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Pfizer and Moderna's updated COVID boosters win FDA nods, with swift rollouts to follow.


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2022 Aug 31, 1:27pm   516 views  17 comments

by Al_Sharpton_for_President   ➕follow (5)   💰tip   ignore  

The public's wait for another round of COVID-19 vaccine boosters is finally coming to an end. (WTF!!!!!)

Wednesday morning, the FDA gave the all-clear to Omicron-targeted COVID-19 shots from Moderna and Pfizer-BioNTech. The pair of bivalent mRNA vaccines have scored emergency use authorizations as single-dose inoculations to be given at least two months after primary or initial booster vaccination, the regulator said in a release.

The updated boosters each house two messenger RNA (mRNA) components of the coronavirus—one of the original SARS-CoV-2 strain, and another one in common between the BA.4 and BA.5 lineages of the omicron variant.

Moderna’s re-tooled vaccine has been given the thumbs up in adults ages 18 years and older, while Pfizer and BioNTech’s updated booster can be used in people ages 12 and up.

"As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants," FDA commissioner Robert Califf said in a statement.

The emergency nods likely set the shots up for a quick nationwide rollout around Labor Day.

A CDC endorsement is the last logistical hurdle standing between the shots and a wider public deployment. The public health agency is set to convene its outside advisory panel of vaccine experts this Thursday and Friday.

Hospitals, pharmacies and other vaccination sites could start administering the updated boosters after the CDC's endorsement.

Pfizer-BioNTech and Moderna have also telegraphed their readiness to ship doses shortly after the FDA’s authorization. The U.S. government recently locked up 66 million doses of Moderna’s updated vaccine, plus 105 million doses of Pfizer-BioNTech’s new shot for the upcoming fall campaign.

Around 109 million people in the U.S. have received their first booster dose, according to the CDC, with about 23 million having received a second.

Public health experts are hoping the re-vamped vaccines will improve the nation’s booster rate, which has stagnated in recent months, The Wall Street Journal reports.

Meanwhile, some critics have taken issue with the speed at which Pfizer and Moderna’s updated shots passed muster with regulators. A major point of contention has been whether the boosters should have been greenlit without data from human trials.

For its part, the FDA said it based the decisions on the "totality of available evidence," including the large body of data in the original COVID-19 shots, plus a clinical study in an earlier BA.1-targeted vaccine.

Pfizer recently said it would kick off human safety and effectiveness trials on its re-tooled shot by the end of August, while Moderna has one such phase 2/3 study underway.

https://www.fiercepharma.com/pharma/pfizer-and-modernas-bivalent-covid-19-booster-nods-are-here-will-labor-day-rollout-follow

Comments 1 - 17 of 17        Search these comments

1   RedStar   2022 Aug 31, 1:33pm  

"Pfizer recently said it would kick off human safety and effectiveness trials on its re-tooled shot by the end of August, while Moderna has one such phase 2/3 study underway."

They boldly admit they haven't even started safety trials. WTF!

The world has turned into a herd of lemmings...
2   Onvacation   2022 Aug 31, 1:52pm  

Hasn't the virus mutated from Omicron which came out in November of last year? We went through the Greek alphabet of strains in less time than that.
9   Patrick   2022 Sep 18, 1:03pm  

https://nitter.pussthecat.org/AlexBerenson/status/1571494428543700994#m



@AlexBerenson
6h
Complex new paper on antibody-dependent enhancement from Japanese researchers, but the takeaway is simple: mRNA vaccines probably increase the risk of Omicron infection.

The mRNAs should be pulled from the market just as first-generation monoclonal antibodies were.




11   Patrick   2022 Sep 18, 1:07pm  





Why are Pfizer and Moderna on this list?
12   GNL   2022 Sep 18, 1:10pm  

Patrick says







Why are Pfizer and Moderna on this list?

Do you have a link that shows this?
13   Ceffer   2022 Sep 18, 1:17pm  

They frittered away their trillion dollars on media, medical and political whores, and what do they have to show for it? A mere worldwide projected 300 million deaths or so when all the morbidity and mortality wraps up, and only five percent of the useless eater to fertilizer goal. Third worlders can outproliferate that population loss in no time. What a waste of precious printing press fiat money. That's over 3000 dollars per death, and very cost inefficient.
14   Al_Sharpton_for_President   2022 Sep 18, 2:03pm  

Patrick says


Why are Pfizer and Moderna on this list?

