- In today’s Recommendation for Industry, we discuss the current data on COVID case rates and hospitalizations. Read more below.
- FDA committee approves Moderna COVID vaccine for kids 6 to 17. Previously only Pfizer was approved for ages 5-17 and the CDC had recommended that age range receive a single-dose booster. The CDC reports that 67% of the US population is currently living in areas of medium or high community transmissions, this was up from 55% last week. In its weekly update on variant and subvariant activity, the CDC said BA.5 now makes up 13.3% of new sequenced samples, up from 7.7% last week. Also, BA.4 now makes up 8.3% of new cases, up from 5.4% the week before.
- Data in Clinical Infectious Disease show low level of COVID rebound with Paxlovid. This study was done prior to Omicron variants BA.4 and BA.5. Paxlovid, made by Pfizer, is a two-drug regimen (nirmatrelivir and ritonavir) taken together twice a day for 5 days. Paxlovid, once taken for 2 to 8 days and testing negative, some people are testing positive again while their symptoms also reappear. Within the study, out of 483 participants only 4 reported rebound- which were fully vaccinated.
- Study spotlights Omicron’s impact on unvaccinated, rural Americans. Though it causes less severe disease than the Delta variant, the highly transmissible Omicron SARS-CoV-2 variant has been twice as deadly in unvaccinated people and has therefore hit rural Americans harder than those living in cities. This study can be read here. During the study period, the incidence rate increased from 538.9 new cases per 100,000 population to 2,827.9. And the death rate rose from 6.1 per 100,000 to 11.2. Currently, scientists are predicting a higher probability of chronic illness from long COVID in rural areas due to unvaccinated populations.
- FDA advisers OK COVID-19 vaccines for kids aged 6 months to 5 years old. Moderna and Pfizer were approved. Moderna will be given in two 25 microgram doses (this is a fourth of an adult dose). Pfizer will be given to kids 6 months through 4 years old a three-shot series consisting of 3 microgram doses (one tenth of an adult dose). The FDA still needs to sign the approval and the CDC has to formally recommend this decision of vaccinating this age group.
Public Health & Food Safety:
- WHO discourages mass vaccination for monkeypox outbreak. More than 3,100 confirmed and suspected cases of monkeypox in 32 non-endemic and 7 endemic countries. WHO emphasized contact tracing and isolation to limit further spread of the poxvirus. Researchers in Italy have detected monkeypox DNA in semen samples from patients, offering more evidence that sexual transmission may be at play in the current outbreak.
- FDA Infant Formula Update: Mead Johnson Nutrition/Reckitt in Singapore is sending 4.5 million pounds of base powder that will be used to produce about 5.7 million cans (more than 66 million full-size, 8- ounce bottles). The shipments will begin in June. Additionally, the FDA announced Nestle in Germany will be providing 28,200 cans (745,000 full-size, 8-ounce bottles) in June to the U.S. as well.
- Senate bill dictates infant formula fix. The name of this bill is the FDA Safety and Landmark Advancements (FDASLA) Act. Senator Patty Murray said, “[this Act] requires [the] FDA to investigate and resolve the mailroom issues that hindered its response, requires manufacturers to notify the FDA of issues that could disrupt supply, requires FDA to put forward a concrete plan to get formula on shelves as soon as possible, and more. “ There are many more elements this bill brings to the table and those can be found here.
- Raspberries recalled in Canada over norovirus contamination. New Alasko Limited Partnership is recalling Alasko brand IQF Whole Raspberries because of possible norovirus contamination. The recalled product has been sold in Canada in Quebec, Ontario and Nova Scotia. #Lot: SY 21278P.O: 116381-01BB: 2023-OC-04 Inner Bag:6 95058 00205 4 Outer Carton: 1 069505 800205 1
- Protein bars recalled after testing finds E. coli contamination. Built Brands, LLC. of American Fork, UT, is recalling 4,196 individual bars of its “Banana Cream Pie Puffs” protein bar because of potential pathogenic E. coli contamination. The product comes in a 40-gram package marked with lot # D22151011 on the outside of the wrapper.
Recommendations for Industry
COVID Trends Continue, but Severity Remains Low
As both TAG’s weekly COVID matrix and the CDC community level map are showing, cases and hospitalizations are on an increase in much of the U.S., particularly in the Western half of the country. We are also seeing more states in yellow (medium risk) based on hospitalization, but only Washington DC is at red (high risk). Delaware, which had been in the red for the past few weeks, has now decreased to yellow.
