Even Unrelated Vaccines Can Help Protect Against COVID-19

Key Points:

• In today’s Recommendations for Industry, we discuss new studies suggesting that flu shots, measles vaccines, and the common cold can cross-protect against COVID. Read more below.
• A recently published study found that SARS-CoV-2 infection during pregnancy is associated with an increased risk for adverse pregnancy outcomes, including induced abortion, cesarean sections, preterm birth and fetal growth restriction. It was not associated with risk for miscarriage, antepartum hemorrhage or stillbirth. The national cohort study used de-identified administrative claims data for 78,283 pregnancies with an estimated conception date before April 30, 2020, and pregnancy end after March 11, 2020, and used diagnostic and laboratory testing data to identify infected mothers.
• Stating that Omicron is like a tidal wave moving from west to east on top of an earlier Delta variant surge, the WHO said Europe’s cases doubled over the past 2 weeks, becoming dominant in the western countries and now spreading in the Balkans. But Omicron may be headed for a rapid drop in Britain, US as scientists are seeing signals that the wave may have peaked in Britain and is about to do the same in the U.S., at which point cases may start dropping off dramatically. The reason: The variant has proved so wildly contagious that it may already be running out of people to infect, just a month and a half after it was first detected in South Africa. But there is still much uncertainty about how the next phase of the pandemic might unfold, as plateauing or ebbing is not happening everywhere at the same time or at the same pace. And weeks or months of overwhelmed hospitals still lie ahead even with a drop-off.
• Europe is starting to think we should treat COVID as an endemic illness, like the flu. Spain’s Prime Minister, Pedro Sanchez, is the latest leader to suggest it’s time to reevaluate COVID. Britain’s government has already told the public that it must “learn to live with the virus.”
• The World Bank said the global economy is entering a slowdown due to threats from COVID-19 variants; rises in inflation, debt, and income inequality that threaten the recovery of emerging and developing countries; dissipating pent-up demand for products; and expiring fiscal and monetary supports.
• Long term exposure to air pollution may heighten the risk of COVID infection suggests research published in Occupational & Environmental Medicine. The association was strongest for particulate matter, which showed an infection rate equating to an extra 294 cases/100,000 people a year.
• In booster news, the Pfizer booster tied to fewer COVID cases in health workers – Israeli healthcare workers who received a third dose of the Pfizer vaccine had significantly lower rates of infection in the next 39 days, according to a single-center study in JAMA. Fourth COVID vaccine dose boosts immunity in kidney transplant patients producing a good antibody response in half of kidney transplant recipients who did not respond adequately after three doses, according to a study involving 92 transplant patients yesterday in Annals of Internal Medicine.

Public Health & Food Safety:

• On January 11, the FDA released an updated version of the “Procedures for Standardization of Retail Food Safety Inspection Officers,” providing regulatory personnel with the process and criteria for demonstrating proficiency in required performance areas. The FDA also released an updated “Standardization Field Workbook.”
• The USDA’s new labeling for genetically modified foods goes into effect Jan. 1.
• Increasing public awareness of food quality and safety has prompted a rapid increase in food authentication of halal food, for which authentication is often challenging because of the complex nature of food and the increasing number of food adulterants that cause detection difficulties. This review provides an overview of recent studies on the analytical techniques used in the analysis of halal food authenticity; highlights the classification of different methodologies; explores methodological developments, and novel emerging techniques and their implementations, illustrating the advantages, disadvantages, and shortcomings.

Recommendations for Industry

Even Unrelated Vaccines Can Help Protect Against COVID-19

Encouraging employees to keep all vaccinations current could provide another tool in the toolbox of COVID-19 protections. As shown by a new study from Weill Cornell Medicine and the University of Oxford, the generalized immune-boosting properties of even unrelated vaccines can provide cross-protection against COVID, crystallizing decades of evidence. Using values for cross-protection consistent with data from earlier studies on measles, influenza, tuberculosis and other immunizations, the researchers found that an unrelated vaccine that provided just 5 percent protection against serious COVID-19, and was delivered to only a small portion of the population, would have caused a substantial reduction in caseloads and hospital usage. The results showed the potential power of all vaccines in keeping the immunological system primed and healthy.

Another study, led by Imperial College London researchers, found that T cells from common colds also can cross-protect against COVID infection – and could provide a blueprint for a second-generation, universal vaccine for current and future SARS-CoV-2 variants, including Omicron. In studying why COVID exposure doesn’t always result in infection, the researchers found that high levels of pre-existing T cells, created by the body when infected with other human coronaviruses like the common cold, can protect against COVID-19 infection. Rather than attacking COVID’s surface spike protein – which seeks to mutate and evolve when attacked, the T cells provide protection by attacking proteins within the virus which mutate much less. 

In continuing to increase our knowledge of COVID-19, such studies are providing further tools for protection, while cautioning that each is an additional protective measure that, in sync with other protections (masking, distancing, handwashing, wellness checks, etc.) can help to decrease infections which can decrease the development of new variants, and help provide a quicker end to the pandemic.

