Category: Covid-19 Vaccine

Pfizer logo is seen in this illustration taken, May 1, 2022. REUTERS/Dado Ruvic/Illustration/File Photo Acquire Licensing Rights

Nov 30 (Reuters) - Pfizer (PFE.N) has been sued by Texas Attorney General Ken Paxton, who on Thursday accused the drugmaker of misrepresenting the efficacy of its widely-used COVID-19 vaccine.

In a complaint filed in a Lubbock County state court, Paxton said it was misleading for Pfizer to claim its vaccine was 95% effective because it offered a "relative risk reduction" for people to who took it.

Paxton said the claim was based on only two months of clinical trial data, and vaccine recipients' "absolute risk reduction" showed that the vaccine was just 0.85% effective.

He also said the pandemic got worse even after people started taking the vaccine, developed by Pfizer and its German partner BioNTech (22UAy.DE).

"Pfizer intentionally misrepresented the efficacy of its COVID-19 vaccine and censored persons who threatened to disseminate the truth in order to facilitate fast adoption of the product and expand its commercial opportunity," the complaint said.

The lawsuit seeks to stop New York-based Pfizer from making alleged false claims and silencing "truthful speech" about its vaccine, and more than $10 million in fines for violating a Texas law protecting consumers from deceptive marketing.

Pfizer said more than 1.5 billion of people have received its vaccine. The drugmaker has reported more than $74 billion of revenue in 2021 and 2022 related to COVID-19 immunizations.

In a statement, Pfizer said its representations about its vaccine have been "accurate and science-based," and that it believed Paxton's lawsuit had no merit.

Pfizer also said its vaccine has "demonstrated a favorable safety profile in all age groups, and helped protect against severe COVID-19 outcomes, including hospitalization and death."

Infectious disease experts have said relative risk reduction is a more meaningful way to judge a vaccine's efficacy than absolute risk reduction. Relative risk shows how well a vaccine protects recipients relative to a study's control group.

Paxton, a Republican, has criticized Biden administration efforts to fight the pandemic.

Earlier this year, he began probing whether Pfizer, Moderna (MRNA.O) and Johnson & Johnson (JNJ.N) misrepresented their vaccines' efficacy, to examine the "scientific and ethical basis" for public health decisions addressing COVID-19.

"Pfizer did not tell the truth about their COVID-19 vaccines," Paxton said in a statement. "We are pursuing justice for the people of Texas, many of whom were coerced by tyrannical vaccine mandates to take a defective product sold by lies."

The lawsuit is Paxton's second against Pfizer in November.

In a case unsealed on Nov. 21, Paxton accused Pfizer and a supplier of manipulating quality control tests, resulting in the distribution of ineffective drugs to treat attention deficit hyperactivity disorder in children.

The status of the probe into Moderna and Johnson & Johnson was not immediately clear. Paxton's office did not immediately respond to requests for comment.

Reporting by Jonathan Stempel in New York; Additional reporting by Caroline Humer; Editing by Chizu Nomiyama and Daniel Wallis

Our Standards: The Thomson Reuters Trust Principles.

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Pfizer is sued by Texas over COVID vaccine claims - Reuters

By Bethany Blankley The Center Square

Texas Attorney General Ken Paxton this week sued Pfizer, alleging the pharmaceutical giant unlawfully misrepresented the effectiveness of its COVID-19 vaccine and attempted to censor public discussion about it.

The lawsuit comes six months after his office launched an investigation into three pharmaceutical giants in May. It was filed in the District Court of Lubbock County, Texas, and solely names Pfizer., Inc., as the defendant.

Paxton alleges that Pfizer engaged in false, deceptive and misleading acts and practices by making unsupported claims about its COVID-19 vaccine in violation of the Texas Deceptive Trade Practices Act.

Because of Pfizers claims, placing their trust in Pfizer, hundreds of millions of Americans lined up to receive the vaccine, Paxtons 54-page brief states. Contrary to Pfizers public statements, however, the pandemic did not end; it got worse.

More Americans died in 2021, with Pfizers vaccine available, than in 2020, the first year of the pandemic. This, in spite of the fact that the vast majority of Americans received a COVID-19 vaccine, with most taking Pfizers."

Paxton's lawsuit adds: By the end of 2021, official government reports showed that in at least some places a greater percentage of the vaccinated were dying from COVID-19 than the unvaccinated. Pfizers vaccine plainly was not 95% effective.

