Risks of Vaccines Compared to COVID-19 Infection in 12-17 Year Olds

NY Times: Covid Is a Greater Risk to Young People Than the Vaccines (July 4, 2021)

This article elaborates on the risks of vaccination, especially due to myocarditis, compared to the risks posed by COVID-19 infection. Even using very cautious estimates, the authors find that the risks of hospitalizations, cardiac morbidity, and deaths are likely to be much lower in those who receive the vaccine.

Key points:

  • “Among the 6.14 million Americans 17 and under who have been fully vaccinated, there have been 653 possibly related hospitalizations lasting a day or longer…. If that rate holds, it means that if all 73 million Americans ages 17 and under are eventually vaccinated, there will be around 7,700 hospitalizations.”
  • “So far, 326 Americans age 17 and younger have died of Covid-19.”
  • “If the coronavirus were eventually to infect all 73 million children in the United States, we would conservatively expect Covid-19 to be responsible for around 14,600 hospitalizations….[and] lead to over 27,000 additional hospitalizations from the [MIS-C] syndrome.”
  • Unlike hospitalizations related to vaccines which have typically been brief and uneventful, “Covid-related hospitalizations in adolescents can be long and complicated, with nearly one-third requiring patients to enter the intensive care unit.”
  • “Bad things inevitably happen to a small number of people after any vaccination, a few caused by the vaccines, but most not…The virus is more dangerous.”

My take: 12-17 year olds are at less risk from COVID-19 infection than other age groups, however, this risk is still greater risk than the risk of vaccination. Protecting them with immunizations also protects other vulnerable populations and may decrease the risk of vaccine-resistant variants.

Related article: Eric Topol NY Times: It’s Time for the F.D.A. to Fully Approve the mRNA Vaccines An excerpt: “Now more than 180 million doses of the Pfizer vaccine and 133 million of Moderna’s have been administered in the United States, with millions more doses distributed worldwide. In the history of medicine, few if any biologics (vaccines, antibodies, molecules) have had their safety and efficacy scrutinized to this degree…it’s frankly unfathomable that mRNA vaccines have been proved safe and effective in hundreds of millions of people and yet still have a scarlet “E”.”

Persistent Villous Atrophy in Celiac Disease Despite a Gluten-Free Diet

A recent study (F Fernandez-Banares et al. Am J Gastroenterol 2021; 116: 1036-1043. Persistent Villous Atrophy in De Novo Adult Patients With Celiac Disease and Strict Control of Gluten-Free Diet Adherence: A Multicenter Prospective Study (CADER Study) shows that there is a high likelihood of persistent villous atrophy among adults with celiac disease (CD) despite adherence with a gluten-free diet (GFD). Thanks to Ben Gold for showing me this paper.

Key findings:

  • Among 76 patients (median age 36.5 years) who were prospectively followed for 2 years, persistent villous atrophy was observed in 40 (53%). In this group, 72.5% were asymptomatic (based on Likert scales) and 75% had negative serology
  • Detectable fecal gluten immunogenic peptides (f-GIPs) were present in at least one sample in 69% of patients. (Two samples obtained at f/u visits which were ~every 6 months during study)
  • Excellent or good adherence to GFD was demonstrated in 68.4% of patients based on dietetic evaluations. Only 6 (8%) were clearly nonadherent
  • “There were no significant differences in the rate of clinical and serological remission between patients with villous atrophy and those with mucosal recovery”
  • The authors did not find potentially modifiable predictive factors

Discussion:

  • The authors note that serology is “not useful for monitoring patients on a GFD.” Anti-TTG2 and EMA, in a recent meta-analysis, had a pooled sensitivity of around 50%.
  • “Adults are significantly less likely than children to normalize their duodenal histology.”

Editorial:

  • The associated editorial by Rej et al (pg 946-948) outline a personalized approach for dealing with persistent villous atrophy:
    • In those with persistent symptoms/positive GIPs/elevated serology/micronutrient deficiency, the first step is careful dietetic assessment. After this, endoscopy could be considered to confirm presence or absence of mucosal healing.
    • In those with no symptoms and no abnormalities, use of monitoring endoscopy needs to be weighed against the costs as well as potential complications.
    • Other points in the editorial: 1. GIPs have poor concordance with mucosal healing and 2. causes of poor mucosal healing include the following: natural slow healing process, super sensitive to gluten, ongoing gluten exposure, and refractory celiac disease.

