CHD Sues CDC to Obtain Documents on COVID Vaccine Injuries and Deaths Reported in VAERS
Children’s Health Defense today filed a federal lawsuit against the Centers for Disease Control and Prevention to obtain documents related to the agency’s safety monitoring of COVID-19 vaccines through the Vaccine Adverse Event Reporting System database.By
Brenda Baletti, Ph.D.Children’s Health Defense (CHD) today filed a lawsuit in U.S. District Court for the District of Columbia against the Centers for Disease Control and Prevention (CDC) to obtain documents related to the agency’s safety monitoring of the COVID-19 vaccines through the Vaccine Adverse Event Reporting System (VAERS) database.
The lawsuit alleges the CDC violated provisions of the Freedom of Information Act (FOIA) by failing to respond to CHD’s FOIA requests to provide key analysis of reports in the vaccine safety database and intra- and inter-agency communications about those reports.
CHD submitted the FOIA requests in the summer of 2022.
The agency said the requested information would be forthcoming by December of last year, but the documents were never delivered.
CHD is asking the court to compel the release of the requested documents in compliance with the FOIA.
Mary Holland, CHD president and general counsel, explained the significance of the lawsuit to The Defender:
“The CDC continues to ask the American public to believe that COVID shots are safe, without providing the evidence. Our lawsuit demands that the CDC give us hard data to back up its claim. No one should take vaccine safety on faith.”
CDC analysis of VAERS data
The CDC and the U.S. Food and Drug Administration (FDA) jointly administer VAERS, a database that allows healthcare professionals and others to file reports about vaccine-related injuries.
While VAERS reports of adverse events don’t prove causality, the CDC considers VAERS to be a key “early warning system” for detecting unusual or unexpected patterns of adverse event reporting that can signal safety problems with a vaccine.
According to the co-sponsored VAERS “Standard Operating Procedures” (SOP) for COVID-19, dated Jan. 29, 2021, the CDC and the FDA would coordinate monitoring for “potential new safety concerns for COVID-19 vaccines” by performing routine VAERS surveillance.
Each agency would use a different standard approach to data mining to screen for potential safety signals.
The CDC would run proportional reporting ratio (PRR) data mining on a weekly basis, or as needed. PRR would compare the reports of specific adverse events suffered after receiving a Moderna or Pfizer mRNA vaccine to reports made after receiving any other vaccine to see if there is an indication that the COVID-19 mRNA vaccines cause more adverse events than vaccines generally considered by the CDC to be safe.
The SOP stipulated that the FDA would conduct a bi-weekly thorough manual review of serious adverse events and through empirical Bayesian (EB) data mining, which uses a different statistical method to compare adverse events related to the COVID-19 vaccine with those related to non-COVID-19 vaccines in order to identify safety signals.
According to the CDC, if these forms of data mining raise a safety signal, then the agencies would do further analysis to confirm whether the adverse event was caused by the vaccine and that data would be shared with the public.
Both agencies failed to make data public.
Last month CHD filed a federal lawsuit against the FDA to obtain documents related to its empirical Bayesian data mining, The Defender Reported.
In today’s case, CHD made two requests.
The first request sought the records of all PRR conducted by the CDC related to COVID-19 from Oct. 1, 2021, to the present, along with all communications within the CDC and with the FDA about the PRR results and follow-up investigations required by the SOP done in connection with those results.
The second request sought the daily email alerts from VAERS contractors hired by the CDC listing identification numbers for all adverse events of special interest, which are events requiring further investigation.
CDC’s conflicting statements about its VAERS monitoring
Since last year, the CDC has issued a series of conflicting statements to The Epoch Times and CHD regarding their ongoing monitoring of the VAERS database.
In June 2022, the CDC told CHD that “no PRRs were conducted by the CDC” and that data mining was outside of the agency’s purview.
This was despite the fact that the SOP document dated Jan. 29, 2021, stipulated the CDC and FDA would begin ongoing data mining analysis then.
Next, in July 2021, the CDC told The Epoch Times that it had in fact been performing PRRs since January 2021 and was continuing to do so.
