Posted on 08/31/2022 7:19:37 AM PDT by Pollard
Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. The bivalent vaccines, which we will also refer to as “updated boosters,” contain two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2.
The Moderna COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 18 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 12 years of age and older.
The monovalent COVID-19 vaccines that are authorized or approved by the FDA and have been administered to millions of people in the United States since December 2020 contain a component from the original strain of SARS-CoV-2.
What you need to know:
Who is eligible to receive a single booster dose and when:
“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19,” said FDA Commissioner Robert M. Califf, M.D. “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.”
The Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent contain mRNA from the SARS-CoV-2 virus. The mRNA in these vaccines is a specific piece of genetic material that instructs cells in the body to make the distinctive “spike” protein of the original virus strain and the omicron variant lineages BA.4 and BA.5. The spike proteins of BA.4 and BA.5 are identical.
“The FDA has been planning for the possibility that the composition of the COVID-19 vaccines would need to be modified to address circulating variants. We sought input from our outside experts on the inclusion of an omicron component in COVID-19 boosters to provide better protection against COVID-19. We have worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently. The FDA has extensive experience with strain changes for annual influenza vaccines. We are confident in the evidence supporting these authorizations,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization.”
For each of the bivalent COVID-19 vaccines authorized today, the FDA evaluated immunogenicity and safety data from a clinical study of a booster dose of a bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of omicron lineage BA.1. The FDA considers such data as relevant and supportive of vaccines containing a component of the omicron variant BA.4 and BA.5 lineages. Furthermore, data pertaining to the safety and effectiveness of the current mRNA COVID-19 vaccines, which have been administered to millions of people, including during the omicron waves of COVID-19, contributed to the agency’s evaluation.
Data Supporting the Moderna COVID-19 Vaccine, Bivalent Authorization
To evaluate the effectiveness of a single booster dose of the Moderna COVID-19 Vaccine, Bivalent for individuals 18 years of age and older, the FDA analyzed immune response data among approximately 600 individuals 18 years of age and older who had previously received a two-dose primary series and one booster dose of monovalent Moderna COVID-19 Vaccine. These participants received a second booster dose of either the monovalent Moderna COVID-19 Vaccine or Moderna’s investigational bivalent COVID-19 vaccine (original and omicron BA.1) at least 3 months after the first booster dose. After 28 days, the immune response against BA.1 of the participants who received the bivalent vaccine was better than the immune response of those who had received the monovalent Moderna COVID-19 Vaccine.
The safety of a single booster dose of the Moderna COVID-19 Vaccine, Bivalent for individuals 18 years of age and older is supported by safety data from a clinical study which evaluated a booster dose of Moderna’s investigational bivalent COVID-19 vaccine (original and omicron BA.1), safety data from clinical trials which evaluated primary and booster vaccination with the monovalent Moderna COVID-19 Vaccine, and postmarketing safety data with the monovalent Moderna COVID-19 Vaccine.
The safety data accrued with the bivalent vaccine (original and omicron BA.1) and with the monovalent Moderna COVID-19 Vaccine are relevant to the Moderna COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.
The clinical study that evaluated the safety of a booster dose of the bivalent vaccine (original and omicron BA.1) included approximately 800 participants 18 years of age and older who had previously received a two dose primary series and one booster dose of the monovalent Moderna COVID-19 Vaccine, and then at least 3 months later, received a second booster dose with either the monovalent Moderna COVID-19 Vaccine or Moderna’s investigational bivalent COVID-19 vaccine (original and omicron BA.1).
Among the study participants who received the bivalent vaccine, the most commonly reported side effects included pain, redness and swelling at the injection site, fatigue, headache, muscle pain, joint pain, chills, swelling of the lymph nodes in the same arm of the injection, nausea/vomiting and fever.
Data Supporting the Pfizer-BioNTech COVID-19 Vaccine, Bivalent Authorization
To evaluate the effectiveness of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 12 years of age and older, the FDA analyzed immune response data among approximately 600 adults greater than 55 years of age who had previously received a 2-dose primary series and one booster dose with the monovalent Pfizer-BioNTech COVID-19 Vaccine. These participants received a second booster dose of either the monovalent Pfizer-BioNTech COVID-19 Vaccine or Pfizer-BioNTech’s investigational bivalent COVID-19 vaccine (original and omicron BA.1) 4.7 to 13.1 months after the first booster dose. After one month, the immune response against BA.1 of the participants who received the bivalent vaccine was better than the immune response of those who had received the monovalent Pfizer-BioNTech COVID-19 Vaccine.
The safety of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 12 years of age and older is based on safety data from a clinical study which evaluated a booster dose of Pfizer-BioNTech’s investigational bivalent COVID-19 vaccine (original and omicron BA.1), safety data from clinical trials which evaluated primary and booster vaccination with the monovalent Pfizer-BioNTech COVID-19 Vaccine, and postmarketing safety data with the monovalent Pfizer-BioNTech COVID-19 Vaccine.