By October 2022, the U.S. Centers for Disease Control and Prevention reported that roughly 226.6 million people were fully vaccinated after receiving one Johnson & Johnson dose or two doses of Pfizer-BioNTech and Moderna vaccines, the New York Times reported. Another more than 111 million people received additional booster shots at the time.

The complaint notes that Pfizers efficacy claim was based on a relative risk reduction metric used during its initial, two-month clinical trial. Such metrics, according to the U.S. Food and Drug Administration, are misleading and unduly influence[s] consumer choice.

It also states that Pfizers clinical trial failed to measure whether the vaccine protects against transmission; despite this, Pfizer embarked on a campaign to intimidate the public into getting the vaccine as a necessary measure to protect their loved ones.

When efficacy failed, Pfizer then pivoted to silencing truth-tellers, Paxton argues. The brief states, How did Pfizer respond when it became apparent that its vaccine was failing and the viability of its cash cow was threatened? By intimidating those spreading the truth, and by conspiring to censor its critics. Pfizer labeled as criminals those who spread facts about the vaccine. It accused them of spreading misinformation. And it coerced social media platforms to silence prominent truth-tellers.

The lawsuit follows an investigation Paxton launched into Pfizer, Moderna and Johnson & Johnson in May to determine if the companies engaged in gain-of-function research and misled the public about their practices. The investigation sought to determine if the companies misrepresented the efficacy of their COVID-19 vaccines and violated the Texas Deceptive Trade Practices Act. Investigators also looked into potential manipulation of vaccine trial data and the relative risk reduction method that was used instead of absolute risk reduction method.

Paxtons lawsuit stems from information it received after sending Civil Investigative Demands to the pharmaceutical giants.

The COVID-lockdown era was a deeply challenging time for Americans, Paxton said when launching the investigation. If any company illegally took advantage of consumers during this period or compromised peoples safety to increase their profits, they will be held responsible. If public health policy was developed on the basis of flawed or misleading research, the public must know. The catastrophic effects of the pandemic and subsequent interventions forced on our country and citizens deserve intense scrutiny, and we are pursuing any hint of wrongdoing to the fullest.

The federal government under former President Donald Trump entered into a $1.9 billion agreement with Pfizer, which was approved by the U.S. Food and Drug Administration on Dec. 11, 2020. Trump pushed the Pfizer-BioNTech COVID-19 vaccine through what he called Operation Warp Speed, making it available through Emergency Use Authorization as an experimental drug. Operation Warp Speed spent $12.4 billion on the vaccines, TIME reported.

As Pfizer declared its vaccine was 95% effective, on Dec. 17, 2020, Trump tweeted, "The Vaccine and the Vaccine rollout are getting the best of reviews. Moving along really well. Get those shots everyone!"

After he lost his reelection, at an RNC event at Mar-a-Lago in April 2021, Trump said everyone should refer to the COVID-19 vaccines as the "Trumpcine."

In a January 2022 interview, he said the vaccines saved tens of millions throughout the world. His former White House domestic policy advisor Joe Grogan also said Trump handed [President Joe] Biden three vaccines, TIME reported. Biden is just really making our COVID response look a lot better than the media gave us credit for.

Trump continues to take credit for the vaccines, arguing they are effective and saved lives.

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Texas AG sues Pfizer citing misrepresentation of COVID-19 vaccine efficacy - The Highland County Press

Texas

State attorney general Ken Paxton files suit despite medical consensus that vaccine prevents severe infection and death

The attorney general of Texas is suing the pharmaceutical company Pfizer, alleging that it exaggerated the effectiveness of its Covid-19 vaccine and deceived the public.

Ken Paxton announced the lawsuit on Thursday after filing it in Lubbock state district court in north-west Texas, the Texas Tribune reported.

Paxtons suit comes as a consensus of health experts and scientists have said that the vaccine prevents severe infection and death from Covid-19.

Paxton accused Pfizer of [engaging] in false, deceptive, and misleading acts and practices by making unsupported claims regarding the companys Covid-19 vaccine in violation of the Texas Deceptive Trade Practices Act, according to a press release shared to X, formerly known as Twitter.

Paxton argued that Pfizers claims about effectiveness implied that it would effectively end the Covid-19 pandemic, and that it failed to do so within a year of being introduced.

The lawsuit also added that claims the vaccine was 95% effective were not accurate, and that Covid-19 infection as well as death rates worsened as the vaccine became increasingly available.

Pfizer released results on the effectiveness of Covid in November 2020, finding that the shot was 95% effective in the first 28 days after receiving the vaccine.

