2022-23 U.S. Seasonal Influenza Vaccine Overview

Key Points:

COVID

1. In today’s Recommendation for Industry, we discuss 2022-23 U.S. Seasonal Influenza Vaccine Overview. Read more below.
2. Paxlovid, molnupiravir benefit older COVID-19 patients, 2 studies show. One from Israel suggesting that nirmatrelvir-ritonavir (Paxlovid) reduced rates of hospitalization and death in people 65 years or older, and research from Hong Kong demonstrating that Paxlovid and molnupiravir lowered rates of death, disease progression, and the need for supplemental oxygen in older hospitalized patients. Within the US, the FDA has granted emergency use of oral Paxlovid and molnupiravir for treatment of patients with mild or moderate COVID-19 at high risk for severe illness within 5 days of symptom onset.
3. mRNA COVID vaccines protect against severe Omicron for at least half a year. Researchers at the National Centre for Infectious Diseases in Singapore studied the effectiveness against infection and severe illness of two or more doses of the Pfizer/BioNTech or Moderna mRNA COVID-19 vaccines or the inactivated Sinovac, CoronaVac, or Sinopharm Chinese COVID-19 vaccines in 2,441,581 residents aged 30 years or older from Dec 27, 2021, to Mar 10, 2022. Among the 2,441,581 participants, 319,943 (13.1%) tested positive for COVID-19, and 1,513 (0.4%) were severe infections. Estimated vaccine effectiveness (VE) of an mRNA booster against Omicron infection was 31.7% to 41.3% after 15 to 60 days and waned rapidly over time. Estimated mRNA booster VE against severe COVID-19 was 87.4% and didn’t wane for up to 6 months. The estimated VE of three doses of inactivated vaccine against severe illness was 69.6%.

Monkeypox

1. Monkeypox epicenter moves from Europe to Americas. Monkeypox transmission has dropped in Europe, was the initial epicenter of the current outbreak, but now cases are rising in the Americas, making the region the hot spot. As of Aug 22, 41,664 laboratory-confirmed cases of monkeypox and 12 deaths have been reported to the WHO from 96 countries and territories. The average age of monkeypox case-patients is 36, and 98.2% of cases worldwide are in men. Among all cases with sexual identity information provided, 95.8% identify as men who have sex with men (MSM). Sexual transmission was noted among 82.1% of cases, with 60.6% of case-patients likely exposed in a party setting with sexual contacts. The Centers for Disease Control and Prevention (CDC) yesterday reported 694 new US case, raising the national total to 18,101. Four pediatric cases were reported in the country last week, including a child from California and 3 from Georgia. The Food and Drug Administration (FDA) earlier this week warned that fecal microbiota transplant (FMT) donors should be screened for monkeypox, as rectal swabs show the presence of the virus.
2. CDC survey shows changing sexual behaviors in light of monkeypox. Half of US men who have sex with men (MSM) are changing their sexual behaviors because of the monkeypox outbreak, according to a new survey conducted by the Centers for Disease Control and Prevention (CDC) and published today in Morbidity and Mortality Weekly Report (MMWR). From Aug 5 to Aug 15, 824 men MSM completed an online survey on sexual behavior, and 48% reported reducing their number of sex partners, 50% reported reducing one-time sexual encounters, and 50% reported reducing sex with partners met on dating apps or at sex venues since learning about the monkeypox outbreak. Of the survey participants 1 in 5 said they had received at least one dose of the Jynneos monkeypox vaccine. Vaccine uptake was highest among Hispanic or Latino men (27.1%), and lowest among Black men (11.5%).
3. HHS announces $11 million to speed up monkeypox vaccine production. The US Department of Health and Human Services (HHS) announced that it will provide about $11 million to support the first US-based fill-and-finish effort of Bavarian Nordic’s monkeypox vaccine. The support will allow production to begin later this year, months ahead of the 9-month timeline typical for starting up fill-and-finish operations. In July, HHS placed orders for 5 million vials of Jynneos from its earlier bulk vaccine order stored in Denmark. And as part of the contract, Bavarian Nordic agreed to a technology transfer that would allow a US-based contract manufacturer to fill and finish 2.5 million Jynneos vials.