Two months later, the CDC changed its story again. This time it told The Epoch Times that it performed PRR analysis for a four-month period, from March 25, 2022, to July 31, 2022.
March 25, 2022, was three days after CHD emailed the CDC reminding them of their pending FOIA requesting the PRR analysis.
At that time, the CDC also said that its PRR results were “generally consistent” with the empirical Bayesian mining the SOP indicated would be done by the FDA and that it had not revealed any unexpected safety signals.
“Given it is a more robust data mining technique, CDC will continue relying upon EB data mining at this time,” the CDC spokesperson told The Epoch Times.
In January 2023, The Epoch Times reported that the CDC provided it with some of the PRR analysis it conducted between March and July 2022. The CDC shared an overall PRR analysis of all events reported from Dec. 14, 2020, to July 29, 2022.
But, it only shared its weekly analysis from three weeks — the weeks of July 15, 22, and 29, 2022. It is unclear whether the CDC did analysis during other weeks, or whether it never did the ongoing analysis mandated by the SOP.
That analysis revealed hundreds of safety signals, including signals for serious conditions such as blood clotting in the lungs, intermenstrual bleeding, lack of oxygen to the heart and even death.
The CDC admitted it gave false information about COVID-19 vaccine surveillance, including inaccurately saying it had conducted a certain type of analysis more than a year before it actually did.
Yet, given its conflicting statements, what surveillance analysis the CDC actually did, and when it did it, remains unclear. Access to this information would reveal when the CDC knew about safety signals related to the COVID-19 vaccine.
CHD’s FOIA request seeks all of these documents in order to clarify this timeline.
CDC anticipated spike in VAERS reports with COVID vaccine
Despite the fact that health officials and scientific journals have downplayed or dismissed the importance of VAERS during the pandemic, the CDC states in the SOP that it is a key “front-line system to monitor the safety of vaccines licensed for use in the United States.”
Information revealed through FOIA requests demonstrates that the CDC was anticipating a spike in VAERS reporting when the new vaccines were released and spent millions of dollars hiring contractors to process the data. Communication with these contractors is part of CHD’s FOIA lawsuit.
A FOIA request revealed, in late August 2020, that the CDC contracted with General Dynamics to handle VAERS reports for COVID-19 vaccines. The contract anticipated up to 1,000 reports per day, with up to 40% of them serious in nature, Josh Guetzkow reported. The value of the year-long contract was $9.45 million.
“This means that months before the EUA [emergency use authorization] of any COVID vaccines, the CDC anticipated up to a 600% increase over the average annual number of VAERS reports in recent years with 8 times the rate of serious reports,” Guetzkow said in his report.
In March 2021 the contract was amended to process backlogged reports filed through Feb. 28 for an additional $21.5 million. The CDC also contracted Eagle Health Analytics to assist with the processing for an additional $6 million.
Although other financial information about the dollar amounts associated with the contracts was redacted, Guetzkow estimated that the CDC paid contractors at least $40 million over two years to process VAERS data.
Every Friday, VAERS publishes vaccine injury reports received as of a specified date. Reports submitted to VAERS require further investigation before a causal relationship can be confirmed. Historically, VAERS has been shown to report only 1% of actual vaccine adverse events.
As of Feb. 3, 2023, a total of 1,517,779 reports of adverse events following COVID-19 vaccines were submitted between Dec. 14, 2020, and Feb. 3, 2023, to VAERS.
The data included a total of 34,270 reports of deaths and 279,669 serious injuries, including deaths, during the same time period.
There were a total of 21,954 reports of adverse events following the new COVID-19 bivalent booster as of Oct. 21, 2022. The data included a total of 173 deaths and 1,458 serious injuries. As of Feb. 8, 52.5 million people have received the updated bivalent booster dose.
Of the 31,696 reported deaths, 21,479 cases are attributed to Pfizer’s COVID-19 vaccine, 9,638 cases to Moderna’s, 2,944 cases to Johnson & Johnson’s (Janssen) and no cases yet reported for Novavax.
