When the first COVID-19 vaccines, came to market… two were made with a – what I considered – a process that was too new and too untested… that was the Pfizer & Moderna based on the mRNA process and the third one was being produced by J&J/Jansen using a process that we had used to make our flu vaccines for decades.  Our Congress passed a law that indemnified the pharmas from any law suits/liabilities of producing those vaccines. Over my 52 yr career, I can’t count all the “new meds” that came to market after 10+ yr of clinical trials only to see them pulled from the market from serious adverse events of people taking the meds, either with other meds the pt was taking and/or other comorbidity health issues the pt had.  I don’t ever remember Congress indemnified any pharma- against lawsuits – when they brought out a new med to market. To me, that was a red flag… and millions of doses being administered under a FDA “emergency use authorization”.  This article dated Aug, 2022, does now – does not recommend the J&J even as a booster – but we got both the initial J&J vaccination and as a booster and WE ARE STILL ALIVE…

There seems to be too much “fuzzy data” being published about the adverse events with these vaccines and they seem to LUMP all the vaccines together, when the J&J vaccine is an entirely different animal than the other two.

We always get our annual flu vaccine – during the optimum time frame – of the last of Sept thru the first couple of weeks in Oct.  Unless something that is published about the “new” COVID-19 vaccines and the only ones made available is made using the mRNA process..  I think that we are going to skip any more COVID-19 vaccines… there appears to be some very effective treatments for anyone testing positive for COVID-19. Everyone can make their own choice to take what seems like what is going to be multiple “jabs” per year in perpetuity.  To me that suggests that these mRNA vaccinations may only be providing a passive immunity that will typically last 60-90 days.

Before We Push the New Omicron Vaccine, Let’s See The Data

https://sensiblemed.substack.com/p/before-we-push-the-new-omicron-vaccine

The White House is pushing Americans hard to take a novel Covid vaccine before the studies are complete.

But where’s the data to support such a sweeping recommendation? The new mRNA vaccines expected to be authorized next month have no clinical trial results that are public. In fact, we know nothing about them. Urging the American people to blindly obey to take a novel mRNA vaccine is not only bad medicine, it’s bad policy. And it’s certainly not following the science.

We just saw this data ambush approach two months ago with the Covid vaccines for babies and toddlers. Here’s how the timeline played out. The White House and public health officials promised them and pushed them hard for children between the ages of 6-months and 5 years. Then vaccine manufacturers released data and declared them safe and effective (the media blindly parroted the message). Here’s the catch. The underlying data actually showed the study sample was too small to make safety conclusions, and most of the claimed effectiveness was statistically invalid. The Pfizer vaccine in babies and toddlers had no statistically significant efficacy. Moderna’s vaccine had an efficacy of just 4% in preventing asymptomatic children aged 6 months to 2 years. (Some European countries have restricted the use of Moderna’s vaccine for anyone under the age of 30 due to the risk of myocarditis). One frustrated CDC official told me the vaccines are so ineffective in young children it wouldn’t matter if you, “inject them with it or squirt it in their face.” Maybe that’s why after a month of pushing Covid vaccination for children under five, only 3% of them got the jab.

Supporters of pushing the new omicron vaccine might point to annual influenza vaccines that are blindly offered each year, but:

1) they use a traditional vaccine platform that has withstood the test of time. In contrast, the novel Covid vaccines have been associated with a serious adverse event rate of 1 in 5,000 doses according to a German study published three months ago by the Paul-Ehrilich Institut. While the National Institutes of health has dedicated over a billion dollars to study long-Covid (which has yielded nothing), its spent virtually no money to investigate Covid vaccine complications, like heart injury in young people.

2) There is currently no scientific consensus that a repeated Covid booster strategy is the right approach. Some scientists are concerned about what is called immune imprinting from multiple booster doses that can weaken the immune system. A recent article published in the journal Science noted a reduced immune response against the Omicron strain among people previously infected who then received three Covid vaccine doses compared to a control group that previously had Covid and did not have multiple shots.

3) The new Omicron vaccine, which is based on earlier Omicron strains, has been tested against newer Omicron strains currently in circulation—a distinct research advantage over studying flu shots. But the results have not been made public. Doesn’t the public have a right to know the results?

It may be that an omicron specific vaccine recommendation for the fall is warranted, but pushing it hard before the data is available makes a mockery of the scientific method and our regulatory process.  In fact, why have an FDA, if White house doctors feel that a new medication would likely benefit public health.

Despite the secrecy surrounding data on the new vaccine, Dr. Jha endorsed the new vaccine in his remarks.  “Based on everything we’ve seen so far, all the data suggests it should be highly effective against the new variants,” Jha said.  

Is that aspirational political talk or a scientific conclusion based on sound data? The distinction is critically important because the public has lost trust in health officials after watching them repeatedly make things up as they go and declare them as truths rather than hypotheses. We need public health leaders to show some humility, stick to the science, and be more transparent with data then they ever have been before. If Jha is following the science, we need to see the data.

Marty Makary MD, MPH is a professor at the Johns Hopkins School of Medicine, the Johns Hopkins Carey Business School, and author of the New York Times bestselling book The Price We Pay.

 

 

Filed under: General Problems