Good Friday Morning, especially to Pfizer, for no other reason than they are why I now am fully vaccinated against the novel coronavirus from China. Pfizer’s CEO says he expects a booster shot in the next 12 months or so. That makes sense. I’d expect that for all vaccines, Pfizer, Moderna, Johnson & Johnson, AstraZeneca, or the upcoming Novavax.
I read an interesting report in Nature that suggests that the South African variant could hold the key to future immunity to COVID-19. The SA variant is more dangerous and viral. However, the human immune system’s reaction to that variant is so strong that it covers other variants of COVID-19. The preliminary thinking is that we solve that variant, and we beat the virus long term. The reason I suggest that’s possible long-term is that research and predictive modeling of all the possible mutations of the virus suggests that this virus has a limited number of modifications it could make, meaning we could potentially beat this thing.
Anyway, if you haven’t gotten vaccinated yet, I highly recommend it. Round 2 of the shot was rougher for me, but I was good to go once I popped some ibuprofen. This newsletter will go into the destructive decision of the FDA/CDC in pausing the Johnson & Johnson rollout. Even if you follow me on social media, I assure you, you don’t even know the half of it. Links to follow.
Where you can find me this week
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National press falsely downplays vaccine effectiveness – The Conservative Institute.
Biden’s gun control proposals are DOA with Congress and Americans – The Conservative Institute.
The Incompetence of the FDA / CDC is Going to Cost Lives
I have a small moleskin notebook that I use to jot down columns, newsletters, and essay ideas. Inspiration is one of those things that’s hard to channel in the moment. Sometimes really great nuggets appear in the middle of freewriting. Still, usually, ideas for what I’m going to do in this space come to me randomly throughout the week. I’ll jot down a few sentences (or pages) to remind myself what to write.
That’s not true this week.
This week is brought to you by the near incandescent rage I experienced when I woke up Tuesday morning. The United States FDA and CDC had decided to pause the Johnson & Johnson rollout. Most mornings, I start my day with the caffeine from a pre-workout drink. By the time I finished absorbing that news, I was wide awake.
In early March, I wrote a whole column praising the US vaccine rollout and blasting Europeans and their decisions to pause the AstraZeneca vaccines. The FDA and CDC nuked that column in a single decision. The US is still better than Europe at administering doses. However, the FDA and CDC did the same thing as Europe in nuking a single vaccine’s credibility. All for nothing.
J&J By The Numbers
Here’s the statement from Johnson & Johnson:
We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine. The United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA) are reviewing data involving six reported U.S. cases out of more than 6.8 million doses administered. Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine.
Let me break some math down for you, which is impossible for your average journalist. Six reported cases in a population of 6.8 million equates to 0.00000088%. Meaning 99.999999% of those receiving a Johnson & Johnson vaccine experienced zero issues on the blood clot front.
Purell’s hand sanitizer label can only claim it kills 99.99% of germs, not 99.999999%. We’re dealing with the definition of a potentially catastrophic freakout. And it’s not something specific to Johnson & Johnson. AstraZeneca, paused for the same reasons in Europe, commissioned a study on this issue and found the following:
A study by Oxford University found the number of people who receive blood clots after getting vaccinated with a coronavirus vaccine are about the same for those who get Pfizer and Moderna vaccines as they are for the AstraZeneca vaccine that was produced with the university’s help. According to the study, 4 in 1 million people experience cerebral venous thrombosis after getting the Pfizer or Moderna vaccine, versus 5 in 1 million people for the AstraZeneca vaccine. The risk of getting CVT is much higher for those who get COVID-19 — 39 in a million patients — than it is for those for get vaccinated. AstraZeneca’s vaccine use has been halted or limited in many countries on blood clot concerns.
Another way of looking at this is this: by vaccinating people, we’re reducing the number of blood clots in the infected population by quite a lot. From 39 in a million to only 4-5 in a million. If you’re making public policy decisions, which one do you go with? I know what I’d do…
Of course, we’re going with the most negative version of all this because the media is rolling with the “vaccines could be dangerous.” And the CDC and FDA are going with that too. The result is that people will lose faith in the very thing that is saving lives.
Furthermore, it’s bizarre we’re stopping AstraZeneca and Johnson & Johnson over this issue and not Pfizer and Moderna. If it’s an actual issue, then pause all of them. They’re not doing that, which suggests that this isn’t the issue they’re making it out to be and makes this decision-making all the more bizarre.
