What Happened to ‘Safe & Effective’?

COVID vaccines were developed in record time, one might say at “warp speed,” the name of the operation instituted by President Trump in 2020. We were assured by those in whom we place trust that these vaccines were “safe and effective.”

In August 2021, President Biden told us, “After a strict process, the FDA has reaffirmed its findings that the Pfizer COVID-19 vaccine is safe and effective, and the FDA has given its full and final approval.”

The CDC said the same, and confirmed just days ago that, “COVID-19 vaccines are safe and effective.” Dr. Anthony Fauci received his first dose of the Moderna vaccine a few days before Christmas in 2020, the same time I received my first dose of the same vaccine.

According to ABC News, “The event was shown live on national television as part of an effort to reassure Americans that the vaccine was safe and effective.” Dr. Fauci felt “extreme confidence” in the vaccine science and wanted to get vaccinated publicly as a symbolic gesture for the rest of the country.

Major medical institutions such as Johns Hopkins University echoed Dr Fauci and the CDC saying, “The Pfizer and Moderna vaccines are strongly recommended as safe and effective at preventing serious illness or death from COVID-19.”

How are vaccines developed? The College of Physicians of Philadelphia explains, “Vaccine development is a long, complex process, often lasting 10-15 years and involving a combination of public and private involvement.”

Johns Hopkins agrees, “A typical vaccine development timeline takes 5 to 10 years, and sometimes longer, to assess whether the vaccine is safe and efficacious in clinical trials, complete the regulatory approval processes, and manufacture sufficient quantity of vaccine doses for widespread distribution.”

Normally, it’s a step wise process,

Each clinical trial phase follows completion of the prior phase

Can take a long time to accumulate cases needed to assess vaccine efficacy outside pandemic

Manufacturing capacity is scaled-up after phase III trial and regulatory approval

But this may be accelerated during a pandemic:

Some clinical trial phases are combined

Cases accumulate rapidly to assess vaccine efficacy because of the pandemic

Manufacturing capacity is scaled up during the clinical trials but at financial risk

For COVID, this process was definitely accelerated. It was in March 2020 that COVID went from an interesting news item to a battering ram pounding the entire world. And just 9 months later, not 5 to 10 years later, Dr. Fauci, myself, and many others received their first vaccine doses.

The mission of the FDA is to protect public health by, “ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices,” and vaccines certainly fall into this category. Many bemoan the process when it is slow. How often do patients suffering from currently untreatable or inadequately treatable diseases wish the approval process was faster, hoping they don’t die waiting for the next wonder drug to be approved?

How has this played out with the COVID vaccines? I must add the standard and necessary disclaimer that I am not anti-vaccine, having been personally fully vaccinated. Nor am I offering medical advice, only an analysis of where we are with COVID vaccines now two years into this current pandemic. Any vaccine decisions should be between you and your physician based on a thoughtful analysis of risks and benefits, as is standard for any medical intervention.

Several reports are worthy of analysis regarding the “safe and effective” assertions made by regulatory authorities and leaders. Start with safety.

Last week, as reported by Yahoo! Finance, the FDA released, under orders from a U.S. District Judge, 55,000 pages of clinical trial documents which Pfizer submitted to the FDA as part the approval process. Originally the FDA wanted to suppress this data for 75 years as they had “limited resources” to prepare this data for release, yet they took approximately 75 days to review and analyze this same data before granting approval.

In the appendix is a “List of adverse events of special interest,” noting 1,291 different adverse events post vaccination, running 9 pages. There is always the issue of association versus causation, but the fact that Pfizer submitted this data to the FDA and the FDA fought to prevent its release raises red flags.

Aside from the FDA submission, there is the VAERS database which specially tracks vaccine related adverse effects. As Yahoo! Finance reported:

From mid-December, 2020 through February 18, 2022, the U.S. government’s database, the Vaccine Adverse Events Reporting System (VAERS), has received 1,134,984 reports of adverse events, including 24,402 deaths, following COVID vaccination. Additionally, there have been 4,021 cases of myocarditis and pericarditis in the U.S. With 2,475 cases associated with Pfizer, 1,364 cases with Moderna and 171 cases with J&J’s COVID vaccine. These include 643 reports of myocarditis and pericarditis in children aged 12 to 17.

The U.S. Department of Defense also reported, “Sharp spikes in miscarriages, myocarditis, cancer diagnoses, Bell’s palsy, female infertility” post-vaccination. Yet this is deemed unnewsworthy and the media’s so-called “fact checkers” are always trying to “add context” rather than encourage further analysis and discussion.

Then there is efficacy. British independent new site, The Expose, reported last week:

The latest data published by the UK Health Security Agency confirms deaths are rising dramatically among the triple vaccinated population whilst declining steadily among the not-vaccinated population in England.

With the most recent figures showing the fully vaccinated accounted for 9 in every 10 Covid-19 deaths over the past month; and the triple vaccinated accounted for 4 in every 5 of them.

The data are from an official government website which reports 70 percent of individuals in England receiving at least one vaccine dose, 65 percent getting two doses, and 50 percent boosted, meaning three doses. They also found vaccine effectiveness for the AstraZeneca vaccine dropping “to almost no effect from 20 weeks after the second dose.” For Pfizer and Moderna, the effectiveness dropped “to around 10% by 25 weeks after the second dose.”

They note that booster efficacy also quickly wanes, “Vaccine effectiveness estimates for the booster dose are very similar, irrespective of the primary course received.”

This is just one bit of data and as the U.K. government points out, “This raw data should not be used to estimate vaccine effectiveness.” But it’s also noteworthy, as are similar reports from other countries. NPR reported last summer, “Highly vaccinated Israel is seeing a dramatic surge in new COVID cases.”

These reports raise questions of both safety and efficacy of the COVID vaccines. This does not require a knee-jerk response of no vaccines for anyone or the opposite of how-dare-you-question the vaccines. Instead, why not a middle ground of asking questions, analyzing, and honestly reporting the data?

CDC Director Rochelle Walensky last admitted that the CDC dropped the ball on honesty saying, the CDC mislead the public about long-term effectiveness with “too little caution and too much optimism.” She went further, “Nobody said ‘waning’ when this vaccine is going to work, oh, maybe it will wear off or not be as potent against the new variant.”

By necessity, we as a society need to have a basic level of trust in our medical and government institutions, regulatory or leadership. We are told one thing repeatedly, and threatened, shamed, or chastised if we ask questions or challenge the narrative. Then when news or data are released that contradicts the narrative, trust in our institutions diminishes.

We have seen this numerous times with COVID, over subjects like natural immunity, off-label therapeutics, lockdowns, mask mandates, and social distancing, where discussion or disagreement is not allowed. Going further, many political issues became verboten to question or discuss, including Trump-Russia collusion, Hunter Biden’s laptop, election integrity, and so on. Those who dared question the establishment narrative were banned from social media and polite society.

Businesses and lives were ruined by COVID and the resulting restrictions and mandates. Given the world’s collective sacrifice, aren’t we entitled to honesty and transparency from those who create these rules and hold the fates of so many individuals in their hands? Or has everything about COVID been simply a means to an end, replacing freedom and liberty with top-down control?

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