- In today’s Recommendation for Industry, we take a look at the latest statistics on COVID and expectations for the next few months. Read more below.
- FDA advisory committee is recommending Omicron variant to be within COVID boosters. The proportion of BA.4 and BA.5 increased in the week ending June 25th, mainly due to BA.5. The CDC said on June 28th that BA.4 and BA.5 now make up 52.3% of subtyped samples, up from 35% the previous week. A rising proportion of BA.5 made up most of the jump, with BA.5 now making up 36.6% of samples and BA.4 making 15.7% of samples. Though mRNA vaccine manufacturers said they can start distributing bivalent vaccine doses this summer, they noted it would take a few months longer to produce versions that target BA.4 and BA.5.
- Data collected this week from New York Times shows the following statistics: Daily average cases of 108,963, test positive rate of 15%, and 377 daily deaths. To compare, at the height of Omicron in January there was a reported daily average of about 800,000 cases.
- Maternal deaths climbed 33% during COVID-19. Maternal deaths in the first months of the COVID-19 pandemic increased 33%—and even higher in Black and Hispanic women, according to a study in Jama Network Open. Pre-pandemic data from 2018-2020 was used to compare with pandemic death rates. Pre-pandemic death rate was 18.8 per 100,000 births while the pandemic period was found to be 25.1 per 100,000 births. Late maternal mortality (42 days to 1 year after birth) increased 41%. For underlying cause-of-death codes, the authors determined that the largest relative increase was among indirect causes (56.9%), specifically other viral diseases (2,374.7%), diseases of the respiratory system (117.7%), and diseases of the circulatory system (72.1%). Relative increases in direct causes (27.7%) were mostly associated with diabetes in pregnancy (95.9%), high blood pressure (39.0%), and other pregnancy-related conditions (48.0%).
- BioNTech, Pfizer to start testing universal vaccine for coronaviruses. The two companies would start tests on humans of next-generation shots that protect against a wide variety of coronaviruses in the second half of the year. Their experimental work on shots that go beyond the current approach include T-cell-enhancing shots, designed to primarily protect against severe disease if the virus becomes more dangerous, and pan-coronavirus shots that protect against the broader family of viruses and its mutations.
Public Health & Food Safety:
- Abbott Nutrition remains closed for flood cleanup; no word on how long it will take. Operations were shut down the third week of June after floodwaters from a local storm drain system were overcome by torrential rain. The plant has only put word out that they need to clean and sanitize the plant before production begins again. There was no timeline mentioned for when production will pick up.
- CDC opens monkeypox center as Europe begins vaccinations. On June 28, the CDC activated its Emergency Operations Center (EOC) to better address the monkeypox outbreak. Spain became the first European Union country to receive delivery of monkeypox vaccines ordered by the European Commission’s Health Emergency Preparedness and Response Authority (HERA) in response to a growing outbreak mainly affecting men who have sex with men. Doses will be distributed based on population, with Portugal, Germany, and Belgium the next countries receiving doses. The European Medicines Agency also is reviewing the use of smallpox vaccine Imvanex to treat people exposed to monkeypox. Previous studies have shown smallpox vaccines are roughly 85% protective against monkeypox, and Imvanex is already licensed as a smallpox vaccine in the EU.
- US rolls out monkeypox vaccine plan. Under a new plan, 296,000 doses of the Jynneos vaccine will be made available in the U.S. throughout July with a combined 1.6 million additional doses becoming available in the coming months. Vaccines are primarily intended for those who had close physical contact with someone diagnosed with monkeypox, those who know their sexual partner was diagnosed with monkeypox, and men who have sex with multiple men where monkeypox is known to be or is spreading. While the WHO Director-General said that high-risk groups (e.g., children, immunocompromised individuals, and pregnant women) may be at a higher risk, there have been no reported cases in children in the U.S., and of the 305 US cases, all but 5 have been in men.