— Read on childrenshealthdefense.org/defender/chd-lawsuit-cdc-covid-vaccine-vaers/
Tag: FDA
Gilead Issues A Voluntary Nationwide Recall of Two Lots of Veklury® (Remdesivir) Due to Presence of Glass Particulates
COMPANY ANNOUNCEMENT
Gilead Issues A Voluntary Nationwide Recall of Two Lots of Veklury® (Remdesivir) Due to Presence of Glass Particulates
This recall has been completed and FDA has terminated this recall.
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company’s announcement as a public service. FDA does not endorse either the product or the company.
Summary
Company Announcement
Date:December 03, 2021
FDA Publish Date:December 03, 2021
Product Type: Drugs
Reason for Announcement: Presence of glass particulates
Company Name: Gilead Sciences Inc.
Brand Name: Veklury
GileadProduct Description: Veklury® (remdesivir 100 mg for injection)
Company Announcement
Foster City, CA, Gilead Sciences Inc. (Nasdaq: GILD) today announced it is voluntarily recalling two lots of Veklury® (remdesivir 100 mg for injection) to the user level. Gilead Sciences Inc. received a customer complaint, confirmed by the firm’s investigation, of the presence of glass particulates.
Risk Statement: The administration of an injectable product that contains glass particulates may result in local irritation or swelling in response to the foreign material. If the glass particulate reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. To date, Gilead Sciences Inc. has not received any reports of adverse events related to this recall.
Veklury is indicated for the treatment of adults and pediatric patients ≥ 12 years old and weighing ≥40 kg requiring hospitalization for COVID-19. The lyophilized form of Veklury (remdesivir 100 mg for injection) is distributed in single dose clear glass vials in powder form and reconstituted at the site of use. Veklury lots 2141001-1A and 2141002-1A were distributed nationwide in the United States, beginning October 2021. NDC, lot, expiration date and distribution dates can be found in the table below.Product DescriptionNDCLot #Expiration DateDistribution date to wholesalersVeklury® (remdesivir 100mg for injection) 61958-2901-022141001-1A
2141002-1A01/2024
01/202410/25/21-10/26/2021
10/26/21-11/02/2021
Gilead is notifying its distributors and customers via UPS next day air mail to hospital pharmacies and is facilitating the return of any remaining vials from the affected lots. Hospitals that have Veklury which is being recalled should stop using the affected lots and return the product vials per the instructions.
Consumers with questions regarding this recall can contact Gilead Medical Information at 1-866-633-4474 Monday to Friday 6am – 4pm PST or through their website at http://www.askgileadmedical.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Company Contact Information
Consumers: Gilead Medical Information 1-866-633-4474
Product Photos
- Content current as of:12/03/2021
- Regulated Product(s)
- Drug
- VEKLURY Brand Name for REMDESIVIR
INDICATION:
VEKLURY is indicated for the treatment of COVID-19 in adults and pediatric patients (≥28 days old and weighing ≥3 kg) with positive results of SARS-CoV-2 viral testing, who are:
- Hospitalized, or
- Not hospitalized, have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.
CONTRAINDICATIONS:
VEKLURY is contraindicated in patients with a history of clinically significant hypersensitivity reactions to VEKLURY or any of its components
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use VEKLURY safely and effectively. See full prescribing information for VEKLURY.
VEKLURY® (remdesivir) for injection, for intravenous use VEKLURY® (remdesivir) injection, for intravenous use Initial U.S. Approval: 2020
—————————
RECENT MAJOR CHANGES————————–
Indications and Usage (1) 12/2022 Dosage and Administration
Dosage and Administration Overview (2.1) 04/2022 Recommended Dosage in Adults and Pediatric Patients 28
Days of Age and Older and Weighing at Least 3 kg (2.3) 04/2022 Dosage Preparation and Administration in Adults and Pediatric
• • • •
o For non-hospitalized patients diagnosed with mild-to-moderate COVID-19 who are at high risk for progression to severe COVID- 19, including hospitalization or death, the recommended total treatment duration is 3 days (2.3).
