Operation Warp Speed Strategy

M Slaoui, M Hepburn. NEJM 2020; 383: 1701-1703. Full text: Developing Safe and Effective Covid Vaccines — Operation Warp Speed’s Strategy and Approach

As an aside, I have always thought that the name, “Operation Warp Speed,” sounded like a line from the movie Spaceballs.

This article provides insight into the strategy for “Operation Warp Speed” (OWS). An excerpt:

OWS’s strategy relies on a few key principles. First, we sought to build a diverse project portfolio that includes two vaccine candidates based on each of the four platform technologies…In addition, advancing eight vaccines in parallel will increase the chances of delivering 300 million doses in the first half of 2021…

Of the eight vaccines in OWS’s portfolio, six have been announced and partnerships executed with the companies: Moderna and Pfizer/BioNTech (both mRNA), AstraZeneca and Janssen (both replication-defective live-vector), and Novavax and Sanofi/GSK (both recombinant-subunit-adjuvanted protein). These candidates cover three of the four platform technologies and are currently in clinical trials. The remaining two candidates will enter trials soon...

No scientific enterprise could guarantee success by January 2021, but the strategic decisions and choices we’ve made, the support the government has provided, and the accomplishments to date make us optimistic that we will succeed in this unprecedented endeavor.

Related article:

NY Times (11/9/20): Pfizer’s Early Data Shows Vaccine Is More Than 90% Effective

Weekend News: Elevators, Maskne, Fraudulent Mask Exemptions, Vaccine Optimism, and Taking Healthcare from Millions

Weekend News:

:NY Times: Maskne Is the New Acne, and Here’s What Is Causing It

Maskne — the most common kind of which is acne mechanica, a.k.a. the type of acne a football player may get where the helmet rubs — is also enough of a thing that the Covid-19 task force of the American Academy of Dermatology (A.A.D.) felt compelled to release advice on the subject.

The article describes how mask can trigger acne and ways to prevent/treat this.

Related: American Academy of Dermatology: 9 WAYS TO PREVENT FACE-MASK SKIN PROBLEMS

NY Times: Don’t Whistle on the Elevator. Don’t Even Talk. (print version article title)

“The good news is: If you don’t like small talk in the elevator, those days are over,”…“Imagine if you have a 30-story office building in New York City and you’re trying to get 5,000 people in between 7 and 9 in the morning,”

From NPR:

This administration should present its ‘plan’ and pass it before taking healthcare insurance from millions.


Liver Briefs -June 2019

YH Yeo et al. Hepatology 2019; 69: 1385-97.  The prevalence of high risk individuals in the U.S. who are susceptible (not immune) to hepatitis B has decreased from 83% to 69% from 2003 to 2014.  That still leaves 64 million who would benefit from HBV vaccination.

M Sharma et al. Hepatology 2019; 69: 1657-75. This meta-analysis compared therapies for primary prevention of esophageal varices and concluded that nonselective beta-blocker (NSBB) monotherapy may decrease all-cause mortality and carried a lower risk of serious complications than variceal band ligation (VBL). However, the commentary (1382-84 by L Laine) reaches a different conclusion. “Current recommendations for primary prevention with VBL or NSBB or carvediolo still appear to be acceptable…using a shared decision-making approach” to weigh issue such as daily medication or periodic endoscopy.

J Nguyen et al. J Pediatr 2019; 207: 90-6. This study modeled the cost-effectiveness of early treatment with direct-acting antiviral therapy in adolescents with hepatitis C infection.  With pangenotypic agenst, the cost would be $10000 to $21000 per QALY gained.

S Trinh et al. Clin Gastroenterol Hepatol 2019; 17: 948-56. This retrospective hepatitis B study examined the changes in renal function between 239 tenofovir disoproxil fumarte (TDF) treated patients and 171 entecavir treated patients.  Key finding: TDF was not associated with higher risk of worsening renal function in this cohort with a mean followup of 43-46 months in patients with baseline normal renal function.  In patients with renal impairment, deterioration of renal function was noted in TDF-treated patients.  Thus, TDF should be avoided in patients with impaired renal function.


Rhododendrom in Sandy Springs


Another Reason For HPV Vaccine –Prevention of Anal Cancer

Briefly noted: A recent study (L Vuitton et al. Clin Gastroenterol Hepatol 2018; 16: 1768-76) document a high prevalence of anal canal high-risk human papillomavirus (HPV)  infection in all subjects (n=469, median age 54 years) and even higher rates in patients with Crohn’s disease (n=70).  The authors detected HPV DNA in anal tissues from 34% of the subjects and high risk (oncogenic) HPV in 18%.  In patients with Crohn’s disease, high risk HPV was detected in 30%.

