Poor antibody response to BioNTech/Pfizer COVID-19 vaccination in SARS-CoV-2 naïve residents of nursing homes

 Pieter Pannus, Kristof Y Neven, Stéphane De Craeye, Leo Heyndrickx, Sara Vande Kerckhove, Daphnée Georges, Johan Michiels, Antoine Francotte, Marc Van Den Bulcke, Maan Zrein, Steven Van Gucht, Marie-Noëlle Schmickler, Mathieu Verbrugghe, André Matagne, Isabelle Thomas, Katelijne Dierick, Joshua A. Weiner, Margaret E. Ackerman, Stanislas Goriely, Maria E Goossens, Kevin K. Ariën, Isabelle Desombere, Arnaud Marchant

doi: https://doi.org/10.1101/2021.06.08.21258366

This article is a preprint and has not been certified by peer review [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.

PDF: https://www.medrxiv.org/content/10.1101/2021.06.08.21258366v1.full.pdf

Abstract

Background Residents of nursing homes (NH) are at high risk of COVID-19 related morbidity and death and may respond poorly to vaccination because of old age and frequent comorbidities.

Methods Forty residents and forty staff members either naïve or previously infected with SARS-CoV-2 were recruited in two NH in Belgium before immunization with two doses of 30µg BNT162b2 mRNA vaccine at day 0 and day 21. Binding antibodies (Ab) to SARS-CoV-2 receptor binding domain (RBD), spike domains S1 and S2, RBD Ab avidity, and neutralizing Ab against SARS-CoV-2 wild type and B.1.351 variant were assessed at days 0, 21, 28, and 49.

Results SARS-CoV-2 naïve residents had lower Ab responses to BNT162b2 mRNA vaccination than naïve staff. These poor responses involved lower levels of IgG to all domains of the vaccine antigen, lower avidity of RBD IgG, and lower levels of Ab neutralizing the vaccine strain. No naïve resident had detectable neutralizing Ab to the B.1.351 variant. High and comparable Ab responses were observed in residents and staff previously infected with SARS-CoV-2. Clustering analysis revealed that poor vaccine responders not only included naïve residents but also naïve staff, emphasizing the heterogeneity of responses to mRNA vaccination in the general population.

Conclusions The poor Ab responses to mRNA vaccination observed in infection naïve residents and in some naïve staff members of NH suggest suboptimal protection against breakthrough infection, especially with variants of concern. Adapted vaccination regimens may be needed to provide optimal protection against COVID-19 to vulnerable populations.

Summary Poor antibody responses to COVID-19 mRNA vaccination were observed in SARS-CoV-2 infection naïve residents and some naïve staff members of nursing homes. This suggests suboptimal protection against breakthrough infection, especially with variants of concern, and the need for adapted vaccination regimens.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT04527614

Funding Statement

This work was supported by the Belgian Federal Government [COVID-19_SC004, COVID-19_SC049, COVID-19_SC059]; the European Regional Development Fund of the Walloon Region (Wallonia-Biomed portfolio) [411132-957270]; and the Flemish Research Foundation [grant number FWO-G0G4220N to K. K. A.].

https://www.medrxiv.org/content/10.1101/2021.06.08.21258366v1

Community-level evidence for SARS-CoV-2 vaccine protection of unvaccinated individuals

 

Oren Milman, Idan Yelin, Noga Aharony, Rachel Katz, Esma Herzel, Amir Ben-Tov, Jacob Kuint, Sivan Gazit, Gabriel Chodick, Tal Patalon & Roy Kishony

DOI: https://doi.org/10.1038/s41591-021-01407-5

PDF: https://www.nature.com/articles/s41591-021-01407-5.pdf

Abstract

Mass vaccination has the potential to curb the current COVID-19 pandemic by protecting individuals who have been vaccinated against the disease and possibly lowering the likelihood of transmission to individuals who have not been vaccinated. The high effectiveness of the widely administered BNT162b vaccine from Pfizer–BioNTech in preventing not only the disease but also infection with SARS-CoV-2 suggests a potential for a population-level effect, which is critical for disease eradication. However, this putative effect is difficult to observe, especially in light of highly fluctuating spatiotemporal epidemic dynamics. Here, by analyzing vaccination records and test results collected during the rapid vaccine rollout in a large population from 177 geographically defined communities, we find that the rates of vaccination in each community are associated with a substantial later decline in infections among a cohort of individuals aged under 16 years, who are unvaccinated. On average, for each 20 percentage points of individuals who are vaccinated in a given population, the positive test fraction for the unvaccinated population decreased approximately twofold. These results provide observational evidence that vaccination not only protects individuals who have been vaccinated but also provides cross-protection to unvaccinated individuals in the community.

https://www.nature.com/articles/s41591-021-01407-5

High-affinity, neutralizing antibodies to SARS-CoV-2 can be made in absence of T follicular helper cells

  

View ORCID ProfileJennifer S. Chen,  View ORCID ProfileRyan D. Chow, Eric Song, Tianyang Mao, Benjamin Israelow, Kathy Kamath, Joel Bozekowski, Winston A. Haynes, Renata B. Filler, Bridget L. Menasche, Jin Wei, Mia Madel Alfajaro, Wenzhi Song, Lei Peng, Lauren Carter, Jason S. Weinstein, Uthaman Gowthaman,  View ORCID ProfileSidi Chen, Joe Craft, John C. Shon,  View ORCID ProfileAkiko Iwasaki, Craig B. Wilen, Stephanie C. Eisenbarth

doi: https://doi.org/10.1101/2021.06.10.447982

This article is a preprint and has not been certified by peer review [what does this mean?].

