All posts by mrossol

Married, 1st generation American, Christian, conservative, GCC parent, Agribusiness manager, long-time Mac-owner, in Ohio.

Boosters for Men 16-40: A Regulatory Gamble

I might re-title this piece “You Still Don’t See What is Going On?” The evidence I see points to ‘total politicalization’ of the pandemic. I fear the results if the people don’t say “No more.” mrossol

12/8/2021 by Vinay Prasad

If the following events occurred during the last presidential administration, there would be widespread condemnation from leading academic medical voices. Instead, the silence is deafening. Consider the timeline of boosters, the massive White House Pressure behind boosters, and the open safety question:

In early April 2021, Albert Bourla, Pfizer’s CEO was quoted as saying boosters will be necessary within 12 months.

Immediately there was push back from Fauci, and other government officials that evidence was needed prior to such an announcement.

In July 2021, Bourla specified that his company would seek FDA authorization for boosters in August.

There again was pushback from senior officials, and a few days later, there was a private meeting between Pfizer executives & senior scientists part of the administration

Shortly thereafter, the White House launched a media campaign pushing for boosters. (We all remember the Sunday show bonanza). The White House decided the deadline would be Sept 20.

On Sept 1, 2021, it was reported that Marion Gruber and Philip Krause, two long time officials in FDA’s office of vaccine products, and the Director and Deputy Director, would resign .

Multiple news outlets reported that this decision, after decades working at FDA, was due to the fact that the white house had launched a media campaign promising American’s boosters for all by the end of the month.

This decision was coercive to the employees of the FDA who could no longer consider the application impartially, as they faced strong political pressure to authorize.

The two senior FDA scientists joined others in a Lancet paper arguing why boosters were not supported by solid science, to which Fauci was critical.

Yet, based on this controversy, the White House was advised to walk back their plan for boosters.

 

The advisory committee to the FDA is held, but the committee does not sate the White House. They vote for a smaller proposal of boosters in older people and select high risk populations— not boosters for all Americans.

The FDA can authorize boosters, but the CDC’s ACIP provides more tailored recommendations. That group was reluctant to recommend boosters for younger people— even those at high risk due to occupation. (Note: this is because as you are younger and healthier, the benefit/ harm balance is more uncertain, more below)

Yet, the CDC director, a White House Appointee, overrode that decision!

In November 2021, the FDA, without the influence of Gruber and Krause, moved to approve boosters for all >18 without advisory committee.

On Nov 19, the CDC held an advisory meeting of ACIP to tailor recommendations and:

Paul Offit (a Member of FDA vaccine advisory committee, but not ACIP) and, Marion Gruber and Philip Krause (the two officials who resigned) wrote a stinging rebuke in the Washington Post, critical of the decision

In December, this time without any advisory committee (neither VRBAC nor ACIP), the FDA expanded boosters again to 16 and 17 year olds with scant data.

Philip Krause (the resigned Deputy Director) and Luciana Boro (former FDA senior scientist) penned a blistering op-ed in dissent in WaPo

Meanwhile, while this was happening:

  • Mounting evidence showed myocarditis is far more common than initially thought.

  • Estimates from Ontario, Canada, Israel and other locations show rates as frequent as 1 in 3 to 6k. The FDA confirms this with an Optum analysis.

  • Myocarditis affects men > women

  • The highest risk age is 12-40 with 16-24 the peak demographic

  • Moderna has higher risks than Pfizer

  • Several European nations suspend Moderna in the young

  • Data from Ontario shows that greater time between is associated with less myocarditis

  • Safety experts, such as Walid Gelad, follow this issue with expert precision

 

What does all this mean?

There is little doubt that the risk benefit profile of a dose 3 is likely to be favorable in older individuals and those with comorbidities or who are immunocompromised. There is also no doubt that the risk/benefit profile is entirely uncertain in younger individuals.