Renal impairment: VEKLURY is not recommended in patients with eGFR less than 30 mL/min. (2.4)
Administer VEKLURY via intravenous (IV) infusion over 30 to 120 minutes. (2.5, 2.6)
Dose preparation and administration: Refer to the full prescribing information for further details for both formulations. (2.5, 2.6) Storage of prepared dosages: VEKLURY contains no preservative. (2.7)
Patients Weighing At Least 40 kg (2.5)
Dosage Preparation and Administration in Pediatric Patients 28 Days of Age and Older and Weighing 3 kg to Less
Than 40 kg (2.6)
Warnings and Precautions, Hypersensitivity Including Infusion-related and Anaphylactic Reactions (5.1)
04/2022
04/2022 01/2022
———————-
DOSAGE FORMS AND STRENGTHS ———————-
• For injection: 100 mg of remdesivir as a lyophilized powder, in a single-dose vial. (3)
• Injection: 100 mg/20 mL (5 mg/mL) remdesivir, in a single-dose vial. (3)
——————————–
CONTRAINDICATIONS ——————————
VEKLURY is contraindicated in patients with a history of clinically significant hypersensitivity reactions to VEKLURY or any components of the product. (4)
—————————
WARNINGS AND PRECAUTIONS-—————-
• Hypersensitivity including infusion-related and anaphylactic reactions: Hypersensitivity reactions have been observed during and following administration of VEKLURY. Slower infusion rates, with a maximum infusion time of up to 120 minutes, can be considered to potentially prevent signs and symptoms of hypersensitivity. Monitor patients during infusion and observe patients for at least one hour after infusion is complete for signs and symptoms of hypersensitivity as clinically appropriate. If signs and symptoms of a clinically significant hypersensitivity reaction occur, immediately discontinue administration of VEKLURY and initiate appropriate treatment. (5.1)
• Increased risk of transaminase elevations: Transaminase elevations have been observed in healthy volunteers and have also been reported in patients with COVID-19 who received VEKLURY. Perform hepatic laboratory testing in all patients before starting VEKLURY and while receiving VEKLURY as clinically appropriate. Consider discontinuing VEKLURY if ALT levels increase to greater than 10 times the upper limit of normal. Discontinue VEKLURY if ALT elevation is accompanied by signs or symptoms of liver inflammation. (5.2)
• Risk of reduced antiviral activity when coadministered with chloroquine phosphate or hydroxychloroquine sulfate: Coadministration of VEKLURY and chloroquine phosphate or hydroxychloroquine sulfate is not recommended based on data from cell culture experiments demonstrating a potential antagonistic effect of chloroquine on the intracellular metabolic activation and antiviral activity of VEKLURY. (5.3)
——————————–
ADVERSE REACTIONS
The most common adverse reactions (incidence greater than or equal to 5%, all grades) observed with treatment with VEKLURY are nausea, ALT increased, and AST increased. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 12/2022
INDICATIONS AND USAGE
VEKLURY is a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleotide analog RNA polymerase inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (28 days of age and older and weighing at least 3 kg) who are:
• Hospitalized, or
• Not hospitalized and have mild-to-moderate COVID-19, and are at
high risk for progression to severe COVID-19, including hospitalization or death. (1)
————————
DOSAGE AND ADMINISTRATION
• The only approved dosage form of VEKLURY for pediatric patients weighing 3 kg to less than 40 kg is VEKLURY for injection (supplied as 100 mg lyophilized powder in vial). (2.1)
• Testing: In all patients, before starting VEKLURY and during treatment as clinically appropriate, perform renal and hepatic laboratory testing. Assess prothrombin time before starting VEKLURY and monitor as clinically appropriate. (2.2)
Recommended dosage:
*Adults and pediatric patients weighing at least 40 kg: a single loading dose of VEKLURY 200 mg on Day 1 followed by once- daily maintenance doses of VEKLURY 100 mg from Day 2 via intravenous infusion. (2.3)
*Pediatric patients 28 days of age and older and weighing 3 kg to less than 40 kg: a single loading dose of VEKLURY 5 mg/kg on Day 1 followed by once-daily maintenance doses of VEKLURY 2.5 mg/kg from Day 2 via intravenous infusion. (2.3)
