VAX: J&J officially applies for FDA approval !

Pivotal question: Is 66% effectiveness good enough ?
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This is an updated and expanded post of my takeaways that draws on several sources, most notably, WSJ analyses and J&J’s press releases.

> Overall, J&J’s vaccine was 66% effective against moderate or severe symptoms … and “appeared to be generally safe and well tolerated”

Note: The Pfizer-BioNTech and Moderna shots were more than 94% effective in late-stage testing.

But, the competitive brands’ results may not be directly comparable.

J&J’s trial occurred as at least one variant (i.e. the South African strain) that appears to have some impact on vaccine efficacy was circulating, while the Moderna and Pfizer-BioNTech trials were completed before variants of concern started transmitting widely. Source

> The vax was 72% effective in the US … lower in Latin America (66%) and South Africa (57%).

Note: The lower effectiveness in South Africa is a red flag re: effectiveness against mutating strains of the virus and probably distorts the comparisons against Pfizer & Moderna

> When considering only severe cases, J&J said its vaccine was 85% effective across all regions studied. 

Note: The J&J study tracked moderate and severe cases of Covid-19, defined as testing positive for the virus and having certain symptoms including shortness of breath, cough, fever or respiratory failure.

> The J&J vaccine prevented 100% of hospitalizations and deaths — all hospitalizations and deaths in the study group occurred among people who got the placebo. Bloomberg

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> Good news: the J&J vaccine is a single dose and only requires refrigeration, not sub-zero freezer storage, making broad-scale distribution more practical.

> More good news: The J&J vax is already in high volume production, awaiting regulatory approval. J&J says that is has “millions of doses available for shipment immediately upon authorization … will deliver 100 million in the U.S. by mid-year … and expects to make more than one billion doses in total this year globally.” Source

> Bad news:  If the FDA follows the same timeline as for the Pfizer & Moderna vaccines, regulatory approval won’t come until the end of February or early March. For eager vax chasers (like me), that’s an eternity.

Open issue: J&J is an adenovirus vaccine that attacks the COVID virus using double-stranded DNA;  Pfizer and Moderna vaccines uses single-stranded “messenger” RNA (mRNA).  The long-term health effects of these specific vaccines (both types) are uncertain and potentially significant since they “involve” a person’s natural DNA structures.  Only time will tell.

More immediate: The J&J vaccine was only marginally effective against the spreading South African COVID strain, suggesting that a 2nd “booster” shot may eventually be required.  The Pfizer’s & Moderna’s clinical trials were conducted before the South African strain was evident, so their potency against that strain is uncertain Early early indications are that they may be more effective, but still may eventually also require an additional booster shot.

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> J&J reminder:

“It’s a pandemic vaccine preventing death and hospitalization and severe disease in an acute situation, now in the middle of a pandemic.”

Said differently, these vaccines are intended to prevent severe consequences (i.e. hospitalization or death), not necessarily to stop infections.

> WSJ conclusion:

Even though it wasn’t as effective as the (Pfizer & Moderna) vaccines, J&J’s vaccine performance would be strong enough to protect many people and help build the community immunity.

> My take:

Disappointed that effectiveness rate isn’t higher.  If it were, brand choice would be a no-brainer (save for potential longer-run health consequences — which haven’t been evaluated for any of the vaccines) 

Keeping things in perspective, 72% effectiveness in the U.S. is greater than zero … greater than most vaccines that have ever been deployed for other infections… and, roughly the same as the first-dose-only effectiveness of the  Moderna vaccineSource

And, keeping an eye on the goal line, J&J’s vaccine was 100% preventative of hospitalization and deaths. 

So, barring any  differentiating long-term health consequences that could be significant (and haven’t been studied yet for any of the vaccines), I plan to take the first vax that I can get my hands on.

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DISCLAIMER: I’m not a medical professional or scientist — just a curious, self-interested guy.  So, don’t take anything that I say or write as medical advice. Get that from your doctor! 

2 Responses to “VAX: J&J officially applies for FDA approval !”

  1. Dixie C Says:

    J&J is reportedly studying now whether a second dose of their vaccine some weeks later will increase effectiveness rates against all strains. I’m guessing that the result will be positive.

  2. VAX: Breaking thru the vaccination bottlenecks… | The Homa Files Says:

    […] See J&J officially applies for FDA approval ! […]

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