House votes to declassify info about origins of COVID-19
By LISA MASCARO
WASHINGTON (AP) — The House voted unanimously Friday to declassify U.S. intelligence information about the origins of COVID-19, a sweeping show of bipartisan support near the third anniversary of the start of the deadly pandemic.
The 419-0 vote was final congressional approval of the bill, sending it to President Joe Biden’s desk. It’s unclear whether the president will sign the measure into law, and the White House said the matter was under review. … If signed into law, the measure would require within 90 days the declassification of “any and all information relating to potential links between the Wuhan Institute of Virology and the origin of the Coronavirus Disease.”
That includes information about research and other activities at the lab and whether any researchers grew ill.
Almost all of America’s leaders have gradually pulled back their COVID mandates, requirements, and closures—even in states like California, which had imposed the most stringent and longest-lasting restrictions on the public. At the same time, the media has been gradually acknowledging the ongoing release of studies that totally refute the purported reasons behind those restrictions. This overt reversal is falsely portrayed as “learned” or “new evidence.” Little acknowledgement of error is to be found. We have seen no public apology for promulgating false information, or for the vilification and delegitimization of policy experts and medical scientists like myself who spoke out correctly about data, standard knowledge about viral infections and pandemics, and fundamental biology.
The historical record is critical. We have seen a macabre Orwellian attempt to rewrite history and to blame the failure of widespread lockdowns on the lockdowns’ critics, alongside absurd denials of officials’ own incessant demands for them. In the Trump administration, Dr. Deborah Birxwas formally in charge of the medical side of the White House’s coronavirus task force during the pandemic’s first year. In that capacity, she authored all written federal policy recommendations to governors and states and personally advised each state’s public health officials during official visits, often with Vice President Mike Pence, who oversaw the entire task force. Upon the inauguration of President Joe Biden, Dr. Anthony Fauci became chief medical advisor and ran the Biden pandemic response.
We must acknowledge the abject failure of the Birx-Fauci policies. They were enacted, but they failed to stop the dying, failed to stop the infection from spreading, and inflicted massive damage and destruction particularly on lower-income families and on America’s children.
More than 1 million American deaths have been attributed to that virus. Even after draconian measures, including school closures, stoppage of non-COVID medical care, business shutdowns, personal restrictions, and then the continuation of many restrictions and mandates in the presence of a vaccine, there was an undeniable failure—over two presidential administrations—to stop cases from rapidly escalating.
Numerous experts—including John Ioannidis, David Katz, and myself—called for targeted protection, a safer alternative to widespread lockdowns, in national media beginning in March of 2020. That proposal was rejected. History’s biggest public health policy failure came at the hands of those who recommended the lockdowns and those who implemented them, not those who advised otherwise.
WASHINGTON, DC – APRIL 09: White House coronavirus response coordinator Deborah Birx speaks as (L-R) National Institute of Allergy and Infectious Diseases Director Anthony Fauci, U.S. Vice President Mike Pence and Labor Secretary Eugene Scalia listen during the daily coronavirus briefing in the Brady Press Briefing Room at the White House on April 09, 2020 in Washington, DC. U.S. unemployment claims have approached 17 million over the past three weeks amid the COVID-19 pandemic. Alex Wong/Getty Images
The tragicfailure of reckless, unprecedented lockdowns that were contrary to established pandemic science, and the added massive harms of those policies on children, the elderly, and lower-income families, are indisputable and well-documented in numerousstudies. This was the biggest, the most tragic, and the most unethical breakdown of public health leadership in modern history.
In a democracy, indeed in any ethical and free society, the truth is essential. The American people need to hear the truth—the facts, free from the political distortions, misrepresentations, and censorship. The first step is to clearly state the harsh truth in the starkest possible terms. Lies were told. Those lies harmed the public. Those lies were directly contrary to the evidence, to decades of knowledge on viral pandemics, and to long-established fundamental biology.
Here are the 10 biggest falsehoods—known for years to be false, not recently learned or proven to be so—promoted by America’s public health leaders, elected and unelected officials, and now-discredited academics:
1. SARS-CoV-2 coronavirus has a far higher fatality rate than the flu by several orders of magnitude.
2. Everyone is at significant risk to die from this virus.
3. No one has any immunological protection, because this virus is completely new.
4. Asymptomatic people are major drivers of the spread.
5. Locking down—closing schools and businesses, confining people to their homes, stopping non-COVID medical care, and eliminating travel—will stop or eliminate the virus.