• Hospitalized patients: The treatment course of VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID- 19 has been made. (2.3)
o For hospitalized patients requiring invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 10 days. (2.3)
*For hospitalized patients not requiring invasive mechanical ventilation and/or ECMO, the recommended treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days. (2.3)
• Non-hospitalized patients: The treatment course of VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19 has been made and within 7 days of symptom onset. (2.3) 1
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosage and Administration Overview
2.2 Testing Before Starting and During Treatment with VEKLURY
2.3 Recommended Dosage in Adults and Pediatric Patients 28
Days of Age and Older and Weighing at Least 3 kg
2.4 Renal Impairment
2.5 Dosage Preparation and Administration in Adults and Pediatric Patients Weighing at Least 40 kg
2.6 Dosage Preparation and Administration in Pediatric Patients 28 Days of Age and Older and Weighing 3 kg to Less Than 40 kg
2.7 Storage of Prepared Dosages
3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Including Infusion-related and Anaphylactic Reactions
5.2 Increased Risk of Transaminase Elevations
5.3 Risk of Reduced Antiviral Activity When Coadministered with
Chloroquine Phosphate or Hydroxychloroquine Sulfate
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 12.4 Microbiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Description of Clinical Trials
14.2 NIAID ACTT-1 Study in Hospitalized Subjects with
Mild/Moderate and Severe COVID-19
14.3 Study GS-US-540-5773 in Hospitalized Subjects with Severe
COVID-19
14.4 Study GS-US-540-5774 in Hospitalized Subjects with
Moderate COVID-19
14.5 Study GS-US-540-9012 in Non Hospitalized Subjects with Mild-to-Moderate COVID-19 and at High Risk for Progression to Severe Disease
14.6 Study GS-US-540-5823 in Hospitalized Pediatric Subjects
with COVID-19
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
- Sections or subsections omitted from the full prescribing
information are not listed.
FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE
VEKLURY is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (28 days of age and older and weighing at least 3 kg) who are [see Clinical Studies (14)]:
2 2.1 •
• •
•
2.2
• Hospitalized, or
• Not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.
DOSAGE AND ADMINISTRATION Dosage and Administration Overview
VEKLURY may only be administered in settings in which healthcare providers have immediate access to medications to treat a severe infusion or hypersensitivity reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary [see Dosage and Administration (2.5, 2.6),
Warnings and Precautions (5.1)].
Administer VEKLURY for the treatment of COVID-19 in adults and pediatric patients (28 days of age and older and weighing at least 3 kg) by intravenous infusion only. Do not administer by any other route.
There are TWO different formulations of VEKLURY:
o VEKLURY for injection (supplied as 100 mg lyophilized powder in vial) must be reconstituted with Sterile Water for Injection prior to diluting with 0.9% sodium chloride injection.
▪ The only approved dosage form of VEKLURY for pediatric patients weighing 3 kg to less than 40 kg is VEKLURY for injection (supplied as 100 mg lyophilized powder in vial).
o VEKLURY injection (supplied as 100 mg/20 mL [5 mg/mL] solution in vial) must be further diluted in 250 mL of 0.9% sodium chloride injection infusion bag.
There are differences in the way the two formulations are prepared. Carefully follow the product- specific preparation instructions below [see Dosage and Administration (2.5, 2.6)].
Testing Before Starting and During Treatment with VEKLURY
—-Testing Before Starting and During Treatment with VEKLURY
Determine eGFR in all patients before starting VEKLURY and monitor while receiving VEKLURY as clinically appropriate [see Dosage and Administration (2.4) and Use in Specific Populations (8.4, 8.6)].
—Perform hepatic laboratory testing in all patients before starting VEKLURY and while receiving VEKLURY as clinically appropriate [see Warnings and Precautions (5.2) and Use in Specific Populations (8.7)].
—-Determine prothrombin time in all patients before starting VEKLURY and monitor while receiving VEKLURY as clinically appropriate [see Adverse Reactions (6.1)].