The suit also claims that Pfizer [conspired] to silence those who were critical of the shot, common arguments made amid other anti-vaccine figures.

Paxtons suit asks that Pfizer be prohibited from making representations about the efficacy of its Covid-19 vaccine, the Hill reported.

The attorney general is also requesting $10,000 for every alleged violation by Pfizer, in addition to other financial restitution. The total civil penalties against Pfizer total up to more than $10m, according to Reuters.

In a statement, Pfizer said the states case has no merit, adding that the vaccine has been administered to 1.5 billion people and helped protect against severe Covid-19 outcomes, including hospitalization and death.

The representations made by the company about its Covid-19 vaccine have been accurate and science-based, it read.

The lawsuit is Paxtons second against Pfizer in November. The attorney general previously sued the pharmaceutical company and an additional supplier for allegedly altering quality-control tests on ADHD medication for children.

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Texas lawsuit claims Pfizer exaggerated effectiveness of Covid vaccine - The Guardian US

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FIRST ON FOX: The Biden administration worked together with employees of Google-owned YouTube in 2021 to target alleged "misinformation" relating to the COVID-19 virus and its vaccinations, according to documents obtained by FOX Business.

The documents, acquired through a source close to the House Judiciary Committee, reveal a level of correspondence previously unknown to the American public, as President Biden and his aides sought to promote coronavirus vaccinations in efforts to quell the raging pandemic.

The campaign was led by former White House Director of Digital Strategy Rob Flaherty, who has since left the administration to help run Bidens 2024 re-election campaign as a Deputy Campaign Manager.

Flaherty emailed Google team members in April 2021 to "connect [] about the work youre doing to combat vaccine hesitancy, but also crack down on vaccine misinformation," according to the documents.

Flaherty continued, asking for trends surrounding vaccine misinformation on the website, while offering government assistance in the form of COVID experts at the White House to partner in product work with YouTube.

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Google, in an internal email, noted that after a subsequent meeting with Flaherty, the White House staffer "particularly dug in on our decision making for borderline content" which is content that doesnt cross Community Guidelines but rather brushes up against it, according to YouTube.

A week later, Google acknowledged that it sent the White House the total amount of videos removed for COVID vaccine misinformation, while discussing the governments desire for even more data.

"Really [Flahertys] interested in what were seeing that is NOT coming down," read an internal Google email between employees, seemingly referring to videos that had not yet been removed.

The next day, YouTubes Government Affairs team emailed YouTubes Product team flagging the interactions with the White House.

The logos for Google and the Google-owned video streaming service YouTube are seen outside Google's Silicon Valley headquarters in Mountain View, California, on April 14, 2018. (Smith Collection/Gado/Getty Images / Getty Images)

"there is a very high degree of interest now coming from the White House now regarding vaccine misinfo/vaccine hesitancy and our work around borderline content," the internal email from YouTube read.

"Unfortunately, the role of tech in addressing vaccine hesitancy is about to come under a massive spotlight particularly as the supply of the vaccine is soon to outpace demand," the April 2021 correspondence added.

Then, the Government Affairs team asked if the Product team could brief the White House on YouTubes work to reduce borderline content.

"We were hoping to get something on the books in the next two weeks or so to prevent anything from potentially spiraling out of control," the email stated, stressing the urgency of the situation.

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A week later, an update was presented, with YouTubes Government Affairs team writing the Product team to inform them of the discussions between YouTube and the White House.

President Biden speaks about his domestic agenda from the East Room of the White House in Washington, D.C., on Oct. 28, 2021. (AP Photo/Susan Walsh / AP Newsroom)

"Over the last several weeks, the Google & YT GAAP team have had conversations with the White House staff on YouTubes policies and all the great work that is being done to raise authoritative information and fight harmful misinformation related to COVID-19 misinformation," the email stated.

The Government Affairs team then asked if the YouTube Product team could meet directly with White House staff to highlight their efforts, because "[White House] staff continue[d] to have questions on the raise/reduce efforts," related to supposed misinformation.

The email continued, imploring the Product team to meet with the White House as it could be beneficial for a future working relationship.

"we believe having the opportunity for you both to share more background would be hugely beneficial as we seek to work closely with this administration on multiple policy fronts," the Government Affairs team wrote.

Rep. Jim Jordan, R-Ohio, and chairman of the House Judiciary Committee, speaks during a hearing in Washington, D.C., on July 12. (Al Drago/Bloomberg via Getty Images / Getty Images)

The revelations of the documents between the White House and Google come roughly a year after the original Twitter Files were released, sparking a national debate about freedom of speech online.