6. Masks will protect everyone and stop the spread.
7. The virus is known to be naturally occurring, and claiming it originated in a lab is a conspiracy theory.
8. Teachers are at especially high risk.
9. COVID vaccines stop the spread of the infection.
10. Immune protection only comes from a vaccine.
None of us are so naïve as to expect a direct apology from critics at my employer, Stanford University, or in government, academic public health, and the media. But to ensure that this never happens again, government leaders, power-driven officials, and influential academics and advisors often harboring conflicts of interest must be held accountable. Personally, I remain highly skeptical that any government investigation or commission can avoid politicization. Regardless of their intention, all such government-run inquiries will at least be perceived as politically motivated and their conclusions will be rejected outright by many. Those investigations must proceed, though, if only to seek the truth, to teach our children that truth matters, and to remember G.K. Chesterton’s critical lesson that “Right is right, even if nobody does it. Wrong is wrong, even if everybody is wrong about it.”
Scott W. Atlas, MD is the Robert Wesson Senior Fellow in health policy at Stanford University’s Hoover Institution, Co-Director of the Global Liberty Institute, Founding Fellow of Hillsdale’s Academy for Science & Freedom, and author of A Plague Upon Our House: My Fight at the Trump White House to Stop COVID from Destroying America (Bombardier Press, 2022).
The views expressed in this article are the writer’s own.
Former company employees who filed qui tam (whistleblower) suits were the most instrumental in bringing to light the evidence that resulted in the largest number of federal settlements over the past 10 years.
From 1991-2000 qui tam law suits accounted for only 9% of settlements with the government. But from 2001-2010, qui tam settlements comprised 67% of the billions in payouts.
The federal government levied the largest financial penalties for the illegal off-label promotion of drugs and state governments levied the largest penalties for deliberate overcharging of Medicaid–both crimes yielded pharmaceutical companies with huge profits. Public Citizen found that state Medicaid programs were paying as much as 12 times the actual cost of a drug.
Additional unlawful practices by pharmaceutical companies include: unlawful monopoly practices to extend patent pricing or collusion with other companies, kickbacks to providers, hospitals, doctors; concealing negative study findings; poor manufacturing practices and selling contaminated products; environmental violations; accounting or tax fraud and insider trading; illigal distribution of unapproved pharmaceutical products.
Thus, the size of the financial penalties levied paled when compared with the profits from illegal practices–which is why this industry has escalated its criminal marketing modus operandi.
We wholeheartedly agree with the assessment of Public Citizen: “Clearly, the continuing increase in violations by pharmaceutical compaines–despite the large financial settlements– demonstrates that the current enforcement system is not working. The lack of criminal prosecution that would result in jailing of company executives has been cited as a major reason for the continuing large-scale fraud, in addition to the fact that current settlement payouts may not be a sufficient deterrent.”
Adding insult to injury, who do you think is footing the cost of legal and settlement expenditures incurred by pharmaceutical companies? Just check the increased price of drugs and figure it out.
Finally, government suits against pharmaceutical companies have avoided charging or penalizing pharmaceutical companies for the severe harmful consequences suffered by consumers from illegal marketed harmful drugs. This failure to address the disabling adverse drug effects and drug-linked deahts resulting from illegal pharmaceutical activities contributes to the devaluation of human beings–thereby buttressing this industry’s disregard for the welfare of its customers.
Vera Hassner Sharav
Let’s start with the fact the PFDA (the P is not a typo) asked a federal court for 75 years to make public the many thousands of pages of data submitted to them by Pfizer to support the EUA they (the PFDA) issued.
One interpretation of this action is that they wanted the data to stay hidden for a long time to hide fraud and/or criminality (same thing). The other is that they only had enough staff to complete this task within 75 years. Let’s ignore the 2nd one as absurd on its face (especially since they seem to be pouring out documents monthly after the judge ordered them to). Where there is a will there is a way apparently.