My take: HPV infection predisposes to anal cancer which represent 3-4% of lower-digestive tract cancers. The high rate of HPV

Related blog posts:

near Banff

Science in a Hyperpartisan Age

Two recent commentaries (L Rosenbaum. NEJM 2017; 376: 1607–09; DJ Hunter et al. NEJM 2017; 376: 1605–7) discuss the intersection of science and politics.

Some key points from the first commentary:

  • “When doubt is wrapped up in one’s cultural identity or powerful emotions, facts often not only fail to persuade, but may further entrench skepticism.”  This is referred to as “biased assimilation.”
  • People with “higher levels of science comprehension are actually also the most adept at dismissing evidence that challenges their beliefs.”  Liberals, “for instance, are far more likely than conservatives to dismiss science suggesting that genetically modified foods are safe.”
  • “It’s easy to forget that most scientific facts, and related policies, don’t induce tribalism. You don’t see partisan battles over treatment for myocardial infarction.”
  • Dan Kahan, an expert on the way emotion and identity affect our interpretation of scientific facts says that our president “is our science communication environment polluter in chief.”  Such polluters “cunningly incite cultural battles that ultimately heighten distrust of science.”
  • For vaccine skeptics, if criticized, will try to elicit a backlash against the “academic elite.”

The second commentary focuses on the issue of climate change.  Key points:

  • “Average temperatures have increased by 1.3 to 1.9 degrees F over the past century…and increases have accelerated in recent years…the three hottest years recorded in the U.S. were 2012, 2015, and 2016.”
  • Summer heat waves increase mortality, worsen mosquito-related diseases, jeopardize crop production, increase ozone which worsens lung function, and contribute to forest fires.  Increases in “extreme heat leads to more aggression and violence.”
  • Climate change increases severe storms like hurricanes and cause indirect effects like waterborne-disease outbreaks.
  • The authors advocate for the CDC’s Building Resilience against Climate Effects (BRACE) (https://cdc.gov/climateandhealth/)
  • “U.S. leadership is critical to global action. Jobs in the renewable energy sector…already outnumber those in power generation from coal, natural gas, and oil combined.”
  • “Climate change has become unnecessarily politicized.” Tools for discussing this topic: http://climateforhealth.org/lets-talk -1 hour webinar available and links to specific ways to make an impact.

My take:  While I concede that I am not an expert on this topic, it is clear that climate change is having effects on population health and there are ways to reduce the future impact. Please don’t call me an elitist.



“Not Up For Debate: The Science Behind Vaccination”

Wednesday’s well publicized debate unfortunately discussed vaccination.  Perhaps it is not surprising that a businessman/entertainer, Donald Trump, reiterated misinformation.  Yet, the two former physicians (Ben Carson and Rand Paul) on the stage also provided misleading information.  A good write-up of this issue from the NY Times: Not Up for Debate: The Science Behind Vaccination

Here’s an excerpt:

Here are the facts:

  • Vaccines aren’t linked to autism.
  • The number of vaccines children receive is not more concerning than it used to be.
  • Delaying their administration provides no benefit, while leaving children at risk.
  • All the childhood vaccines are important.

1400 Different Immunization Schedules -What Could Go Wrong?

A recent study (J Pediatr 2015; 166: 151-6) has examined the frequency of “alternative” (non-standard) vaccination schedules among 222,628 children in New York (2009-2011), using a statewide mandatory immunization information system.

Key findings:

  • 25% of children followed an non-standard immunization schedule.
  • At 9 months of age, children on an non-standard schedule were less likely to be up-to-date (15% compared with 90%, P<0.05).

The authors note that in a separate study that there were “1400 individualized vaccination patterns.”  These patterns break down into three: delays of vaccine, selective refusal of specific vaccines, and reduction in the number of vaccines.

In a brief summary, Sarah Long notes that for parents/doctors –“Although their intent is heightened protection of their children/patients from harm, the result is the opposite.  Alternative “schedules” are completely untested for immunogenicity or safety.”

One limitation of this study is that it was conducted in New York.  There is wide variability in the resistance to vaccination among states.

Bottomline: Their has been an increase in the use of non-standard vaccine schedules.  This is contributing to community vulnerability to vaccine preventable diseases.