- Swimmer’s itch cases beginning, follow CDC recommendations. Swimmer’s itch, also called cercarial dermatitis, appears as a skin rash caused by an allergic reaction to certain microscopic parasites that infect some birds and mammals. These parasites are released from infected snails into fresh and salt water (such as lakes, ponds, and oceans).
- To prevent from getting swimmer’s itch do not swim in areas where swimmer’s itch is a known problem or where signs have been warning of unsafe water; do not swim near or wade in marshy areas where snails are commonly found; towel dry or shower immediately after leaving the water; do not attract birds (e.g., by feeding them) to areas where people are swimming; encourage health officials to post signs on shorelines where swimmer’s itch is a current issue.
- If contracted, you may find relief from using corticosteroid cream, applying cool compresses to the affected areas, bathing in Epsom salts or baking soda, soaking in colloidal oatmeal baths, applying baking soda paste to the rash, or by using an anti-itch lotion.
Recommendations for Industry
COVID Westward Migration Continues
TAG’s weekly COVID matrix is continuing to show a westward migration of cases, with cases in the Eastern U.S. generally decreasing, with some fluctuation. We’re also seeing, though, that case rates may no longer be a strong depictor of state rates as the level of focus on COVID varies significantly among states, with some variations in testing, reporting of home test results, and some states even discontinuing reporting altogether.
There has been a bit of a surge in the UK, due to the BA.4 and BA.5 variants, but cases are only a very small fraction of what they were in January. We continue to see this as indicative of what the U.S. is facing – not a huge surge, but continuing cases, with about a four-month window from the beginning of a new surge to its culmination. At this time, we’ve seen no significant increases in cases in the U.S.; the transmission rate in most states in below 1.0; and hospitalizations appear to be stable, but COVID infections continue to occur, so we are not yet out of the woods. So, to reiterate what seems to have become a catchphrase for COVID: Keep doing what you’ve been doing, particularly watching for symptoms and having employees stay home when ill.
In case you missed it:
- In Tuesday’s Recommendation for Industry, we provided updates on COVID-19 and Monkeypox. Read more here.
- Pfizer’s Omicron-Targeting COVID-19 Vaccines Generate Stronger Immune Response. A modified booster shot targeting Omicron specifically increased neutralizing antibody levels 13.5 to 19.6 times higher than the current shot. A booster targeting both Omicron and the original virus increased neutralizing antibody levels 9.1 to 10.9 times, depending on the dose. Federal health authorities are trying to decide whether to stick with the current shots for a fall vaccination campaign or use a tweaked version. The study didn’t measure whether and how well the shots reduced the risk of COVID-19. Early lab testing showed the modified vaccines were also effective against the Omicron subvariants BA.4 and BA.5, but lost some of their power, generating about three times lower antibody levels against those subvariants than against the original Omicron subvariant. Moderna Inc. also found its Omicron-targeting booster produced a stronger immune response, suggesting possible benefit to modifying the shots to improve protection against an evolving virus.
- Britain is being hit by a new wave of COVID. This is Britain’s third COVID wave this year. Within the last week 1.7 million people in the UK were infected with COVID (week ending in June 18), 23% more than the previous week. BA.4 and BA.5 are the cause for this increase. In addition to Britain having an increase in cases, Portugal and South Africa all are experiencing jumps in numbers. The vaccine to be given in the fall hasn’t been determined yet by scientists; they aren’t sure if they should stick with the protection of the original strain or the most prevalent Omicron variant.
- Beijing to reopen schools, Shanghai declares victory over COVID. Shanghai has reported zero new local cases for the first time in two months. In-person classes for schools will resume soon. Both Beijing and Shanghai came out of their two-month long lockdowns on June 1, this was all due to the Omicron variants that hit. Shanghai is requiring that residents show a negative COVID-19 test within the last 24 hours to enter public venues.