Now why would they want to keep the data hidden? What lies within the realm of possibilities is that at the time they went to court, they knew the EUA and the resulting massive national and global vaccine campaign were pre-determined and independent of whatever “science” emerged to support or not support the campaign. Unfortunately for them, the “science” was not supportive. At all. So they tried to suppress the serious troubling toxicity and lack of efficacy data contained within those documents. Well the court ordered them to make public thousands of pages of documents each month. My hypothesis above seems to be validated by the uncovering of what is not just troubling, but absolutely terrifying data on the lack of safety in pregnancy. While Dr Naomi Wolf and the WarRoom/DailyClout Research Volunteers recently corrected a report that overcounted miscarriages in one section of the Pfizer documents, they are right to have early and often called attention to signals about this issue overall. Indeed in May 2022, they broke the story of another section of the Pfizer documents, in which the mortality rate of fetuses and babies of women vaccinated with Pfizer’s mRNA injection was about 80 per cent.
Now, let’s do a dive on just one page of the many thousands. See below, Section 5.3.6, Page 12 of the document called “Cumulative Analysis of Post-Authorization Adverse Event Reports.”
Looking at the first bullet under the header: Pregnancy cases: 274 cases including: In this paragraph, at first read, it is just a list of adverse events and numbers, detailed in a way that is confusing at best, and obfuscating at worst. I think it is the latter because, if you do some simple arithmetic trying to parse that paragraph, you end up with this:
270 pregnancies were reported in vaccinated women during the first 12 weeks of the vaccine campaign. In 238 of them, “no outcome was provided.” So, they only knew the outcome of 32 pregnancies reported. What happened in those 32 pregnancies they followed up on?
My hands are literally trembling as I write this, but here goes. In these 32 pregnancies, there were
A report by Public Citizen documents the enormous scale of pharmaceutical industry lawless activities during the past two decades–crimes that resulted in a minimum of $1 million in penalties paid to the government.
Between 1991-2010, there were 165 criminal and/or civil settlements by major pharmaceutical companies comprising of $19.8 billion in penalties.
Four of the world’s largest drug companies–GlaxoSmithKline, Pfizer, Eli Lilly, and Schering-Plough–accounted for 53% ($10.5 billion) of penalties during these two decades.
If that isn’t shocking enough, during the past five years, Big Pharma has been engaged in a veritable crime spree:
73% of these settlements (121) and 75% of the penalties ($14.8 billion) occurred between 2006-2010.
“While the defense industry used to be the biggest defrauder of the federal government under the False Claims Act (FCA), a law enacted in 1863 to prevent defense contractor fraud, the pharmaceutical industry has greatly overtaken the defense industry in recent years. The pharmaceutical industry now tops not only the defense industry, but all other industries in the total amount of fraud payments for actions taken against the federal government under the False Claims Act.”
Former company employees who filed qui tam (whistleblower) suits were the most instrumental in bringing to light the evidence that resulted in the largest number of federal settlements over the past 10 years.
From 1991-2000 qui tam law suits accounted for only 9% of settlements with the government. But from 2001-2010, qui tam settlements comprised 67% of the billions in payouts.
The federal government levied the largest financial penalties for the illegal off-label promotion of drugs and state governments levied the largest penalties for deliberate overcharging of Medicaid–both crimes yielded pharmaceutical companies with huge profits. Public Citizen found that state Medicaid programs were paying as much as 12 times the actual cost of a drug.
Additional unlawful practices by pharmaceutical companies include: unlawful monopoly practices to extend patent pricing or collusion with other companies, kickbacks to providers, hospitals, doctors; concealing negative study findings; poor manufacturing practices and selling contaminated products; environmental violations; accounting or tax fraud and insider trading; illigal distribution of unapproved pharmaceutical products.
Thus, the size of the financial penalties levied paled when compared with the profits from illegal practices–which is why this industry has escalated its criminal marketing modus operandi.
We wholeheartedly agree with the assessment of Public Citizen: “Clearly, the continuing increase in violations by pharmaceutical compaines–despite the large financial settlements– demonstrates that the current enforcement system is not working. The lack of criminal prosecution that would result in jailing of company executives has been cited as a major reason for the continuing large-scale fraud, in addition to the fact that current settlement payouts may not be a sufficient deterrent.”