Here’s how well the vaccines are working right now, the WSJ reports:
The U.S. Centers for Disease Control and Prevention has identified a small cohort of approximately 5,800 cases of Covid-19 infection among more than 66 million Americans who have completed a full course of vaccination.
These so-called breakthrough cases, which are defined as positive Covid-19 test results received at least two weeks after patients receive their final vaccine dose, represent 0.008% of the fully vaccinated population.
Vaccines are 99.992% effective (which is higher than the clinical studies). When it comes to modern medical science, these things are about as close to a medical miracle you can get. It’s astonishing how well these things are stopping a novel coronavirus that emerged from China at the end of 2019.
Israel is the greatest testament to this. 62% of their population is now vaccinated, and COVID-19 has been leveled. Their daily case number went from around 1,000 – 1,200 in the winter to now only around 25 new cases a day. A virus that’s spreading that slow, even including mutations, is a non-factor to public policy. That also suggests the thresholds for herd immunity in the United States are much lower than the 90+% range people like Fauci have floated in a scaremongering manner.
Given all this data, it’s astonishing we’re pausing anything at all. Eric Topol points this out:
When 1 of 585 Americans have died from covid (0.17%), I don’t understand why we would hold up the use of a vaccine with <1 per 300,000 (0.0003%) risk of a serious side-effect.
This decision is an utter failure of risk management during a pandemic when we need swift action. There is a cost to halting any vaccine, both in absolute numbers and vaccines’ reputation.
The CDC/FDA harms vaccine reputation
Before the CDC/FDA made their decision to pause the J&J rollout, we’d seen the impacts of even brief pauses to AstraZeneca in Europe. Here’s what happened in the two-week span where Europe screwed its vaccine rollout. From Reuters:
An increased number of French, German, Italian and Spanish adults said they considered the vaccine unsafe, YouGov found, although faith in other vaccines by Pfizer Inc and Moderna Inc was unaffected.
“Not only have we seen considerable rises in those who consider it unsafe in the last two weeks in Europe, the AstraZeneca vaccine continues to be seen as substantially less safe than its Pfizer and Moderna counterparts,” lead data journalist at YouGov Matt Smith said in a statement.
Sixty-one percent of French adults surveyed said the vaccine was unsafe, a rise of 18 percentage points compared to February, YouGov said.
Just over half of German adults surveyed said they thought the vaccine was unsafe, a rise of 15 percentage points compared to February, while 43% of Italians had serious doubts, an increase of almost a third.
Spain showed a similar increase to Italy in the level of concern, YouGov said. Only in Britain was trust in the vaccine stable.
A vaccine that has nearly single-handedly destroyed COVID-19 in the UK is now distrusted across Europe, and that distrust is the majority position. You can’t just reverse that by saying, “ok, everything is fine!” People are, understandably, going to say, “give me the vaccine that wasn’t questioned by the government!” Public policy has consequences. You can’t hand-wave them away.
The same thing is happening in the United States. YouGov performed a similar poll in the United States and found:
The CDC recommendation to pause Johnson & Johnson vaccine use causes public confidence in the vaccine to sink 15 points:
Perceptions before CDC announcement
Safe – 52%
Unsafe – 26%
Perceptions after CDC announcement
Safe – 37% (-15)
Unsafe – 39% (+13)
For now, it doesn’t appear that pause has impacted Pfizer and Moderna that much. Hopefully, that lasts.
There’s another double-edged issue with Johnson & Johnson’s pause. We were not using J&J like the other vaccines. Many states were using J&J to do mass vaccination sites and target poor and minority communities with low adoption of the Pfizer or Moderna vaccines. Because J&J was a one-shot solution, it allowed states to go into communities with less access and run events and then leave with fully vaccinated populations, which would severely blunt the surge of the virus there too. The best evidence we have suggests that states were finding success with those strategies.
That pause is throwing a wrench into those plans. Because J&J doesn’t require Moderna or Pfizer’s refrigeration requirements, state health departments could take the shots into these communities in a much more mobile fashion. Instead of getting people to get a vaccine, the vaccine comes to them. That’s harder to do with Pfizer and Moderna. Bloomberg notes:
Those most affected, other than seniors and disabled homebound New Yorkers, are “people experiencing homelessness, or those who have difficulty getting time off from work or other obligations and benefited from the J&J one-shot feature,” said Patrick Gallahue, a spokesperson for the city Health Department. Epicenter NYC, a news organization that has registered thousands of New Yorkers for vaccines, said restaurant workers — a group that is 44% Hispanic — have tough schedules for the two shot regimen. Around 20% of the Hispanic population in New York City has been vaccinated, compared to 36% of White people.
