ALERT: FDA Approves Pfizer Shot
Booster Plans raise Question about Dose and Duration
Aug 23, 2021
UPDATE: AUG 25
Two crucial points: FDA allows interchangeable use of Pfizer vaccines — the emergency use version and the approved one. It allows this on the basis that the ingredients are identical. However the legal liability is not.
Secondly, mandating an experimental drug offends the Nuremberg Code. States and companies that demand the approved vaccine have stronger legal protection.
Hat tip to Children’s Health Defense for trawling the small print of the FDA’s Aug 23 announcement.
When I listened to the press conference I heard Acting FDA Commissioner Janet Woodcock note that the ‘new and old’ would be interchangeable. She moved on so swiftly that I admit I missed the significance.
Robert Malone, the inventor of mRNA vaccines and DNA vaccines told Steve Bannon’s War Room that while it may be true that the emergency use-authorized version of Pfizer contains the same shot as the Comirnaty Pfizer-BioNTech, it has a different letter of authorization.
The immunity against liability or prosecution applied only to the EMA version, ie the Pfizer product. The Comirnaty Pfizer-BioNtech product will be open to prosecution once it enters use, Malone said.
Further, Malone says the FDA bypassed the usual external advisory committee which would have been open to public comments. The FDA said it was not necessary as the vaccine “did not raise concerns or controversial issues.”
"What they have done is jammed through something that will allow the government, commercial entities and states to mandate vaccination for the military and others but by their own statements they don't have the data to support the safety and efficacy claims."
On Aug 24, Chief White House medical adviser Anthony Fauci told MSNBC the US would “get control” of coronavirus by the fall of 2022 — which he later revised to spring of next year.
Malone noted “moving the goalposts” from 70% to 90% of population being “fully vaccinated” with at least two Covid shots. With efficacy falling under 40% in Israel the target of herd immunity through vaccination has now been dropped, Malone said.
UPDATE: AUG 24
PACKAGE INSERT PUBLISHED
Additional side effects and warnings do not reflect widespread reports or VAERS data.
It is not clear whether the insert is included with the Comirnaty Pfizer-BioNTech’s COVID-19 shot but it is published on the FDA web site. 1
Warnings and precautions
Pfizer has added more, notably myocarditis and pericarditis, but the warnings on the document do contain the caveat that there is no information about long-term effects. It also mentions fainting. It warns of a diminished immune response after the vaccine to immunocompromised persons.
Severe allergic reaction (anaphylaxis) is one contraindication. The company keeps the same warnings of adverse reactions, including fatigue, headaches, muscle pain, chills, joint pain, fever and injection site swelling.
Pregnancy
Available data on Comirnaty administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. It is not known whether Comirnaty is excreted in human milk.
It has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility.
Caveat
All the warnings, precautions, contraindications and adverse effects come with the caveat that “clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.”
Ingredients
Each dose contains 30 mcg of a nucleoside-modified messenger RNA (mRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2.
Readers may wonder where the strange name comes from. According to Scott Piergrossi, Brand Institute president of operations and communications, “The name is coined from Covid-19 immunity, and then embeds the mRNA in the middle, which is the platform technology, and as a whole the name is meant to evoke the word community.”
EARLIER REPORT
FDA still does not apparently require a full information insert with the shot. It has not published any updated Guidance for Industry — nor for the FAQ page for individuals.
Just joined the online presser: they only allowed about 5 questions. The two speakers stuck very closely to the press release, here. Even the Q&A (listen here) was limited to 10 minutes — which to any sane person conflicts with their claims that the pandemic represents an existential threat to humanity.
Acting FDA Commissioner Janet Woodcock on the rebranded Comirnaty: It is important people get vaccinated but we don’t have data on the proper dose, nor do we have full data on safety in children younger than in the EUA.
It would be a great concern if people vaccinate children for we don’t have the dose, the safety data or the efficacy data. “They are not just small adults. We must have the data and the dose before recommending that children be vaccinated.”