My take: This study shows that there is ongoing gluten exposure in the majority of patients even in those with excellent or good adherence to a GFD; in addition, it shows that clinical/serological markers are NOT effective in predicting mucosal healing in adults. Nevertheless, it is not clear that followup endoscopy is beneficial.

Related blog posts:

Forbes (7/1/21): 99.5% Of People Killed By Covid In Last 6 Months Were Unvaccinated, Data Suggests

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How Insurance Companies Can Help Stop the Pandemic in the U.S.

From AJC, Hashem Dezhbakhsh: An incentive to encourage vaccination

This is a good read. An excerpt:

Vaccine hesitancy, which can prolong the pandemic, is a textbook example of a negative consumption externality, where an individual’s choice can harm or impose costs on others. Indoor smoking, drunk driving, or littering are other examples…

One policy option is to use the insurance mechanism, with risk assessment and risk pricing as its enforcing arms….

For example, a risky driver has a higher auto insurance premium than a safe driver, a smoker has a higher health insurance premium than a non-smoker,…Similarly, health insurance premiums, deductibles, and co-pays can be set higher for those who are unvaccinated...

Using risk pricing to set insurance premiums and co-pays for these individuals makes good sense and is fair policy. It incentivizes individuals to vaccinate, while also providing a fairer insurance pricing system by charging those with self-selected higher risk a higher price, instead of shifting their medical costs to others through uniform insurance pricing.

Hydrangeas

AGA Guidelines: Pre-endoscopy COVID-19 Testing No Longer Needed

May 20, 2021: AGA Guideline–Summary: New AGA guidance: stop COVID-19 testing prior to endoscopy (for U.S.)

Full report (48 pages): AGA Rapid Review and Guideline for SARS-CoV2 Testing and Endoscopy PostVaccination: 2021 Update

“AGA has now updated its July 2020 recommendations regarding pre-procedure testing. Based on the latest available data, routine COVID-19 testing prior to endoscopy is no longer needed to perform endoscopy safely.

Read on for four key points from AGA’s newest, evidence-based COVID-19 clinical guidance. Review the full Rapid Recommendations document ahead of print — it will be published soon in Gastroenterology.

Key guidance for gastroenterologists:

  • Routine SARS-CoV-2 testing prior to endoscopy is no longer needed to perform endoscopy safely: Our systematic review found that there is little benefit in routine testing, given very low rates of infection (i.e. asymptomatic prevalence and transmission) during endoscopy to both patients and staff (0-0.5% across representative studies), with potential significant burden, including delays in care, impact of cancer burden, cost, health disparities and reduced endoscopy efficiency. Previously identified benefits of testing, including informed rationing of personal protective equipment (PPE) and patient and staff reassurance, have less relevance given adequate supply of PPE and reduced anxiety in later stages of the pandemic.
  • Vaccination status should not dictate decision-making for implementing pre-procedure SARS-CoV-2 testing: The studies included in our review were conducted prior to vaccination and show minimal benefit of testing as outlined above. While indirect data show that vaccination reduces that risk even further, the available evidence supports eliminating pre-procedure testing regardless of vaccination status of patients.
  • All patients should receive symptom screening prior to endoscopy: Centers should continue to implement universal screening of patients for COVID-19 symptoms, using a screening checklist, and follow universal precautions, including physical distancing, masks and hand hygiene in the endoscopy unit. For patients who have a positive symptom screen, pre-procedure testing can then be utilized for further triage.
  • For centers that value the small benefits (patient and staff reassurance or anxiety) over the downsides (delays care, potential exacerbation of health disparities, endoscopy efficiency, downstream consequences of false negatives and false positives), pre-procedure testing with rapid PCR tests can be considered: Rapid RT-PCR tests that can be performed on the day of endoscopy are preferable as they pose less burden to patients. In the pre-procedure setting, there is limited utility of rapid isothermal tests or antigen tests. There is no role for antibody tests in this context.”

These recommendations are only applicable IF:

My take: This is great news for our patients and hopefully will be widely adopted.

COVID-19 Vaccine in Israel: Rapid Reduction in Risk of Death

N Dagan et al. NEJM 2021;384:1412-23. DOI: 10.1056/NEJMoa2101765. PDF: BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting

Each study group (vaccinated and unvaccinated) included 596,618 persons. Key finding:

  • Estimated effectiveness in preventing death from Covid-19 was 72% (95% CI, 19 to 100) for days 14 through 20 after the first dose.

