ status of these ingredients.