Key Points:

• In today’s Recommendations for Industry, we discuss TAG’s interpretation of COVID trends being seen in TAG’s matrix and other news indicating a “nudge” – not a surge – in the US. Read more below.
• Weekly WHO Update: Global COVID-19 cases climb for second week in a row. Led mainly by surges in Asian hot spots, COVID-19 cases last week increased for the second straight week, though deaths continued to fall. Cases are up 7% compared to the week before, with cases up 21% in the Western Pacific region. Deaths overall declined 23% compared to the week before, though they were up 5% in the Western Pacific region.
• In the U.S. , new COVID-19 cases are holding steady or increasing in about 19 states, according to data from Johns Hopkins University. Although health officials have warned that overall COVID-19 infections could rise across the US in a few weeks, parallel to trends in the UK and Europe, leading public health officials are not expecting another dramatic surge in new cases, largely due to the level of immunity the population has from vaccination and the fierce outbreak during the winter Omicron wave.
• FDA announced that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on Apr 6 to discuss the future role of booster shots, following emergency use authorization (EUA) submissions from both Pfizer and Moderna for fourth doses. Moderna is seeking emergency use authorization for a two-dose primary series of its COVID-19 vaccine for children ages 6 months to 6 years and plans to ask for regulatory authorization in Europe and is seeking to have larger-dose shots cleared for older children and teens in the U.S.
• Millions of Americans are wondering about their protection after a winter of booster shots and Omicron infections. As mask mandates are lifted and restrictions removed in a step toward normalcy, a test to measure immunity would be a powerful tool to measure individual risk.  With FDA recommending against checking antibody levels because there’s no agreed-upon way to calculate how any given antibody level protects you from infection or severe disease, scientists are trying to fill the knowledge gap, but it’s not a straightforward concept due to factors such as not all antibodies can prevent infection, levels can vary person to person, natural and vaccine-acquired immunity varies, and antibody levels are just one factor of immunity.
• COVID-19 patients can safely use inexpensive pulse oximeters at home to watch for a drop in blood oxygen that signals the need to seek advanced care, according to a systematic review published in The Lancet Digital Health. The review showed that pulse oximetry enabled early identification of decreasing oxygen levels and helped triage patients with guided care escalation and has led to recommendations for creating a remote patient monitoring (RPM) program with pulse oximetry including a cutoff point in blood oxygen saturation of 92% and a decrease of more than 3% after exertion.
• In a press release, AstraZeneca said its antibody preventive treatment Evusheld retains neutralizing antibody activity against Omicron and its BA.2 subvariant. New preclinical authentic ‘live’ virus data from Washington University School of Medicine demonstrated that Evusheld (tixagevimab co-packaged with cilgavimab) retains potent neutralizing activity against Omicron BA.1, BA.2, and BA.1.1.1., significantly reducing the viral burden and limited inflammation in the lungs for all three subvariants.

Recommendations for Industry

Trends Indicate Slight Nudge (not surge) in U.S. COVID Cases

As expected with the increased COVID Omicron BA.2 cases in the UK and Europe, both TAG’s weekly COVID matrix and news articles are showing a slowing in the rate of declining cases in the US, with a slight uptick of cases in the Northeast. If the trend continues as has been seen in the past, we expect this uptick to continue from the Northeast to the East Coast to the Midwest to the West.

We do not, however, expect there to be a surge in cases, rather a slight “nudge” upward. In that, we are in agreement with Dr. Anthony Fauci, who stated, “The bottom line is we’ll likely see an uptick in cases … Hopefully we won’t see a surge — I don’t think we will.” Much of this expectation is due to the level of immunity the population has already attained from vaccination as well as the large outbreak during the winter Omicron wave. Additionally, even with CDC’s estimates that BA.2 caused about 35% of cases in the US last week, there has not been a significant impact on severe illness, hospitalizations or deaths.

Even with this nudge in cases, TAG is not suggesting any deviation from our current recommendations in managing the virus. We are not advising any changes in policy. Just hold to the course we’re on and continue monitoring community rates and workplace symptoms.

Risk Matrix:

There are currently 2 states (Alaska and Idaho) that, while their TPRs are below 10%, their case rates are still above 25 cases/100K.

• Alaska (TPR: 7%; Case Rate: 29 cases/100K)
• Idaho (TPR: 3%; Case Rate: 32 cases/100K)

In Case You Missed It:

• In Tuesday’s Recommendations for Industry, we had a short discussion on increasing influenza cases around the US and also how COVID-19 is trending across the country. Read more here.
• The WHO is encouraging countries, “especially those that have received the multiplex influenza and SARS-CoV-2 reagent kits from GISRS, to conduct integrated surveillance of influenza and SARS-CoV-2 and report epidemiological and laboratory information in a timely manner to established regional and global platforms” (WHO).
• Recent research published in JAMA has found that “alcohol-related deaths increased by 25% in the United States during the first year of the COVID-19 pandemic,” with deaths caused by alcohol overdoses also increasing by ~26% (CIDRAP).
• Even those with “less severe or asymptomatic forms” of COVID-19 infection had a greater likelihood of developing Type 2 diabetes (Washington Post).
• As the BA.2 COVID-19 subvariant may be rising, the FDA will be meeting on April 6, 2022, to discuss future booster shots as well as Pfizer and Moderna’s 4^th booster dose. Additionally, “AstraZeneca today said its antibody preventive treatment Evusheld retains neutralizing antibody activity against the BA.2 subvariant, as well as the Omicron variant” (CIDRAP).
• From CIDRAP, “The estimated overall accuracy of a second COVID-19 rapid antigen test among asymptomatic New York City workers was 94% in a comparative effectiveness study published late last week in JAMA Network Open. The study authors noted that while the gold-standard diagnostic test for COVID-19 is real-time quantitative polymerase chain reaction (RT-qPCR), rapid antigen tests are often used to screen asymptomatic populations because they produce results faster and are less expensive.”

Influenza:

• There are continuing reports of rising flu cases in France, Latvia, and the US as COVID protocols are relaxed.
• Within the US, influenza activity is increasing in most of the country. Influenza activity is high in Oklahoma and Arkansas. Levels are moderate in Idaho. 
• From the WHO: The WHO Consultation and Information Meeting on the Composition of Influenza Virus Vaccines for Use in the 2022-2023 Northern Hemisphere Influenza Season was held on 21-24 February 2022 in Geneva, Switzerland. The recommended composition of influenza virus vaccines for use in the 2022-2023 northern hemisphere influenza season can be consulted here.

Food Safety & Public Health:

• Health officials in Ukraine worry about a surge in other infectious diseases: polio, cholera, and measles.  Historically, Ukraine had low vaccination rates against these diseases.
• There is a norovirus outbreak in the Vancouver area linked to locally sourced oysters.