TAG’s Take on FDA’s New Vaccine Booster EUA

• In today’s Recommendations for Industry, we discuss TAG’s perspective on FDA’s new vaccine booster EUA. Read More Here.
• Johnson and Johnson report that a second does of their J&J vaccine substantially increased their protection against COVID-19, with two doses delivering “94% efficacy against mild to severe COVID-19 in the United States” which is “up from 74 percent” with just one shot! Additionally, J&J’s protection is showing little signs of waning since the first dose.
• The American Academy of Pediatrics (AAP) has announced that children currently represent about 26% of all COVID-19 cases, with nearly 226,000 children indicating that they have COVID-19 in the past week alone!
• The UN will discuss COVID-19 vaccine inequity, today (AP). During the General Assembly Meeting, President Biden has pledged another 500 million Pfizer vaccine doses to lower-and middle-income countries.
• HIV is likely to be another aspect of COVID-19 issues raised in Africa. With the high rate of immunocompromised individuals can also increase the amount of time COVID-19 stays within the body giving the virus more chances to mutate and potentially creating more variants!
• The British government announced new incoming vaccination/quarantine rules for vaccinated individuals; however, as it’s separated by country, it has caused confusion and outrage. There is also fear that it can lead to more vaccine hesitancy.
• The Mormon Church has announced that all those in temples should be wearing a face mask ‘at all times’.

Food Safety & Public Health:

• A recent study has found that consumer attitudes towards GMOs can change and anti-GMO attitudes can “decrease significantly when they are continuously exposed to a science-based message by a trusted organizational body”.
• There are some really cool agriculture technologies that have come up! Ag Funder News reports on many types of technologies while also discussing Cargill, Nestle, and Heineken’s new regenerative agriculture programs. Additionally, Ford and Walmart are working together for autonomous food delivery tech.
• The FDA has announced the new “Office of Digital Transformation”.

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TAG’s Take on FDA’s New Vaccine Booster EUA

On Wednesday the FDA amended its emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose at least six months after the second dose for certain groups considered to be at higher risk.

Those groups include those who are:

• 65 years of age and older.
• 18-64 years old at high risk of severe COVID-19.
• 18-64 years old “whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.”

It is the third group that has caused the most question and discussion, as Acting FDA Commissioner Janet Woodcock, M.D. explained that the update would “allow for a booster dose in certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others.”

This third group tends to include workers who have contact with symptomatic patients, the general public where masking practices vary and where customers may be symptomatic, and groups who still cannot be fully vaccinated.  A third dose of the Pfizer vaccine will boost the level of circulating antibodies in a person’s immune system and can offer extra protection against symptomatic and severe infection as the Delta surge crests in the U.S.

Based on this announcement, we’re likely to see more specific guidance from the FDA and CDC in coming weeks, and TAG encourages individuals to consider their personal situation, including risk of exposure and underlying health conditions to determine if a booster dose is necessary.  Employers can also consider the layered risk mitigation measures they have in place when determining if their employees are at a greater risk of exposure and should consider a booster dose.

If you or your employees have questions on the booster – or vaccines or COVID-19 in general, please contact TAG. We would be happy to consult with you or provide a Townhall for your company.

50-State Risk Matrix, updated September 21, 2021

This week 27 states have a TPR > 10% and case rate >25 cases/100K. Idaho’s TPR is at 22%, with Tennesse at 19% and South Dakota at 18%. Other states like Mississippi and Oklahoma have a Test Positive Rate at 17%. On the other hand, states like 21 states have a TPR 25 cases/100K.

Case rates, though, have risen slightly across the majority of states. States with a case rate >100 cases/100K people include Alaska (101 cases/100K), Tennessee at 109 cases/100K, and West Virginia at 102 cases/100K. Similarly, Kentucky’s case rate is at 98 cases/100K and South Carolina’s case rate is also 98 cases/100K. While we had seen a drop (last week) in case rates – many states finally below 100 cases/100K, that seems to risen up again.

Yet as case rates are rising, Test Positive Rates and Rts have mixed rise/falls, too!

Additionally, while case rates have risen across the country (week-over-week), we do continue to see those states with higher rates of vaccination having lower case rates than those with lower rates of vaccination.

• In this Tuesday’s Recommendations for Industry, we discuss answers to Flu vaccine questions. Read More Here.
• The FDA has approved Pfizer’s COVID-19 booster for seniors and those within high-risk groups to be given 6 months after the second dose.
• While all three approved COVID-19 vaccines in the U.S. are protective against COVID-19 hospitalizations, Moderna has shown to be the most effective (93%) at preventing hospitalization while Pfizer is at 88% and J&J vaccine at 71%.
• A study published in JAMA has found that allergic reactions to the mRNA COVID-19 vaccines are rare, in fact “serious allergic reaction[s] that require hospitalizations [are at a rate of] 1 in 4.7 million vaccinations for Pfizer and 1 in 2.5 per million for Moderna”. Of the 22 allergic reactions, 20 allergic reactions were in women, wherein 15 had a history of allergies to either antibiotics, foods, and other forms of medications.
• Starting in November, the Biden administration will lift travel restrictions for fully vaccinated foreign travelers into the United States. International travelers into the U.S. “will need to show proof of vaccination before boarding and a negative coronavirus test within three days of coming to the United States” while unvaccinated Americans who want to travel back to the U.S. from abroad will, “need to test negative for the coronavirus one day before traveling to the United States and show proof that they have bought a test to take after arriving in the United States”.
• Pfizer’s COVID-19 vaccine is demonstrating a strong immune response in children between 5 to 11 years old.
• Published in CDC’s MMWR last week, long COVID is most likely to occur in those 40 years and older, women, and those with at least one underlying health condition.

Seasonal Flu:

• The World Health Organization’s September 13 influenza update has found that worldwide influenza A and B viruses are being detected in similar proportions; however, activity remains at lower levels than expected for this time of the year.
• In the US, flu cases were lower this past week than last.

Food Safety & Public Health:

• There is a quickly growing Salmonella Oranienburg outbreak linked to an unknown food source that has sickened 127 people, some at home and some at restaurant clusters.
• The coli cake mix probe has also ended.
• OSHA has announced enhanced, expanded measures to protect workers from hazards of extreme indoor and outdoor heat. OSHA is implementing an enforcement initiative on heat-related hazards, developing a National Emphasis Program on heat inspections, and launching a rulemaking process to develop a workplace heat standard. In addition, the agency is forming a National Advisory Committee on Occupational Safety and Health Heat Injury and Illness Prevention Work Group to provide better understanding of challenges and to identify and share best practices to protect workers.” They will a) prioritize heat-related complaints; b) instruct compliance safety and health officers; c) expand the scope of other inspections to address heat-related hazards.