A related story: “Disneyland” Measles Outbreak (from USA Today) and from NY Times (1/21/15): Measle cases linked to Disneyland (& unvaccinated students).  1/28/15 Measles in Arizona reaches ‘critical point’

Related blog posts:

More Measles Cases -Here’s the Data

This past month a recent perspective article (NEJM 2014; 371: 1661-3) provides an update on measles and the problems with vaccination rates.

Key points:

  • More measles cases in 2014 (592 thru Aug 29) than in any year in the past 20.  Already, the number of cases this year is >3-fold the number in 2013 and ~10-fold more than in 2012
  • Most cases are due to infections acquired during travel or due to cases being brought into U.S. by foreign travelers
  • Problem has expanded due to increasing number of unvaccinated children.  Vaccines “that remain in the vial are completely ineffective.”
  • Measles remains one of the most contagious illnesses and typically one person can infect up to 18 susceptible persons.  Due to its contagiousness, a high level of herd immunity (>92-94% immune) is needed to prevent sustained spread of virus.
  • Measles can be deadly with case fatality rate of 0.2% to 0.3% in the developed world and much higher in the developing world (2-15%).
  • Even a few cases are very expensive to control. A 2004 Iowa outbreak of only three patients cost more than $140,000 to contain/investigate.  An outbreak in Arizona with only 7 patients cost more than $800,000.

Related blog posts:

Parental Immunity (to Education) and Vaccine Decision-Making

A recent NY Times editorial by the lead author of a provocative study in Pediatrics (Published online March 3, 2014  (doi: 10.1542/peds.2013-2365) argues that educational efforts to inform parents may not improve vaccination rates in children.

Here’s a link: http://nyti.ms/1sq4X2s  and here’s an excerpt:

“we found that parents with mixed or negative feelings toward vaccines actually became less likely to say they would vaccinate a future child after receiving information debunking the myth that vaccines cause autism.

Surprising as this may seem, our finding is consistent with a great deal of research on how people react to their beliefs being challenged. People frequently resist information that contradicts their views, such as corrective information— for example, by bringing to mind reasons to maintain their belief — and in some cases actually end up believing it more strongly as a result….

A more promising approach would require parents to consult with their health care provider, as the Oregon law also allows them to do. Parents name their children’s doctor as their most trusted source of vaccine information. That trust might allow doctors to do what evidence alone cannot: persuade parents to protect their children as well as yours and mine.

Related blog posts:

“Too many vaccines and autism” is debunked

Based on false science, many parents think that refusing or delaying vaccinations will be safer for their children and decrease the risk of autism.  While the scientific underpinnings for such a concept have no basis (Pediatrics 2004; 114: 793-804, and Institute of Medicine. Immunization safety review: vaccines and autism. Washington, DC: National Academies Press; 2004), lingering concerns persist.  Into this background, another rigorous study (J Pediatr 2013; 163: 561-7) has concluded that there is “no association between exposure to antigens from vaccines during infancy and the development of autism spectrum disorder (ASD),” autism, or ASD with regression.

So how did the authors reach this conclusion?

Using a case-control study from three managed care organizations (MCOs) of 256 children with ASD and 752 control children, the authors examined exposure to total antibody stimulating proteins and polysaccharides from vaccines.  They utilized vaccine registries and medical records.  The children in this study were born between 1994-1999 and were aged 6-13 years at the time of data collection.

The results showed that with each 25-unit increase in total antigen exposure, the adjusted odds ratio (aOR) for ASD was 0.999 for cumulative exposure to age 3 months. The aOR stayed the same at 7 months and 2 years.  When autism or autism with regression were examined, similarly there was no increased risk.

One of the strengths of this study was that members of these MCOs have routine immunizations as a covered benefit; this helps minimize socioeconomic factors which could influence results.  A small number of ASD cases (5%) and controls (2%) had an older sibling with autism; results were unchanged when these children were excluded.

In many ways, this finding is completely anticipated and in agreement with the Institute of Medicines most recent 2013 report on immunizations (The Childhood Immunization Schedule and SafetyStakeholder ).  As the authors note in their discussion, “beginning at birth, an infant is exposed to hundreds of viruses and other antigens, and it has been estimated that an infant theoretically could respond to thousands of vaccines at once.”

Bottom-line: Vaccines prevent disease without causing autism.  Vaccine refusal increases the risk of disease for those who refuse and creates collateral damage as well.

Related blog entries: