Tag Archives: Pfizer Pharmaceuticals

Some Important Information On The Covid Booster

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On Thursday, Dr. Marty Makary and Tracy Beth Hoeg wrote an article for The New York Post about the new Covid booster. Dr. Makary is a health care expert at Johns Hopkins University.

The article reports:

Pfizer’s version, approved this week as well, also has zero efficacy data and has not been tested on humans at all. We only have data about antibody production from 10 mice.

The FDA, or Moderna (frankly, it’s hard to tell the difference sometimes), should disclose what happened to the patient who took the new vaccine and had a complication that required medical attention.

The public has a right to know.

The last time the Biden administration approved and recommended a novel COVID bivalent booster, last fall, with no human-outcomes data, it was an epic fail.

Only 17% of Americans took it (and some of those were forced to do so by their employer or school).

Not foreseeing such weak public support for the booster last year, the Biden administration had prepaid pharma $4.9 billion for 171 million doses — many of which were tossed in the wastebasket.

Now it is making the same mistake.

Two weeks ago, the Biden administration upped its orders for the pediatric version of the new COVID vaccines from 14.5 million doses at $1.3 billion to 20 million doses for $1.7 billion, which is more than four times as many pediatric doses as were used last year.

There clearly seems to be a special push this time to give it to children — the same group European regulators are not supporting.

In fact, the original Moderna vaccine was banned in parts of Europe for people under age 30.

European doctors are not alone.

Dr. Paul Offit, a vaccine-mandate supporter and FDA adviser from the University of Pennsylvania, told The Atlantic this week that he’s not going to take the new COVID vaccine.

He didn’t take the bivalent booster last fall either, despite being 72 years old.

While he disagreed with Jha on the booster, he recently confessed, “Yes, he was wrong, but you know you can’t say that exactly.”

Yes, you can.

The article also notes:

Unlike influenza, COVID-19 is constantly circulating, so there is ample opportunity to run a trial; indeed, Moderna already ran a randomized trial.

Its trial of just 50 people began four months ago and oddly only reported 14-day side effects.

Why didn’t it enroll more people in its trial? Why didn’t it report three-month effectiveness and do a proper trial?

Conducting a placebo-controlled trial in people during this time would not only yield useful information; it would enable further study of those subjects three and six months from now, when a winter surge may occur.

Let’s be honest: Follow-up studies of COVID vaccines in general have revealed a disappointing truth — mild efficacy against infection is transient, lasting just a few months.

Perhaps Pfizer and Moderna knew the FDA regulatory process was greased for them and they didn’t have to.

Please follow the link to read the entire article. Our government is not doing us any favors by encouraging Covid booster shots.

The Logic Of This Escapes Me

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On Tuesday, Townhall posted an article quoting Pfizer CEO Albert Bourla on the effectiveness of the Pfizer vaccine against the coronavirus.

The article reports:

Speaking during remarks to a J.P. Morgan healthcare conference this week, Pfizer CEO Albert Bourla openly stated current vaccines the company developed for Wuhan coronavirus offer “limited, if any” protection against contracting current variants of the disease. He then encouraged booster shots. 

If two shots offer questionable protection, why in the world would anyone want to get a booster shot? What are you boosting?

The article also notes:

The statement from Bourla comes as the Biden administration continues to justify vaccine mandates for federal workers, contractors and private businesses. The Supreme Court heard arguments about President Biden’s mandates for private companies and medical workers last week. A ruling is expected soon on the constitutionality of the mandates.

A number of people who have pointed out the waning efficacy of Pfizer’s vaccines, which Bourla touted last year as being “100 percent” effective against contracting or transmitting the virus, have been banned by social media companies.

One of the problems with this entire discussion is the omission of natural immunity. In April 2021, Denver Channel 7 reported the following:

The Centers for Disease Control and Prevention estimates about 35% of all Americans have been infected with COVID-19 over the last year.

From February 2020 to March 2021, the CDC estimates 114.6 million Americans were infected with COVID-19, 97.1 million had symptomatic illnesses and 5.6 million were hospitalized with COVID-19.

How many more have had Covid since then and have natural immunity? Just for the record, I had Covid in November 2020 and a very recent blood test showed that I still had antibodies. I think it’s time to consider natural immunity when we discuss the coronavirus and the vaccines.

Beware Of The Side Effects

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Pfizer and Merck have rushed to produce drugs that will lessen the severity of the coronavirus in people who contract the disease. Unfortunately, as with all medications, these drugs have side effects–some of which are dangerous.

On Sunday Newsmax reported the following:

Experts warn that despite the first antiviral pills for COVID-19 promising protection for those at risk of severe disease, Pfizer’s or Merck’s new medications may not be safe for everyone, NBC News reported over the weekend.

One of the two drugs in Pfizer’s Paxlovid antiviral cocktail could cause severe or life-threatening interactions with commonly used medications, including statins, blood thinners and some antidepressants, and the FDA does not recommend Paxlovid for those with severe kidney or liver disease.

In addition, due to concerns about the potential side effects of Merck’s molnupiravir, the FDA has restricted its use to adults and only in cases in which other treatments are inaccessible or are not ”clinically appropriate.”

Please follow the link above to read the entire article for further details.

Americans with high cholesterol are routinely put on statins; Americans with a-fib or other heart issues are routinely put on blood thinners. Hopefully doctors will take this into consideration before prescribing the antiviral pills. All medications have side effects–medicine is a risk vs. reward profession. I am concerned, however, about the too close relationship between the FDA and the pharmaceutical companies. Many doctors who have been seeing Covid patients for the past two years believe that there are effective, inexpensive ways of dealing with the disease that have been blocked by the FDA in favor of protocols that provide greater profits for the pharmaceutical industry.

Actually Following The Science

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On December 21st, The New York Post posted an article titled, “Biden needs to tell the FDA to stop blocking lifesaving COVID treatments.”

The article lists a number of treatments for COVID that have been tested scientifically and proven to be effective:

Fluvoxamine, a commonly available medication, reduced COVID deaths by 91 percent in a randomized controlled trial conducted with impeccable methodology and recently published in The Lancet. This study affirms another trial on the drug published last spring in the Journal of the American Medical Association. The drug is safe, has a plausible mechanism of action, costs $10 and has no contrary studies that might challenge the breathtaking results published. Yet I’ve never heard our public-health officials mention fluvoxamine.

…Merck’s lifesaving drug molnupiravir received an up-vote from the FDA’s external experts three weeks ago, yet the agency has not authorized the drug. Pfizer’s Paxlovid drug cut COVID deaths to zero (compared with 10 deaths in the control group), yet in the five weeks the FDA has been sitting on the application the agency has not even scheduled an advisory meeting to review it. Maybe functionaries don’t want to change their holiday plans.

The article also notes that the outbreak of the Omicron variant of COVID may actually contain some good news:

We also need straight talk when it comes to Omicron. Now 73 percent of new US COVID infections are from Omicron, a strain resulting in more mild illness. A University of Hong Kong study found that Omicron is one-tenth as infective in lung cells compared with the Delta variant. That explains why Omicron patients report far fewer cough and fever symptoms and far fewer people develop severe illness. Instead, the vast majority of Omicron-infected people get common-cold symptoms.

The fear headline is that Omicron partially evades antibody immunity. That’s true; so did Delta. But, also like Delta, Omicron does not escape existing T-cell immunity, according to a new Johns Hopkins study, which is consistent with mounting population data. Cases from the epicenter in Gauteng, South Africa, are plunging, down 44 percent Monday from the prior day. According to South African Health Minister Dr. Joe Phaahla, only 1.7 percent of COVID cases were hospitalized the second week of the Omicron-dominant wave, compared with 19 percent the same week of the Delta wave.

We now have laboratory data, epidemiological data and bedside observations to conclude that Omicron is a milder variant. We are witnessing how pandemics end — a virus mutates down and becomes endemic as population immunity increases.

There is a light at the end of this tunnel, but our government bureaucrats keep putting it out.

Disconcerting At Best

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On Tuesday, Trending Politics posted an article about a statement from Dr. Fauci about vaccines that is far from comforting.

This is the statement:

“This would not be the first time, if it happened, that a vaccine that looked good in initial safety actually made people worse,” Fauci said. “There was the history of the Respiratory Syncitial Virus vaccine in children, which paradoxically made the children worse.”

The article continues:

“In the late 1960s, children in Washington, DC received an RSV vaccine in which the virus was inactivated with formalin,” Reuters reported. “Eighty percent of the children given the shot were hospitalized with severe respiratory disease, and two died. Many scientists had thought the formalin was responsible for the vaccine’s problems, but the chemical has been used safely in other vaccines.”

“The problem, they report this month in the journal Nature Medicine, was that the children’s antibodies were not binding strongly enough to the inactivated virus to produce a protective immune response,” the report noted. “Instead, the antibodies were dragging the dead virus with them, triggering a massive attack by other arms of the immune system.”

