Tag: Pfizer

FDA Claims It Needs 55 Years Before Revealing Data on Approval of Pfizer Vaccine

Ohio Star Staff
Doctor giving vaccination to patient

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.”

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FDA Approves Moderna and Pfizer Boosters for Adults

Ohio Star Staff

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.

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Mom to Sue After Son Vaccinated at School Without Consent

Ohio Star Staff

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.

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Commentary: Tennessee Legislature Must Pass Big COVID Test in ‘Special Session’

The Epoch Times

The red state/blue state dichotomy is not simple.

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.

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Commentary: Defense Department Pulls a Bait and Switch on Vaccines

Ohio Star Staff

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. 

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Commentary: Vaccination Rates Not Linked to Lower COVID Rates, Epidemiology Paper Finds

Ohio Star Staff

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.”

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Analysis: COVID-19 Is Not a ‘Pandemic of the Unvaccinated’

Admin

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.

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FDA Fully Approves Pfizer’s COVID Vaccine

The Center Square

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.

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Feds: Vaccinated Americans Will Need Booster Shots

The Center Square

The Biden administration announced Wednesday that federal health experts now recommend vaccinated Americans receive a COVID booster shot.

The boosters will be widely distributed to the public after research indicated that the vaccine’s effectiveness declines over time.

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Commentary: Government’s Failed COVID Messaging Is to Blame for Vaccine Hesitancy

Ohio Star Staff

It was always going to be Herculean to inoculate, with an untried vaccine, a multi-ethnic nation of 330 million, across a vast continent—in an era when the media routinely warps the daily news.

Some minorities understandably harbored distrust of prior government vaccination programs.

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Biden Administration Allegedly Planning to Distribute Johnson and Johnson Vaccine to Illegal Aliens

Ohio Star Staff

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.

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Not One State Reported a Sizable Increase in Coronavirus Cases Last Week

Ohio Star Staff
Sick person talking to CDC employee

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.

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Pfizer: Israeli Data Finds Vaccine Prevents 94 Percent of Asymptomatic Infections

Ohio Star Staff

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.

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Pfizer Says Its Vaccine Significantly Halts COVID-19’s Spread, Effective Against UK Variant

Ohio Star Staff

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.

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Pfizer Vaccine Is Effective Against Fast-Spreading Brazilian Coronavirus Variant, Study Shows

Ohio Star Staff

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.

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Pfizer, Moderna Vaccines May Offer Less Protection Against South African Coronavirus Variant

Ohio Star Staff

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.

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Pfizer Vaccine Effective Against Contagious Coronavirus Strain, Study Shows

Ohio Star Staff

The vaccine developed by Pfizer and BioNTech protects against a highly contagious strain of coronavirus that originated in South Africa and the U.K., according to a study published Thursday.

The study, which was commissioned by Pfizer, is likely to alleviate some fears that the virus variant would evade protections offered by the vaccine.

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Pfizer, U.S. Reach Deal for 100 Million Additional Coronavirus Vaccine Doses

Ohio Star Staff

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.

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Coronavirus Vaccines Can Guard Against New, More Contagious UK Strain, Experts Say

Admin

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%.

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Tennessee Nurse Who Fainted After Receiving COVID-19 Vaccine Says It Was Due to Underlying Condition

Corinne Murdock

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.

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Pfizer Vaccine Vials Contain More Doses Than Expected, FDA Says

Ohio Star Staff

Some vials containing Pfizer’s coronavirus vaccine contain more doses than expected, potentially expanding the country’s supply by up to 40%, public health officials said late Wednesday.

The FDA advised that the extra doses were acceptable to use and that it was collaborating with Pfizer over the issue.

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Ohio Gov. DeWine, Who Owns Pfizer Stock, Has Received $22,700 in Contributions from the Drug Company Since 2018

Jack Windsor

  Governor DeWine unexpectedly called a press conference on Monday.  It was the day the Pfizer vaccine arrived in Ohio and DeWine called it “historic,” our “hope” and the “beginning of the end” of COVID.  A video of he and First Lady Fran DeWine can be viewed below as the…

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US Wants to Double COVID-19 Vaccine Order from Pfizer

Ohio Star Staff

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.”

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Three Ohio Cities Rank High Among Cities Needing the Most COVID-19 Vaccines

The Center Square

With COVID-19 vaccines expected in states throughout the country next week, some communities need more than others, according to a recently released study, and Ohio is home to three of those cities.

According to the personal finance website WalletHub, Cleveland, Toledo and Cincinnati rank among the top 10 of 90 large cities in the United States in terms of vaccine need based on 13 key factors, such as frontline healthcare workers, nursing home residents, essential workers, residents diagnosed with various diseases and other things.

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First Person Receives Pfizer’s Vaccine as Britain Begins Mass Coronavirus Vaccination Effort

Ohio Star Staff

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.

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CDC Committee to Discuss COVID-19 Vaccine Next Week

The Center Square

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.

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COVID-19 Vaccine Temperature Requirements Could Create Logistics Challenge

The Center Square

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. 

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Pfizer Notified Biden Before Trump on Vaccine Success

Ohio Star Staff

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.”

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Gov. Mike DeWine Re-Imposes Statewide Mandatory Mask Mandate

Jack Windsor

  COLUMBUS, Ohio – Governor Mike DeWine made time during Wednesday night’s special broadcast to laud Pfizer and their progress on a coronavirus vaccine before effectively re-instating a mandatory mask mandate across the state. “On Monday, our country received some very promising news regarding a Coronavirus vaccine that Pfizer is…

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Commentary: Was Pfizer’s Vaccine News Slow-Walked Until After the Election?

Ohio Star Staff

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.

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