A thin, healthy 16 to 40 year old man with no medical problems has something to gain and something to lose from taking a booster. The potential benefit is a short term reduction in mild symptomatic disease (that’s known with some confidence). The uncertain benefit is whether there is a reduction in severe covid or hospitalization in this age group. At the same time, there is something to lose, a 3rd dose could precipitate myocarditis. Myocarditis, like all AEs, falls across a distribution. Many events will be mild, and most may self resolve, but some will not be mild, as the nature of idiosyncratic adverse events, and some may lead to long term issues.

In regulatory science, the bar to debut products in healthy young people is very high. We do not promote mass campaigns without knowing with some confidence the benefits outweigh the risks. In a pandemic, it is reasonable to have a more permissive standard, but we cannot actually recommend vaccination to any person if there is a net health harm in that cohort.

For boys/men 16-40, their is massive uncertainty whether or not the third dose will confer net benefit, and that is not suitable for regulatory science. This is why the top 2 vaccine experts at FDA resigned, and why they keep writing op eds.

Meanwhile twitter experts engage in propaganda campaigns. The principal ways they lie are the following: they never present myocarditis data by age and sex, but lump together all people (this dilutes the safety signal). They assert that the virus is always more likely to cause myocarditis than the vaccine (this lie has been contradicted by UK data for dose 2 Moderna). They do not seem to understand that the upper bound reduction in severe disease may diminish with each addition dose (i.e.) less and less myocarditis is enough to offset the potential benefit.

Finally, the White House is not an impartial agency. The white house is facing plummeting approval ratings, supply chain issues, and inflation. COVID19 case counts hurt their political prospects, but myocarditis does not. They are in no position to adjudicate which is worse and where the balance tips. Somehow, we understood that the last president should not decide when vaccines were approved. Why is it hard to understand that this president should not decide when boosters are mandated?

Fear is a powerful drug, and it blurs your vision. When you are afraid you cannot see clearly. Approving a vaccination scheme that turns out to, on average, harm boys or men of a certain age would be a catastrophic blunder. Confidence in vaccination will reach new lows, and vaccines as a culture war issue will intensify. America may not survive it. The 2 officials were right to resign. I would not want this on my watch.

 

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Should you wear an n95/kn95/kf94?

1/2/2022  by Vinay Prasad, MD.

If you are a hospital health care worker, and you are entering the room of a patient with known tuberculosis or covid19, then by all means, wear the n95 mask!*

If you are anyone outside of this, does it make sense to wear an n95 when you fly on airplanes or visit the grocery store or walk from the door of the restaurant to your table or walk around outside alone?

Does it make sense to mandate these masks (or smaller versions for school kids)?

The answer to all these questions is: no, it makes no sense. Let me make that case for you.

First, this post is for adults who have been vaccinated or have natural immunity. If you are an adult, particularly if you are older than 40, and have not have covid, nor been vaccinated, then I would advise you to get the shot, but let’s be honest: If you fit this bill, you sure as hell are not reading an article about whether you should wear an n95! The people who are most deeply considering wearing this type of mask, or wearing already, are those with 2 or 3 or 4 (improperly gotten) shots in the arm!

Second, this post is not for individuals or kids with immunocompromised status (e.g. post B cell depletion therapy), etc. You should seek the guidance of your physician. I think it might even make sense for individuals with resolving immuno-depletion to wear an n95 at certain times, but that is a far longer post.

Third, this post is for the current moment, not pre-vax 2020, where I would have made some changes.

Now, for the average healthy person with some immunity to COVID19 (vax or natural), here is why you should not wear this mask: the harms to benefits is a bad proposition.

Downsides:

First, these masks are uncomfortable, if fit and worn correctly, they can cause pain. I will attest to that, having worn them often at work recently, and here is Stef Baral,

Some people say they don’t always hurt. Ok (read on), but they are inconvenient and can cause subjective dyspnea, for instance if you wear them at the gym, or carry a heavy box of stairs, or (wrt kids) play, for e.g.