Adding insult to injury, who do you think is footing the cost of legal and settlement expenditures incurred by pharmaceutical companies? Just check the increased price of drugs and figure it out.
Finally, government suits against pharmaceutical companies have avoided charging or penalizing pharmaceutical companies for the severe harmful consequences suffered by consumers from illegal marketed harmful drugs. This failure to address the disabling adverse drug effects and drug-linked deahts resulting from illegal pharmaceutical activities contributes to the devaluation of human beings–thereby buttressing this industry’s disregard for the welfare of its customers.
THE COVID CRIMINALS: The Pandemic was created and orchestrated fraudulently by a Global Criminal Organization led by Bill Gates, Fauci, Tedros, Drosten, Klaus Schwab, Rothschilds, Pfizer, BlackRock, …
— Read on
Pfizer CEO Albert Bourla has made “misleading” and unsubstantiated statements on the merit of giving COVID-19 vaccines to young children, according to a case report published by a UK pharmaceutical watchdog on Jan. 27.
During an interview with the BBC published on Dec. 2, 2021, Bourla was asked whether he believed it was likely that 5- to 11-year-olds in the UK and Europe would be vaccinated against COVID-19 and whether it was a good idea.
The interview was published after the U.S. Food and Drug Administration authorised the use of the Pfizer-BioNTech COVID-19 vaccine for young children, but the UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), didn’t approve the product for the same age group until Dec. 22, 2021.
While acknowledging that it was up to the UK authorities to decide whether or not to approve and deploy the vaccines, Bourla replied, “I believe it’s a very good idea.”
He cited disruptions in education and the potential of developing so-called long-COVID, saying, “so there is no doubt in my mind about the benefits completely are in favour of doing it.”
Syringes in front of displayed Biontech and Pfizer logos on Nov. 10, 2020. (Dado Ruvic/Illustration/Reuters)
Following complaints from UsForThem—a children’s welfare campaign group founded in response to the COVID-19 lockdowns—a panel from the Prescription Medicines Code of Practice Authority (PMCPA) ruled that Bourla’s statements breached a number of rules in the Association of the British Pharmaceutical Industry (ABPI) code of practice.
After Pfizer appealed against the ruling, an appeal board upheld five counts of breaches of three ABPI codes that require information and claims to be accurate, balanced, capable of substantiation, not raising unfounded hopes of successful treatment, and not be misleading with respect to the safety of the product.
The PMCPA described Bourla’s statements as being of a “strong unqualified nature.” It also said they inferred there was “no need to be concerned about potential side-effects of vaccination in healthy children aged 5-11” and that the implication was “misleading and incapable of substantiation.”
The PMCPA said it has received an undertaking from Pfizer to prevent similar breaches in the future.
Code breakers are charged for administrative costs, but the self-regulatory body does not have the power to impose fines or other legal sanctions.
Bourla was initially found to have also breached the code for promoting the Pfizer-BioNTech vaccine in the 5–11 age group when it was not authorised by the MHRA, but the appeal board overturned the ruling, agreeing with Pfizer that its CEO was asked a specific question and it was not unreasonable to talk about the issue in principle. The board also noted that two other COVID-19 vaccines were also under investigation for the age group.
The appeal board also overturned previous rulings that said Pfizer had failed to maintain high standards and brought discredit upon the industry.
Most Serious Rulings
Pfizer didn’t respond to The Epoch Times’ request for comment. In a previous statement to The Telegraph in November 2022, when the newspaper obtained the unpublished ruling, a spokesman for Pfizer said the company was “committed to the highest levels of integrity in any interaction with the public.”
“We are pleased the UK’s PMCPA Appeal Board found Pfizer to have maintained high standards and upheld confidence in our industry, the two most serious rulings in this complaint from a UK campaign group,” the statement reads.
“In the UK, we have always endeavoured to follow the principles and letter of our industry Code of Practice throughout. We will review the case report in detail when we receive it, to inform future activity,” it added.
Speaking to The Epoch Times on Tuesday, Ben Kingsley, head of legal affairs at UsForThem, said he was “thrilled” the regulator ultimately agreed with them that the Pfizer CEO’s statements were misleading and unsubstantiated after the pharmaceutical giant opposed their claims “with all of the resources at its disposal” throughout the process.
