Horowitz: The FDA’s indefensible approval of the Pfizer shot



Jesse Jackson and his wife are the latest victims of our government's refusal to focus on early treatment. After having been fully vaccinated, they are the latest high-profile people to be hospitalized with the virus.

Based on the government's own narrative, there is now nowhere for the lockdown/mask/shot cartel to run or hide from their failure nor their continued denial of the efficacy of prior natural immunity and early treatment for those without prior infection. Even for those vaccinated, the safest and most effective way forward is to test for prior immunity and treat pre-emptively or early those who have not yet been infected. Anything else will result in a growing death toll, endless life-altering side effects from the vaccine, an erosion of human rights, and the crushing of our economy and way of life.

The narrative of "the pandemic of the unvaccinated" collapsed quickly. As I predicted, not only did the data show the vaccine barely worked to stop infection, but the protection against critical illness wanes over time and might even induce a form of antibody-mediated viral enhancement, which continuously makes the virus worse. Thus, the more we push boosters, the more we suffer viral enhancement, waning antibodies, and the massive risk of side effects accompanying each shot.

In a CDC briefing from Aug. 18, director Rochelle Walensky let the cat out of the bag — that not only does the protection wear off, but it might enhance the disease.

"And even though our vaccines are currently working well to prevent hospitalizations, we are seeing concerning evidence of waning vaccine effectiveness over time and against the Delta variant," said Walensky during the briefing. "Additionally, reports from our international colleagues, including Israel, suggest increased risk of severe disease amongst those vaccinated early. Given evidence, we are concerned that the current strong protection against severe infection, hospitalization and death could decrease in the months ahead. Especially among those who are at higher risk or who were vaccinated earlier during the phases of our vaccination rollout. In the context of these concerns, we are planning for Americans to receive booster shots."

Stop the tape! Walensky now concedes the following:

  • There is zero justification to mandate the vaccine given that it doesn't stop infection and transmission.
  • Even the personal protection from serious illness wanes after about six months or so and increasingly so for those most vulnerable to the virus who need the protection the most.
  • The vaccine efficacy wanes both over time and with mutant strains that will likely continue.
  • In a stunning admission, she says that reports from Israel seem to "suggest increased risk of severe disease amongst those vaccinated early." This could indicate some degree of antibody dependent disease enhancement. After all, if the immunity is waning, then there is always a concern that the antibodies are strong enough to bind but not strong enough to block, which creates a more dangerous conduit for the virus into the cells, which is what people like mRNA vaccine inventor Dr. Robert Malone have been warning about. The FDA itself conceded in its memorandum (p.52) on the EUA approval of the shots, "Risk of vaccine-enhanced disease over time, potentially associated with waning immunity, remains unknown and needs to be evaluated further in ongoing clinical trials."

Yet what is Walensky's solution? To exacerbate this cycle and give yet another round of shots to everyone. Not only will this cause needless death and injury without long-term protection, but it will likely enhance viral immune escape even more. A pre-print study from Spanish researchers found that the antibody levels produced by booster shots to the Alpha variant seemed to net decreasing results. "Our results with the Alpha variant suggest that 3rd doses of present vaxes to the general population might not be the best approach to increase the immunity to the emerging VOCs," gently concluded the authors. However, if these boosters are going to produce half-baked levels from the get-go, not only will the efficacy wane quicker (after users suffer all the side effects), but the risk for antibody dependent disease enhancement grows more alarming.

Israel, a country where nearly every older adult is vaccinated and many have received booster shots, is now concerned about the discovery of an even more virulent strain. Scientists have been warning that the devastating results of mass vaccination, particularly with a narrow-spectrum preventive vaccine like the spike protein shots, would create a super virus through viral immune escape. "Plans to vaccinate those with high risk of fatal disease followed by a drive to reach herd immunity while in uncontrolled transmission among the rest of the population is likely to greatly increase the probability that a resistant strain is established," warned a group of European scientists in a paper published last month in Nature.

How can the FDA approve this shot when it has not fully studied the effects of myocarditis and other side effects? How can agency officials fully approve it when they themselves admit the shot requires an unknown number of boosters? Data from Israel revealed: "A full course of the Pfizer-BioNTech vaccine was just 39% effective at preventing infections and 41% effective at preventing symptomatic infections caused by the Delta Covid-19 variant, according to Israel's health ministry." Again, how can this be approved and marketed as a vaccine?

The FDA's industry guidance for EUA status (p.13) requires a 50% threshold of efficacy to even get emergency use authorization, much less full approval! With our government admitting it is now below this threshold and waning with every day and every new variant, how can full approval be justified, particularly of the Pfizer shot?