Second, if you wish to substantively lower the risk of exposure, you will have to wear them for long periods of time, and in many places. You cannot take them off to eat or drink. You will live a diminished life.

Third, you will have to do it forever. But you will not be able to do it forever. You will fail in month 2 or month 3 or year 2 or year 3. You will slip, and eventually exposure is guaranteed. This is a strategy to delay exposure; nothing can avert exposure as long as you are still a human being who plans on being around a while.

Fourth, why delay exposure? After vaccination (and losing weight), there is nothing more you can do to lower your risk of bad outcomes. The virus will never disappear. It will circulate in humans for a thousand years. And, exposure may even be best before vaccine immunity wanes appreciably. With some partial vaccine immunity, natural infection may be milder and solidify longer immunity. Even then, a few years later you will get covid19 again. That’s life, it was never zero risk.

Upsides:

Wearing the mask provides a short term benefit if done religiously. Remember back a few years ago. If you had an event you absolutely did not want to be sick for, you might not go out to nightclubs, or stay up late for a few days before. This made some sense.

Similarly, if you have some major life event you absolutely do not want to be sick for, or say you are visiting family abroad, and absolutely do not want to test positive so you can return to USA, and you were going to be in a high risk, time limited situation (crowded indoors meeting for an hour), then maybe you would wear one. This is similar to the logic of wearing one when you go visit a sick patient with known COVID19 (see * below).

Kids in school

It is ludicrous and delusional to impose these masks on healthy kids in school: indoors or outdoors. Whether or not one chooses to vaccinate a kid 5 to 18, how many doses, and how far apart is a personal medical choice in my opinion. But it is clear that many kids have either had vax or had natural immunity or both.

Seroprevalence estimates find that substantial numbers of kids have already had covid19 (40% at time of FDA vax adcom), and many may not have thought twice about it.

Kids will get exposed to this virus many times in their lifetime. Avoiding exposure with the discomfort and inconvenience of this mask is not worth it.

But more to point, there is zero credible data that the policy: Kids should wear this mask works. Kids will not wear the mask religiously. They must remove it to eat and drink. They will move it around when left alone. The seal will break.

So, it is not clear that the policy: you ought to wear it; will even slow spread among kids in the short term, even if that was a worthy goal (I don’t think it is). PS cloth masks, which many believed in, failed entirely in RCT.

The mask will surely impact kids’ speaking and communicating; it will impact their ability to run and play. It has downsides.

Some will argue that kids testing positive will halt school. First, let me re-state: you have no evidence that this mask policy will change the rate of positive results. It may not even impact the rate of absenteeism/ halting school.

Second, even if k94 kids masks did slow + results, that is only a benefit due to the foolish policies we have around kids. When human beings create bad policies around testing (overtesting asx kids) and pair them with prolonged quarantine periods (also unproven/ also not clear what the goal is), then of course avoidance of + results is important. But the answer is to fix our bad policies, not double down on them.

All kids will eventually get COVID19. That fact is inevitable. You would prefer they do so while they are still young (and thin), and if appropriate, vaccinated. But you should worry more about their mental health/ drugs and alcohol/ and other issues b/c the numerical risks to them are low.

What is going on here

COVID19 does damage the brain. But not primarily by binding to neurons. Instead it creates irrational anxiety among a certain class of social media user who continually escalates what is necessary to “keep us safe.” It has now reached an apogee with rising cases. In fact it tracks cases, lagging just 1 day behind.

The anxiety is irrational because it does not consider rates of events and contrast them with other risks we accept. It does not consider that policies (mask mandates for kiddos) are implemented in a messy world where people being people can erode any theoretical gain. It seldom conducts RCTs to test its delusions, so it can never course correct. It is irrational because it seldom considers harms or inconvenience. It is irrational because it doesn’t understand numerical risk. Many adults have proven themselves to be incapable of thinking about risk, and that was having attended schools; The next generation might fare worse with all the school closures.