- COVID-19 vaccines saved an estimated 20 million lives in 1 year. The scientists estimated that 18.1 million deaths would have occurred during the study period without vaccination. Of those, the model estimated that vaccination prevented 14.4 million deaths, or 79%. When they accounted for under-reporting, however, they found that COVID vaccination prevented an estimated 19.8 million deaths out of a total of 31.4 million potential deaths that would have occurred without vaccination—a reduction of 63%. The authors found that high- and upper-middle-income countries accounted for the greatest number of prevented deaths (12.2 million). Scientists claim that more deaths could have been prevented if the target of vaccinating 40% of the population in each country had been met by the end of 2021.
- HealthMap.org reported that Asia has warned of early occurrences of “summer flu” – in China, Macau, Japan, specifically. There’s also a report in Oklahoma of a “continuation” of the flu season.
- The US CDC flu tracker indicates lowering in case rates, but the “low” isn’t as low as what we’ve seen in the past indicating that there’s still a small undercurrent of flu out there. There is currently a 2.5% test positive rate.
Public Health & Food Safety:
- Acute hepatitis outbreak swells to nearly 900 cases; global data shows ‘mixed picture’. There are cases across 33 countries with more than half from European regions, mainly the United Kingdom. The United Kingdom makes up about 30% of all cases while the United States sits at about 35%. Most cases have been identified in children less than five years old. Forty-four children have required liver transplantation, and there have been 18 reported deaths. In terms of current COVID infection, in both Europe and the U.S. rates of detection are approximately 10%. There was a hypothesis that the COVID-19 vaccination caused a rare variant of multisystem inflammatory syndrome in children causing organ damage. Researchers ruled out the vaccination as a contributing factor because the majority of children were unvaccinated.
- Scientists Zero in on Origins of the Monkeypox Outbreak. Genetic analysis suggests that although the monkeypox virus is rapidly spreading in the open, it has been silently circulating in people since about 2018. Health officials have already identified two versions of monkeypox among American patients, suggesting at least two separate chains of transmission. Researchers in several countries have found cases with no known source of infection, indicating undetected community spread. And one research team argued last month that monkeypox had already crossed a threshold into sustainable person-to-person transmission. If the virus has adapted to include people as hosts, monkeypox outbreaks could become more frequent and more difficult to contain. That carries the risk that monkeypox could spill over from infected people into animals, sporadically triggering new infections in people. The longer it takes to contain the virus, the higher the odds that it will find a permanent new home in people or animals. As of Wednesday, the United States had identified 244 cases in 26 states and the District of Columbia. The global toll has surpassed 3,400 confirmed cases, and another 3,500 cases are being evaluated, tripling the numbers from two weeks ago.
- WHO: Monkeypox not a global public health emergency. This event will continue to be closely monitored for several more weeks to see if the situation warrants a reconsideration of their advice. Currently the advice still stands for using caution around individuals who may be infected and to avoid close contact with individuals when possible. WHO currently reports 4,265 confirmed cases worldwide. Additional states within the US such as Minnesota and Kentucky are reporting their first monkeypox cases. In wastewater within San Francisco there have been traces of monkeypox identified. San Francisco currently has 10 confirmed cases.
- Study documents rise of antibiotic-resistant typhoid. Antibiotic-resistant strains of typhoid fever are now spreading from South Asia to other parts of the world. Caused by the bacterium Salmonella enterica serovar Typhi, it is frequently transmitted by contaminated water and food and person-to-person contact, and it tends to spread in areas with poor sanitation. Scientists report that countries where typhoid fever isn’t endemic should introduce typhoid conjugate vaccine (TCV) as the disease could become an issue in the future.
- Solicitor General of United States finds Prop 12 violates Interstate Commerce Clause. Prop 12 claims animals kept in “less than” spaces are “confined cruelly” and bars their sale in California. Essentially, California would be able to dictate how other state’s farms are raising their animals. This applies to egg-laying hens, mother pigs, and calves raised for veal. It also prohibits in-state sale of products from caged animals out-of-state. Solicitor General filed an amicus brief finding Proposition 12 violating the constitution and will create unnecessary burdens for interstate commerce. State attorney generals are supporting the pork producers on behalf of Alabama, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, and Wyoming. Now, the Solicitor General of the United States (“10th justice”) has joined the 26 states.