Speaking on the interactions between YouTube and the Biden administration, House Judiciary Chairman Jim Jordan, R-Ohio, told FOX Business, "We knew the Biden White House worked to censor American speech with the help of Big Tech. Internal documents from Google obtained by the Judiciary Committee and Select Subcommittee show that their scheme extended to YouTube."

"The Committees will continue their critical investigative work to protect Americans' First Amendment rights and put an end to the vast government censorship enterprise," he added.

CLICK HERE TO READ MORE FROM FOX BUSINESS

Two of the journalists involved in the Twitter Files publication, Matt Taibbi and Michael Shellenberger, are set to appear Thursday before Jordans Select Subcommittee on the Weaponization of the Federal Government on Capitol Hill.

The hearing will "examine the federal government's involvement in social media censorship, as well as the recent attacks on independent journalism and free expression," a year after the original Twitter Files.

In a statement, a YouTube spokesperson told FOX Business of the Judiciary Committee findings, "While we receive input from governments around the world, we apply our policies independently, transparently, and consistently, regardless of the speaker or the political views expressed."

The White House was unable to be reached for comment by FOX Business.

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White House worked with YouTube to censor COVID-19 & vaccine 'misinformation': House Judiciary Committee - Fox Business

Novavaxs partner, SK bioscience,today announced that Novavaxs updated COVID-19 vaccine (NVX-CoV2601) has received Emergency Use Authorization from the Ministry of Food and Drug Safety in the Republic of Korea.Doses are available in market for use this vaccination season.InSouth Korea, SK bioscience and Novavax have a licensing agreement where SK bioscience has exclusive commercial rights to Novavaxs updated COVID-19 vaccine.

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Novavax's Updated COVID-19 Vaccine Receives Emergency Use Authorization in the Republic of Korea - Nov 29, 2023 - Novavax Investor Relations

A headline shared online falsely claims that Iceland has banned COVID-19 vaccines and cites sudden deaths for which there is no evidence, according to the Icelandic national health authority.

Iceland has not banned COVID vaccines and there are no soaring sudden deaths, Gurn Aspelund, chief epidemiologist at the Icelandic Directorate of Health, told Reuters in a Nov. 29 email.

Social media posts on platform X (archived), formerly Twitter, and on Facebook (archived) from Nov. 25, 2023, shared the headline from the Newsaddicts website, which in turn credits a Nov. 20 blog post as its source for saying the shots were banned.

However, no such announcement of a ban can be found on the Directorate of Health of Icelands website and no reliable independent news reporting supports the claim.

Iceland is currently using the newly updated vaccine Comirnaty XBB.1.5/Pfizer, Aspelund said, adding that COVID vaccination for 2023 fall/winter is recommended for those with medical indications, including all individuals 60 years of age and older, individuals 5 years and older with underlying conditions or as recommended by their physician, as well as healthcare workers.

The blog post suggesting that COVID vaccines were "removed" offers no evidence other than quoting (archived) a Nov. 17 Icelandic newspaper article, which the blog translates as saying: Next week, the public will be able to get an influenza vaccination at the health center, but not Covid vaccination at the moment.

In response to a request for comment sent by direct message, the blog post author said: "I don't know who makes the claim that Iceland is banning covid EUA countermeasures, in my substack article I described precisely what was announced in Iceland and provided clarifications made by my friend, the local journalist who called health officials."

In 2021, Iceland along with other Scandinavian countries temporarily discontinued giving some COVID vaccines to younger adults. But the Health Directorate said in a May 1, 2023, statement that two updated bivalent vaccines, Pfizer-BioNTech's Comirnaty and Moderna's Spikevax, will be available to adults for primary vaccinations.

As of Oct. 5, 80.5% of the population (archived) in Iceland has received the primary course, that is two doses of a COVID vaccine. The latest information on COVID and vaccination can be found in Icelandic and English online.

(Updated on Nov. 30 with comment in paragraph 7 from author of blog post)

VERDICT

False. Iceland has not banned COVID vaccines and vaccination is recommended for specific groups of the population.

This article was produced by the Reuters Fact Check team. Read more about our fact-checking work.

Our Standards: The Thomson Reuters Trust Principles.

