The National Institutes of Health (NIH) Thursday declined to comment recently revealed revelations that Pfizer is not currently shipping its fully Food and Drug Administration (FDA) approved vaccine called Comirnaty in the United States.
Instead, Pfizer continues to ship – and healthcare providers continue to distribute – the Pfizer BioNTech vaccine, which has only received Emergency Use Authorization (EUA) approval from the FDA.
Twitter late Thursday acknowledged that Just the News founder and Editor-in-Chief John Solomon’s account was “suspended in error” this week over a post about a COVID-19 vaccine.
The respond follows an appeal earlier in the day by Solomon after his account was suspended Tuesday for his tweet linking to the article “Pfizer to continue distributing version of COVID-19 vaccine not fully approved by FDA.”
The Centers for Disease Control and Prevention has updated the amount of time it recommends people isolate themselves after testing positive for COVID-19, shortening it from 10 days to five.
“Given what we currently know about COVID-19 and the Omicron variant, CDC is shortening the recommended time for isolation from 10 days for people with COVID-19 to 5 days, if asymptomatic, followed by 5 days of wearing a mask when around others,” the CDC said in a statement Monday.
The CDC changed the guidance because officials believe the data indicates the majority of COVID-19 transmission takes place early in the course of the illness, “generally in the 1-2 days prior to onset of symptoms and the 2-3 days after,” the statement said.
Just a day after taking the Moderna booster shot, a New York Times editor unexpectedly died of a heart attack.
“This is Carlos’s wife, Nora. It’s with deepest sorrow that I have to share with you that Carlos passed away last night of a heart attack. I’ve lost my best friend and our kids lost a truly great dad. I will be off social media for awhile,” Carlos Tejada’s wife announced on his Twitter account on Dec. 18.
New York-based Pfizer has sold and shipped hundreds of millions of doses of its Food and Drug Administration (FDA) approved COVID-19 vaccine Comirnaty to the European Union (EU) despite saying last week that it is not being shipped in the United States.
“Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they will supply an additional 100 million doses of COMIRNATY®, the companies’ COVID-19 vaccine, to the 27 European Union (EU) member states in 2021,” Pfizer said in an April press release. “This announcement is a result of the European Commission’s (EC) decision to exercise its option to purchase an additional 100 million doses under its expanded Advanced Purchase Agreement signed on February 17, 2021. This brings the total number of doses to be delivered to the EU to 600 million.”
Through Ohio attorneys representing Miami University in a lawsuit against the school over its mandatory COVID-19 vaccine policy, The Ohio Star confirmed that at least none batches of Pfizer’s Emergency Use Authorization (EUA) vaccine were deemed Biologics License Application (BLA) compliant.
BLA compliance is typically reserved for Food and Drug Administration (FDA) approved drugs. That is the licensing procedure for drugs seeking to become FDA approved.
The majority opinion released on Friday by the 6th Circuit Court of Appeals, which restored the Biden administration’s Occupational Safety and Health Administration (OSHA) Emergency Temporary Standard (ETS) requiring employers with more than 100 employees to mandate that all employees take a COVID-19 vaccinefalsely asserts that Pfizer’s Food and Drug Administration (FDA) fully approved vaccine is currently available and in use among the general public.”
“At the same time, the options available to combat COVID-19 changed significantly: the FDA granted approval to one vaccine on August 23, 2021, and testing became more readily available,” the majority opinion asserts on page 24 of the ruling.
The majority opinion was written by Obama-appointed Judge Jane Branstretter Stranch of the United States Court of Appeals for the Sixth Circuit.
A Kentucky congressman Saturday said that Pfizer’s Food and Drug Administration (FDA) approved COVID-19 vaccine is not available in the United States after The Ohio Star spent a week reporting on that subject.
“Your first sentence, ‘Comirnaty is available in the US,’ is false. Show us one location it’s available to prove otherwise. The FDA requires Pfizer to disclose to other countries BioNTech is ‘subject to an EUA and is not approved or licensed by the FDA,'” Rep. Thomas Massie (R-KY-04) said on Twitter.
Last week in this space, I included a few words about Robert F. Kennedy, Jr.’s remarkable new book, The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health. I also included a link to Kennedy’s appearance on “Tucker Carlson Today.”
It was a remarkable exchange and I commend both the book and the interview to your attention. I disagree with Kennedy about various things, including the efficacy of vaccines in general, but his assessment of the highest-paid employee of the federal government, Anthony Fauci, is worth the price of admission.