Prosac is showing promising anti-covid19 results. In addition to treatment RCTs post exposure, we should randomly assign the most anxious op-ed writers and twitter users to it, and see if it improves outcomes for us all.


*why wear it here? B/c in the case of tb you may avoid the exposure entirely, and in the case of active COVID19 pt you can avoid the certain exposure with a short, time limited use of mask (e.g. 20 mins), and you are less likely to miss work or spread covid19 in the next few days to your other patients with this very simple, short term act, and hospital policy mandates it.

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It Is Time to Face Reality about the Vaccines

It Is Time to Face Reality about the Vaccines

I just discovered Dr. Prasad and it seams that his is a balanced analysis of the current COVID situation: variants, vaccines, masks, and other risks. I would be interested in seeing more on COVID treatments, but perhaps he stays with what he knows. I’m guessing I re-post more of him. mrossol

A number of studies are converging on the fact that 2 doses of vaccination has poor vaccine effectiveness against Omicron. 3 doses does slightly better, but the effect will rapidly wane as antibody titers fall, and infection is certain as the number of exposures increase. These studies have immediate implications for vaccine and health-care policies.

First, Kaiser Southern California. Here are data for 2 doses of mRNA for effectiveness against Omicron. Follow the red line. Over time, it is 0%.

3 doses does better, for now. But look at the confidence interval of the red line. We have no idea if it will be preserved.

Now, let’s turn to the Province of Ontario, vaccine effectiveness 2 dose or 3 dose is in the toilet; Note the y axis, and broad confidence interval post dose 3. Here dose 3 would fail to meet the FDA standard of at least 50% VE, with lower bound CI >30%— the standard for EUA.

Now let us examine Denmark; here are the raw probabilities of secondary attack in a household.

Putting these 3 studies together: what is the conclusion? Two doses of vaccine does nothing or almost nothing to stop symptomatic sars-cov-2. Three doses barely does anything, and the effect will likely attenuate over time. Finally, as the number of exposures increase from 2 to 22 to 202, the cumulative probability of infection will approach 1. 

NOTE: This is not an argument about the benefits of vaccination for the individual— vaccines likely (and evidence shows they) still have great protection against severe disease; instead this is an argument about the effects of vaccination on symptomatic diseases, and (some good portion of) transmission.

Conclusion: you cannot contain the viral spread of omicron by boosting.

The moment we see that, the policy conclusions start to fall into place.

Booster mandates make no sense for young people/ working people/ hospitals/ anywhere. Young people will only be, at best, slightly less likely to spread for a short period of time, but the epidemic waves will eventually over take them. Boosting should happen in populations where it further reduces severe disease and death— aka older and vulnerable people. Focus on that and let college kids off the hook.

Some argue there is still a justification to boost because you can help prevent hospitals from being overwhelmed. Sadly, that argument fails in several ways. First, you have no evidence boosting younger people will slow hospitalizations. A vaccinated younger person already has very low risk of being hospitalized. Boosting may not further lower what is already very low. We simply have no evidence. Event rates are sparse at those ages.

Second, this argument would mean the state could tell people what to eat and how much to exercise, and how much to drink. Food, drink and obesity are drivers of hospitalizations. Instead, we have not accepted these infringements in the past. The justification for vaccine mandates is that it helps curb population spread. The latest vaccine effectiveness figures show that effect is now nearly gone, and transient at best. Ergo, the mandates are unjustified.

Firing nurses and other health care workers for being non-compliant with mandates is now defeating. We are better off having them work. Time to bring them back.

Draconian avoidance of omicron is not tenable. Omicron or a future variant will eventually find us all. It may even be preferable to encounter omicron a few weeks or months after your last vaccine than a year or two later, as the infection may be milder. As I explain in a prior post, wearing an n95 makes no sense.

It is time to face reality.

Reposted from the author’s blog.