PDF: https://www.biorxiv.org/content/10.1101/2021.06.10.447982v1.full.pdf

Abstract

T follicular helper (Tfh) cells are the conventional drivers of protective, germinal center (GC)-based antiviral antibody responses. However, loss of Tfh cells and GCs has been observed in patients with severe COVID-19. As T cell-B cell interactions and immunoglobulin class switching still occur in these patients, non-canonical pathways of antibody production may be operative during SARS-CoV-2 infection. We found that both Tfh-dependent and -independent antibodies were induced against SARS-CoV-2 as well as influenza A virus. Tfh-independent responses were mediated by a population we call lymph node (LN)-Th1 cells, which remain in the LN and interact with B cells outside of GCs to promote high-affinity but broad-spectrum antibodies. Strikingly, antibodies generated in the presence and absence of Tfh cells displayed similar neutralization potency against homologous SARS-CoV-2 as well as the B.1.351 variant of concern. These data support a new paradigm for the induction of B cell responses during viral infection that enables effective, neutralizing antibody production to complement traditional GCs and even compensate for GCs damaged by viral inflammation.

Competing Interest Statement

KK, JB, WAH, and JCS declare the following competing interests: ownership of stocks or shares at Serimmune, paid employment at Serimmune, and patent applications on behalf of Serimmune. Yale University (CBW) has a patent pending entitled "Compounds and Compositions for Treating, Ameliorating, and/or Preventing SARS-CoV-2 Infection and/or Complications Thereof." Yale University has committed to rapidly executable nonexclusive royalty-free licenses to intellectual property rights for the purpose of making and distributing products to prevent, diagnose, and treat COVID-19 infection during the pandemic and for a short period thereafter.

https://www.biorxiv.org/content/10.1101/2021.06.10.447982v1

Budget office approves Biden's plan to retract insulin, epipen discounts

 The White House this week gave President Biden the greenlight to move forward with removing a Trump-era health care policy designed to bring down the price of insulin.

Biden’s bid to retract the rule was approved on Monday, as reported by Politico, with the expectation that the Department of Health and Human Services could publish the retraction within the coming days.

The measure, signed off on under the previous administration in December, aimed to require some 340B community health centers to deliver savings to low-income patients for insulin and epinephrine in a bid to bring down unaffordable prices.

Spokespeople for the White House and the Department of Health and Human Services did not return FOX Business’ request for comment.

The rule was scheduled to go into effect in January but was frozen at that time.

Earlier this year, the National Association of Health Care Centers said the rule would "adversely impact Community Health Centers" and make it harder for low-income patients to afford the medications.

President Donald Trump focused on lowering the price of drugs during his tenure. Biden has made similar promises, including calling for allowing Medicare to negotiate lower prices for prescription drugs.

https://www.foxbusiness.com/politics/wh-budget-office-approves-bidens-plan-to-remove-insulin-epipen-discounts-report

HEPA air purifiers reduce airborne COVID-19 particles

 As COVID-19 restrictions ease nationwide and more people host indoor gatherings, investing in a high efficiency particulate air (HEPA) purifier might not be a bad idea, says a University of Cincinnati College of Medicine researcher.

Several published studies evaluating aerosols and submicron particles similar in size to the SARS-CoV-2 virion have shown that portable HEPA purifiers are able to significantly reduce airborne COVID-19 particles, says Ahmad Sedaghat, MD, Ph.D., director of the UC Division of Rhinology, Allergy and Anterior Skull Base Surgery.

Sedaghat identified the medical literature showing published studies on the effectiveness of HEPA purifiers. His review is available online in the scholarly journal of the American Academy of Otolaryngology-Head and Neck Surgery Foundation.

Air purifiers could benefit hospitals and physician offices where aerosol-generating procedures occur, but they are also useful for reducing COVID transmission anywhere that large groups of individuals congregate.

"One of the issues with COVID-19, is when physicians perform an aersol-generating medical procedure any asymptomatic COVID-19 positive patient may release SARS-CoV-2 laden aersols into the air," explains Sedaghat. "Guidance from the Centers for Disease Control indicates that we can rely on our HVAC systems to slowly decontaminate the air during an hour timeframe. Studies in the medical literature are showing us that we can use portable air purifiers to do a better and faster job of decominating these airborne particles to keep our patients and staff safe."

"Air purifiers with HEPA filters can be used as very effective means to decontaminate the air above and beyond what many HVAC systems may offer," says Sedaghat who also published studies documenting COVID-19 infection leading to reduced taste and smell in patients and possibly attacking the central nervous system.

