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Marty Makary MD, MPH Profile picture
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Jan 13 • 2 tweets • 1 min read
“According to CDC data, three groups benefit from booster dosing with regard to protection from hospitalization..” the elderly, the immunocomp & those with mult comorb that put them @ risk of sev dis
“Healthy young people are not in those 3 groups..That’s the CDC data.” -Dr Offit
Interesting to see our nation's chief drug regulator defend Pharma after Dr. Offit and other vaccine experts have challenged the universality of the bivalent vaccine-for-all recommendation: open.substack.com/pub/sensibleme…

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More from @MartyMakary

Marty Makary MD, MPH Profile picture
Jun 14, 2022
Listening now to FDA deliberate on mRNA vaccines for kids 6-23 months old, I'm very concerned they are using very little primary data in that age group. Instead they are extrapolating, assuming data from older people apply to 6-month-old babies. What they call "immunobridging" /4
Table 73:
“Vaccine effectiveness in participants ages 6-23 mo. was inferred through immunobridging to the young adult data in Study P301 using the co-primary endpoints of GMC ratio and difference in SRRs at 28 days post-Dose 2 (Day 57).”

This violates basic scientific principles
"Inferred through "immunobridging" young adult data from another study?? This is statistical acrobatics, which appears to be done to achieve a desired outcome. There is no justification to bypass rigorous safety & efficacy clinical trials in children.
Read 5 tweets
Marty Makary MD, MPH Profile picture
Mar 29, 2022
Is this following the science?? FDA will authorize 4th doses this week by bypassing the typical voting process of their external experts. FDA will then convene them after the authoriz to "discuss". It's like a judge issuing a verdict and then having lawyers make their arguments.
There is zero clinical data that a 4th dose reduces hospitalization risk. There isn't even any evidence that a 3rd dose reduces hospitalization risk in young people.
The editor of the New Engl Journal, who sits on VRBPAC, has said he "hadn't yet seen enough data on fourth doses to make a determination about whether they are needed for anyone beyond those who are already recommended to get them -- adults who are severely immune deficient"
Read 5 tweets
Marty Makary MD, MPH Profile picture
Feb 23, 2022
After a year of urging the CDC to increase the interval btw the first 2 mRNA doses (to lower complications & increase durability), the CDC finally did it--changed their rec, acknowledging the longer spacing "may reduce the risk for severe side effects" 1/4 thehill.com/homenews/admin…
Ever wonder why a quarter of America was knocked down/in bed for a day after their 2nd dose? The interval was too short.

As several of us argued from the start, no vaccine has multiple doses given that close together. But the FDA and CDC were too rigid to listen.

2/4
How many people were hurt by the CDC's stubbornness?

The original 3/4 week interval between doses was chosen (with good intentions) to get the trial done quickly, but by mid-spring 2021, ample data emerged favoring a longer interval: medpagetoday.com/opinion/marty-…

3/4
Read 4 tweets
Marty Makary MD, MPH Profile picture
Nov 28, 2021
With Omicron, therapeutics are once again missing from the Covid conversation. Molnupiravir & Paxlovid both block virus replication and thus work across variant strains. Fluvoxamine acts on a common inflammatory pathways so would logically work with omicron infections as well.
I'm constantly amazed at how little awareness and coverage there has been on fluvoxamine, which is available now. It's not a medication with mixed results/controversy. A 2nd RCT reported a 91% reduction in Covid deaths. It can also be used in combination with new antivirals.
There has been such an intense focus on vaccines that therapeutics have been understated and often overlooked. Even some physicians are unaware of the fluvoxamine studies (maybe because Drs. Fauci and Walensky have not talked about them). Vaccines save lives but so do medications
Read 4 tweets
Marty Makary MD, MPH Profile picture
Nov 9, 2021
Based on the data: We should not be giving healthy kids a 2nd vax dose at a 3wk interval, esp boys where 1/7K get myocarditis and 1/136 of them died, i.e. from the vax itself(NEJM study). Vax deaths could approximate Covid deaths in boys 5-11 w/no comorbid wsj.com/articles/shoul…
CDC: 94 Covid deaths/2yrs (incl when Tx was crude & Covid rates higher) out of 28M kids5-11. Nearly all likely had a comorb (extrap from our prior study, adolesc hosp study/known under-coding of obesity, word on the ground). CDC still won't tell us # child deaths in healthy kids.
Based on the data of kids w/ NO comorbid, an estimated 0-10 kids 5-11 have ever died of Covid

VS.

Approx 15 would die from the vax 2nd dose (extrap from adolescents). The case to vax kids w/a comorbid is strong. The case for a 2nd vax dose in healthy kids is far from compelling
Read 5 tweets
Marty Makary MD, MPH Profile picture
Oct 18, 2021
With every new Covid death I hear about, including the great Colin Powell, I'm increasingly frustrated by the fact that Molnupiravir is not offered under compassionate use. The drug cut Covid deaths to zero in the phase 3 trial of high-risk patients. wsj.com/articles/fda-c…
The clinical benefit to high-risk patients was so dramatic, that they had to stop the study early.
Many other therapeutics that are safe are being overlooked. Steroid nebulizer, hypertonic saline nasal spray, and Fluoxamine all have placebo-controlled trial data that shows a significant clinical benefit: covid19treatmentguidelines.nih.gov/therapies/immu…
Read 5 tweets

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