- In today’s Recommendation for Industry, we discuss what it means to be up to date in COVID vaccinations. Read more below.
- CDC Recommends the First Updated COVID-19 Booster. The CDC is recommending the COVID-19 boosters from Pfizer-BioNTech for people ages 12 years and older and from Moderna for people ages 18 years and older. These updated boosters add Omicron BA.4 and BA.5 spike protein components to the current vaccine composition to restore protection that has waned since previous vaccination by targeting variants that are more transmissible and immune evading. In the coming weeks, CDC also expects to recommend updated COVID-19 boosters for other pediatric groups, per the discussion and evaluation of the data by ACIP on Sept. 1, 2022.
- Study finds Omicron hospital risk 10 times higher in unvaccinated. After the emergence of the Omicron variant, the rate of COVID-19 hospitalizations in the United States was 10.5 times higher in unvaccinated adults and 2.5 times higher in those who were vaccinated but received no booster than in booster recipients, according to a new study. Monthly COVID-19 hospitalization rates were 3.5 to 17.7 times higher in unvaccinated patients than in their vaccinated counterparts, regardless of whether they had received a booster. Hospitalization rates were 10.5 times higher in the unvaccinated and 2.5 times higher in vaccinated patients with no booster than in booster recipients.
- COVID markers decline as US faces uncertain fall. Most US COVID-19 markers continue to indicate slow downward trends, with 7-day averages for cases, hospitalizations, and deaths all decreased from the week before, the Centers for Disease Control and Prevention (CDC) said in its last weekly update. The CDC has urged people getting the updated booster to get vaccinated against flu at the same time. The 7-day average for new daily fatalities dropped 28.1% compared to the previous week, to about 315 a day. As of Sep 7, the 7-day average for new daily COVID-19 cases, at 70,488, has decreased 18.8% compared to the week before.
- Study raises questions on dose-sparing monkeypox vaccine approach. Dutch researchers published a preprint study done on neutralizing antibodies produced by two subcutaneous doses of Bavarian Nordic’s monkeypox vaccine, Jynneos, and it indicated the dose-sparing strategy might not yield a very strong immune response. Subcutaneous, or intradermal, dosing is being employed in the United States as a way of using one-fifth the usual vaccine dose, thereby allowing many more people to get vaccinated using the same vaccine supply. Officials hoped the strategy would provide the same level of protection as a full Jynneos dose. Researchers most notably pointed out that results show almost no neutralizing antibodies 4 and 8 weeks after vaccination in those who received the first of the advised 0.5-milliliter doses.
- FAQs on Testing for Monkeypox: On September 9, the FDA published a list of frequently asked questions on testing for Monkeypox in order to address the public health emergency. Those can be found here.
- Tpoxx found to be well-tolerated, safe in US monkeypox patients. In Morbidity and Mortality Weekly Report, researchers from the Centers for Disease Control and Prevention (CDC) provided data on safety outcomes on 369 patients who received the monkeypox antiviral drug tecovirimat (Tpoxx), noting that few adverse events were reported. Of the 369 patients in the study who were administered Tpoxx orally, adverse events were reported in 3.5% of patients, with only one adverse event classified as serious. In Los Angeles County there is an investigation of a death in a monkeypox patient- this is the second case in the US. Globally, the WHO said in a new epidemiologic report that there have been 18 deaths globally.
Food Safety & Public Health
- FDA Announces Targeted Sampling, Additional Efforts to Enhance the Safety of Leafy Greens. Over the last several years, the FDA and partners in the public and private sectors have worked to enhance the safety of leafy greens through the development and implementation of the Leafy Greens STEC Action Plan (LGAP). This work includes prioritized inspections, focused sampling, stakeholder engagement and collaboration, data sharing, root cause investigations, and advancements in the science of detection and prevention. Prevention, Response, and Addressing Knowledge Gaps are the main focuses of this approach as well as accomplishments that have been made since the action plan launched in March 2020- these can be found here.
- FDA announces targeted leafy green sampling in the Salinas Valley. The U.S. Food and Drug Administration has announced targeted sampling of leafy greens grown on farms and ranches during the fall 2022 harvest season in the Salinas Valley region of California, releasing results from a 2021 sampling assignment, and providing an update on other work under the action plan. During the fall 2022 harvest season, the FDA plans to collect about 240 lettuce samples from farms and ranches in the Salinas Valley. All samples will be tested for Salmonella spp. and E. Coli O157:H7 and sampling will begin in mid-September and run through October.
- Starbucks Espresso drink recalled over metal fragments in product. PepsiCo Inc is recalling certain Starbucks Vanilla Espresso Triple Shot beverages because of possible contamination by foreign material, specifically metal fragments. The recalled products are in Arkansas, Arizona, Florida, Illinois, Indiana, Oklahoma, and Texas.
- Abbott recalls certain Similac formula over packaging defects. Abbott Nutrition is recalling certain Similac bottles of formula over a packaging defect. This product was distributed in Michigan and Ohio. Specifics on the recalled products can be found here.
- Public alert warns against HelloFresh meal kits linked to new E. Coli outbreak. Federal officials have reported a new outbreak of E. Coli 0157:H7 linked to ground beef in HelloFresh meal kits. No recall is being issued because the product is believed to not be for sale any longer. But the USDA has recommended that if you still have this product at home to throw it away and do not consume it.