It should be noted that in 2019, the NIH admitted that “we are still lacking a safe and effective RSV vaccine.” But it somehow developed a “safe and effective” Covid-19 vaccine in a matter of months?

As noted before, the American public has no way of knowing if the Pfizer-BioNTech vaccine was rigorously tested, because the FDA refuses to fully release the documents for 75 years. A “whistleblower” on the inside of Pfizer’s clinical trials has documented many alleged serious issues, including “falsifying data.”

The phenomenon that Dr. Fauci is alluding to, “leaky vaccines,” has been well-documented. A Penn State University study showed that “leaky” vaccines can cause viruses to become lethal for the unvaccinated.

“Not all vaccines prevent infection,” PSU noted. “Some, known as leaky vaccines, prolong host survival or reduce disease symptoms without preventing viral replication and transmission. Although leaky vaccines provide anti-disease benefits to vaccinated individuals, new research by CIDD’s Andrew Read, David Kennedy and colleagues at the Avian Oncogenic Virus Group in the United Kingdom, and The University of New England in Australia, has demonstrated that leaky vaccines can make the situation for unvaccinated individuals worse.”

How in the world can anyone justify a vaccine mandate if they are aware of the problems with the vaccine?

In July 2021, Deseret News posted the following:

Israel — the poster child for COVID-19 vaccination and the first country to reach herd immunity — has seen a recent rise in cases. Recently, most of the people testing positive are vaccinated, reported The Washington Post.

The trend has brought a slew of questions about the efficacy of COVID-19 vaccines and the implications of new strains for future outbreaks. While these trends initially seem like cause for vaccine skepticism, a closer look at Israel’s current outbreaks shows that vaccines are effective and working — even against the delta variant.

No. If people are getting sick, the vaccines are NOT working. People may be getting less sick, but if they are still getting sick and still spreading the virus, maybe the vaccine is not working as well as it should.

The article also includes the following:

The people who are not testing positive in the current outbreak are those who have had COVID-19 previously and recovered. These people account for 9% of Israel’s population but less than 1% of recent infections, according to Kovler’s analysis. This has brought new questions about whether natural infections are more protective against the delta variant than vaccinations — but the answer is not yet certain.

Yet, America does not consider natural immunity in its vaccine mandates. Europe does.

The Search For Transparency

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On Wednesday, NewsMax posted an article about the Food and Drug Administration’s (FDA) timeline in releasing data on the Pfizer vaccine.  The FDA has requested 75 years to produce the data.

The article reports:

Public Health and Medical Professionals for Transparency has filed Freedom of Information Act requests for the data, which the FDA at first said would take 55 years to produce at 500 pages per month for the entire 329,000 page cache of documents.

Now the FDA is asking a judge to give it 75 years to produce the data, saying there’s over 59,000 more pages than weren’t mentioned in the first request. That would take the full release to 2096, wrote Aaron Siri, a lawyer working on the case.

“If you find what you are reading difficult to believe — that is because it is dystopian for the government to give Pfizer billions, mandate Americans to take its product, prohibit Americans from suing for harms, but yet refuse to let Americans see the data underlying its licensure,” he wrote.

The medical group is suing to speed things up.

The group says the data should be made public quickly because the FDA spent only 108 days reviewing it before granting emergency use authorization to the Pfizer-BioNTech vaccine — and because vaccine mandates are being issued by local and federal entities, Epoch Times reported.

The article concludes:

On Dec. 2, Rep. Ralph Norman, R-S.C., introduced a bill calling for the head of the FDA to release all records about the vaccine in 100 days.

“Since the Biden administration is hell-bent on forcing these vaccine mandates on us, the public has every right to know how this vaccine was approved, especially in such a short amount of time,” he said in a statement. “After all, the FDA managed to consider all 329,000 pages of data and grant emergency approval of the Pfizer vaccine within just 108 days.”

The article cites what I think is one of the most important issues here:

that is because it is dystopian for the government to give Pfizer billions, mandate Americans to take its product, prohibit Americans from suing for harms, but yet refuse to let Americans see the data underlying its licensure

That should not happen in a free country.

 

Follow The Money

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As I have previously stated, I have wondered why the emphasis in dealing with the coronavirus is on vaccines (and now booster shots) rather than treatments and the natural immunity people have from having recovered from the virus. I think I have found at least part of the answer to that question.

One America News posted an article today with the following headline, “Pfizer, Moderna seen reaping billions from COVID-19 vaccine booster market.”