Contrast this to natural immunity, and it is simply indefensible for our government to treat vaccinated people as less a threat than those with prior infection. How good is natural immunity? The U.K., which is the only country that publishes granular weekly surveillance data, shows that the number of "probable" reinfections is just 0.025%. Almost all of them were likely very mild cases. The trend line also shows that the reinfection cases have not grown with the Delta variant.

This all demonstrates that not only should those who already have immunity shy away from the risk of these shots, but even those who don't should focus on early and prophylactic treatment to get them over the inevitable exposure to the virus. A truly honest government would be promoting this message rather than doubling and tripling down on failure as the only solution to a problem they continue to make worse.

Surgeon general says Americans should expect more vaccine mandates following FDA approval of Pfizer vaccine



The U.S. Surgeon General on Sunday told Americans to expect more private businesses to implement vaccine mandates following the FDA's full approval of the Pfizer/BioNTech vaccine.

"For businesses and universities that have been thinking about putting vaccine requirements in place in order to create safer spaces for people to work and learn, I think that this move from the FDA ... will actually help them to move forward with those kinds of plans," U.S. Surgeon General Dr. Vivek Murthy told CNN on Sunday.

The Food and Drug Administration acted Monday to give full approval to the Pfizer vaccine after previously authorizing the emergency use of three COVID-19 vaccines in the U.S.

Pfizer's vaccine was approved after months of review for quality, safety, and effectiveness.

"The FDA's approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA's rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product," Acting FDA Commissioner Janet Woodcock, M.D, said.

"Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty's safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities," Peter Marks, M.D., Ph.D., director of FDA's Center for Biologics Evaluation and Research, said.

"We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S," he added.

The FDA's full approval of the COVID-19 vaccines is widely expected to give a measure of assurance to vaccine-hesitant Americans and perhaps convince some who have not yet been vaccinated to get shots.

Large corporations including Google, Disney, Facebook, McDonald's, Twitter, and many more are already requiring that workers get vaccinated before returning to the office. Local and state governments have also implemented vaccine requirements for employees, though several states with Republican governors have moved to ban local officials from imposing vaccine or mask mandates.

According to MarketWatch, some employers face lingering concerns on imposing vaccine requirements, citing resistance from employees or the effect it will have on company culture and morale. With many businesses struggling to find workers to fill positions, some employers don't want to alienate potential hires by requiring vaccination.

However, a Gallup poll published last week suggested that most workers are in favor of vaccine mandates. A plurality of 36% of U.S. workers surveyed said they strongly favor vaccine mandates, and 52% of workers overall support the requirements.

COVID-19 vaccines remain effective at preventing severe illness and death, except in exceedingly rare cases, but as CDC Director Rochelle Walensky noted two weeks ago, "What they can't do anymore is prevent transmission."

That's because the Delta variant, which is more contagious than previous variants of the virus, has demonstrated it is capable of causing breakthrough infections among those who have received a COVID-19 vaccine.

For the vast majority of people who have been vaccinated, breakthrough infections of COVID-19 cause only mild symptoms.

The risk of infection and severe disease or death remains much higher for unvaccinated individuals. The CDC recommends that everyone age 12 years old and older should get vaccinated to be protected from COVID-19.

A new report from the Kaiser Family Foundation estimates that preventable hospitalizations of unvaccinated COVID-19 patients has cost the U.S. health care system over $2 billion.

FDA grants full approval for Pfizer COVID-19 vaccines



The Food and Drug Administration on Monday granted full authorization to Pfizer-BioNTech's COVID-19 vaccine, the Washington Post reports.

The groundbreaking vaccine was previously authorized for people over the age of 12 in the United States under an emergency use authorization.

What are the details?

In a statement on the FDA approval, Pfizer CEO Albert Bourla said, "Based on the longer-term follow-up date that we submitted, today's approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed. I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity."

The vaccine will still be available for children ages 12 to 15 years under the previous emergency authorization.

Pfizer, in light of the new approval, can now directly market shots to consumers, and the approval may also encourage more companies and school districts to mandate vaccinations.

Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the CDC — which approves vaccines — said that doctors will now be able to prescribe the vaccination on an off-label basis.

"Not that we're recommending off-label uses, but there is a broader potential use of that product," he said. "When we give a biologics license, we are really saying that we have a lot of confidence in that product, in the safety, efficacy, manufacturing information, not just when it's used exactly according to how it's labeled, but potentially if it were used somewhat differently by physicians."

"Off-label" also means that physicians will be able to authorize patients to get an extra Pfizer vaccine when necessary and without having to wait until boosters shots are made available to the general public.

The outlet noted that a federal official speaking on the condition of anonymity, however, said, "Many of us are worried that full approval means you don't get more of the people who should get vaccinated, but instead the worried well [sic] are going to get additional doses."

Biden administration officials say that they plan to roll out booster shots beginning Sept. 20.