As I remarked a couple of weeks ago, I thought I had done writing about COVID. Surely, I thought, the hysteria is on the wane. Most people are rational. They know that the flimsy porous masks you see everywhere are useless tokens of conformity. They understand that the disease is serious for only a tiny part of the population. They also know staying home and practicing “social distancing” has its own liabilities, not least of which is a diminution in the potency of one’s immune response.
At least two parents have accused a prep school in South Los Angeles of vaccinating their children without their permission after bribing them with pizza, according to NBC Los Angeles. One distressed mother claimed that her 13-year-old son was told not to tell his parents after he was given a Pfizer COVID-19 injection at Barack Obama Global Prep Academy.
Maribel Duarte told NBC LA on Monday that her son recently came home from school with a vaccine card after he had accepted the jab. The boy told his mom that he agreed to get the shot after he was offered pizza. Duarte said that the woman who administered the shot and signed the form told her son not to tell his parents because she didn’t want to get in trouble.
On Monday, the Food and Drug Administration (FDA) requested that the courts allow the agency to wait until the year 2076 to release all of the relevant documents regarding the approval of the vaccine developed by Pfizer and BioNTech, as reported by the Daily Caller.
The FDA made its request after a lawsuit was filed against the agency by the group Public Health Medical Professionals for Transparency (PHMPT). The PHMPT had previously made a Freedom of Information Act (FOIA) request on September 9th asking for the release of the vaccine approval documents; after the FDA denied the request, the group filed its lawsuit on September 16th.
The FDA concluded that there were roughly 329,000 pages in total that would qualify under this FOIA request. In its appeal to the courts, the agency said that, at most, employees would be able to “process and produce the non-exempt portions of responsive records at a rate of 500 pages per month.” Under this process, the FDA said that it would hand over prioritized documents to the plaintiff, and release non-exempt documents on a “rolling basis.”
The Food and Drug Administration (FDA) approved Moderna and Pfizer’s COVID-19 vaccines for booster shot use for adults in the U.S., the agency announced Friday,
The announcement was made just two months after the FDA first rejected the White House’s plan to administer booster shots to all adults the week of Sept. 20. FDA Acting Commissioner Janet Woodcock approved the booster without holding the usual public meeting to review the data, and the Centers for Disease Control and Prevention (CDC) will meet Friday afternoon to discuss the authorization, according to the FDA press release.
“Throughout the course of the COVID-19 pandemic, the FDA has worked to make timely public health decisions as the pandemic evolves. COVID-19 vaccines have proven to be the best and highly effective defense against COVID-19,” Woodcock said in the press release.
A Louisiana mother is threatening to sue, claiming that her 16-year-old son was vaccinated for COVID-19 while at his Jefferson Parish high school without her consent.
Jennifer Ravain alleged that during a visit by an Oschner Health System mobile vaccination clinic to East Jefferson High School, her son was allowed to sign a consent form and receive a COVID-19 vaccination despite the Louisiana Department of Health requirement of a parent’s signature for persons under 18 being vaccinated, WWL-TV reported.
Nowhere is that more apparent than Tennessee where—despite having one of the most conservative electorates in the country—the leadership has been passive at best in responding to the wishes of their supporters during these days of great crisis.
On August 24, Secretary of Defense Lloyd Austin issued a memo to senior Pentagon leadership announcing that he was implementing a mandatory COVID-19 vaccination policy for all military service members. The day before, the FDA had issued full authorization to Pfizer for their Comirnaty COVID-19 vaccine product (the nomenclature of which is meant to be a mashup of the words “COVID”, “mRNA”, and “community”) . At first glance it would seem that the mandatory vaccination policy, while scientifically unsound and strategically foolish, was at least a policy being implemented according to both the letter of the directive and in accordance with the law. But a further examination of the facts and the manner in which this order is being implemented makes clear that the military’s implementation of this order is illegal and highly unethical.
In the memo, Secretary Austin issued a directive and a promise, that “Mandatory vaccination against COVID-19 will only use COVID-19 vaccines that receive full licensure from the Food and Drug Administration (FDA), in accordance with FDA-approved labeling and guidance.” The problem with this is that the Comirnaty vaccine product that was approved by the FDA is not available anywhere in the Military Health System. It is not even in production, according to the military’s TRICARE healthcare providers. If a soldier goes to a military hospital or a private provider to receive an approved Pfizer COVID vaccine, he will be administered the unapproved Pfizer-BioNTech vaccine which is a vaccine that is not approved but has been administered under an Emergency Use Authorization (EUA). We are told that this is but a brand name difference, that the formulation is the same, and they can be used interchangeably. But as the FDA was approving the Comirnaty product, they were renewing the authorization for the Pfizer-BioNTech product. If it’s just a matter of brand name, why issue an approval for one brand name and an EUA renewal for the other? This is because they are not actually the same.