Fifth Era of Vaccinology

A recent commentary (A Desmond, P Offit. NEJM 2021; 384: 1081-1083. Full text: On the Shoulders of Giants — From Jenner’s Cowpox to mRNA Covid Vaccines) succinctly describes the five major vaccine-related advances. The link also provides access to an audio interview with Dr. Offit

1st Advance: In 1796, Edward Jenner “found that an animal virus (cowpox) could protect against disease caused by a human virus (smallpox)… Jenner’s work ultimately led to the eradication of a disease that is estimated to have killed more than 300 million people in the 20th century”

2nd Advance: In 1885, Louis Pasteur developed an inactivated virus vaccine for rabies. This has led to the development of many other inactivated vaccines, including the influenza vaccine.

3rd Advance: In 1937, Max Theiler attenuated yellow fever virus by means of serial passage in mouse and chicken embryos. This has led to the development of numerous attenuated vaccines to prevent polio (Sabin, 1960s), measles (1963), mumps (1967), rubella (1969), varicella (1995), and rotavirus (2008).

4th Advance: In 1980, Stanford biochemists Richard Mulligan and Paul Berg developed recombinant DNA technology which led to vaccines containing purified surface proteins. This led to the hepatitis B virus (1986), human papillomavirus (2006), and influenza virus (2013) vaccines.

Some of the notable improvements related to vaccines:

  • In U.S., the incidence of polio dropped from 29,000 cases in 1955 to elimination
  • In U.S., during the “2019–2020 influenza season, the influenza vaccine prevented an estimated 7.52 million infections, 3.69 million medical visits, 105,000 hospitalizations, and 6300 deaths”
  • In U.S., the measles vaccine has nearly eliminated a virus that previously caused 2 million to 3 million infections, 50,000 hospitalizations, and 500 deaths every year
  • In U.S., “since the hepatitis B virus vaccine started being routinely recommended for newborns in the early 1990s, rates of hepatitis B virus infection among children younger than 10 years have fallen from about 18,000 per year to nearly zero”
  • Globally, “between 2000 and 2018, roughly 23 million measles deaths were prevented by vaccination…Live attenuated rotavirus vaccines are countering a virus that once killed more than 500,000 infants and young children each year”

5th Advance: In 2020 “with the recent authorization of mRNA vaccines, we have entered the fifth era of vaccinology. This class of vaccines doesn’t contain viral proteins; rather, these vaccines use mRNA, DNA, or viral vectors that provide instructions to cells on how to make such proteins. The SARS-CoV-2 pandemic will be an important test of whether these new platforms can fulfill their promise of creating safe, effective, and scalable vaccines more quickly than traditional methods.”

Related blog posts:

New Data: Acid Blockers NOT Associated with Risk of SARS-CoV-2, SARS-CoV-2 in the Pancreas, & Vaccine Passport

X Fan et al. Gastroenterol 2021; 160: 455-458. Full text link: Effect of Acid Suppressants on the Risk of COVID-19: A Propensity Score-Matched Study Using UK Biobank

Among 9469 included participants, 1516 (16%) were regular users of acid suppressants, and 7953 (84%) were not…propensity score matching (PSM) was applied to match users of acid suppressants and nonusers. 

Key findings:

  • The odds ratio (OR) of testing positive for COVID-19 associated with PPI or H2RA therapy in the PSM cohort was 1.083 (95% confidence interval [CI], 0.892–1.315) and 0.949 (95% CI, 0.650–1.387), respectively.
  • Omeprazole use alone was significantly related to an increased risk of SARS-CoV-2 infection from the subgroup analysis in patients with upper gastrointestinal diseases (OR, 1.353; 95% CI, 1.011–1.825)

My take: This study provides reassurance that acid blockers are unlikely to contribute to the risk of SARS-CoV-2 or to related complications.

Related blog post: PPIs Associated with Increased Risk of COVID-19

Other COVID-19 Information:

AASLD COVID-19 Vaccine Recommendations (for patients with Liver Disease)

Link to 38 page guidance, last updated 2/2/21: AASLD EXPERT PANEL CONSENSUS STATEMENT:
VACCINES TO PREVENT COVID-19 INFECTION IN PATIENTS
WITH LIVER DISEASE

Key points:

  • “Due to their mechanism of action, both mRNA COVID-19 vaccines are recommended for all patients with CLD (compensated or decompensated) and immunosuppressed SOT recipients.”
  • “The AASLD recommends that providers advocate for prioritizing patients with compensated or decompensated cirrhosis or liver cancer, patients receiving immunosuppression such as SOT recipients, and living liver donors for COVID-19 vaccination based upon local health policies, protocols, and vaccine availability.”