• In today’s Recommendations for Industry, we discuss the flattened rate of COVID transmission increasing the urgency to maintain all protections and TAG’s US Risk Matrix. There is potential that cases may be rising. Read More Here.
• With a new vaccine on the market (Johnson & Johnson), the New York Times breaks down what vaccine efficacy numbers mean.
• As part of the National Consumer Protection Week, the FDA has announced (and is warning the public) of the importance of being aware of COVID-19 Vaccine Scams. As we’ve stated before, please be wary of untoward vaccine offers.
• Although COVAX immunizations have begun in Africa and there has been a 6-week decline in global COVID-19 cases, COVID-19 cases are rising again.
• A recent Public Health England (non-peer-reviewed) study found that, in real life situations, both the Pfizer and AstraZeneca COVID-19 vaccines are effective against COVID-19 and offer protection against the B117 variant.
• Although the CDC has long decried the use of hydroxychloroquine to fight against COVID-19, the World Health Organization now echoes that sentiment declaring that there is no evidence of benefit for its use.
• A research letter printed in JAMA found that those who had previously been infected with COVID-19 – then later received a single dose of mRNA vaccine, had “higher antibody titer responses”. It is important to note that the sample size is small (n = 59) and there is still much more research needed. However, the researchers state that “given the ongoing worldwide vaccine shortages, the results inform suggestions for a single-dose vaccination strategy for those with prior COVID-19 or placing them lower on the vaccination priority list.”
• Finally, a meta-analysis and systematic review of convalescent plasma has found that, ultimately, there is no real benefit of convalescent plasma (although it was granted an EUA by the FDA in August 2020).
• The CDC warns that despite increases in vaccination (and the availability of a third vaccine), the U.S. may yet see a fourth COVID-19 wave.
• As cases seemingly decrease, some states are lifting their mask mandates and lifting business restrictions (including Texas and Mississippi). Without knowing for certain the true trajectory of COVID, TAG does not recommend loosening restrictions.
• On Tuesday, Brazil recorded its highest single-day toll of the pandemic at 1,7000 COVID-19 related deaths. The accelectation of the pandemic in Brazil (due to the variant’s spread) is something that TAG will be keeping an eye on. Preliminary studies indicate that the variant may be more contagious and may also reinfect those who had been previously infected with other variants.
• Germany will extend it’s COVID-19 lockdown measures through March 28, 2021.

COVID Rates Have Plateaued, May Rise. Don’t Relax Your Protections!

In January and February, COVID-19 case rates were steadily decreasing. However, March rates have become flat with indications that rates are likely to start increasing due to two key factors:

• Transmission of the variants are continuing to increase, becoming the predominant strains in some areas.
• Some states are relaxing, or even completing eliminating, control requirements.

With these two key factors, TAG is not only continuing to recommend that businesses maintain all COVID protections – as we have for months, we are stating it louder and stronger, with an even higher level of urgency. Don’t relax your standards yet! You don’t need to increase them, just don’t reduce them – even if your state is.

TAG Risk Matrix.

Based on TAG’s matrices since last week:

• The Government Stringency Index is 43 this week. It is lower than last week’s 46, indicating that there has been a decrease in government stringencies. This is reflected as states are opening back up. 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.
• Eight (8) states are in the Highest-Risk Quadrant (Outbreak Index > 50). This is up from 5 of last week. States in the High and Highest-Risk Quadrants are Alabama, Idaho, Iowa, Georgia, Kansas, Mississippi, South Dakota, and Texas.
• In Figure 1, this week, we compare the case rate/100K (Table 1) in the population the to percentage of a state’s population that has been vaccinated (with first and second doses). Table 2 and 3 compare last week and this week’s percentage of states’ populations that have received their first and second vaccinations, respectively.

[Figure 1]

[Table 1]

[Table 2]

[Table 3]

• Two (2) states have a TPR ≥10% and a case rate ≥ 25/100K people (Table 4). This is down from 3 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, 7 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 4]

• In Figure 2, we compare the case rate/100K in the population to the number of COVID-19 tests administered and changes in Test Positive Rates

[Figure 2]

• In Monday’s Recommendations for Industry, we discuss FDA’s issuance of an EUA for the J&J Janssen COVID-19 Vaccine for those 18 years of age and older. Read more here.
• The head of the CDC warns that we must be vigliant of the COVID-19 variant B117. A few weeks ago, B117 cases only accounted for 1 – 4% of all COVID cases. Now, the B117 variant accounts for 10% of all COVID-19 cases.
• A recent survey of the U.S. population finds 55% of adults have either received one dose or will get it as soon as they can. This is a ~20% increase since December!
• COVID Act Now reports that CNN discusses evidence of a new variant (B.1.526) spreading in New York City. This variant may be more effective at evading immune responses; it contains two mutations (one found in the B.1.351 variant first identified in South Africa and another found in the P.1 variant first identified in Brazil).  
• Moderna is ready to test its new vaccine version designed to be more effective against some newer varaints.
• COVID testing in the U.S. has fallen by 30% in recent weeks. Some places are testing half as many people as in November and other sites are only testing at 35% of capacity. Some reasons for the COVID testing decreases can be attributed to potentially fewer exposures, less travel, bad weather leading to closed sites, increased vaccine rollout, pandemic fatigue, but also a decrease in infections and spread.
• Thousands of farmworkers in the United States, who ensure the functionality and supply of our food system, are being prioritized for COVID-19 vaccination!
• The New York Times reports that “Every coronavirus variant of concern to researchers around the world has been circulating in Houston [Texas] at a low level for at least six to eight weeks, a new study has found. Houston is the first U.S. city to find all of the variants, including those recently reported in California and New York and the ones found in Brazil, Britain and South Africa”.
• Canada is set to receive 6.5 million Covid-19 vaccines by end of March.
• The FDA is allowing for more flexible storage and transportation conditions for the Pfizer COVID-19 vaccine; undiluted frozen vials of the vaccine can be “transported and stored at conventional temperatures commonly found in pharmaceutical freezers […] for up to two weeks” as opposed to being in ultra-low temperature freezers.
• The FDA has released new guidance for medical manufacturers related to addressing future SARS-CoV-2 variants that may emerge.
• Queen Elizabeth is urging Britons to get a coronavirus vaccine; she discusses her experience with it, urging that people should “think about others rather than yourself.”
• In last Wednesday’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]