COVID Mitigation Continues with Booster Guidance and Antivirals

• In today’s Recommendations for Industry, we discuss COVID post-infection antiviral medication trials that are nearing completion. Read more below.
• Viruses limited by COVID-19 restrictions may arise again this fall, including “common respiratory viruses” like the common cold!
• The CDC has released “Who is Eligible for a COVID-19 Booster Shot.” Booster shots are available for anyone who received the complete series of Pfizer vaccines at least 6 months ago. (See article below for a detailed list.)
• S. COVID-19 cases drop for the first time in 3 months since the start of the summer’s fourth wave that was driven by the Delta variant.
• A recent MMWR reports that, “S. counties without school mask requirements saw pediatric COVID-19 cases increase nearly twice as fast in the 2 weeks after schools reopened than counties with mask mandates.”
• COVID-19 hospitalization rates are tied to poverty and race. While White, Black, and Hispanic populations living high-poverty census areas were more likely to be hospitalized, Black and Hispanic populations had much higher rates of hospitalization. Additionally, “33.1% of hospitalized patients were in the highest quartile of service industry workers, 30.8% were in the highest quartile of public transportation commuters, and 30.0% were in the highest quartile of people 25 years or older who didn’t have a bachelor’s degree.”
• Life expectancy has fallen in 27 of 29 nations. Higher death rates were linked to those 60 in Europe.
• There is research now, through companies like Merck and Pfizer, to develop an anti-COVID pill. This research is being conducted in various countries including the US and Israel.
• While daily cases rise dramatically to new highs in Russia (NYT), the potential new U.S. travel rule may exclude fully vaccinated Russians (and others) who have been fully vaccinated with Russia’s Sputnik V vaccine (Washington Post).
• Multisystem inflammatory syndrome in adults (MIS-A), similar to the multisystem inflammatory syndrome in children (MIS-C), is also rare and also difficult to diagnoses in adults! It can begin roughly 4 weeks after COVID-19 symptoms onset; however, it appears similar to other coronavirus-related inflammation events.

Seasonal Flu:

• The WHO is recommending that two strains for the Southern Hemisphere’s 2022 flu season be switched out and replaced. The Northern Hemisphere’s flu vaccine will be different than the Southern Hemisphere’s upcoming vaccine.
• Global influenza surveillance still finds relatively lower numbers than usual, though Influenza A & B are being detected at similar proportions.
• In the U.S., states like Nevada and Ohio are showing moderate influenza activity levels; however, cases still remain low.

Food Safety & Public Health:

• Cilantro has been identified as the potential source of the recent Salmonella Oraneienburg outbreak that has sickened almost 300 people across 29 states.
• Drug-resistant malaria has been identified in Africa. Read more on CIDRAP.
• Bacillus cereus in dairy products is difficult to estimate; however, preventive controls are necessary to continue to keep it under control. Global increases in dairy consumption necessitate using novel analytical methods to detect spores and more.
• There is a renewed warning about Salmonella infected through an outbreak linked to feeder rodents.

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COVID Mitigation Continues with Booster Guidance and Antivirals

CDC Updates COVID Booster Guidance. The CDC has released an update on individual eligibility for the COVID-19 “booster shot.” The official guidance from both CDC and FDA states that individuals should stay with the vaccine they initially received for booster doses. The update specifically states that the Pfizer “booster” is available for those who received the complete series of Pfizer vaccines at least 6 months ago who are:

• 65 years and older
• 18+ who have underlying medical conditions
• 18+ who work in high-risk settings
• 18+ who live in high-risk settings

The CDC further defines those in high-risk settings to include:

• First responders (healthcare workers, firefighters, police, congregate care staff)
• Education staff (teachers, support staff, daycare workers)
• Food and agriculture workers
• Manufacturing workers
• Corrections workers
• S. Postal Service workers
• Public transit workers
• Grocery store workers

When going to one’s booster appointment, bring the vaccination card you originally received.

Moderna and J&J are also submitting packages for FDA authorization for booster doses, but individuals who received these vaccines and feel the need for a supplemental shot should talk with their health care provider for advice.  Because the Pfizer vaccine is licensed and approved by the FDA, healthcare providers are now allowed to prescribe the vaccine “off-label.”

COVID Fight Also Turning to Antiviral Medications. While vaccines and masking continue to be critical in the fight against COVID, there are now international efforts underway to develop and test antiviral treatments to reduce symptoms, severity, and length of the virus after a person is infected. Similar to Tamiflu, used to reduce the risks and duration of influenza, the COVID antivirals are given early upon exposure and diagnosis to fight the virus; they also have the potential to limit household transmission.

An article from Kaiser Health News discusses three “promising” antivirals being tested in clinical trials, with results expected by winter. They include “top contender” molnupiravir from Merck & Co. and Ridgeback Biotherapeutics, PF-07321332 from Pfizer, and AT-527 from Roche and Atea Pharmaceuticals. Each would be prescribed as pills to be taken for 5 to 10 days after diagnosis.

Remdesivir is the only antiviral approved for COVID treatment thus far, but it is intended for hospitalized patients, not early treatment; and the new medications would be prescribed as pills to be taken for 5 to 10 days, rather than intravenously as remdesivir is.

If the trials have positive results, the medications will be submitted to FDA for emergency use authorization or full approval, at which time the Biden Administration will procure approximately 1.7 million courses of Merck’s molnupiravir, as announced in June. The administration also is investing more than $3 billion to accelerate the discovery, development and manufacturing of antiviral medicines to develop the next generation of COVID-19 treatments.

TAG has long considered the missing element in the COVID fight to be post-diagnosis medications to reduce the impact, and potentially the transmission, of the virus. We look forward to the continuance of the trial, FDA authorization or approval, and wide availability of antivirals – and will continue to keep you informed as information is provided.

• In last Thursday’s Recommendations for Industry, we discussed TAG’s perspective on FDA’s new vaccine booster EUA. Read More Here.
• Johnson and Johnson report that a second dose 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.”