Little new information on side effects.
CBER Director Peter Marks said they inspected facilities where the shot is made, used updated information from Pfizer with a longer follow-up of 20k shot recipients and 20k placebo “who did not have Covid one week after shot.” That equals 91% effectiveness.
Company will do post-marketing safety study including into pregnancy after vaccination. Nothing new on myocarditis.
Journalist questions concerned shooting younger children and boosters for all.
See Jon Rappoport for specialists who contest the rushed approval and who are calling for an inquiry. 2
Backgrounder
The Food and Drug Administration’s decision seems to have surprised the other commercial-regulatory bodies. The Centers for Disease Control said it would meet on Aug 30 to decide its updated recommendations for the vaccine.
The FDA’s move to approve Comirnaty Pfizer-BioNTech’s COVID-19 shot is expected to spark a wave of new vaccine mandates by local governments and businesses, removing some of the threat of legal action from reluctant staff. However there are still a number of exemptions and the U.S. federal government has not said how it will respond.
The Biden administration expects to offer booster shots to vaccinated people from Sep 20 (subject to FDA full approval, which has now been given).
Forked tongue
The FDA's wording is forked: the vaccine "meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”
So does it work or does it simply compare favourably with established products and if so which?
As a two-dose injection it got emergency authorization in Dec 2020. It has now been granted the status of an approved drug for people aged 16 and over. Pfizer says it will apply for approval for 12 years and over within months.
The state-corporatist media says about 60% of eligible individuals in the U.S. are “fully vaccinated”. However on Aug 12 the FDA authorized an extra shot for certain people whose immune systems had been compromised.
What does fully vaccinated mean in these circumstances? The Biden administration last week said booster shots would be available from mid-September in a rolling program for each person eight months following the second shot.
Side effects uncertain
Some journalists and health professionals have claimed that it would be unfair to offer a third shot when many people have still not had the first.
This is a diversionary tactic because it avoids the numerous pressing questions that are still awaiting answers:
• how many boosters are needed and for how long?
• what is the current list of adverse side effects?
• what is the effect on antibody dependent enhancement (ADE) of repeated booster shots?
• what is the status of the investigation into myocarditis, or heart inflammation, in young people which the Centers for Disease Control announced in August?
The CDC has only just begun its investigation according to a Aug 20, 2021 announcement on its web site. Myocarditis (inflammation of the heart muscle) has in some cases followed the Pfizer mRNA shot, as well as that of Moderna. The CDC comment is also forked, saying most of these people fully recover from heart inflammation while also saying that information is not yet available about potential long-term effects.
Some specialists disagree that recovery is common, saying that once the heart muscle is weakened it is often permanently damaged.
Long term plans
Moreover, health officials are not telling vaccinated people when or whether the process of repeat shots will end. The current official narrative remains focused on the variants despite the common scientific understanding that viruses weaken as they mutate — and that even if they become more infectious they become less harmful. The government narrative ignores this.
The German-American lawyer Reiner Fuellmich, who is investigating possible contraventions of the Nuremberg Code, the key document on medical ethics, says he has evidence of plans for repeated vaccinations every few months. It includes a statement from a German manufacturer who was told in October 2020 by a German regional health minister that vaccines would become mandatory and that there would be booster shots every six months.
The FDA announcement comes as governments, including those of Australia and Britain, are building new prisons for use as containment camps for those who refuse the vaccine.
Australia and the U.S are also considering using federal authority over interstate travel establish checkpoints under federal control. If you don't have the appropriate vaccine papers you may be arrested and taken to a detainment camp.
FDA release
In its press announcement the FDA said the shot continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years.
Acting FDA Commissioner Janet Woodcock said “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S."
https://www.fda.gov/vaccines-blood-biologics/comirnaty
https://www.fda.gov/media/151707/download
https://blog.nomorefakenews.com/2021/08/23/fda-gives-full-approval-to-covid-vaccines-no-public-hearing-no-transparency/