Tag Archives: FDA approval

The Next Step

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Just the News is reporting today:

The Pfizer and BioNTech Covid-19 vaccine became the first Monday morning to receive full FDA approval. The two-dose immunization was initially the first to receive emergency use authorization in December of 2020.

The Biden administration, local governments, and some employers hope that the full approval means Americans who have, until now, been skeptical about receiving an unauthorized jab, will have their fears reduced and opt to receive the inoculation. The full approval is expected to lead to more businesses and institutions requiring vaccinations for employees and students.

This move paves the way for the healthcare tyranny many of us have feared.

On August 7th Global Research posted the following:

Open Letter to the Unvaccinated

You are not alone! As of 28 July 2021, 29% of Canadians have not received a COVID-19 vaccine, and an additional 14% have received one shot. In the US and in the European Union, less than half the population is fully vaccinated, and even in Israel, the “world’s lab” according to Pfizer, one third of people remain completely unvaccinated. Politicians and the media have taken a uniform view, scapegoating the unvaccinated for the troubles that have ensued after eighteen months of fearmongering and lockdowns. It’s time to set the record straight.

It is entirely reasonable and legitimate to say ‘no’ to insufficiently tested vaccines for which there is no reliable science. You have a right to assert guardianship of your body and to refuse medical treatments if you see fit. You are right to say ‘no’ to a violation of your dignity, your integrity and your bodily autonomy. It is your body, and you have the right to choose. You are right to fight for your children against their mass vaccination in school.

You are right to question whether free and informed consent is at all possible under present circumstances. Long-term effects are unknown. Transgenerational effects are unknown. Vaccine-induced deregulation of natural immunity is unknown. Potential harm is unknown as the adverse event reporting is delayed, incomplete and inconsistent between jurisdictions.

You are being targeted by mainstream media, government social engineering campaigns, unjust rules and policies, collaborating employers, and the social-media mob.

You are being told that you are now the problem and that the world cannot get back to normal unless you get vaccinated.

You are being viciously scapegoated by propaganda and pressured by others around you. Remember; there is nothing wrong with you.

You are inaccurately accused of being a factory for new SARS-CoV-2 variants, when in fact, according to leading scientists, your natural immune system generates immunity to multiple components of the virus. This will promote your protection against a vast range of viral variants and abrogates further spread to anyone else.

You are justified in demanding independent peer-reviewed studies, not funded by multinational pharmaceutical companies. All the peer-reviewed studies of short-term safety and short-term efficacy have been funded, organized, coordinated, and supported by these for-profit corporations; and none of the study data have been made public or available to researchers who don’t work for these companies.

You are right to question the preliminary vaccine trial results. The claimed high values of relative efficacy rely on small numbers of tenuously determined “infections.”  The studies were also not blind, where people giving the injections admittedly knew or could deduce whether they were injecting the experimental vaccine or the placebo. This is not acceptable scientific methodology for vaccine trials.

You are correct in your calls for a diversity of scientific opinions. Like in nature, we need a polyculture of information and its interpretations. And we don’t have that right now. Choosing not to take the vaccine is holding space for reason, transparency and accountability to emerge. You are right to ask, ‘What comes next when we give away authority over our own bodies?’

Do not be intimidated. You are showing resilience, integrity and grit. You are coming together in your communities, making plans to help one another and standing for scientific accountability and free speech, which are required for society to thrive. We are among many who stand with you.

Angela Durante, PhD
Denis Rancourt, PhD
Claus Rinner, PhD
Laurent Leduc, PhD
Donald Welsh, PhD
John Zwaagstra, PhD
Jan Vrbik, PhD
Valentina Capurri, PhD

There are two sides to this story. Unfortunately the media is only reporting one of them. Please do your own research on the vaccines and their safety.

Common Sense From An Uncommon Source

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Yesterday Just the News posted an article with some interesting news about vaccine mandates. Americans seem to be waking up to the fact that vaccine mandates could be the prelude to some serious losses of freedom.

The article reports:

COVID-19 vaccine mandates are provoking an unlikely set of opponents: Labor unions.

Long known as a generally left-of-center cohort, unions — especially teacher’s unions — are not a social force one would expect to mount a sustained opposition against such mandates, which have been growing in number in recent weeks. Yet a broad, unaffiliated coalition of unions is signalling its intent to oppose the mandates, at the very least for their own members. 