Food Safety & Public Health

1. Patient count in outbreak linked to Daily Harvest frozen food continues to climb. The number of people with “adverse reactions” to frozen crumbles from Daily Harvest has tripled since the FDA first reported illnesses related to the product in late June. As of Aug. 25, the Food and Drug Administration had received 369 reports of illnesses from consumers. The outbreak is linked to Daily Harvest brand frozen French lentil and Leek crumbles.
2. FAO guidance supports the move to digital food control. The Food and Agriculture Organization of the United Nations (FAO) issued guidance on how to design and implement a food control electronic notification system, taking into account a country’s needs and resources. It covers the system’s legal basis, structure, and operational points, as well as the infrastructure and human resource requirements. E-notification systems facilitate the distribution of information on border rejections and product withdrawals helping authorities, companies, and consumers to take action. However, they require a reliable internet connection, which is not available in every country.
3. Amaranth Grain recalled in 17 states because of Salmonella contamination. Bob’s Red Mill Natural Foods Inc., of Milwaukie, OR, is recalling Bob’s Red Mill brand Organic Amaranth Grain Gluten Free because of potential Salmonella contamination. The product was distributed in California, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, North Carolina, New Hampshire, New Jersey, Nevada, New York, Oregon, Pennsylvania, Texas and Washington, as well as internationally in the Philippines. To find the specific product recalled click here.
4. Hepatitis A cases in Hungary prompt berry mix recall. A berry mix has been recalled across Europe after a number of people were sickened in Hungary by Hepatitis A. Ten to 15 people in Hungary were hospitalized after eating at a restaurant and subsequent testing by a Hungarian laboratory found Hepatitis A in a 2.5-kilogram bag of the berry mix. Ardo’s Fruitberry mix is produced and packed by a subcontractor of the group in Poland. Countries listed in a Rapid Alert System for Food and Feed (RASFF) notification as being sent affected product include Austria, Belgium, Croatia, Germany, Greece, Hong Kong, Ireland, Netherlands, Romania, Spain, Sweden and the United Kingdom.

Recommendations for Industry

2022-23 U.S. Seasonal Influenza Vaccine Overview

With September marking the unofficial beginning of fall, it’s time (already!) to be thinking about flu prevention and protection, including vaccination. As such, CDC has published its annual flu report detailing current information and recommendations. These include three key elements:

1. Recommending September and October as the ideal times for most persons to get vaccinated against the flu, CDC adds that vaccination should continue as long as influenza viruses are circulating, and unexpired vaccine is available. For young children (ages 6 months through 8 years) however, CDC recommends two doses, with the first given as soon as the vaccine is available; for adults >65, it is recommended that a higher dose or adjuvanted influenza vaccine be given.
2. CDC specifies that the composition of 2022–23 U.S. seasonal influenza vaccines is basically two Influenza As (H1N1 and H3N2) and Influenza B. Additionally, updates to the description of influenza vaccines are expected to be available for the 2022–23 season, including one influenza vaccine labeling change that occurred after the publication of the 2021–22 ACIP influenza recommendations.
3. With COVID also expected to continue to circulate in the U.S., the report confirms the safety of receiving the flu and COVID vaccines at the same time.

While a majority of Americans are resuming at least fairly active and social lifestyles amidst the beginning of flu season and continuation of COVID, it is important that workplaces continue to monitor wellness and ensure ill persons stay home. Not only does this help reduce overall spread of the viruses; it helps keep your workforce intact and productive.

In case you missed it:

COVID

1. In last Thursday’s Recommendation for Industry, we discussed the continued trend of Monkeypox and Covid. Read more here.
2. Regular physical activity tied to lower risk of COVID, poor outcomes. At least 150 minutes (2.5 hours) of moderate physical activity—or 75 minutes (1.2 hours) of vigorous exercise—weekly was linked to a lower risk of COVID-19 infection, hospitalization, severe illness, and death during periods dominated by the Beta and Delta variants, according to a systematic review and meta-analysis published. Adults who engaged in moderate physical activity for at least 150 minutes or vigorous exercise for at least 75 minutes per week were at lower risk for COVID-19 infection (-11%), hospitalization (-36%), severe COVID-19 (-44%), and COVID-related death (-43%). The relative risks (RRs) for regular exercisers were 0.89 for infection, 0.64 for hospital admission, 0.66 for severe illness, and 0.57 for COVID-related death.
3. BA.5, BA.4.6 COVID variants continue US expansion. BA.5 now accounts for 88.9% of sequenced samples, up slightly from 88% the previous week. Also, BA.4.6, which first gained traction in the central Midwest, gained more ground and now accounts for 6.3% of sequenced samples, up from 5.3% the week before. The nation’s 7-day average for new daily cases continues to fall slowly and is at 92,602, the lowest since mid-May, according to the New York Times tracker. The 7-day average for new daily deaths is 459. In related news, Pfizer and BioNTech updated its efficacy findings as part of an ongoing phase 2/3 trial of its three-dose primary series for kids aged 6 months through 4 years. Overall, the study suggests 73.2% efficacy, reinforcing initial findings.
4. Moderna files for emergency use of BA.4/BA.5 Omicron booster. Following a similar move made by Pfizer and BioNTech, Moderna has submitted their application for emergency use of their bivalent COVID booster vaccine that targets BA.4 and BA.5 Omicron subvariants. The goal of Moderna is to be able to administer doses in September. In a statement, Moderna said its application is for a 50-microgram booster dose for adults ages 18 and older. It targets the original SARS-CoV-2 strain, plus the Omicron BA.4 and BA.5 subvariants. The Biden administration has signaled that it will offer updated boosters to people ages 12 and older soon after Labor Day, according to the New York Times. In its weekly report on the pandemic, the WHO said cases declined 9% last week, with deaths down by 15% compared to the previous week.

