- In today’s Recommendations for Industry, we discuss COVID-19 tests and the updated Risk Matrix (things are getting better). Read more below.
- Since the White House announced that all federal employees need to be vaccinated against COVID-19 by November 22, 2021, the USDA is now required to collect proof of vaccination from each employee through a survey (to be completed by November 9, 2021 by employees).
- While the outbreak has improved in the U.S. and many parts of the world, Alaska is struggling to handle an ever-worsening outbreak. As you’ll see in today’s Risk Matrix, Alaska continues to see increasing case rates and Test Positive Rates.
- As the COVID-19 virus has mutated, certain COVID-19 tests have become less effective and/or have increased potential of providing an incorrect result. While we discuss that today in our Recommendations for Industry, here is the FDA’s notice. To see a full list of Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2, click here!
- Two new studies, reported in CIDRAP, one from China and another from the UK have found that long COVID-19 is tied to severe initial illness. Additionally, when compared with patients who had recovered from flu, COVID-19 survivors more often reported long-lasting symptoms. The UK study found that “Males reported significantly more breathing and cognitive symptoms than females, who were more likely to report headaches, abdominal issues, and anxiety or depression. Older survivors reported more breathing problems, cognitive symptoms, pain, and fatigue than younger patients, who were more likely to report headaches, abdominal difficulties, and anxiety or depression.”
- The CDC is highly encouraging pregnant people to become COVID-19 vaccinated to prevent serious illness, death, and other adverse outcomes due to COVID-19. Read the health advisory here and spread the news!
- A new study in PLOS further highlights what we’ve discussed for a while; seven COVID-19 symptoms are more predictive of COVID-19 illness, including: loss or change of smell, loss or change of taste, fever, new persistent cough, chills, appetite loss, and muscle aches.
- While Singapore has seemingly high case rates of COVID-19, ultimately, the country – with a full vaccination rate of 82% of the population over 12 years of age – has focused more on reducing the “severity of infections and hospitalizations” rather than the number of daily cases. In fact, unlike in the U.S., with such a highly vaccinated population and despite the high daily cases, “hospitals have not become overwhelmed, with 98% of new cases either asymptomatic or with mild symptoms.” Like other countries, Singapore also feels that “reducing cases to zero was not a possible long-term solution.”
- YouTube is banning anti-vaccine misinformation and associated accounts.
- Pfizer has submitted its initial data on COVID-19 vaccines for children (5 – 11 years old) to the FDA, with authorization anticipated by late October or early November.
- A recent survey has found that the Delta variant drove 39% of unvaccinated adults to get vaccinated this summer. Other factors contributing to increased vaccinations include the overflow of hospitals and knowing someone who has become seriously ill or died from COVID-19.
- The CDC is reporting that Americans who received a third COVID-19 vaccine dose are reporting similar side effects at relatively the same rates as after second COVID-19 doses.
- COVID-19 test manufacturers are warning of potential COVID-19 rapid test shortages with the new positioning for mass-scale rapid COVID-19 testing.
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Recommendations for Industry
COVID-19 Employee Testing: TAG Addresses Your Questions
In previous issues, we have discussed the Biden Administration vaccine/testing mandate for businesses with 100+ employees, for which OSHA is still drafting the Emergency Temporary Standard (ETS). Because of the testing option, TAG has been receiving a number of questions on the availability, applicability, and efficacy of various tests.
While we don’t yet know what specifications OSHA will include in the ETS, if any, we can provide some information from various government sources on tests.
- On September 17, the Department of Defense issued a statement on the $647 million in contracts it, in coordination with the Department of Health and Human Services (HHS), had awarded for four over-the-counter COVID-19 test kits. Those tests include: $205.2 Million Contract to OraSure Technologies, $284.2 Million Contract to Quidel Corp., $47.8 Million Contract to Abbott Rapid DX North America, and $109.8 Million Contract to Intrivo Holdings Corp. However, the release states only that the procurements “were funded through the American Rescue Plan Act to supply critical medical resources to the nation,” so we don’t know what availability the administration will be making for these tests.