Moderna Gets BARDA Award For $483 Mln To Speed Up COVID-19 Vaccine Development
https://www.nasdaq.com/articles/moderna-gets-barda-award-for-%24483-mln-to-speed-up-covid-19-vaccine-development-2020-04-16

Moderna Announces Funding Award from BARDA for $8 Million with Potential of up to $125 Million to Accelerate Development of Zika Messenger RNA (mRNA) Vaccine
https://www.businesswire.com/news/home/20160907005586/en/Moderna-Announces-Funding-Award-from-BARDA-for-8-Million-with-Potential-of-up-to-125-Million-to-Accelerate-Development-of-Zika-Messenger-RNA-mRNA-Vaccine

BARDA The Biomedical Advanced Research and Development Authority (BARDA), within the Administration for Strategic Preparedness and Response (ASPR), in the U.S. Department of Health and Human Services, (HHS) provides an integrated, systematic approach to the development of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies such as chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases.

Together with our industry partners, BARDA promotes the advanced development of medical countermeasures to protect Americans and strengthen the health security of the nation.

https://www.medicalcountermeasures.gov/BARDA

Remember, that asshole Rick Bright who bragged about shitcanning HCQ was from BARDA. Trump shitcanned him. OMG, endangering us all!!!!
https://www.newyorker.com/news/daily-comment/trumps-firing-of-a-top-infectious-disease-expert-endangers-us-all

DOD Funding Mobile mRNA-Vaccine-Making System That Fits In A Box
https://insidehealthpolicy.com/inside-drug-pricing-daily-news/dod-funding-mobile-mrna-vaccine-making-system-fits-box

DARPA Awards Moderna up to $56 Million to Enable Small-Scale, Rapid Mobile Manufacturing of Nucleic Acid Vaccines and Therapeutics
https://www.businesswire.com/news/home/20201008005279/en/DARPA-Awards-Moderna-up-to-56-Million-to-Enable-Small-Scale-Rapid-Mobile-Manufacturing-of-Nucleic-Acid-Vaccines-and-Therapeutics

DARPA, Moderna, mRNA Technology, and Pandemic Prevention

Indeed, as previously reported by UncoverDC, DARPA’s mostly silent role in the pandemic is significant. The agency strategically aligned with Moderna in 2013 to begin funding work on messenger RNA vaccine technology that is the foundation of the current COVID-19 mRNA “vaccine” program. Prior to the pandemic, DARPA’s collaboration with Moderna produced the “first systemic mRNA therapeutic to show the production of a secreted protein in humans.” Moreover, in 2017, DARPA introduced the Pandemic Prevention Platform (P3), designed around RNA vaccine technology. In a hint toward future ambitions, DARPA indicated that by “growing viruses needed to support evaluation of therapies in laboratory tests,” the program aims to develop an integrated platform that uses nucleic acid sequences to halt the spread of viral infections in sixty days or less.
https://uncoverdc.com/2022/06/14/darpas-4-1-billion-2023-budget-funds-fourteen-critical-technologies/

DARPA Hires Pfizer to Perform Groundbreaking Vaccine Research
https://www.fool.com/investing/general/2013/12/05/darpa-hires-pfizer-to-perform-groundbreaking-vacci.aspx

OK, boys, we invested all this money. Let's take it for a test drive. Release the Kraken!
15   Patrick   2022 Sep 18, 3:08pm  

GNL says

Do you have a link that shows this?


Took 10 seconds of search and paste:

https://about.bgov.com/top-defense-contractors/
17   Patrick   2022 Sep 29, 2:04pm  

https://www.theepochtimes.com/exclusive-fda-withholding-autopsy-results-from-people-who-died-after-getting-covid-19-vaccines_4763765.html?rs=SHRNCNWJ&utm_source=share-btn-copylink


FDA Withholding Autopsy Results on People Who Died After Getting COVID-19 Vaccines

The U.S. Food and Drug Administration (FDA) is refusing to release the results of autopsies conducted on people who died after getting COVID-19 vaccines.

The FDA says it is barred from releasing medical files, but a drug safety advocate says that it could release the autopsies with personal information redacted.

The refusal was issued to The Epoch Times, which submitted a Freedom of Information Act for all autopsy reported obtained by the FDA concerning any deaths reported to the Vaccine Adverse Event Reporting System following COVID-19 vaccination.

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