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Fact Check: Iceland has not banned COVID vaccines - Reuters.com

Pfizer PFE.N has been sued by Texas Attorney General Ken Paxton, who on Thursday accused the drugmaker of misrepresenting the efficacy of its widely-used COVID-19 vaccine.

In a complaint filed in a Lubbock County state court, Paxton said it was misleading for Pfizer to claim its vaccine was 95% effective because it offered a relative risk reduction for people to who took it.

Paxton said the claim was based on only two months of clinical trial data, and that the pandemic got worse even after people started taking Pfizers vaccine.

Pfizer intentionally misrepresented the efficacy of its COVID-19 vaccine and censored persons who threatened to disseminate the truth in order to facilitate fast adoption of the product and expand its commercial opportunity, the complaint said.

Paxton, a Republican and critic of Biden administration efforts to fight the pandemic, added in a statement: We are pursuing justice for the people of Texas, many of whom were coerced by tyrannical vaccine mandates to take a defective product sold by lies.

Pfizer did not immediately respond to requests for comment.

The lawsuit seeks to stop New York-based Pfizer from making alleged false claims and silencing truthful speech about its vaccine, and more than $10 million in fines for violations of a Texas law protecting consumers from deceptive marketing.

It is Paxtons second lawsuit against Pfizer in November.

In a case unsealed on Nov. 21, Paxton accused Pfizer and a supplier of manipulating quality control tests, resulting in the distribution of ineffective drugs to treat attention deficit hyperactivity disorder in children.

(Reporting by Jonathan Stempel in New York; Editing by Chizu Nomiyama)

Topics Lawsuits Texas COVID-19

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Texas sues Pfizer, says company lied about efficacy of COVID vaccine - The Anniston Star

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Pirola, or BA.2.86, is the third most prevalent Covid strain in the U.S., and although there may be concerns the new monovalent vaccineswhich protect against the XBB lineage that Pirola isnt a part ofdont offer protection against Pirola and its subvariants, drugmakers and the CDC are sure the vaccines offer defense.

A hand with a medical syringe is seen in front of a text "Pirola BA.2.86 SARS-CoV-2" of a spreading ... [+] Covid-19 variant in the background.

Pirola made up 8.8% of cases as of November 25, almost triple the number of cases the variant made up during the previous two-week period ending on November 11, when Pirola wasnt even one of the top five most prevalent variants, according to data from the Centers for Disease Control and Prevention.

Its circulating the most in the Northeast, where its the second most common variant in the region (13%) after HV.1.

Pirola joined four other variants as variants of interest by the World Health Organization on Monday, a step up from its variant under monitoring label in August.

Both Pfizer-BioNTech and Novavax told Forbes their latest vaccines offer some protection from Pirola, and a September clinical trial from Moderna found its latest shot provided an 8.7-fold increase in protection.

The public health risk posed by this variant is low, according to the CDC, and updated vaccines are expected to increase protection against Pirola.

Some experts arent so sure Pirola and its offspringsmost notably JN.1will be very protected under the new vaccines. The authors of a bioRxiv study wrote in a pre-publication comment, which hasnt yet been peer reviewed, that the newer vaccines could spur the spread of the more recent Pirola viruses.

Its unknown whether Pirola causes different symptoms than other variants, according to the CDC. Pirola is a part of the Omicron family and is a highly mutated offshoot of its parent variant BA.2, which was the dominant strain in 2022 and made up 85% of cases in April 2022. JN.1, one of Pirolas mutations, has rapidly spread in other countries. It was first detected in the U.S. in September and has been found in at least 11 countries, according to the CDC.

18,119. Thats how many hospitalizations the U.S. saw the week of November 18, according to the CDC. This is up almost 9% from the previous week. There was an 8.3% increase in deaths506that same week.

HV.1 is the most prevalent Covid strain in the U.S., and made up 31.7% of cases as of November 25. It first took the lead in late October, knocking EG.5, or the Eris variant down to second place. Eris made up 13.1% of cases as of November 25 and is the ancestor of HV.1. Both variants are of the XBB lineage, so the new Covid vaccines offer protection against them. Though HV.1 is highly transmissible, theres no evidence that its more severe than other variants, Ross Kedl, professor of immunology and microbiology at University of Colorado Anschutz School of Medicine, told Health.

Because of the amount of cases it made up, Pirola was previously lumped together with other BA lineage variants on the CDCs variant tracker. It wasnt listed as a stand alone variant until the November 11 data was released.

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What To Know About Rapidly Spreading 'Pirola' Covid Variant BA.2.86And If Vaccines Offer Protection - Forbes

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