"If people are walking around coughing or sneezing because it is allergy season and by chance they happen to be one of these asymptomatic carriers of COVID-19, there is a danger of transmission in individuals not vaccinated," says Sedaghat. "People are catching the disease from asymptomatic carriers."

"The results of this study can be applied to our daily lives outside of a physician's office," says Sedaghat. "If you want to host larger gatherings you should consider putting the air purifiers into your living room to help decontaminate anything that is released into the air. HEPA based air purifiers work the best. HEPA based air purifiers decontaminate these airborne particles much faster and more effectively than non HEPA filters."

"They aren't terribly expensive and you can buy these at any home improvement or department store to help decontaminate air borne coronavirus," says Sedaghat. "This may be more important for controlling the spread of COVID-19 for people who are still not vaccinated."

Air purifiers offer added protection but UC researchers also found that better-fitting facemasks greatly improve protection against COVID-19 as well.

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More information: David T. Liu et al, Portable HEPA Purifiers to Eliminate Airborne SARS-CoV-2: A Systematic Review, Otolaryngology–Head and Neck Surgery (2021). DOI: 10.1177/01945998211022636

https://medicalxpress.com/news/2021-06-hepa-air-purifier-airborne-covid-.html

COVID diagnosis could cost you way more in 2021

 COVID-19 could be a much more expensive experience for folks who fall ill this year, thanks to the return of deductibles and copays, new research suggests

Most folks who became gravely ill with COVID last year didn't face crushing medical bills because nearly all insurance companies agreed to waive cost-sharing for coronavirus care during the height of the pandemic, explained Dr. Kao-Ping Chua, a health policy researcher and pediatrician at the University of Michigan.

But some people did get a big bill because their insurer refused to waive cost-sharing, and their debts provide a good idea of what many hospitalized COVID patients will have to pay this year, Chua said.

"We've had some really big insurers abandon their cost-sharing waivers this year," Chua said. "Insurers seem to be acting like the pandemic is over, and we feel that it's premature for them to be acting in that manner."

Chua noted that as of last week, some 20,000 Americans were hospitalized for COVID even though there's been a continuing decline in cases.

For this study, Chua and his colleagues reviewed claims data for multiple insurers across the United States, looking specifically for people who got a full bill for their COVID hospitalization.

They identified more than 4,000 hospitalizations between March and September 2020 where it didn't appear the insurer waived cost-sharing. These patients had to pay a share of all their care, from hospital room and board down to the doctors who saw them and the medications they received.

Folks who didn't benefit from cost-sharing waivers wound up paying about $3,800, on average, out of pocket if they had private insurance and an average of $1,500 if they were covered by a Medicare Advantage plan, the data showed.

"Now that insurers are abandoning their cost-sharing waivers, that's approximately what the bills might be for patients covered by plans that have chosen to do that," Chua said.

By comparison, respiratory infections in the pre-COVID period from 2016 to 2019 resulted in average out-of-pocket spending for privately insured folks of $1,600 to $2,000, researchers said in background notes.

The findings were published on the preprint server medRxiv and have not been peer-reviewed yet.

The cost of treating COVID-19 "could be higher than the amounts you see in this study, in fact," said Cheryl Fish-Parcham, director of access initiatives at Families U.S., a national nonpartisan consumer health care advocacy organization. "Besides the hospital costs themselves, people may face costs when they go home if they have long-term effects of COVID."

Chua's team also found that even those who benefited from some sort of cost-sharing waiver still wound up paying for part of their COVID hospital care.

About seven out of 10 COVID hospitalizations resulted in a bill of some sort for privately insured patients, and about half of hospitalizations for those covered by Medicare Advantage.

Even if hospital costs were waived, people still received bills from the doctors who provided their inpatient care and the ambulance services who got them to the hospital, Chua said.

"Even though insurer cost-sharing waivers covered most of the bill, they didn't cover all COVID hospitalization-related care," Chua said.

Those folks faced average bills of nearly $800 with private insurance and nearly $300 with Medicare Advantage.

While the threat of a big COVID hospital bill might prompt some reluctant folks to get vaccinated, Chua said he'd "rather this not be the way that people get convinced to get a vaccination."

That's because he's worried the risk of a big hospital bill will keep people from getting care that could save their lives.

"I don't want the possibility of high cost-sharing to dissuade people from getting the care they need," Chua said.

If insurers keep backing out of COVID cost-sharing waivers, the U.S. federal government needs to intervene, Chua concluded.

"There should be consideration of a federal mandate that requires insurers to cover all costs of COVID hospitalizations throughout the duration of the pandemic," Chua said.

Fish-Parcham is hopeful that the federal government also will step in to limit out-of-pocket expenses for all health care, COVID or not.

In the meantime, many states offer consumer assistance programs that help people resolve billing issues between patient and insurer, Fish-Parcham noted.

"We encourage consumers to use those programs if they exist in their states," Fish-Parcham said.

Insurance industry group America's Health Insurance Plans did not respond to a request for comment.

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https://medicalxpress.com/news/2021-06-covid-diagnosis-money.html