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Cole 392

Cole 392

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SPFRONTMAN

SPFRONTMAN

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azsunfun said:
New variant coming 🤣 here's the question. On Thursday, Moderna said initial data showed its updated coronavirus vaccine is effective against the “Eris” and “Fornax” subvariants in humans.. the problem is they have a vaccine for a variant that was just found to weeks ago, quickest vaccine ever made!🤣🤣🤣
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FUCK their shot, not gonna do another, ever! Not gonna let me on a flight because no shot card? Where's the middle finger emoji? Daughter in-law works at an urgent care. Yesterday and today she said those 90% were covid patients.
 
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azsunfun

azsunfun

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CDC playing games with our lives.
The Centers for Disease Control and Prevention (CDC) V-safe website quietly stopped collecting adverse event reports with no reason or explanation.




The V-safe website simply states: “Thank you for your participation. Data collection for COVID-19 vaccines concluded on June 30, 2023.” If you go there today, V-safe directs users to the FDA’s VAERS website for adverse event reporting, even though officials continually derided VAERS as “passive” and “unverified.”



VAERS and V-safe are mutually exclusive safety collection databases operated by the FDA and CDC, respectively. VAERS is an older way of collecting safety data where one can fill out a form online, or manually, or by calling a toll-free number, whereas V-safe is a device “app” which requires online registration. Both VAERS and V-safe collect personal information, lot numbers, dates and associated information, but V-safe was an active collection system geared towards a younger app-using demographic.

Here is the last report before deletion.



Does this mean that the CDC believes that the mRNA Covid-19 injections are so safe, there is no need to monitor adverse event reports any longer? What is the argument against continued monitoring, especially since the V-safe website was already up and paid for?

While CDC’s V-safe was stealthily and abruptly turned off, refusing to accept new safety reports, to this very day the CDC continues to urge everyone ages 6 months and older to stay up to date with COVID-19 vaccines and boosters.


As a drug safety expert, I personally can’t cite another example of any agency or manufacturer halting collection of safety data. It seems even worse because mRNA technology is relatively new with long-term manifestations unknown. On top of this, both manufacturers and the FDA refuse to share the list of ingredients, such as lipid nanoparticles, which could affect individuals differently and take a long time to manifest clinically.

Safety Data Collection Should Never Stop

Now, contrast that with the fact that the National Highway Traffic and Safety Administration (NHTSA) will still accept a safety report for a 30-year-old Ford Bronco II. Indeed, this is an oddly specific example, but only because I drove this exact vehicle as a family hand-me-down as a student, through my residency, fellowship, for my tenure as a Yale professor on the mean streets of New Haven and even during my years at the FDA as a medical officer /senior medical analyst.

Like mRNA shots, Bronco IIs are still available on the market and people are still using them up to this very day. My Bronco became an intermittent topic of conversation with friends and FDA colleagues. One day, I was informed by a patrolling security guard at the FDA that it was the oldest car on campus.

I didn’t know much about cars (or mRNA technology) back then, but when a fellow FDA-er informed me that my Bronco II had noteworthy safety problems and that the NHTSA still had their eye on this vehicle (rollover accidents were more common and more fatal) I addressed the problem: I got rid of the reliable relic, even though I really liked it.

NHTSA is still accepting safety reports on things like my 30-year-old Ford Bronco II, but the CDC isn’t accepting new safety reports on 2-year old novel mRNA vaccines
 
rmarion

rmarion

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t.me

The Voice of Q

🚨REMINDER🚨 Just 3 weeks ago, 08/16/2023, Russian MIL alleged the US “prepared” the pandemic in 2019, and that they were planning to “manufacture biological crises” again. Now the MSM and the Biden regime are trying push masks and a new variant is on the loose. Coincidence?
t.me t.me
 
94Nautique

94Nautique

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HubbaHubbaLife said:
Anyone see the way Face The Nation on Sunday rolled out their resident Virus expert who used to head FDA.... oh and by the way he serves on Pfizers board. Man this is getting way too obvious to see the play now.
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Sorry, our house is anti-propaganda so we don’t watch face the nation. For this exact reason. Do your families a favor and don’t watch that stuff.
 
W

wzuber

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94Nautique said:
Sorry, our house is anti-propaganda so we don’t watch face the nation. For this exact reason. Do your families a favor and don’t watch that stuff.
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Sad but true......
Yep, poison for the mind....
Just another cover up, distraction & propoganda entity working solely for the leftist destruction machine.
 
Wedgy

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rmarion said:
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Kill the Bastard's, and let God sort it out. Onward Christian Soldiers. Fallen, no matter, living on eternally.
Eye for an Eye. Tooth for Tooth. They want it? Make them earn it. "For the wages of Sin, is Death..." Word.