Risk Matrix:

Every state (and the District of Columbia) has a TPR > 10%; case rates throughout the country are all >25 cases/100K. As we saw last week, there were some states with case rates >100 cases/100K; now we are seeing the majority of states have a case rate >100 cases/100K (even going into 200 or 300 cases/100K). There are only 5 states with case rates <100 cases/100K:

• Alaska (65 cases/100K persons)
• Idaho (60 cases/100K persons)
• Maine (67 cases/100K persons)
• Montana (70 cases/100K persons)
• Wyoming (98 cases/100K persons)

In case you missed it

• In Tuesday’s Recommendations for Industry, we discussed the Omicron variant. Read more here.
• On Sunday Jan 09, the CDC updated its “Quarantine and Isolation” webpage to allow readers to better understand what to do. The updates have extra charts for readers to better understand when to test and when traveling can be allowed.
• Omicron is sweeping the nation and across the globe. On one hand, the WHO is warning that over half of all Europeans may become infected with the Omicron variant in the next 6 – 8 weeks; there’s a push to strengthen mask rules (Euronews). In the U.S., there is an increasing number of young children (<4 years old, who aren’t able to be vaccinated) being hospitalized and testing positive for COVID-19. However, officials say there is “no sign of an increase in severe cases” (NYT1).  Similarly, the COVID-19 variant is also spreading across hospitals and “a quarter of hospitals are reporting critical staffing shortages due to workers being sick or off work for quarantine” (CIDRAP). However, it also seems that “Omicron activity has already peaked in some Mid-Atlantic states, with Omicron now setting its sights on the Midwest, where the pace is picking up.” Additionally, with the rise of cases, the CDC has recommended that “[s]ome people with a weakened immune system can get a fourth dose of the coronavirus vaccine as early as this coming week” (NYT2).
• Two studies in South Africa have found that the Omicron variant “has a much higher rate of ‘asymptomatic carriage’ than earlier variants, which could explain why it has spread so rapidly across the globe” (Reuters).
• The U.S. has issued a “Do Not Travel” warning for Canada admist the rise of COVID-19 cases. The CDC elevated its travel recommendation for Canada to “Level 4: Very High” (NBC). 
• From the FDA:
  • On Dec. 21, the FDA published the webpage: Wastewater Surveillance for SARS-CoV-2 Variants describing how the FDA has developed the capacity to sequence SARS-CoV-2 RNA from wastewater samples, which is useful for detecting and monitoring SARS-CoV-2 at the population scale. Monitoring for both known and unknown variants of the virus can provide information about the evolution of the virus, which is critical to evaluating the effectiveness of FDA-regulated COVID-19 vaccines, therapeutics and diagnostics.
  • On Dec. 29, the FDA implemented temporary changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates as the agency further adapts to the evolving COVID-19 pandemic and the spread of the Omicron variant. Through Jan.19, the agency intends to continue mission-critical work but has temporarily postponed certain inspectional activities with the hopes of restarting these activities as soon as possible
  • The FDA has authorized 24 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 747 revisions to EUA authorizations.

Influenza

• China is reporting another H5N6 avian flu case, along with another H9N2 infection in a child.
• A retrospective study shows worse outcomes from patients hospitalized with COVID-19 than the flu.
• A handful of co-infections of flu and COVID-19 are reported in Israel, the US and Brazil.
• In the U.S., the flu positivity rate is 3.8%. Seasonal influenza activity in the United States is increasing, including indicators that track hospitalizations. Influenza activity is increasing, with the eastern and central parts of the country seeing the majority of viruses reported and the western part of the country reporting lower levels of influenza virus circulation. The majority of influenza viruses detected are A(H3N2). Earlier in the season, most influenza A(H3N2) infections occurred among children and young adults ages 5-24 years; however, in recent weeks, the proportion of infections occurring among other age groups, especially adults age 25 years and older, has been increasing. The amount of activity varies by region. 10 jurisdictions experience moderate and 31 experience high or very high activity.
• Globally: The majority of influenza viruses detected are A(H3N2).

Public Health & Food Safety News

• Giant rats are being used in Tanzania to rapidly screen sputum samples for TB. Once trained, they can screen 100 samples in 20 minutes at a cost of as little as $0.20 per sample – this is much faster than the traditional microscopic analyses by technicians.
• MRSA starins may have originated in hedgehogs, long before antibiotics. From CIDRAP, “A new study led by researchers in Denmark and the United Kingdom has identified hedgehogs as a reservoir of a well-known antibiotic-resistant pathogen. The study, published last week in Nature, suggests that a strain of methicillin-resistant Staphylococcus aureus (MRSA) that has become one of the predominant livestock-associated MRSA lineages in Europe likely originated in hedgehogs. Furthermore, the particular strain of MRSA appears to predate, by more than 100 years, the advent of the antibiotic era. The authors of the study say the findings are inconsistent with the view that widespread antibiotic resistance in bacterial pathogens is solely driven by antibiotic use in human and veterinary medicine, and highlights the importance of a One Health perspective on antimicrobial resistance.”
• FDA will be holding public meetings to discuss proposed changes to agricultural water requirements in the Produce Safety Rule. The first virtual meeting will be February 14^th, while the second virtual meeting will be February 25^th. Register for the first meeting here.
• According to Food Safety News, “Fruit juices, cantaloupe, papayas [are now] listed in FDA’s import enforcement report update.”
• Canada’s Food Inspection Agency has conducted a study on Undeclared Allergens in Bakery Products between 2019 to 2021. “A targeted survey tested 182 bakery products for the presence of undeclared allergens. 91.2% (166) of samples did not contain any undeclared allergens. 8.8% (16) of samples were positive for undeclared allergens such as milk protein (beta-lactoglobulin and casein), egg, peanut and sesame. Positive results were forwarded to the CFIA’s Office of Food Safety and Recall to determine if the levels found would pose a health concern to allergic individuals. There were 5 product recalls in this survey.”
• Former Blue Bell’s president’s trial is delayed until Summer 2022.