3
2.3
• •
Recommended Dosage in Adults and Pediatric Patients 28 Days of Age and Older and Weighing at Least 3 kg
The recommended dosage for adults and pediatric patients weighing at least 40 kg is a single loading dose of VEKLURY 200 mg on Day 1 via intravenous infusion followed by once-daily maintenance doses of VEKLURY 100 mg from Day 2 via intravenous infusion.
The recommended dosage for pediatric patients 28 days of age and older and weighing 3 kg to less than 40 kg is a single loading dose of VEKLURY 5 mg/kg on Day 1 via intravenous infusion followed by once-daily maintenance doses of VEKLURY 2.5 mg/kg from Day 2 via intravenous infusion.
Hospitalized patients:
The treatment course of VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19 has been made.
• The recommended total treatment duration for hospitalized patients requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) is 10 days.
• The recommended treatment duration for hospitalized patients not requiring invasive mechanical ventilation and/or ECMO is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days.
Non-hospitalized patients:
The treatment course of VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19 has been made and within 7 days of symptom onset.
• The recommended total treatment duration for non-hospitalized patients diagnosed with mild-to- moderate COVID-19 who are at high risk for progression to severe COVID-19, including hospitalization or death, is 3 days.
VEKLURY must be diluted prior to intravenous infusion. Refer to Dosage and Administration (2.5, 2.6) for detailed preparation and administration instructions.
2.4 Renal Impairment
VEKLURY is not recommended in patients with eGFR less than 30 mL per minute [see Dosage and Administration (2.2) and Use in Specific Populations (8.4, 8.6)].
2.5 Dosage Preparation and Administration in Adults and Pediatric Patients Weighing at Least 40 kg
There are differences in the way the two formulations are prepared. Carefully follow the product-specific preparation instructions below.
4
VEKLURY for Injection (Supplied as 100 mg Lyophilized Powder in Vial)
Reconstitution Instructions
Remove the required number of single-dose vial(s) from storage. For each vial:
• Aseptically reconstitute VEKLURY lyophilized powder by adding 19 mL of Sterile Water for Injection using a suitably sized syringe and needle per vial.
• Only use Sterile Water for Injection to reconstitute VEKLURY lyophilized powder.
• Discard the vial if a vacuum does not pull the Sterile Water for Injection into the vial.
• Immediately shake the vial for 30 seconds.
• Allow the contents of the vial to settle for 2 to 3 minutes. A clear, colorless to yellow solution, free
of visible particles, should result.
• If the contents of the vial are not completely dissolved, shake the vial again for 30 seconds and
allow the contents to settle for 2 to 3 minutes. Repeat this procedure as necessary until the contents of the vial are completely dissolved. Discard the vial if the contents are not completely dissolved.
• Following reconstitution, each vial contains 100 mg/20 mL (5 mg/mL) of remdesivir solution.
• Use reconstituted product immediately to prepare the diluted drug product [see Dosage and
Administration (2.7)].
Dilution Instructions
Care should be taken during admixture to prevent inadvertent microbial contamination. As there is no preservative or bacteriostatic agent present in this product, aseptic technique must be used in preparation of the final parenteral solution. It is always recommended to administer intravenous medication immediately after preparation when possible.
• Reconstituted VEKLURY for injection, containing 100 mg/20 mL remdesivir solution, must be further diluted in either a 100 mL or 250 mL 0.9% sodium chloride injection infusion bag. Refer to Table 1 for instructions.
CDC and FDA ‘altered’ Covid guidance and even ‘suppressed’ findings while under political pressure, bombshell report suggests: Whistle-blower employees say they feared ‘retaliation’ if they spoke up
- Federal investigators interviewed top-level directors and managers at agencies
- They also opened a hotline for employees to report ‘political interference’
- Government Accountability Office uncovered widespread allegations of this
- They raised fears that Covid guidance may have been ‘altered or suppressed’
- GAO warned none of the agencies had systems in place for reporting allegations
- Said they had failed to train staff in how to report and spot political interference
- Follows allegations White House waged a war on science early in the pandemic
CDC and FDA officials ‘altered’ Covid guidance and even ‘suppressed’ findings related to the virus due to political pressure, a bombshell report suggests.