On Friday, the San Francisco Chronicle published an article noting that California has some of the lowest COVID-19 case rates in the US, even though the Golden State’s vaccination rate lags many states that are currently struggling with the delta variant.
“One clear example is the New England states of Vermont and Maine,” the Chronicle reported. “Relatively shielded from the worst of the nation’s previous surges, they have struggled against the delta variant, which has sent their case rates soaring.”
On Friday, September 17, the CDC published a study that refutes the common claim that COVID-19 is a “pandemic of the unvaccinated.” Coauthored by more than 50 MD’s and Ph.D.’s, the study contains data on the vaccine status of adults hospitalized with COVID-19 (C-19) at 21 U.S. hospitals across 18 states during March to August of 2021.
Contrary to assertions from the Associated Press and Anthony Fauci that fully vaccinated people comprise only 1% of those being hospitalized or killed by C-19, the study found that 13% of patients hospitalized with C-19 had been fully vaccinated. Moreover, that 13% figure is just the tip of the iceberg because the authors excluded from their study a large group of hospitalized C-19 patients, the bulk of whom were likely vaccinated.
The U.S. Food and Drug Administration gave full approval Monday to the Pfizer COVID-19 vaccine, a major step that will likely have significant implications for vaccination mandates nationwide. The Moderna and Johnson & Johnson vaccines have not yet received full FDA authorization.
The Pfizer vaccine previously received FDA authorization, which allowed its emergency use but did not give the full approval. Pfizer is the first company to receive full approval in the U.S.
Joe Biden is planning an effort to distribute doses of the Johnson & Johnson vaccine to illegal aliens pouring into the United States across the southern border, as reported by Breitbart.
The report first came from the Washington Post, after several officials with the Department of Homeland Security (DHS) spoke under condition of anonymity. According to the officials, federal authorities will soon begin administering the single-shot vaccine to illegals currently held in U.S. custody along the southern border with Mexico. DHS plans to get illegals vaccinated as soon as possible upon their entry into the country, to be done even before they are fully processed.
For the first time in months, not one state reported a dramatic weekly increase in coronavirus cases.
While average daily cases fell by less than 10% in 11 states, 37 states saw cases fall by over 10% and just two states had cases marginally increase, according to data from Johns Hopkins University. The United States also averaged fewer than 40,000 daily cases last week, a 21% drop from the week prior and the lowest total since September.
Death and hospitalization rates have also plummeted nationwide. The U.S. has averaged 600 deaths per day, the lowest point in approximately 10 months. If the number continues to fall the nation could soon hit its lowest point of the entire pandemic, according to the Associated Press.
Pfizer’s coronavirus vaccine was over 94% effective in preventing asymptomatic cases of COVID-19, according to real-world Israeli data released late Thursday.
The latest analysis suggests that Pfizer’s vaccine could overwhelmingly halt asymptomatic spread — a main driver of infections since asymptomatic people are often unaware they have the virus. The data also showed that the vaccine was 97% effective in preventing symptomatic cases, hospitalizations and deaths, slightly higher than the 95% effectiveness found in its clinical trials.
Pfizer said Wednesday that real-world data suggests its coronavirus vaccine is 94% effective in halting asymptomatic infections and effective against a highly transmissible variant first discovered in the United Kingdom.
Israeli analysis of vaccine distribution shows the vaccine being over 97% effective in preventing symptomatic cases and death, higher than the 90% efficiency that was reported in the vaccine’s Phase III trials, Pfizer said in a press release Thursday. Over 80% of the tested specimens were against the UK variant known as B.1.1.7.
Pfizer’s coronavirus vaccine was able to neutralize the highly transmissible Brazilian virus variant, a new lab study showed.
The effectiveness of the vaccine against the variant was “roughly equivalent” to the original strain, researchers told the New England Journal of Medicine. Its ability to combat the variant, known as P.1, is especially encouraging in Brazil, where it has spread throughout the country.