- With COVID having mutated since its original detection, this has affected the accuracy of some molecular, antigen, and serology tests. An FDA regularly updated webpage provides information on the Molecular Tests that it has found could be impacted by the mutations, making them less accurate. Thus far, FDA has listed four tests as potentially being impacted: Accula SARS-CoV-2 Test(Mesa Biotech Inc.), Linea COVID-19 Assay Kit (Applied DNA Sciences, Inc.), TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.), and Xpert Xpress SARS-CoV-2, Xpert Xpress SARS-CoV-2 DoD, Xpert Omni SARS-CoV-2 (Cepheid). While some are listed “out of an abundance of caution,” the impact should be reviewed and taken into consideration for these tests.
- Additionally, FDA has been issuing EUAs for certain Molecular Diagnostic Tests based on specific conditions of authorization required of the manufacturer and authorized laboratories. The list of 261 tests includes test attributes information, such as whether each is authorized for screening (of asymptomatic individuals without known exposure) pooling, multi-analyte, saliva, home collection, and/or home testing.
While this leaves a lot of questions about test selection, there is unlikely to be any further answers until OSHA publishes its ETS. If you do have general testing questions or would like assistance with your vaccine/testing program, please give TAG a call. We are continuing to stay updated on all things COVID-19 and can provide assistance.
RISK MATRIX
TAG’s Weekly Matrix is showing a downward trend in the Delta curve across the U.S., just as is being seen worldwide. There are, however, pockets of significant concern with high or increasing case rates. TAG recommends that businesses stay updated on the conditions in your local area to determine the level of risk and ensure continuing protections are being implemented.
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In Case You Missed It
- In Tuesday’s Recommendations for Industry, we discussed COVID post-infection antiviral medication trials that are nearing completion. Read more here.
- Viruses limited by COVID-19 restrictions may arise again this fall, including “common respiratory viruses” like the common cold.
- The CDC has released “Who is Eligible for a COVID-19 Booster Shot.” Booster shots are available for anyone who received the complete series of Pfizer vaccines at least 6 months ago. (See article for a detailed list.)
- S. COVID-19 cases drop for the first time in 3 months since the start of the summer’s fourth wave that was driven by the Delta variant.
- A recent MMWR reports that, “S. counties without school mask requirements saw pediatric COVID-19 cases increase nearly twice as fast in the 2 weeks after schools reopened than counties with mask mandates.”
- COVID-19 hospitalization rates are tied to poverty and race. While White, Black, and Hispanic populations living high-poverty census areas were more likely to be hospitalized, Black and Hispanic populations had much higher rates of hospitalization. Additionally, “33.1% of hospitalized patients were in the highest quartile of service industry workers, 30.8% were in the highest quartile of public transportation commuters, and 30.0% were in the highest quartile of people 25 years or older who didn’t have a bachelor’s degree.”
- Life expectancy has fallen in 27 of 29 nations. Higher death rates were linked to those 60 in Europe.
- There is research now, through companies like Merck and Pfizer, to develop an anti-COVID pill. This research is being conducted in various countries including the US and Israel.
- While daily cases rise dramatically to new highs in Russia (NYT), the potential new U.S. travel rule may exclude fully vaccinated Russians (and others) who have been fully vaccinated with Russia’s Sputnik V vaccine (Washington Post).
- Multisystem inflammatory syndrome in adults (MIS-A), similar to the multisystem inflammatory syndrome in children (MIS-C), is also rare and also difficult to diagnoses in adults! It can begin roughly 4 weeks after COVID-19 symptoms onset; however, it appears similar to other coronavirus-related inflammation events.
Seasonal Flu:
- The WHO is recommending that two strains for the Southern Hemisphere’s 2022 flu season be switched out and replaced. The Northern Hemisphere’s flu vaccine will be different than the Southern Hemisphere’s upcoming vaccine.
- Global influenza surveillance still finds relatively lower numbers than usual, though Influenza A & B are being detected at similar proportions.
- In the U.S., states like Nevada and Ohio are showing moderate influenza activity levels; however, cases still remain low.
Food Safety & Public Health:
- Cilantro has been identified as the potential source of the recent Salmonella Oraneienburg outbreak that has sickened almost 300 people across 29 states.
- Drug-resistant malaria has been identified in Africa. Read more on CIDRAP.
- Bacillus cereus in dairy products is difficult to estimate; however, preventive controls are necessary to continue to keep it under control. Global increases in dairy consumption necessitate using novel analytical methods to detect spores and more.
- There is a renewed warning about Salmonella infected through an outbreak linked to feeder rodents.