And remember, when the FDA/CDC re-approves Johnson & Johnson, they’re going to try and restart these initiatives, as they should. But the CDC and FDA have nuked the credibility of J&J in the public’s minds, which could cause a backlash, where people feel like they got the short end of the stick in getting a “lesser” vaccine. In contrast, the “rich and white people” of the world receive the “better” vaccines.
This ripple effect is all happening because of six reported cases. Six. And now the CDC and FDA have introduced a world of harm into the vaccination rollout.
I genuinely hope I’m wrong, and we don’t experience a slowdown in people getting these literal life-saving vaccines. But if we do, and it gets harder and harder to reach specific communities, the CDC and FDA have only themselves to blame. And if you don’t believe me on that: this exact reaction is already happening internationally. The New York Times reports:
With new infections surging on nearly every continent, signs that the vaccination drive is in peril are emerging, most disconcertingly in Africa.
In Malawi, people are asking doctors how to flush the AstraZeneca vaccine from their bodies. In South Africa, health officials have stopped giving the Johnson & Johnson shot, two months after dropping the AstraZeneca vaccine. And in the Democratic Republic of Congo, 1.7 million AstraZeneca doses have gone unused.
The actions of American and European officials reverberated around the world, stoking doubts in poorer countries where a history of colonialism and unethical medical practices have left a legacy of mistrust in vaccines. If the perception takes hold that rich countries are dumping second-rate shots on poorer nations, those suspicions could harden, slowing the worldwide rollout of desperately needed doses.
Dr. Sara Oliver of the C.D.C. told the advisory panel that prolonging the pause in using the Johnson & Johnson vaccine “could have global implications.”
Vaccine trust is not something you can turn on and off. It was deeply irresponsible of the FDA and CDC to take action like this in the middle of a pandemic.
It’s also a black eye on Joe Biden, who is sitting idly by, doing nothing, and letting the successes of Operation Warp Speed, whose coattails he’s been riding, get harmed. Biden campaigned on competence and has yet to lift a finger to improve our vaccination rollout, and with his refusal to step in with the FDA or CDC now actively harming that rollout.
All evidence says that the Johnson & Johnson pause will have far-reaching impacts, both domestically and abroad. And the delay could deepen divisions in the country if people believe they’re getting lesser vaccines (it’s a wrong belief, but the FDA/CDC are fanning that notion). Of all the missteps in the pandemic, this was unquestionably the worst. I hope I’m wrong, but there’s little evidence I am.
The only advice I have is this: get vaccinated. If you have that, then the continued failures of the federal government no longer apply to you. If the government’s failures lengthen the time it takes to get vaccinated, that won’t apply to you. Because the federal government under Biden will argue that because the FDA/CDC has failed, it gives them a reason to push or advocate continued lockdowns or masking. Vaccinations are the ticket out of that stupidity.
Links of the week
The FDA’s Johnson & Johnson-Vaccine Pause Should Outrage Congress: Lawmakers, as well as President Biden, should be livid that the agency has usurped their power. – Charles C. W. Cooke, National Review
America’s Racial Self-Flagellation at the UN Only Helps Rogue States – Commentary Magazine
The Blue States That Make It Hardest to Vote: Democrats are criticizing Republicans for pushing restrictive voting laws. But states such as Joe Biden’s Delaware can make casting a ballot difficult. – The Atlantic
Texans hit hardest by coronavirus are facing another challenge: the pause on the J&J vaccine: Efforts to vaccinate young people, rural Texans, communities of color and people experiencing homelessness have been impacted by the pause. – The Texas Tribune
Court-Packing Would Be the Very Tyranny Democrats Have Warned About – Charles C. W. Cooke, National Review
The Biden Administration Is Quietly Keeping Tabs on Inflation: A months-long effort to monitor and model economic trends inside the White House and the Treasury Department found little risk of prices spiraling upward faster than the Fed can manage. – NYTimes
He won’t allow over-the-counter birth control, but Biden is pushing risky at-home abortions – The Washington Examiner
Twitter Thread(s) of the week
Satire of the week
Thanks for reading!