Commenting on Pfizer’s previous statement on the ruling, Kingsley said the group “found it quite surprising” that Pfizer would consider the rulings about maintaining high standards and upholding confidence in the industry the “most serious” of all.
“I think to the average member of the public, we’d regard misleading us about the safety of their product to be plenty more serious than bringing the repute of the pharmaceutical industry down,” he said.
“So I think it tells you something about the mindset and the priorities of pharma executives that they regard the abuse of the industry as being a more serious matter than misleading the public.”
(L-R) Professor Wei Shen Lim, chair of JCVI’s COVID-19 subcommittee; Professor Jonathan Van Tam, deputy chief medical officer for England; and Dr. June Raine, chief executive of the Medicines and Healthcare products Regulatory Agency, attend a media briefing at Downing Street Briefing Room in London on Nov. 29, 2021. (Stefan Rousseau/WPA Pool/Getty Images)
n June 2021, the UK government’s advisory body on vaccines, the Joint Committee on Vaccination and Immunisation (JCVI), declined to recommend COVID-19 vaccines for healthy children aged between 12 and 15, given the “marginal” benefits young teens would get from the vaccines and the lack of long-term data on the side-effects, including myocarditis.
But the vaccines were later offered to the age group after UK chief medical officers made a recommendation based on wider considerations, including the disruption to children’s education—attributed by some to COVID-19 and by others to the political decision to make children who test positive stay out of school.
The JCVI later recommended a one-off “non-urgent offer” to vaccinate 5- to 11-year-olds. The offer ended in August last year.
In is most recent recommendation, the JCVI said under–50s who are at lower risk of getting seriously ill with COVID-19 will soon be unable to get a booster shot. The offer of primary doses will also end for low-risk people in all age groups.
Resource of Article: Pfizer CEO Made ‘Misleading’ Statements on Vaccinating Children Against COVID-19: UK Watchdog
SearchHamburgerPfizer Signs Agreement to Provide the European Union with PAXLOVID™Wednesday, November 23, 2022 – 11:00amShare
• New agreement to supply up to 3.4 million treatment courses to countries across Europe; this deal supplements the courses provided to 17 EU member states under existing bilateral agreements • Deliveries to participating countries commencing imminently NEW YORK, November 23, 2022 — Pfizer Inc. (NYSE: PFE) today announced an agreement with the European Commission (EC) to supply its COVID-19 oral therapy, PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) to countries participating in the Joint Procurement Agreement across Europe. This agreement, negotiated with the Health Emergency Preparedness and Response Authority (HERA) of the EC, is in addition to the bilateral agreements Pfizer has previously signed with 17 EU Member States. This agreement will supply participating countries up to 3.4 million treatment courses upon orders being placed. Under the terms of the agreement, Pfizer will begin delivery of the initial treatment quantities ordered by the participating countries in November, in parallel to deliveries underway as part of existing bilateral agreements.“Clinical data and real-world evidence for PAXLOVID have shown that it can be an important tool in helping to reduce hospitalizations and deaths in those at increased risk of serious illness from COVID-19,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “As the region prepares for winter and a possible resurgence in COVID-19 infections, the accessibility and availability of treatment options is of the utmost importance. We are pleased to be working with the European Commission to make PAXLOVID available to more patients across Europe.”PAXLOVID is currently authorized for conditional or emergency use in more than 70 countries across the globe. Following the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize PAXLOVID, a conditional marketing authorization (CMA) for PAXLOVID was granted in January 2022 for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of the disease becoming severe. Europe plays a critical role in the delivery of PAXLOVID to patients across the globe, as the site of four of Pfizer’s key PAXLOVID manufacturing facilities.About PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) PAXLOVID is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV-2 3CL protease inhibitor) therapy. It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Nirmatrelvir [PF-07321332], which originated in Pfizer laboratories, is designed to block the activity of the Mpro, an enzyme that the coronavirus needs to replicate. Co-administration with a low dose of ritonavir helps slow the metabolism, or breakdown, of nirmatrelvir in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication. In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions.Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. PAXLOVID, however, works intracellularly by binding to the highly conserved Mpro (3CL protease) of the SARS-CoV-2 virus to inhibit viral replication. Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1, BA.2 and BA.4.PAXLOVID is generally administered at a dose of 300 mg (two 150 mg tablets) of nirmatrelvir with one 100 mg tablet of ritonavir, given twice-daily for five days. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.Our Commitment to Access Pfizer is committed to working toward equitable access to our oral COVID-19 treatment, PAXLOVID, for high-risk patients in need, aiming to deliver safe and effective oral treatment as soon as possible and at an affordable price. If authorized or approved, during the pandemic, Pfizer will offer its oral therapy through a tiered pricing approach based on the income level of each country to promote equity of access across the globe; high and upper-middle income countries will pay more than lower-income countries. Pfizer has established a comprehensive strategy in close partnership with worldwide governments, international global health leaders, including WHO’s Access to COVID-19 Tools Accelerator (ACT-A), and global manufacturers to optimize supply and access of PAXLOVID all around the world. This includes:
Multilateral Supply Agreements: Agreements in place with UNICEFfor the supply of up to 4 million treatment courses to 137 low- and middle-income countries and with Global Fund for up to 6 million treatment courses for supply to 132 Global-Fund grant-eligible countries, subject to regulatory approval or authorization.Expanding Access to Patent-Protected Medicines in Lower-Income Countries: Launched An Accord for a Healthier World, a first-of-its-kind initiative to enable sustained, equitable access to high-quality medicines and vaccines for 1.2 billion people living in lower-income countries. Pfizer has committed to provide its patent-protected medicines and vaccines available in the U.S. or European Union, including PAXLOVID, on a not-for-profit basis to 45 lower-income countries around the world and will collaborate with government and global health leaders to address barriers that limit access beyond supply, like diagnosis, education, infrastructure, storage and more.Accelerating Testing and Treatment: Joined the COVID Treatment Quick Start Consortium, a joint initiative implemented by Duke University, the Clinton Health Access Initiative (CHAI), COVID Collaborative and Americares with support from Pfizer, Open Society Foundations and the Conrad Hilton Foundation. Pfizer will provide treatment courses of PAXLOVID, as well as financial support, to support the Consortium’s efforts to accelerate COVID-19 testing and improve access to treatments in under-resourced parts of the world. The consortium has launched test and treat initiatives in partnership with ten countries in Africa and Southeast Asia. Humanitarian Treatment Donation: As part of its humanitarian response, Pfizer donated 200K treatment courses of PAXLOVID to Ukraine.Voluntary Licensing: Signed a voluntary license agreement with Medicines Patent Pool (MPP) to enable the development and distribution of generic versions of Pfizer’s oral treatment to further expand long-term global supply and access. MPP has signed sublicense agreements with 38 manufacturers, who will supply the generic versions in 95 low- and lower-middle-income countries.
U.S. FDA Emergency Use Authorization Statement PAXLOVID has not been approved, but has been authorized for emergency use by FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS CoV-2 viral testing, and who are at high-risk for progression to severe COVID-19, including hospitalization or death. The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.AUTHORIZED USE The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product PAXLOVID for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.LIMITATIONS OF AUTHORIZED USE
PAXLOVID is not authorized for initiation of treatment in patients requiring hospitalization due to severe or critical COVID-19PAXLOVID is not authorized for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19PAXLOVID is not authorized for use for longer than 5 consecutive days
PAXLOVID may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs.
PAXLOVID may also be prescribed for an individual patient by a state-licensed pharmacist under the following conditions:
Sufficient information is available, such as through access to health records less than 12 months old or consultation with a health care provider in an established provider‑patient relationship with the individual patient, to assess renal and hepatic function; and Sufficient information is available, such as through access to health records, patient reporting of medical history, or consultation with a health care provider in an established provider‑patient relationship with the individual patient, to obtain a comprehensive list of medications (prescribed and non-prescribed) that the patient is taking to assess for potential drug interaction.
The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., telehealth, in-person visit) with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs, if any of the following apply:
Sufficient information is not available to assess renal and hepatic function.Sufficient information is not available to assess for a potential drug interaction.Modification of other medications is needed due to a potential drug interaction.PAXLOVID is not an appropriate therapeutic option based on the authorized Fact Sheet for Healthcare Providers or due to potential drug interactions for which recommended monitoring would not be feasible.
