Key Points:
- In today’s Recommendations for Industry, we discuss post-vaccine symptomatic return to work for those receiving the vaccine and not feeling well. In addition, we discuss the US Risk Matrix. [Read More]
- Johnson and Johnson’s EUA documentation submitted to the FDA has been released. We will discuss this more on Friday.
- In the huge push for global vaccine equity, the first batches of the COVAX (World Health Organization’s COVID-19 Vaccines Global Access) vaccine (AstraZeneca-Oxford vaccine) have been shipped to countries that are part of COVAX. Ghana becomes the first country to receive COVID-19 vaccines through the COVAX program.
- In CIDRAP’s seventh Viewpoint report,”Reassessing COVID-19 vaccine deployment in anticipation of a US B.1.1.7 surge: stay the course or pivot?” experts and health officials believe that there is a “small window note that to maximize protection from COVID-19 vaccines by focusing first doses on people 65 years old and older and delaying second doses to other groups” due to the rise of the B1.1.1.7 strain. Read the press release here.
- VOX reports that recent studies and preliminary evidence suggests that the COVID-19 vaccine does protect against spread of COVID-19.
Recommendations for Industry
Post-Vaccine Symptomatic Return to Work
When considering return to work of post-vaccine persons with COVID-like symptoms, there is a fine line between unnecessarily excluding those with vaccine reactions and inadvertently allowing those who do have COVID to return to work.
In its Post-Vaccine Considerations for Healthcare Personnel, CDC guidance recommends that a person with any systemic signs and symptoms consistent with COVID-19 infection (e.g., cough, shortness of breath, rhinorrhea [runny nose], sore throat, loss of taste or smell) that are not typical for post-vaccination signs and symptoms (e.g., pain, swelling or redness at the injection site) be excluded from work pending evaluation for the virus. Those with only symptoms that are more commonly associated with post-vaccination side effects (e.g., fever, fatigue, headache, chills, myalgia, arthralgia) could return to work if they feel well enough to do so. However, if symptoms persist for more than two days, they should be excluded from work and tested for COVID-19.
These recommendations are for Healthcare Personnel where access to adequate PPE is expected, and currently there is no similar guidance for those working in other critical infrastructure settings, such as the Food and Ag Sector. Because of this, we at TAG recommend, for the time being, a more conservative approach that anyone with symptoms be tested or wait until symptoms resolve to return to work.
TAG recommends that businesses prepare by securing access to rapid home tests prior to your state’s authorization of vaccines for your workforce. While these tests can be less sensitive than PCR tests, they have good sensitivity in terms of confirming or negating COVID-19 in those who are symptomatic. To assist you in assessing these tests, TAG has summarized current research to provide general information on three key tests in the table below.
| FDA EUA? |
Test Type |
Sample Type |
Prescription? |
Sensitivity / Specificity |
Relevant
Links |
|
| Ellume COVID-19 Home Test | Yes | Antigen | Mid-turbinate nasal swab | No – OTC | Symptomatic – 96% Sensitive / 100% Specific
Asymptomatic: 91% Sensitive / 96% Specific |
FDA |
| Abbott BinaxNOW COVID-19 Ag Card Home Test | Yes | Antigen | Bilateral anterior nasal swab | Yes | Symptomatic – 64% Sensitive / 100% Specific
Asymptomatic: 35% Sensitive / 100% Specific |
FDA |
| Lucira COVID-19 All-In-One Test Kit | Yes | LAMP (real-time loop mediated amplification reaction) | Nasal swab | Yes | According to an unpublished study by Lucira [PDF], symptomatic individuals suspected to have COVID-19 self-collected nasal swabs for testing. The self-administered results were compared to a “high sensitivity molecular FDA authorized SARS-CoV-2 assay” that is not specifically named. In 101 participants, the total positive percent agreement across all samples was 94.1% (48/51) or 96.0% (48/50). When samples with high Ct values (>37.5) were excluded, the test achieved 100% (45/45) positive percent agreement. | FDA |
For further assistance in setting a return-to-work strategy for your workforce, give TAG a call.
TAG Risk Matrix.
Based on TAG’s matrices since last week:
- The Government Stringency Index is 46 this week. It is the same as the previous week’s GSI. There are no states in the U.S. where businesses are completely closed. Eight (8) states’ (Arizona, California, Colorado, Connecticut, Hawaii, Massachusetts, New Mexico, and Oregon) businesses are in mixed opening stages.
- Five (5) states are in the Highest-Risk Quadrant (Outbreak Index > 50). This is down from 6 last week. States in the High and Highest-Risk Quadrants are Alabama, Idaho, Iowa, Kansa, and South Dakota.
- In Figure 1, this week, we compare the case rate/100K in the population to the percentage of a state’s population that has been vaccinated. We look at the percentage of population (within a state) that has received both the 1st and 2nd Table 1 compares the last week and this week’s percentage of states’ populations that have been vaccinated.
[Figure 1]
[Table 1]
[Table 2]
- Three (3) states have a TPR ≥10% and a case rate ≥ 25/100K people (Table 3). This is down from 11 states last week. This indicates that testing may not be adequate to fully characterize the true severity of the outbreak in the states. On the other hand, 6 states have a TPR < 10% and a case rate≥ 25/100K people indicates adequate testing that is likely finding most symptomatic cases of illnesses.
[Table 3]
- In Figure 2, we compare case rate/100K in the population to the number of COVID-19 tests administered and change in Test Positive Rates.
[Figure 2]
In Case You Missed It
- In Monday’s Recommendations for Industry, we discussed the current status of vaccinations across the U.S. and the importance of education. Read more here.
- The New York Times discusses vaccine alarmism that addresses the conflicting messages that “may be dissuading people from getting vaccinated.” According to NYT polls, “nearly half of Americans would refuse a shot if one were offered to them.”
- Canada fined two travelers who boarded a plane with falsified coronavirus tests $13,500. Additionally, some tourists from the U.S. mainland tried to bribe officials to allow them into Hawaii and skip the quarantine period after not being able to procure negative COVID-19 test results. For the safety of others, please do not falsify test or vaccine information before traveling. Please respect the quarantine period as required by the place you are visiting!
- A recent JAMA Psychiatry study shows that about 30% of COVID-19 patients in Rome, Italy, who had received hospital care have been diagnosed with PTSD, 17% with depression, and 7% with generalized anxiety. Mental health, especially throughout this pandemic, has been important to be aware of. Please check in with your employees.
- On Friday, Johnson & Johnson (one-shot vaccine) submitted its materials to the WHO for assessment as an emergency listing.
- In Friday’s Recommendations for Industry, we discussed the continued need for mask wearing in offices.
- FDA and HHS have reiterated that there is no current epidemiologic and scientific information of food or food packaging as associated with or being a likely source of viral transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus causing COVID-19. Thus, despite some media reports out of China, there is no credible evidence of COVID-19 transmission through food or food packaging that the virus is not spreading through food.