New York State United Teachers — a major educators’ union with over 600,000 members — said in a statement this week that it was opposed to proposals to make COVID-19 vaccines a mandatory condition of employment. 

“We have advocated since the beginning of the year that any educator who wants a vaccine should have easy access to one,” the group said. “We would support local efforts to encourage more vaccinations, such as through programs that require that those who are not vaccinated get tested on a regular basis. 

“But it’s critical that districts come up with plans to make testing available on-site and at no cost. What we have not supported is a vaccine mandate.”

The article continues:

Opposition has not come solely from the educational sector. Henry Garrido, the executive director of AFSCME’s District 37 in New York City, told local media that the union is “absolutely against an absolute mandate to vaccinate everyone.”

Healthcare unions, meanwhile, have also stated their opposition to mandates. 

“Mandating vaccination is not, nor will it ever be, the answer,” George Gresham, the president of 1199SEIU United Healthcare Workers East, told media this week. 

“As democratic organizations, unions will generally do what their members want,” Jack Fiorito, a management professor at Florida State University who specializes in labor issues, told Just the News this week.

“Surely there are some groups of union members with a majority who are ‘anti-vax,’ and thus their union will likely take an anti-vax stance,” he said. “Even in unions that are pro-vaccine, there would be concern for the rights and wellbeing of those who may not be able to get the vaccine for health reasons (for example, due to some other health problem, vaccine sensitivity, etc.)”

We need to remember that this is an experimental vaccine. I suspect there will be a real push to approve the vaccine within the coming months, and that approval will  negate the argument that the vaccine has not been approved.

A website called uspharmacist.com notes:

“Since 2010, most novel vaccines approved by the FDA required about 8 years of clinical development and were based on evidence from a median of 7 clinical trials, including at least 2 pivotal efficacy trials that were randomized, masked, and used a comparator group,” the authors conclude. “These pivotal efficacy trials enrolled a median of 5,000 patients, who were followed up for serious adverse events for at least 6 months. Given the urgency of developing a COVID-19 vaccine, trials will need to be larger than those supporting prior vaccine approvals and include sufficient follow-up time for emergence of adverse effects.”

At some point all of us need to ask ourselves why we are even talking about a vaccine mandate for a disease that has proven treatments. We also need to ask why immunity in those who have recovered from the disease is not taken into account. And finally we need to ask ourselves why there is such determination by the government that everyone get vaccinated with a vaccine that has not been fully tested. None of this is logical.

We Can Expect More Of This In The Future (Unfortunately)

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Yesterday The New York Post posted an article about the Port Washington High School Senior Prom. The prom will host about 500 people at the Village Clubs of Sandpoint.

The article notes some of the rules for the event:

Forget popular kids and dorks — seniors at one Long Island high school dance will be divided by whether they are vaccinated or unvaccinated against COVID-19, The Post has learned.

The school said that, per state and CDC guidelines, kids who are vaccinated will be able to attend maskless — while those who aren’t will need to wear a face covering.

Students will need to show proof of inoculation to attend mask-free, and will be given wristbands to signify they’ve gotten the jab, Dr. Ira Pernick, the school’s principal, said in a video sent to the senior class this week and seen by The Post.

In addition to wearing masks, those who haven’t been vaccinated will need to show proof of a negative COVID-19 test before the party, Pernick said.

The article concludes:

The state Department of Health said that their implementation of the CDC guidelines “does not require vaccinated and unvaccinated attendees to remain in separate sections.”

Dr. Michael Hynes, superintendent of the Port Washington Union Free School District, said the year-end celebration was adhering to all state Health Department and federal rules.

“The health and safety of our students, staff and community are the Port Washington School District’s foremost priorities,” Hynes said in a statement. “The district is in close contact with local and state health officials and will continue to regularly monitor any changes in guidance.”

It should be mentioned at this point that none of the vaccines have full FDA approval at this time. The vaccines are approved for emergency use only. Pfizer and BioNTech have already started their application process for full U.S. approval of their Covid-19 vaccine. Rival Moderna is expected to submit for the same process for its shot later this month. Why are we in such a rush to put these vaccines into school populations when school populations are the least impacted by the virus?