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Clinical Reports

Veterans Health Administration COVID-19 (VACO) Index for COVID-19 Mortality
This calculator estimates the risk of 30-day mortality after SARS-CoV-2 infection using pre-COVID health status. Developed in collaboration with the US Department of Health and Human Services (HHS), including the CDC, NIH, VA, and the ASPR. This calculator was developed and validated in VA cohorts, and then externally validated in a non-VA patient population, noteworthy because of the VA's predominantly male population. The VACO Index predicts well in all subpopulations in which it was studied.

Antiviral Therapeutics and Vaccines

V-safe After Vaccination Health Checker
V-safe is a smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins after you receive a COVID-19 vaccination. Through v-safe, vaccine recipients can quickly tell CDC if they have any side effects after getting the COVID-19 vaccine. Depending on the answers, someone from CDC may call to check on the recipient and get more information. And v-safe will also remind the recipient to get the second COVID-19 vaccine dose.
COVID-19 Vaccines and Severe Allergic Reactions
CDC has learned of reports that some people have experienced severe allergic reactions—also known as anaphylaxis—after getting a COVID-19 vaccine. As an example, an allergic reaction is considered severe when a person needs to be treated with epinephrine or EpiPen© or if they must go to the hospital. If anyone ever had a severe allergic reaction to any ingredient in a COVID-19 vaccine, CDC recommends that the person should not get that specific vaccine. If the person has had a severe allergic reaction to other vaccines or injectable therapies, they should ask your doctor if they should get a COVID-19 vaccine. CDC recommends that people with a history of severe allergic reactions not related to vaccines or injectable medications—such as allergies to food, pet, venom, environmental, or latex—may still get vaccinated. People with a history of allergies to oral medications or a family history of severe allergic reactions, or who might have an milder allergy to vaccines (no anaphylaxis)—may also still get vaccinated. If recipient has a severe allergic reaction after getting the first shot, they should not get the second shot.
FDA Issues Emergency Use Authorization for Second COVID-19 Vaccine
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 mRNA Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older. The FDA has determined that the Moderna COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the Moderna COVID-19 Vaccine may be effective in preventing COVID-19. The data also show that the known and potential benefits outweigh the known and potential risks—supporting the company’s request for the vaccine’s use in people 18 years of age and older. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information.

Epidemiology

UK reports new variant, termed VUI 202012/01
The United Kingdom reported a new variant, termed VUI 202012/01 (Variant Under Investigation, year 2020, month 12, variant 01). It was defined by multiple spike protein amino acid changes (deletion 69-70, deletion 144-145, N501Y, A570D, D614G, P681H, T716I, S982A, D1118H). There are currently 24,746 viruses from the UK in GISAID EpiCoV with a collection date since 1. November. A small fraction of them, about 6% (all from clade GR) share several of these amino acid changes. Based on evaluation of effect on virus structure and function, the most relevant might be N501Y (host receptor and antibody binding, also reported at gisaid.org/spike) and the deletions in positions contributing to potential spike surface variation (Y145del is where some antibodies like neutralizing 4A8 bind). The other mutations are further down the structure and their effect is less clear. There is also an early NS8 Q27stop codon in these strains which could be relevant as ORF8 deletions have been seen before for this virus (including in Singapore, notably resulting in attenuation). As seen on many occasions before, mutations are naturally expected for viruses and are most often simply neutral regional markers useful for contact tracing. The mutations seen have rarely been affecting viral fitness and almost never affect clinical outcome but the detailed effects of these mutations remain to be determined fully.