The article reports:

Drugmakers Pfizer Inc, BioNTech and Moderna Inc are expected to reap billions of dollars from COVID-19 booster shots in a market that could rival the $6 billion in annual sales for flu vaccines for years to come, analysts and healthcare investors say.

For several months, the companies have said they expect that fully inoculated people will need an extra dose of their vaccines to maintain protection over time and to fend off new coronavirus variants.

Now a growing list of governments, including Chile, Germany and Israel, have decided to offer booster doses to older citizens or people with weak immune systems in the face of the fast-spreading Delta variant.

Late on Thursday, the U.S. Food and Drug Administration authorized a booster dose of vaccines from Pfizer Inc and Moderna Inc for people with compromised immune systems.

Pfizer, along with its German partner BioNTech, and Moderna have together locked up over $60 billion in sales of the shots just in 2021 and 2022. The agreements include supply of the initial two doses of their vaccines as well as billions of dollars in potential boosters for wealthy nations.

Going forward, analysts have forecast revenue of over $6.6 billion for the Pfizer/BioNTech shot and $7.6 billion for Moderna in 2023, mostly from booster sales. They eventually see the annual market settling at around $5 billion or higher, with additional drugmakers competing for those sales.

The vaccine makers say that evidence of waning antibody levels in vaccinated people after six months, as well as an increasing rate of breakthrough infections in countries hit by the Delta variant, support the need for booster shots.

Some early data suggests that the Moderna vaccine, which delivers a higher dose at the outset, may be more durable than Pfizer’s shot, but more research is needed to determine whether that is influenced by the age or underlying health of the people vaccinated.

As a result, it is far from clear how many people will need boosters, and how often. The profit potential of booster shots may be limited by the number of competitors who enter the market. In addition, some scientists question whether there is enough evidence that boosters are needed, particularly for younger, healthy people. The World Health Organization has asked governments to hold off on booster shots until more people worldwide receive their initial doses.

The article concludes:

There’s still a lot of uncertainty around how boosters would be rolled out in the United States. Still, it is possible or even likely that people will be boosted with different vaccines than they were originally vaccinated with. The National Institute of Allergy and Infectious Diseases is already testing mixed boosting, and other countries that have used so-called mix and match vaccination have not had problems with that strategy.

One factor that could curb prices is if the U.S. government continues paying for most or all of the shots administered in the country, rather than leave it in the hands of private health insurers. In that scenario, the government would still be negotiating prices directly with vaccine makers, and could use its buying power to stave off price increases.

Bijan Salehizadeh, managing director at healthcare investment firm Navimed Capital, said the U.S. government is likely going to want to keep paying in order to keep vaccination rates high and prevent new COVID surges, particularly if a Democratic administration is still in power.

“It’s going to be paid for until the virus disappears or mutates to be less virulent,” Salehizadeh said.

Whatever happened to herd immunity?

I Really Don’t Like The Sound Of This

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The coronavirus has seriously eroded a lot of the God-given rights protected by the U.S. Constitution. There are some real questions as to whether or not we will ever get those rights back or whether we will simply continue on the downward slope we are on. I am sure I am not the only grandparent who has not be able to see my grandchildren for more than a year. When did America start restricting the travel of Americans? When did America close schools despite scientific evidence that schools were not spreaders of the coronavirus? Unfortunately, the encroachment of our liberties is about to get worse.

Just the News reported yesterday that a top travel industry association is the final stages of developing a digital passport for international travelers so they can prove they’ve been vaccinated for COVID-19. Will America soon require some sort of proof of vaccination to board an airplane for a domestic flight?

The article reports:

Airlines for America, a trade association that represents major carriers, also has not declared that flyers will need proof of a vaccine before flying, saying U.S. airlines are “committed to restoring service in a manner that prioritizes the safety and wellbeing of our passengers and employees.”

But CEO Alan Joyce of Qantas Airlines, an Australian carrier, said last week that once the vaccine is made available, proof will become standard practice around the world.

“We are looking at changing our terms and conditions to say for international travelers that we will ask people to have a vaccination before they can get on the aircraft,” Joyce told The New York Times.

The Australian government has said that coronavirus vaccines will be “as mandatory as you can possibly make it.”

Pfizer Pharmaceuticals said on Nov. 9 that results from its most recent human trials on its coronavirus vaccine show it is more than 95% effective. Pfizer CEO Albert Bourla said that once his company’s vaccine is approved by the Food and Drug Administration, it will be shipped quickly to locations in the U.S.

I hate to be cynical here, but I am extremely suspicious of any vaccine that the government requires you to take, and I predict that the government will attempt to make it a requirement for Americans to take the vaccine.