See Y'all, on the, "Other Side." Gotta cross the 'Tracks" first though. Ain't that a Bitch. Godspeed, Brothers.
Rednecks, Roughnecks, Leathernecks, and Toughnecks. By the Grace of God, God willing, and the creek don't rise.
Godspeed
 
Wedgy

Wedgy

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Is it ironic, or amusing a Doc who couldn't say whether or not he'd prescribe Hydroxychloroquine, leaves Dodge City, as the Redpills fall... 🤣 ;)
 
azsunfun

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And so it's released. FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants Share Tweet Email For Immediate Release: September 11, 2023 Español Today, the U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc. Consistent with the totality of the evidence and input from the FDA’s expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5. What You Need to Know Individuals 5 years of age and older regardless of previous vaccination are eligible to receive a single dose of an updated mRNA COVID-19 vaccine at least 2 months since the last dose of any COVID-19 vaccine. Individuals 6 months through 4 years of age who have previously been vaccinated against COVID-19 are eligible to receive one or two doses of an updated mRNA COVID-19 vaccine (timing and number of doses to administer depends on the previous COVID-19 vaccine received). Unvaccinated individuals 6 months through 4 years of age are eligible to receive three doses of the updated authorized Pfizer-BioNTech COVID-19 Vaccine or two doses of the updated authorized Moderna COVID-19 Vaccine. The FDA is confident in the safety and effectiveness of these updated vaccines and the agency’s benefit-risk assessment demonstrates that the benefits of these vaccines for individuals 6 months of age and older outweigh their risks. Individuals who receive an updated mRNA COVID-19 vaccine may experience similar side effects as those reported by individuals who previously received mRNA COVID-19 vaccines as described in the respective prescribing information or fact sheets. The updated vaccines are expected to provide good protection against COVID-19 from the currently circulating variants. Barring the emergence of a markedly more virulent variant, the FDA anticipates that the composition of COVID-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine. The U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet tomorrow (Sept. 12), to discuss clinical recommendations on who should receive an updated vaccine, as well as further considerations for specific populations such as immunocompromised and older individuals. Manufacturers have publicly announced that the updated vaccines would be ready this fall, and the FDA anticipates that the updated vaccines will be available in the near future. “Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.” The updated mRNA vaccines are each approved for individuals 12 years of age and older and are authorized under emergency use for individuals 6 months through 11 years of age. As part of today’s actions, the bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States. Data Supporting the Updated mRNA COVID-19 Vaccines (2023-2024 Formula) The mRNA COVID-19 vaccines approved and authorized today are supported by the FDA’s evaluation of manufacturing data to support the change to the 2023-2024 formula and non-clinical immune response data on the updated formulations including the XBB.1.5 component. The updated mRNA vaccines are manufactured using a similar process as previous formulations. In studies that have been recently conducted, the extent of neutralization observed by the updated vaccines against currently circulating viral variants causing COVID-19, including EG.5 and BA.2.86, appears to be of a similar magnitude to the extent of neutralization observed with prior versions of the vaccines against corresponding prior variants against which they had been developed to provide protection. This suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants. The benefit-risk profile of previously authorized and approved mRNA COVID-19 vaccines is well understood as these vaccines have been administered to hundreds of millions of people in the United States. Based on an evaluation of the totality of the evidence, the benefit-risk profile is favorable for individuals 6 months of age and older to receive an updated COVID-19 mRNA vaccine. Although serious outcomes from COVID-19 are less common in younger individuals, they do occur, and it has been demonstrated that recently receiving a COVID-19 vaccine reduces the risk of such serious outcomes. Additional Details on Today’s Actions Specifically, today’s actions include: Approval of Comirnaty (COVID-19 Vaccine, mRNA) to include the 2023-2024 formula, and a change to a single dose for individuals 12 years of age and older. Comirnaty was previously approved as a two-dose series for individuals 12 years of age and older. Approval of Spikevax (COVID-19 Vaccine, mRNA) to include the 2023-2024 formula, a change to a single dose for individuals 18 years of age and older, and approval of a single dose for individuals 12 through 17 years of age. Spikevax was previously approved as a two-dose series for individuals 18 years of age and older. Authorization of Moderna COVID-19 Vaccine for emergency use in individuals 6 months through 11 years of age to include the 2023-2024 formula and lower the age eligibility for receipt of a single dose from 6 years to 5 years of age. Additional doses are also authorized for certain immunocompromised individuals ages 6 months through 11 years, as described in the fact sheets. Authorization of Pfizer-BioNTech COVID-19 Vaccine for emergency use in individuals 6 months through 11 years of age to include the 2023-2024 formula. Additional doses are also authorized for certain immunocompromised individuals ages 6 months through 11 years, as described in the fact sheets. The approval of Comirnaty (COVID-19 Vaccine, mRNA) (2023-2024 Formula) was granted to BioNTech Manufacturing GmbH. The EUA amendment for the Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) was issued to Pfizer Inc. The approval of Spikevax (COVID-19 Vaccine, mRNA) (2023-2024 Formula) was granted to ModernaTX Inc. and the EUA amendment for the Moderna COVID-19 Vaccine (2023-2024 Formula) was issued to ModernaTX Inc. Related Information Comirnaty (COVID-19 Vaccine, mRNA) (2023-2024 Formula) Spikevax (COVID-19 Vaccine, mRNA) (2023-2024 Formula) Moderna COVID-19 Vaccine (2023-2024 Formula) FDA Resources for the Fall Respiratory Illness Season Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) Updated COVID-19 Vaccines for Use in the United States Beginning in Fall 2023 June 15, 2023, Meeting of the Vaccines and Related Biological Products
 
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