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Key Points
January 11, 2021
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In today’s Recommendations for Industry, we discuss
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The FDA has issued an alert that some of the genetic COVID-19 variants may impact the results and lead to false negatives with a few COVID-19 molecular tests (e.g. Accula SARS-Cov-2 Test; TaqPath COVID-19 Combo Kit; Linea COVID-19 Assay Kit).
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Last Thursday, the U.S. hit a new record of single-day deaths from COVID-19 with over 4,085 deaths. Although the vaccine is still being distributed, it is still important to maintain social distancing, wear a mask, continue washing hands, and practice other preventive measures to keep everyone safe.
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In Los Angeles County, California, 1 in 5 COVID-19 tests are positive, indicating that the virus is still spreading at an incredible rate.
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FDA has issued a warning to beware of fraudulent tests, vaccines, and treatments. Be wary of unofficial COVID-19 vaccines and unscrupulous individuals who may be selling or administering the vaccine. Currently, vaccines are being distributed and administered through health departments, hospitals, pharmacies, and other valid medical or pharmaceutical facilities. Do not take a vaccine that is offered outside of locations listed above. If you have questions about the appropriateness of a vaccination site, reach out to your local or state health department.
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Japan has identified a new COVID-19 variant (B.1.1.248 strain with 12 mutations in the spike protein) that has similar mutations as those seen currently in the South Africa and UK variants. However, more studies must still be done to understand how this new variant may affect disease transmissibility or severity.
Recommendations for Industry
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As several of the key points (above) show, we are seeing a renewed expansion of COVID-19 spread – and deaths, including
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A new record high for single-day deaths in the U.S. – more than 4,085.
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Extremely high spread in Los Angeles County, California, with 1 in 5 tests being positive.
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More mutations of the COVID-19 being found around the world, with one being the new variant identified in Japan.
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What does all this mean to you?
It means that, despite the rollout of the vaccines, we need to continue to protect ourselves, families, and co-workers against this continued spread.
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First, that all protective measures need to continue against the virus including:
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Mask wearing when not in one’s home. Masks should always be worn when inside with others and should be worn outdoors if you will be in close proximity.
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Social distancing of six feet from others not of your household and continuing to limit any gathering.
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Frequent handwashing, and no touching of the face, particularly the eyes, nose and mouth.
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Enhanced sanitation, to help reduce any contact transmission.
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Second, vaccines should be taken and highly encouraged for your workers as soon as they become available in your state. There is no evidence that currently available vaccines are not effective against the variants. If adjustments to the vaccines should be needed, these can be made to the current vaccines; there will not be a need to “go back to the drawing board” and start over.
In Case You Missed It...
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In last Friday’s Recommendations for Industry, we discussed how businesses can determine the COVID-19 vaccination priorities and directives of the states in which they operate. Read more.
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We have continued to populate the TAG Vaccine Q&A page. Last Friday, we focused on (a) the efficacy of current tests and (b) managing potentially serious reactions of vaccines.
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A recent study published in JAMA and reported by CIDRAP finds that 14.3% of the US population had antibodies against COVID-19 by November 2020; implying that more people than reported have been infected. This tracks with the discussion that there may be a lot of COVID-19 underreporting. Additionally, there is evidence that about 35% of COVID-19 related deaths have not been reported.
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There is increasing evidence that patients with severe COVID-19 symptoms (post-hospitalization, etc.) have also developed symptoms like those associated with brain injury and other neurological disorders. NPR has summarized the studies.
Keep up to date with COVID-19:
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