Investigators from the watchdog Government Accountability Office (GAO) spoke to more than a dozen directors and managers who worked at the agencies behind the country’s pandemic guidance.
They unearthed allegations of ‘political interference’ in scientific reports, raising fears that research was tampered with.
In its 37-page report, the GAO warned that neither agency had a system in place for reporting allegations of political interference. It also said they had failed to train staff how to spot and report this.
Whistleblowers said they did not speak up at the time for fear of retaliation, because they were unsure how to report the issues or believed leaders were already aware.
This is just the latest in a growing patchwork of reports suggesting politicians influenced ‘scientific’ papers during the pandemic for their own ends.
On Tuesday, the Biden administration’s top medical adviser Dr Anthony Fauci declared the U.S. is now ‘out of the pandemic phase’ of Covid, citing low cases and hospitalizations.
But health experts were quick to question the claim — buried at the end of an interview with PBS’ NewsHour — suggesting he may have bungled his words and should only have said the nation was in a phase of ‘low hospitalizations’.
In the early phase the White House was accused of waging a war on science, with then-president Donald Trump repeatedly pushing for Centers for Disease Control and Prevention (CDC) reports to be amended to support his views, as shown in emails made public by congressional investigators last April.
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‘A few respondents from CDC and [Food and Drug Administration] FDA stated they felt that the potential political interference they observed resulted in the alteration or suppression of scientific findings,’ GAO investigators wrote in the report.
‘Some of these respondents believed that this potential political interference may have resulted in the politically motivated alteration of public health guidance or delayed publication of Covid-related scientific findings.’
The GAO report published last week looked into the two agencies, alongside the National Institutes of Health (NIH) — America’s top research institution— and the Office of the Assistant Secretary for Preparedness and Response (ASPR) — in charge of natural disaster response.
It’s The Biggest FDA Scandal In History: Interview With Whistleblower Linda Martin, Ph.D.
It’s The Biggest FDA Scandal In History: Interview With Whistleblower Linda Martin, Ph.D.
Got Science? Are you sure?
Dr. Brian Hooker invites some of the leading voices in science and medicine to break down the studies and weigh in on the controversies so the rest of us have an opportunity to understand the science that drives public health policy and medical progress. Watch at link Below:
CDC Has Not Been Transparent With the American Public on COVID
An article published this past weekend in The New York Times highlights a glaring problem with the U.S. Centers for Disease Control and Prevention (CDC) and its policy recommendations related to the pandemic during the past two years. The problem has to do with lack of transparency regarding hospitalizations for COVID-19 and the effectiveness of vaccinations for the illness.1 2 The Times article, written by Apoorva Mandavilli, starts out:
For more than a year, the Centers for Disease Control and Prevention has collected data on hospitalizations for Covid-19 in the United States and broken it down by age, race and vaccination status. But it has not made most of the information public. When the C.D.C. published the first significant data on the effectiveness of boosters in adults younger than 65 two weeks ago, it left out the numbers for a huge portion of that population: 18- to 49-year-olds…1 3
The article continues:
Two full years into the pandemic, the agency leading the country’s response to the public health emergency has published only a tiny fraction of the data it has collected, several people familiar with the data said.
The CDC has shared only a “tiny fraction” of its COVID data with the American public?
Former CDC Director Thinks Agency Should Let COVID Data Speak for Itself
According to CDC spokesperson, Kristen Nordlund, one of the reasons for the lack of data transparency is because “basically, at the end of the day, [the data is] not yet ready for prime time,” noting that the CDC’s “priority when gathering any data is to ensure that it’s accurate and actionable.”1 In an interview with Fox News, former CDC director Robert Redfield, MD confirmed this view, saying…
One of the things is that CDC has a tendency to look at data and make sure that they believe that data is accurate. They call it curating the data. So very frequently the data is out of sync to be able to be in real-time to respond.4
But Dr. Redfield suggested that he disagreed with this practice. He said that he believes whatever data the CDC collects should “absolutely get out there in real-time.” He added:
I think the best thing for CDC to do is to tell the American public the truth and let the data there. I’m sure the American public is intelligent enough to understand the explanations. I know there’s a concern that they have that the data may somehow be misinterpreted to determine the efficacy of the vaccines, rather than just tell people the truth.4
CDC Reluctance to Track COVID “Breakthrough Cases” Due to Fear of Contributing to Vaccine Hesitancy
Nordlund reportedly said that another reason for the CDC’s hesitancy to be more transparent was due to fear that its data might be misinterpreted–that information about the number of fully vaccinated people “breakthrough” SARS-CoV-2 infections, for example, could lead to concerns about the effectiveness of the COVID shots.1 2
Epidemiologist Jessica Malaty Rivera, MS, who was a member of the team that ran The COVID Tracking Project,5 dismissed the CDC worries about incomplete data being misinterpreted. She said, “We are at a much greater risk of misinterpreting the data with data vacuums, than sharing the data with proper science, communication and caveats.”
