CDC Updates Mask Guidance, Provides County-Searchable Tool

Key Points:

• In today’s Recommendations for Industry, we discuss CDC’s new masking guidance and the utilization of the County-Searchable Tool. Read more below.
• A recent CDC study has found that about 43% of individuals (>140 million) in the U.S. have been infected with COVID-19 (Washington Post). States like Wyoming, Texas, Wisconsin, and Illinois have had a high percentage of their populations infected. As Omicron cases are decreasing in the U.S., leading to decreased worries and fears surrounding COVID-19 infections (AP News), COVID-19 cases and related deaths have risen in other parts of the world (including South Korea and Hong Kong).
• The CDC’s new masking guidance follows along various measures by community spread at the county level. Find the county-searchable tool, here.
• The FDA has updated its over-the-counter (OTC) COVID-19 test list; the table now includes information about “who can use the test” given the symptoms, age, and other details (including time needed and whether said test results can be approved via telehealth supervision). 
• In the realm of vaccines, a new COVID vaccine produced by Sanofi is found to have 100% efficiency against severe disease and hospitalization (NY Times). On the other hand, the Pfizer COVID-19 vaccine was found to only have 12% efficacy in children 5 – 11 years of age, against the Omicron variant; this is theorized to be due in part to the lower dosages given to children (CNBC).
• There has been a potential deer-to-human COVID-19 infection in Canada (The Guardian).

Influenza:

• In the U.S., and globally; while flu cases continue in various places, generally this flu season is considered a mild one. Activity remains low and decreased after the peak at the end of December 2021.

Food Safety & Public Health:

• Another death associated with Cronobacter sakazakii is expanding the Abbott Nutrition infant formula recall. See FDA’s site to see more information on the lots affected by the recall.
• The USDA has amended the national List for organic handling, crops, and livestock. There have been a few substances removed (including Vitamin B1, procaine, and 14 nonorganic ingredients), while renewing for sucrose octanoate esters (for crops and livestock production) and oxytocin (for livestock production). Read more here.

Recommendations for Industry

CDC Updates Mask Guidance, Provides County-Searchable Tool

Earlier this week, the CDC updated its masking guidance, basing it on community levels of hospital beds being used, hospital admissions, and the total number of new COVID-19 cases in an area. Levels are cited as “low”, “medium”, or “high.” CDC has devoted a tool by which to determine the level of your community and the recommended measures to be taken at each level.

COVID-by-County Status Indication

Low	Medium	High
Stay up to date with COVID-19 vaccines Get tested if you have symptoms	If you are at high risk for severe illness, talk to your healthcare provider about whether you need to wear a mask and take other precautions Stay up to date with COVID-19 vaccines Get tested if you have symptoms	Wear a mask indoors in public Stay up to date with COVID-19 vaccines Get tested if you have symptoms Additional precautions may be needed for people at high risk for severe illness

The page includes a heat map of the US as well as an easy-to-use tool that is searchable by county, enabling larger companies to also set policies by facility rather than general corporate mandates, if desired.

Even given your county level, if rates are high in a facility, TAG recommends that you maintain protections relative to your levels. Rates have dropped across the US but are still high in other parts of the world, so travel protections also should be maintained as required or needed.

Related to testing, FDA has posted an updated list of authorized over-the-counter tests, including information on recommended use by age, etc. Find more information on the OTC COVID-19 tests, here.

In Case You Missed It:

