Vaccine Mandate and Booster Updates

• In today’s Recommendations for Industry, we provide updates on the vaccine mandate and boosters. Read more below.
• Canada’s government announced last Thursday that it has lifted the “global advisory asking Canadians to avoid non-essential travel outside the country”; however, it still discourages and advises against cruise ship travel.
• U.S. pharmacies and doctors are now facing new challenges as booster shot expansions begin to roll out. Some challenges include helping “people understand whether they are eligible” or not, along with the type of vaccines they can receive. Additionally, “other challenges medical providers will contend with include reaching marginalized groups, including homeless people and migrant workers, who may have received the Johnson & Johnson vaccine when it was only meant as a single-dose option, and making sure that people receive the correct dose of a Moderna booster.”
• The CDC has recently placed two countries in its list of “very high” risk for travel destinations, including Ukraine and Singapore.
• The U.S. will be rolling out “a new travel system in two weeks that will open borders up for millions of vaccinated international visitors.” The system will launch November 8^th; for unvaccinated U.S. citizens and permanent residents, travel back to the U.S. will need to be followed by “documentation of a negative [COVID-19] test within one day of departure.” Individuals with documentation of full vaccination are fine.
• Moderna has announced that its COVID-19 vaccine produces a strong immune response in children aged 6 to 11 with antibody levels “that were 1.5 times higher than those seen in young adults.” These results aren’t published or released yet, though.
• A new study from Mount Sinai has shown that “patients experiencing post-acute COVID syndrome (PACS, also known as “long COVID”) may have symptoms for at least 12 months after initial COVID-19 infection, significantly and negatively impacting their cognition, ability to work, participation in physical activity, interaction with others, and overall quality of life.”
• Today, the FDA will consider Pfizer’s COVID-19 vaccine for young children (5 – 11 years old) for EUA.

Flu Status:

• WHO:
  • Globally, despite continued or even increased testing in some countries, influenza activity remained at lower levels than expected for this time of the year.
  • In the temperate zones of the southern hemisphere, influenza activity remained at inter-seasonal levels, although a slight increase in influenza A and B detections was reported from South Africa.
  • Worldwide, influenza B (Victoria) viruses predominated.
• CDC:
  • The Key Update for Week 41 (ending October 16, 2021) finds “seasonal influenza activity in the United States remains low.” Only 0.1% of all specimens tested this week were positive, with an almost even split of Influenza A (47%) and B (53%).

Public Health & Food Safety

• To add to the current Salmonella associated with onion outbreak, onions connected to the outbreak have been sold in Ontario and Quebec and are being recalled. Green Giant is also recalling their onions for potential contamination as they had sourced their onions from ProSource Produce LLC.
• Walmart’s Gardens-branded Essential Oil infused Aromatherapy Room Spray with Gemstones “Lavender & Chamomile” scent has been linked to four recent Burkholderia pseudomallei infections that can be deadly. If you currently have this product, please see the article for what to do.
• UC Davis has received a $10M grant to “develop climate change adaptation strategies for groundwater and irrigated agriculture. Researchers will develop tools to help growers meet goals of California’s Sustainable Groundwater Management Act.”
• The USDA has appointed 13 new members to its National Advisory Committee on Microbiological Criteria for Foods.

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Vaccine Mandate & Booster Updates

The unofficial word on the street is that we are likely to see the OSHA emergency temporary standard (ETS) on the vaccination/testing mandate published by the end of the week. If so – or whenever it publishes – TAG will do a deep dive of the standard to provide our perspectives and recommendations.

On the officially stated side of the coin, FDA not only authorized Moderna and Johnson & Johnson boosters last week, but also authorized the “mix and match” of the Pfizer, Moderna, and J&J vaccines as boosters following the eligibility criteria for each (below). TAG recommends that individuals interested in getting a booster vaccine different than the one originally administered should consult with their health care provider, particularly in relation to side-effect potential.

Eligibility criteria includes:

• The Moderna or Pfizer booster may be administered at least 6 months after completion of the primary series to individuals:
  • 65 years of age and older
  • 18 through 64 years of age at high risk of severe COVID-19
  • 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
• The J&J booster may be administered at least 2 months after completion of the single-dose primary regimen to individuals 18 years of age and older.

• In last Thursday’s Recommendations for Industry, we discussed TAG’s Weekly COVID-19 Matrix, U.S. and global hotspots, continued masking, and vaccine booster shots. Read more here.
• The FDA has authorized Moderna and J&J booster shots. Additionally, they are allowing for the mixing and matching of different COVID-19 vaccines [NYT].
• French pharmaceutical company, Valneva’s COVID-19 vaccine has demonstrated good performance in Phase 3 trials, with a seroconversion rate above 95% and is outperforming the AstraZeneca vaccine. This vaccine uses an inactivated whole virus.
• As Moderna has “reiterated on several occasions that they will not enforce their intellectual property during the pandemic,” the WHO has hired Afrigen Biologics and Vaccines to “figure out how to make an mRNA vaccine against COVID that is as close as possible to the version produced by Moderna” as there is increasing promise that mRNA vaccines can be effective against malaria and tuberculosis. [NPR]
• The WHO reports that last week, Europe was the only region with rises in COVID-19 cases, about a 7% rise (ABC News). The UK currently has one of the highest COVID-19 infection rates right now, owing to a variety of reasons including “half-hearted mask adoption [and] large indoor gatherings.” Additionally, it is speculated that the UK’s hesitation in vaccinating younger teenagers and its early vaccination rollouts may also be contributing (CNBC). There is a potential new COVID-19 Delta variant; it is currently being closely watched as it accounts for about 6% of all UK cases, at this time (BBC). Additionally, Latvia is now the first country to “reimpose lockdown in Europe’s new COVID wave” (The Guardian).
• The CDC Director has announced that there is “no evidence a new sub lineage of the Delta variant is having any significant effect in the United States.” Additionally, there is currently no evidence indicating that the subvariant would impact vaccine and therapeutics effectiveness. [CNN]
• A new CDC MMWR has found that 2 doses of the Pfizer vaccine is “93% effective at preventing COVID-19 hospitalizations among 12 – 18 years old.” Read the full report here.

Public Health & Food Safety

• Recent experiments conducted in Norway have found that common medications can alter flu virus activity. Medications with ingredients like atorvastatin, candesartan, and hydroxocobalamin may alter viral interaction with our cells. As the research explains, “Some of the medicines amplify the effect of viruses in the cells, while others dampen them. The response depends on the target of the drugs in our cells. If the drug target is important for the spread of the virus, we can curb virus activity. But if the target of the medicine is part of the immune system that protects us from viruses, and we inhibit it with the medicine, the virus activity can increase.”
• This time the USDA is serious about reducing Salmonella illness by 25%, in accordance with the Health People 2030 plan.
• Public health is facing a crisis across the U.S.; read more on why and how.