Recent studies indicate that the Pfizer and Moderna coronavirus vaccines may have reduced protection against the South African coronavirus strain, according to reports in the New England Journal of Medicine, raising concerns that they could be less effective against future mutations.
Though both vaccines appeared to generate enough antibodies to neutralize the mutant strain, they both produced fewer antibodies when compared to the original virus. But experts warned that it was unclear just how much protection was needed to neutralize the variant, which scientists believe is more contagious than the original strain.
The Trump Administration has purchased an additional 100 million doses of Pfizer’s coronavirus vaccine, the drugmaker announced Wednesday.
The new agreement means that Pfizer will supply 200 million doses to the United States, according to the company’s statement, which will be distributed through July 2021. Also included in the deal is the option to purchase an additional 400 million doses.
Few people realize that the Moderna vaccine against COVID-19—which the FDA has finally declared “highly effective,” and which is now being distributed to Americans—has actually been available for nearly a year.
The two coronavirus vaccines that have been approved for emergency use authorization in the U.S. will be able to combat a new, more contagious strain of the virus in the U.K., experts said Monday.
Vaccines made by pharmaceutical companies Pfizer and Moderna will be effective against the new strain, which is “very similar” to previous strains at the genetic level, University of Washington’s Institute for Health Metrics and Evaluation affiliate assistant professor Vin Gupta told CNBC. The Food and Drug Administration has approved both vaccines for emergency use authorization after large-scale human trials showed efficacy of more than 90%.
The nurse who appeared to faint after receiving a COVID-19 vaccine in a viral video has recovered, according to a statement issued by her employer. Tiffany Dover, a nurse at CHI Memorial Hospital, reportedly came close to passing out due to a medical condition unrelated to the vaccination.
The hospital also cited information from the Centers for Disease Control (CDC) website, which stated that fainting sometimes occurs after all types of vaccinations.
Pfizer CEO Albert Bourla said on CNN Monday that the U.S. is seeking to double its COVID-19 vaccine order.
“So far, we have an agreement with the U.S. Government to provide them 100 million doses and this is a fixed order and we will provide those 100 million doses starting from now by the end of the first quarter and we will honor this commitment,” Bourla told CNN Chief Medical Correspondent Dr. Sanjay Gupta on “New Day With Alisyn Camerota and John Berman.”
Britain’s National Health Service administered its first doses of a coronavirus vaccine Tuesday, becoming the first country to begin its mass vaccination effort.
Just after 6:30 a.m. Tuesday, 90-year-old Margaret Keenan became the first person to receive a fully authorized vaccine outside of a clinical trial, marking the beginning of a global campaign to end a pandemic that has infected over 65 million people and killed over 1.5 million across the globe.
The group of medical and public health experts that develops recommendations for vaccine use for the Centers for Disease and Prevention (CDC) will meet Tuesday.
CDC’s Advisory Committee on Immunization Practices (ACIP) posted a notice for a meeting scheduled for Dec. 1 without any details, but officials confirmed Friday that COVID-19 vaccination would be on the agenda.
Many states in the U.S. are hinging their COVID-19 mitigation strategies on the availability of a widely available vaccine. An issue bound to arise is the extremely cold temperatures the most promising experimental vaccines need to be kept at and the logistics of delivering them across the country.
Moderna’s COVID-19 vaccine is estimated to remain stable at standard refrigerator temperatures of 36° to 46°F for 30 days. Longer storage means a required temperature of mRNA-1273 needs -4°F for up to six months.
Pfizer said Wednesday that new test results show its coronavirus vaccine is 95% effective, is safe and also protects older people most at risk of dying — the last data needed to seek emergency use of limited shot supplies as the catastrophic outbreak worsens across the globe.
In an interview with WMAL radio show Wednesday morning, Health and Human Services Secretary Alex Azar appeared to confirm that the Trump administration learned of Pfizer’s successful COVID-19 vaccine trial from press coverage not from company officials directly. “I…learned of this from media reports on Monday morning,” Azar told “Mornings on the Mall” program on November 11. “There certainly was a gap in communications, let’s say.”
As the coronavirus pandemic swept across the globe in the spring, President Trump announced his plan to fast-track an effective vaccine that would be available by the new year.
The goal of Operation Warp Speed, launched by the White House in May, was “to produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.” Congress appropriated $10 billion to fund the ambitious program.
The federal government pledged $1.95 billion for an order of 100 million doses, with an option to acquire an additional 500 million doses of a coronavirus vaccine, which is set to enter key large-scale trials in the coming weeks.