• In last Thursday’s Recommendations for Industry, we discussed TAG’s weekly COVID matrix and its indicators for endemic vs. pandemic and related masking requirements. Read more here.
• A new, two-dose COVID vaccine showed 100% efficacy against severe disease. Two doses of a new COVID vaccine, made by the Europe-based Sanofi and GSK, achieved 100 percent efficacy against severe disease and hospitalizations, and it could be an effective booster. The new vaccine had an efficacy of 75 percent against moderate-to-severe disease and showed 58 percent efficacy against symptomatic disease in its Phase 3 clinical trial. Used as a booster dose after one of the other available coronavirus vaccines, the Sanofi-GSK shot increased antibody levels by 18- to 30-fold. The companies intend to submit the vaccine for authorization in the US and Europe.
• Interval between COVID-19 vaccine doses can be 8 weeks for some people, CDC says. The interval between the first and second doses of the Pfizer-BioNTech and Moderna COVID-19 vaccines can be 8 weeks for certain people, the CDC said in updated interim guidance. Previous guidance stated that first and second doses should be separated by 3 weeks for the Pfizer-BioNTech vaccine and 4 weeks for the Moderna vaccine. The CDC said both vaccines remain safe and effective at those intervals, but the longer interval could reduce the risk for myocarditis.
• New studies suggest boosters may protect for months, even years. According to a flurry of new studies, COVID boosters can continue to protect most people from serious illness and death for many months, and perhaps even years.Previous studies have showed that antibodies can wane over time, but that does not necessarily mean that immunity is waning. The new research looked at other parts of the immune system that can remember and destroy the virus, including B cells and T cells. The studies found that this diverse repertoire of defenses should be able to protect people who have had three shots, or even two, for months or years.
• MIS-C risk after COVID-19 vaccination falls to one in a million, study findsThe risk for multisystem inflammatory syndrome in children, or MIS-C, is reduced to just one in a million when a person receives at least one dose of COVID-19 vaccine, researchers reported in The Lancet Child & Adolescent Health. This is “substantially lower” than the previous estimate of around 200 cases per million. The CDC defines a case of MIS-C as anyone younger than 21 years who presents with a fever, inflammation, clinically severe illness requiring hospitalization, and two or more organs involved, who has no alternative plausible diagnosis and has tested positive for current or recent SARS-CoV-2 infection, or reports exposure.
• Global COVID-19 cases fall, except in Asian hot spots. Last week global COVID-19 cases and deaths continued to decline, except for parts of Asia that are experiencing later Omicron surges, according to the WHO weekly update. Cases declined 21% last week over the previous week, continuing a 3-week decline. Deaths dropped 9%.  But both continue to rise in the Western Pacific, led by surges in South Korea, Hong Kong, New Zealand, and Brunei with South Korea, Hong Kong, and Singapore breaking daily records. Genetic sequencing suggests that 99.1% of the world’s cases involve the Omicron variant, with BA.2 now dominant in 18 countries.
• Children’s innate immune systems help fend off COVID-19 more effectively than adult’s.  Although some children fall seriously ill after coming down with COVID-19, most have mild or no symptoms. Immunologists have found that children’s immune systems have higher levels of some innate molecules and increased innate responses compared with adults, which experts think is key to helping children better fight off the virus that causes COVID-19.
• Moderna starts phase 3 study of messenger RNA-based RSV vaccine. Moderna has initiated a phase 3 study of its investigational mRNA-based vaccine for RSV. The company is also testing an mRNA vaccine against influenza with a goal to create combination vaccines that protect against several respiratory viruses, including influenza, SARS-CoV-2 and RSV. The phase 3 study, called ConquerRSV, will enroll around 34,000 adults aged 60 years or older from multiple countries.
• Vaccine-hesitancy discussion guide now available. Healio has launched a new publication, Building Confidence: A COVID-19 Vaccine Discussion Guide, with answers to common questions about the COVID-19 vaccines authorized in the U.S. The initial edition addresses the contents of COVID-19 vaccines; additional versions will address concerns related to blood clots, breakthrough infections and receiving a vaccine after a natural SARS-CoV-2 infection.
• Hong Kong will require its residents to get tested in March.Hong Kong will require its more than 7 million residents to undergo coronavirus testing in March as it struggles to contain its latest wave of infections, which has led the total number of cases in the city to surpass that of the previous two years and left hospitals overflowing. Residents will have to take three tests over a short period, starting in March. And Hong Kong will expand its testing capacity to one million tests a day from about 200,000 a day by next month. New isolation facilities are also being built to house coronavirus patients and a large-scale hospital is also being planned.