Monkeypox

1. Trials for monkeypox antiviral, fractional vaccine dosing launch. US officials have announced the launch of clinical trials to gauge how effective the antiviral drug tecovirimat (Tpoxx) and how protective the intradermal fractional dose of Jynneos vaccine used to treat monkeypox. The UK study plans for Tpoxx are to enroll 500 or more patients who will either be given a 14-day course of the antiviral (2 daily doses of 600 milligrams) or a placebo. The participants will take the medication at home, and the primary outcome will be the rate at which skin and mucosal lesions heal, and the rate at which throat and lesion swabs test negative for the virus. Twenty-five monkeypox-confirmed patients took oral tecovirimat which was well tolerated by all patients with monkeypox infection, with minimal side effects. Ten patients had complete resolution of lesions by day 7 of therapy, while 23 (92%) had resolution of lesions and pain by day 21. The United States case count is at 15,433 cases, the most of any country in the world.

Food Safety & Public Health

1. Tomato flu outbreak in India spreads to two more states. An outbreak of a new viral infection referred to as tomato flu that was first detected in children in the southern Indian state of Kerala in May has spread to two other states. According to an article in the Lancet Respiratory Medicine, 82 children aged under five had been diagnosed with the virus in Kerala as of 26 July. Scientists are still trying to identify exactly what this virus is. It has been referred to as tomato flu because of the painful red blisters it produces on the body, and it is very contagious. Children are particularly vulnerable because it spreads easily through close contact, such as via nappies, touching unclean surfaces or putting things in mouths.
2. Study finds most EU Salmonella outbreaks involve eggs. Eggs have been identified as the main food source of Salmonella outbreaks throughout Europe, according to a study, pork and general meat products followed. Data from 2015 to 2019 was collected for this study. In total, 1,508 Salmonella outbreaks were included in the analysis. Of these, 1,040 were caused by simple foods and 468 by unknown food sources.
3. Tahini sold at Walmarts nationwide recalled over Salmonella. Rushdi Food Industries, an Israeli-based manufacturer, is recalling certain Mighty Sesame 10.9 Oz Organic Tahini (Squeezable) because of potential Salmonella contamination. The recalled product was distributed to stores located in New York, New Jersey, and Connecticut as well as nationwide stores during the first two weeks of May. Mighty Sesame 10.9 oz Organic Tahini (Squeezable) with a UPC code of 858313006208 and an expiration date of March 28, 2023, is the product being recalled.
4. Romaine on Wendy’s sandwiches linked to multistate E. coli outbreak. Thirty-seven individuals have been deemed ill from romaine lettuce associated with Wendy’s. These people are in four different states: Michigan, Ohio, Pennsylvania, and Indiana. Investigation of this outbreak is still ongoing.
   1. Since this is an evolving outbreak, case numbers are being collected and tallied by several sources and may not completely agree. Throughout the investigation of romaine lettuce associated with Wendy’s sandwiches, there is an increasing gap of patients being reported by state and federal services. The CDC has recorded a total of 37 individuals infected while the Michigan Department of Health and Human Services has confirmed 53 patients. Ohio has confirmed 22 cases when the CDC has only 19 reported from the state. Several patients in both Ohio and Michigan have been diagnosed with the hemolytic uremic syndrome (HUS), which is a type of kidney disease that often requires dialysis and sometimes results in kidney transplants and death.