PAXLOVID is not approved for any use, including for use for the treatment of COVID-19.
PAXLOVID is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PAXLOVID under 564(b)(1) of the Food Drug and Cosmetic Act unless the authorization is terminated or revoked sooner.IMPORTANT SAFETY INFORMATION PAXLOVID is contraindicated in patients with a history of clinically significant hypersensitivity reactions (eg, toxic epidermal necrolysis [TEN] or Stevens-Johnson syndrome) to its active ingredients (nirmatrelvir or ritonavir) or any other components of the product. Drugs listed in this section are a guide and not considered a comprehensive list of all drugs that may be contraindicated with PAXLOVID. The healthcare provider should consult other appropriate resources such as the prescribing information for the interacting drug for comprehensive information on dosing or monitoring with concomitant use of a strong CYP3A inhibitor such as ritonavir. PAXLOVID is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions:
PAXLOVID is contraindicated with drugs that are potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance. PAXLOVID cannot be started immediately after discontinuation of any of the following medications due to the delayed offset of the recently discontinued CYP3A inducer:
There are limited clinical data available for PAXLOVID. Serious and unexpected adverse events may occur that have not been previously reported with PAXLOVID use. Risk of Serious Adverse Reactions Due to Drug Interactions: Initiation of PAXLOVID, a CYP3A inhibitor, in patients receiving medications metabolized by CYP3A or initiation of medications metabolized by CYP3A in patients already receiving PAXLOVID, may increase plasma concentrations of medications metabolized by CYP3A. Initiation of medications that inhibit or induce CYP3A may increase or decrease concentrations of PAXLOVID, respectively. These interactions may lead to:
Clinically significant adverse reactions, potentially leading to severe, life-threatening, or fatal events from greater exposures of concomitant medicationsClinically significant adverse reactions from greater exposures of PAXLOVIDLoss of therapeutic effect of PAXLOVID and possible development of viral resistance
Consult Table 1 of the Fact Sheet for Healthcare Providers for clinically significant drug interactions, including contraindicated drugs. Drugs listed in Table 1 are a guide and not considered a comprehensive list of all possible drugs that may interact with PAXLOVID. Consider the potential for drug interactions prior to and during PAXLOVID therapy; review concomitant medications during PAXLOVID therapy and monitor for the adverse reactions associated with the concomitant medications.Anaphylaxis and other hypersensitivity reactions have been reported with PAXLOVID. Cases of Toxic Epidermal Necrolysis and Stevens-Johnson syndrome have been reported with ritonavir, a component of PAXLOVID (refer to NORVIR prescribing information). If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue PAXLOVID and initiate appropriate medications and/or supportive care.Hepatotoxicity: Hepatic transaminase elevations, clinical hepatitis, and jaundice have occurred in patients receiving ritonavir. Therefore, caution should be exercised when administering PAXLOVID to patients with pre-existing liver diseases, liver enzyme abnormalities, or hepatitis. Because nirmatrelvir is co-administered with ritonavir, there may be a risk of HIV-1 developing resistance to HIV protease inhibitors in individuals with uncontrolled or undiagnosed HIV-1 infection.Adverse events in the PAXLOVID group (≥1%) that occurred at a greater frequency (≥5 subject difference) than in the placebo group were dysgeusia (6% and
Pfizer and Clear Creek collaborate on SARS-CoV-2 PLpro inhibitors for COVID-19
Microscope and coronavirus illustration
Dec. 7, 2022
Pfizer Inc. and Clear Creek Bio Inc. have entered into a research collaboration and exclusive license agreement to advance the discovery and development of potential inhibitors of the SARS-CoV-2 papain-like protease (PLpro) for the oral treatment of COVID-19. PLpro is an essential enzyme, which, along with the main protease (Mpro), plays an important role in viral replication. Under the agreement, the two companies will work together to identify a PLpro candidate to progress into the clinic, at which time Pfizer will be solely responsible for further development and commercialization activities. Clear Creek Bio will receive an undisclosed upfront payment and will be eligible to receive additional potential milestone payments plus royalties on future product sales (Pfizer News Release).
The Trailblazing Patriot 