Author

  • Vinay Prasad Vinay Prasad MD MPH is a hematologist-oncologist and Associate Professor in the Department of Epidemiology and Biostatistics at the University of California San Francisco. He runs the VKPrasad lab at UCSF, which studies cancer drugs, health policy, clinical trials and better decision making. He is author of over 300 academic articles, and the books Ending Medical Reversal (2015), and Malignant (2020).
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800,000 Noncitizens Allowed to Vote in NYC Elections

It is mind-boggling how Democrats think, or not think, as in this case. Maybe he was elected by the non-citizens? Unbelievable. mrossol

The Epoch Times,  By Harry Lee,  January 10, 2022 
 
 

New York City Mayor Eric Adams allowed a measure to become law on Jan. 9 making about 800,000 noncitizens in the city eligible to vote in municipal elections.

“I believe that New Yorkers should have a say in their government, which is why I have and will continue to support this important legislation,” Adams said in a statement. “I believe allowing the legislation to be enacted is by far the best choice, and look forward to bringing millions more into the democratic process.”

The bill was approved by the City Council on Dec. 9, 2021, giving the mayor 30 days to veto; Adams allowed it to become law without any action. Former Mayor Bill de Blasio had expressed concerns about the measure but declined to veto it before leaving office on Dec. 31.

“To me, this is something that I’m not sure is legally what a city can do,” he said during a Nov. 23 press briefing. “I think it’s something the state government needs to do.”

The law applies to legal permanent residents, people with working papers, and so-called Dreamers, as long as they’ve been residents of the city for 30 consecutive days.

 

“Dreamers” are people who entered the United States illegally as children and were granted amnesty under Deferred Action for Childhood Arrivals (DACA), a controversial executive order signed by President Barack Obama.

The law doesn’t apply to state or federal elections.

These noncitizen voters also can apply to cast an absentee ballot for municipal elections.

Adams was initially concerned about the 30-day residency requirement. But he told CNN on Jan. 9, “After hearing their rationale and their theories behind it, I thought it was more important to not veto the bill.”

He said that in Brooklyn, where he was the borough president, 47 percent of residents don’t speak English at home.

“I think it’s imperative that people who are in a local municipality have the right to decide who’s going to govern them.”

New York Republican Party Chairman Nick Langworthy criticized the law as “perhaps the worst idea out of New York City Democrats.”

“This radical legislation is unconstitutional, un-American, and downright dangerous. This not only will undermine the credibility of local city elections but will undoubtedly interfere with the integrity of state and national elections across New York State,” Langworthy told reporters before the City Council approved the bill.

“Democrats do not get to create their own brand of citizenship to manipulate elections. This is unconditionally unconstitutional, and we will use every legal method to make sure it’s stopped.”

Dan Stein, president of the Federation for American Immigration Reform (FAIR), also criticized the law as “extreme.”

“About 1.1 million votes were cast in the recent mayoral election. With the addition of some 800,000 foreign nationals to the voter rolls, they will almost certainly have an impact on the outcome of future elections,” Stein said in a Jan. 10 statement. “This number is sure to grow due to an increase in all forms of immigration under President [Joe] Biden, as well as the fact that you only have to live in the city for 30 days to be eligible to vote.”

Former Councilman Ydanis Rodriguez, who sponsored the bill and now serves as the city’s transportation commissioner tapped by Adams, praised the new mayor on Twitter, writing: “Eric has shown once again his relentless commitment to our immigrant communities.

“We build a stronger democracy when we include the voices of immigrants!”

Under the law, the earliest election these noncitizens could participate in would be municipal elections held on or after Jan. 9, 2023.

https://www.theepochtimes.com/800000-noncitizens-allowed-to-vote-in-nyc-elections_4203732.html?utm_source=News&utm_campaign=breaking-2022-01-10-4&utm_medium=email&est=OHZKvKAF6VChwQ0Q+YEPErzic80JQTn7fcZzPX6Q6kSqvcSvZnlE7hEXShU4+Q==

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