From this, we are seeing that the general trend is continuing with a westward movement of the virus, but no drastic increase. Thus, while case rates and hospitalization are currently trending slightly upward in some areas (as also shown by the Our World in Data charts below), the burden of severe illness is low overall.
In case you missed it:
- In Tuesday’s Recommendation for Industry, we discussed the recent monkeypox outbreak. Read more here.
- In-utero COVID exposure tied to language, motor delays by 1 year. Infants born to mothers infected with SARS-CoV-2 during pregnancy were more likely to receive a neurodevelopmental diagnosis by 1 year of age, regardless of whether they were born pre-term. JAMA Network conducted this study.
- Report profiles aerosol spread in hospital COVID-19 outbreak. Airborne particles in three size ranges: larger than 10.0 micrometer (μm,) 2.5 to 10.0 μm, and smaller than 2.5 μm were collected within multiple hospitals in the Boston area. All three particle sizes tested positive within an outbreak facility. The study concluded that “improvements in air filtration, ventilation, and masking in shared hospital spaces may further decrease transmission of SARS-CoV-2 and other airborne respiratory viruses.”
- CDC Rescinds Order Requiring Negative Pre-Departure COVID-19 Test Prior to Flight to the US. This was effective June 12, 2022, at 12:01 AM ET. Passengers flying to the U.S. will no longer need to be tested or show test results or documentation of recovery from COVID. CDC continues to recommend that those travelers boarding a flight to the U.S. get tested for current infection with a viral test as close to the time of departure as possible (no more than 3 days) and not travel if they are sick.
- Federal government to end COVID-19 vaccine mandates for domestic, outbound international travellers. Sources confirm the Canadian government is putting an end to COVID-19 vaccine mandates for domestic and outbound international travellers and federally regulated workers.
- The high rates of influenza are continuing in Australia reported by HealthMap.org
- According to the CDC weekly influenza update, the following has been reported: this week, 2 jurisdictions experienced high activity and 2 jurisdictions experienced very high activity.
Public Health & Food Safety:
- Hepatitis: In the past week, there was just one report related to the continuing concerns with hepatitis of unknown origin. This is down from a high of a couple dozen each week over the previous timeframes. Unclear whether incidence is dropping, or press has just moved on to other topics.
- An ongoing meningitis outbreak in Nigeria has killed 65. About 250 total cases have been reported.
- Transmission (CDC). Monkeypox is spread through direct contact with bodily fluids or sores on the body of someone that is infected. Monkeypox is rare and does not spread easily between people without close contact, so CDC states that the threat of monkeypox to the general U.S. population remains LOW. Currently, 49 cases have been confirmed, with the the blue states in the graph below depicting these cases. Additional data and statistics for this graph can be found here, and we also provide more information in the Recommendations for Industry article.
- WHO Considers Renaming Monkeypox Virus to Minimize Stigma, Racism. The current name doesn’t fit with WHO guidelines that recommend avoiding geographic regions and animal names. The WHO is consulting experts in orthopoxviruses — the family to which monkeypox belongs — on more appropriate names.
- Pandemic policy changes in Canada appear to have eased Rx drug shortages. Implementation of policy measures in March 2020 in Canada stemmed prescription drug shortages—especially generic drugs—exacerbated by the COVID-19 pandemic. To help ensure a steady drug supply, the Canadian minister of health allowed the importation of key drugs at high risk of shortage from countries with similarly rigorous regulatory systems. The government also revised the country’s Patent Act on Mar 25, 2020, to allow the manufacture and sale of versions of patented drugs without needing to negotiate with patent holders. Average 30-day moving shortages per 10,000 drug identification numbers peaked in April 2020, at 2,345, up from 901 shortages 5 years earlier. The numbers now show that there is a positive trend for patients with chronic diseases because of the news Act.
- FSIS Stopping Salmonella Sampling of Raw Siluriformes in all raw fish. This will apply to all domestic and imported products. After July 13, 2022, IPP will no longer receive sampling tasks for the project codes: If any sampling tasks remain after July 13, 2022, IPP should cancel the remaining sampling tasks and select “Not collected for miscellaneous reasons” as the reason for the cancellation.