Recommendations for Industry
Stay Up to Date on CDC’s Definition of Up to Date
Just as COVID vaccines continue to evolve, so too does CDC’s definition of “up to date” in vaccinations, with the most recent definition posted on Sept. 8 detailing up to date for those 12 and older as having all primary series doses and an updated bivalent booster. Specifically, up to date means:
- Ages 6 months-4 years: all COVID-19 primary series doses.
- Ages 5-11: all primary series doses and the original (monovalent) booster.
- Ages 12-17: all primary series doses and one updated Pfizer bivalent booster
- Ages 18 and up: all primary series doses and one updated Pfizer or Moderna bivalent booster.
- Those who are immunocompromised have different recommendations for vaccines and boosters.
In contrast to the original monovalent boosters, the updated bivalent boosters target both the most recent Omicron subvariants, BA.4 and BA.5, and the original SARS-CoV-2. Because of this difference, they are not yet approved for all ages.
A few additional notes from CDC include that a person who has received the primary series but is not yet eligible for a booster is considered to be up to date. And getting a vaccine after recovering from COVID will provide added protection.
While these are CDC current recommendations, the definition of up to date has become a moving target as CDC data monitoring and vaccine development continues to evolve.
In case you missed it:
- In last Thursday’s Recommendation for Industry, we discussed the positive trajectories of COVID and monkeypox. Read more here.
- COVID-19 may have orphaned 7.5 million kids worldwide. Worldwide, about 10.5 million children may have lost parents or caregivers to COVID-19 and 7.5 million were orphaned, according to a 0new study that estimated excess mortality using World Health Organization (WHO) data. The greatest numbers of orphaned children were in Africa (24.3%) and Southeast Asia (40.6%) WHO regions and the least in the Americas (14.0%), Eastern Mediterranean (14.6%), European (4.7%), and Western Pacific (1.8%) regions.
- Global COVID-19 cases continue to fall. For the fourth week in a row, WHO has reported a decline of COVID-19 cases at the global level. Last week cases dropped by 12% compared to the week previous. Of about 4.2 million cases reported last week, the five countries with the most cases were Japan, the United States, South Korea, Russia, and China. Overall deaths also declined last week, falling 5% compared to the week before. However, three regions reported rises: Africa, the Americas, and the Western Pacific. Over the past 2 weeks, the proportion of the Omicron BA.5 variant increased its dominance, from 84.8% to 86.8%, the WHO said. Though US COVID cases continue to fall, illnesses in children last week rose for the second week in a row, according to the latest update from the American Academy of Pediatrics. About 90,600 infections in kids were reported, up 14% from 2 weeks ago.
- Monkeypox Update: FDA Takes Significant Action to Help Expand Access to Testing. The U.S. Food and Drug Administration is announcing steps to further increase monkeypox testing capacity and accessibility nationwide as part of its continued commitment to addressing the ongoing outbreak. The FDA issued guidance that outlines the agency’s current thinking regarding enforcement policies, recommendations for emergency use authorization (EUA) requests for monkeypox diagnostic tests, and the FDA’s plans to prioritize review of EUA requests. As explained in the guidance, the FDA does not intend to enforce requirements for certain tests developed by laboratories that are used without submission of an EUA request where they are appropriately validated and the laboratories notify the FDA within 30 days, among other things. The agency’s intent is to facilitate the development of additional tests to address local availability and accessibility concerns not addressed by current testing capabilities. In addition to the FDA’s guidance, the agency issued the first EUA for a monkeypox in vitro diagnostic. The Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR is intended to detect monkeypox and other non-variola orthopoxvirus DNA using lesion swab specimens.
- Downward monkeypox trends continue in Europe, Americas. Currently, the global total stands at 55,470 cases reported in 100 countries. The Centers for Disease Control and Prevention (CDC) reported yesterday 771 more monkeypox cases, raising the nation’s total to 20,733. Today, Reuters reported the European Union secured an additional 170,920 doses of Bavarian Nordic’s monkeypox vaccine, doubling its supply. The doses will be delivered to the European Union by the end of the year. In related news, the US Department of Health and Human Services (HHS) announced today a $20 million contract with AmerisourceBergen to expand and speed distribution of monkeypox vaccine and treatment. According to HHS, the move allows up to 2,500 shipments per week of frozen Jynneos vaccine and up to 2,500 ambient temperature shipments per week, which can be used for Tpoxx distribution.
Food Safety & Public Health
- Legionella identified as source of Argentina’s deadly pneumonia cluster. Over the weekend, Argentinian health officials announced that Legionella was isolated from samples from four people infected in an unexplained cluster of bilateral pneumonia at a hospital that triggered fears of a possible outbreak of a new pathogen. They said the Legionella bacteria were still being subtyped, but they suspect it is Legionella pneumophila. All of the patients with confirmed infections have connections to the hospital. Of the 11 cases and 4 deaths covered in the WHO statement, 8 involved healthcare workers and 3 involved patients.
- FDA Advises Parents and Caregivers Not to Buy or Give Mother’s Touch Formula to Infants. The FDA is advising parents and caregivers to not buy or give Mother’s Touch Formula to infants under their care. The product is being marketed as an infant formula without the required pre-market notification of the FDA, and it does not meet infant formula nutrient requirements for seven nutrients. If you have purchased this product, the FDA has recommended you discontinue using it or throw it away. If you have used this product and are concerned about your child’s health as a result, contact their health care provider.