The safety data accrued with the bivalent vaccine (original and omicron BA.1) and with the monovalent Pfizer-BioNTech COVID-19 Vaccine are relevant to Pfizer-BioNTech COVID 19 Vaccine, Bivalent because these vaccines are manufactured using the same process.
The clinical study that evaluated the safety of a booster dose of the bivalent vaccine (original and omicron BA.1) included approximately 600 participants greater than 55 years of age who had previously received a 2-dose primary series, one booster dose of the monovalent Pfizer-BioNTech COVID-19 Vaccine, and then 4.7 to 13.1 months later, received a second booster dose of either the monovalent Pfizer-BioNTech COVID-19 Vaccine or Pfizer-BioNTech’s investigational bivalent COVID-19 vaccine (original and omicron BA.1). Among the study participants who received the bivalent vaccine, the most commonly reported side effects included pain, redness and swelling at the injection site, fatigue, headache, muscle pain, chills, joint pain, and fever.
The fact sheets for both bivalent COVID-19 vaccines for recipients and caregivers and for healthcare providers include information about the potential side effects, as well as the risks of myocarditis and pericarditis.
With today’s authorization, the FDA has also revised the EUA of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to remove the use of the monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines for booster administration for individuals 18 years of age and older and 12 years of age and older, respectively. These monovalent vaccines continue to be authorized for use for administration of a primary series for individuals 6 months of age and older as described in the letters of authorization. At this time, the Pfizer-BioNTech COVID-19 Vaccine remains authorized for administration of a single booster dose for individuals 5 through 11 years of age at least five months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine.
The amendments to the EUAs were issued to Moderna TX Inc. and Pfizer Inc.
Added more to their arsenal of population control.
Pfizer's COVID-19 Clinical Trial Phase 1/2/3 in clinicaltrials.gov https://clinicaltrials.gov/ct2/show/study/NCT04368728
Trial start date April 29, 2020. Estimated completion date February 8, 2024
Moderna's COVID-19 Clinical Trial Phase 3 in clinicaltrials.gov https://clinicaltrials.gov/ct2/show/study/NCT04470427
Trial start date July 27, 2020. Estimated completion date December 29, 2022
Normal for Phase 1/2/3 to be run concurrently? Doubt it. Normally, there is a Phase 4 which is when a portion of the public starts getting it and it's monitored.
Thank you for your participation and may the odds be ever in your favor.
The least reputable product endorsement in modern times. Joe Isuzu would market test higher trust in product endorsement.
Covid stimulus checks were actually payments for participation in experimental drug trials.
With or without HUMAN TRIALS?
YADA YADA YADA
EVERYTHING about “COVID” is a LIE.
(**unless you're a taxpayer)
Fool me once, shame on you..
Fool me twice, shame on ME…
Fool me 4-5 more times… I’m just plain asking for trouble!
“Boosters” every three months? How about every week? Do-it-yourself supplies sent to your home by the surveillance state. “Stand in front of the telescreen, comrade, and finish the injection.”
Tyranny never stops until it's forced to.
They are condemning anyone who got 2 jabs into taking this new untested one as a booster
They are condeming anyone who got 1 or 2 boosters already…into having to take this as jab 4 or 5
JnJ is screwed
And entire cabal of profit-corrupted bureaucrats in suits and white coats…
Absolutely determined to get this MRNA into the population
Noticing no more mention of Comirnity - the ‘approved’ Pfizer vaccine. From here on in, only EUA.
“Normally, there is a Phase 4 which is when a portion of the public starts getting it and it’s monitored.”
This time, they did Phase 4 first. Well, minus the monitoring, the control group, documentation, etc.
#FauciLiedMillionsDied - Twitter Search / Twitter
https://twitter.com/Filippo60/status/1564799836540456960?s=20&t=OUKfVqphctF3rHQqDMt9hQ
More from archives..
We are going to have a group taking 5 jabs in roughly 18 months, many who are also jabbed with the latest flu shots regularly. Big Pharma loving this and they are only getting started…..Article mentions two months after latest booster before this latest greatest jab, seems we could go for weekly eventually if we follow their science…
Per the docs who are outside of The Official Narrative, to keep injecting Wuhan1, which has been gone for about 2 years now, just makes immune imprinting worse (why vaxed/boostered get COVID & often more than once, are the majority hospitalized/dying) & also ADE. The first step in surviving the bioweapons is to STOP getting shots. There are very successful, proven SAFE early treatment therapies that work to keep people out of the hospitals & their COVID Death Wards.
ONLY EUA?????
Makes one wonder - WHAT ARE THEY HIDING??
RTFP
This new crap is now the ONLY vaxx authorized for “boosters”
Conveniently they made this “ booster” a 1-jabber - to overcome resistance
For now
They’ll mandate it again in 3-6 months when people keep getting sick and dropping dead
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