Tag: Pfizer

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

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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

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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

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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: Defense Department Pulls a Bait and Switch on Vaccines

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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

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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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Williamson County Commissioners Nominate Top-Level Pfizer Official to Replace Brad Fiscus on School Board

Chris Butler

Two Williamson County commissioners have announced their choice to replace Brad Fiscus on the Williamson County School Board, and that person is Franklin resident Josh Brown, who also does top-level work for Pfizer. Williamson County District Four Commissioners Chad Story and Gregg Lawrence selected Brown against nine other candidates, according to The Tennessean. The remaining commissioners are scheduled to vote on whether to formally appoint Brown to the position at their October 11 meeting.

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

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

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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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Pfizer Launches Trials to Test Booster COVID Shots in Knoxville, Nashville

Corinne Murdock

Pfizer has launched trials in Knoxville and Nashville to test a third booster shot for the COVID-19 vaccine, marketed as an “updated version.” Alliance for Multispecialty Research (AMR) Knoxville’s Volunteer Research Group is conducting the Knoxville study, and Clinical Research Associates is conducting the Nashville study. Pfizer claimed in a press release earlier this month that a third dose of the COVID-19 vaccine would more effectively provide immunization, especially against the Delta variant.

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Metro Nashville Continues to Administer Pfizer Vaccines Ahead of CDC Emergency Meeting on Heart Inflammation Reactions

Corinne Murdock

Metro Nashville health officials will continue to administer Pfizer’s COVID-19 vaccine, which will be discussed in an upcoming emergency meeting called by the CDC. According to preliminary reports, there have been double the expected cases of heart inflammation occurring in both Pfizer and Moderna vaccine recipients. 

The CDC meeting is scheduled for this Friday. Officials will discuss whether there exists a definitive link between the two vaccine types and the reported cases of myocarditis and pericarditis. The Tennessee Star inquired with the Metro Public Health Department (MPHD) if they would continue administering the Pfizer vaccine up until the CDC holds its emergency meeting. MPHD spokespersons confirmed to The Star that they would.

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City of Memphis Gives Away Car in COVID Vaccine Sweepstakes

Corinne Murdock

The City of Memphis, in partnership with a nonprofit, gave away a car as part of a COVID-19 vaccination sweepstakes. The winner was announced on Thursday.

According to the sweepstakes page, the maximum value of the car could’ve totaled $30,000. The winner had a choice between a Chevy Camaro, Chevy Colorado, Nissan Rogue, Nissan Altima, or any similar vehicle of equal or lesser value.

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

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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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Virginia’s COVID-19 Case Numbers, Hospitalizations Down to Spring 2020 Levels

Eric Burk

Virginia’s COVID-19 case numbers hit a new milestone on Monday: just 336 reported cases, according to the Virginia Department of Health; the last time numbers dropped below 400 was in June and April of 2020. According to the Virginia Hospital and Healthcare Association, COVID-19 hospitalizations are low as well, with the seven-day moving average at 775 on Thursday; that number hasn’t been below 800 since late March 2020.

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Bill Allowing Religious Exemptions to Vaccines Regardless of a Public Health Emergency Lives on as Potential Amendment in a Senate Bill

Corinne Murdock

Through amendment, another legislator is seeking to revive a bill affording religious or conscientious exemptions for vaccines during a public health emergency. As The Tennessee Star reported, the original bill seeking to provide those protections was killed by the House Health Subcommittee earlier this month.

The bill carrying this amendment originally only sought to prohibit state or local governments from mandating COVID-19 vaccinations. State Senator Janice Bowling (R-Tullahoma) announced the amendment during the Senate Health and Welfare Committee hearing on Wednesday.

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

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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

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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

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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

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

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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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NAACP Leader Criticizes Tennessee for Allocating Only Five Percent of Coronavirus Vaccine for Minorities

Jason M. Reynolds

The Tennessee Department of Health is setting aside a portion of its COVID-19 vaccines for communities that are poorer and have more people of color, but one minority leader says that is not good enough.

After this current first phase, the state will reserve 5 percent of the vaccine for areas that are poorer and have higher numbers of minorities, CBS News reported.

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

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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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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 vaccine shipment arrives via UPS. During the Monday briefing, The Ohio Star asked DeWine about his alleged ties to drug maker Pfizer. The Star asked: Governor, from a viewer, a two-part question regarding your potential ties to drug makers: First, do you own stock in Pfizer and Moderna – and did these companies contribute to your campaign pre, and post, gubernatorial fund? Second, many people have diversified holdings in pharma, so that would be understandable but in the past as a U.S. Senator you received criticism for approving immunization for drug makers from accountability for harm their drugs do – while holding pharma stock. As Ohio Attorney General you received criticism for stock in companies that an AG’s legal action could affect the value of – now as governor, do you see it as a conflict of interest – holdings and contributions – since you are a primary policymaker and…

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US Wants to Double COVID-19 Vaccine Order from Pfizer

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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

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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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Department of Health: Virginia to Receive 480,000 Vaccine Doses by End of December

Jacob Taylor

The Virginia Department of Health (VDH) announced on Friday that the Commonwealth is preparing to receive 480,000 doses of COVID-19 vaccine by the end of December based on new information from the federal government’s Operation Warp Speed.  

As Governor Ralph Northam noted during a coronavirus briefing on Wednesday, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted last week to officially recommend healthcare personnel and long-term care facility residents as top priority for vaccination.

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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 Chooses Tennessee as One of Four States for COVID-19 Vaccine Distribution Pilot Program

The Center Square

Tennessee is one of four states chosen by pharmaceutical giant Pfizer to help refine plans for the delivery and deployment of the Pfizer-BioNTech COVID-19 vaccine if it receives approval from the U.S. Food and Drug Administration, Pfizer announced Tuesday.

The pilot program will help support states’ planning, deployment and administration of the COVID-19 vaccine and adapt findings for use in other states to support vaccine distribution. Tennessee released its COVID-19 vaccine distribution plan last month.

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Pfizer Notified Biden Before Trump on Vaccine Success

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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 developing. The first results from phase three, the final research phase on their vaccine, show it to be very effective in preventing COVID 19. That’s great news. This should give us all great hope,” said DeWine. He continued “it could be here as early as December. And we will be ready.” The rest of the address covered what the state plans to do before Ohio receives vaccine doses and reaches the governor’s desired level of immunity from significant vaccination uptake. Back in March, DeWine declared a state of emergency in Ohio and on Wednesday night he made it clear Ohio is still under an emergency and intends to extend the order – “today, I was asked by our hospital leaders to confirm that Ohio remains in a state of emergency. I’m telling you tonight it most certainly does.” On Monday, during a specially-called press conference with doctors who lead Ohio’s…

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

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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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U.S. Will Pay $1.95 Billion for 100 Million Doses of Coronavirus Vaccine Doses

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The federal government pledged $1.95 billion for an order of up to 600 million doses of a coronavirus vaccine, which is set to enter key large-scale trials in the coming weeks. The average cost of a dose based on this deal is $3.25.

American pharmaceutical company Pfizer and German partner BioNTech announced the deal in a press release Wednesday. The companies are on track to produce 100 million doses by the end of the year and potentially 1.3 billion doses by 2022.

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