During the past two years, the CDC has frequently been criticized for its COVID and COVID vaccine data collection practices, its mixed and confusing messaging and a growing perception that the agency has not been fully transparent with the American public regarding the pandemic.6 7 8 9 10 11 12 13 14 15 16
Perhaps one of the clearest examples of the CDC’s failure to provide timely and accurate COVID-related information is the agency’s inability or unwillingness to adequately track the number of cases in which fully vaccinated (and boosted) individuals have tested positive for SARS-CoV-2. Because of this, it is not known how many “breakthrough cases” there have been in the United States. Consequently, there is no way to know for sure how effective the COVID shots have been in preventing the spread of the SARS-CoV-2 virus and COVID illness.
This represents a huge and fundamental scientific knowledge gap underlying the primary tool the U.S. government has aggressively pushed on the American people to deal with COVID. But this is only part of the problem. That other part has to do with the lack of reliable information regarding the number of people in the U.S. who have been hospitalized with COVID.
In April 2021, the CDC arbitrarily decided to stop tracking coronavirus breakthrough cases so that it could focus on tracking only breakthrough cases that resulted in hospitalization or death. The assumption was that this major change in policy would allow the agency to more accurately gauge the number of vaccinated people being hospitalized for COVID and, by extension, the overall number of people hospitalized for the illness.12
CDC System for Tracking COVID Hospitalizations in Need of Overhaul
But it has recently come to light that the system the CDC has been using to count COVID hospitalizations is deeply flawed. According to an article in Politico on Feb. 7, 2021 titled “Biden officials trying to recalculate U.S. Covid-19 hospitalizations,” the U.S. government has established a task force to work with “hospitals nationwide to improve COVID-19 reporting.” The task force wants hospitals to report the number of patients who are hospitalized because they have COVID and separate those from the patients who are hospitalized for other reasons but test positive for the SARS-CoV-2 virus after being admitted.17 18
As reported by The Vaccine Reaction earlier this month:
What this suggests is that, in the past, U.S. hospitals have been counting people hospitalized for reasons other than COVID as COVID patients if they happened to test positive for SARS-CoV-2 after admission. This would have the effect of increasing hospital COVID case counts, making the effects of COVID on U.S. hospitals appear worse than they actually were. Remember all those media reports about how overwhelmed hospitals were with COVID patients? It now appears that at least some of that reporting may have been inaccurate, even grossly inaccurate.18
So not only do we not know how effective the COVID shots have been in real-world circumstances, we do not know how many vaccinated (or unvaccinated) people have been hospitalized for COVID–which means that we really do not know how many people have actually died of COVID, in general. It is no wonder the CDC has consistently found it so difficult to be forthcoming.
References
1 Mandavilli A. The C.D.C. Isn’t Publishing Large Portions of the Covid Data It Collects. The New York Times Feb. 20, 2022.
2 Rumpf S. CDC Under New Scrutiny For Collecting Wide Variety of Covid-Related Data But Publishing ‘Only a Tiny Fraction’. MSN Feb. 20, 2022.
3 Mandavilli A. Younger Americans Benefited Less From Booster Shots Than Older People. The New York Times Feb. 4, 2022.
4 Fox News. CDC reportedly published ‘tiny fraction’ of COVID data. Feb. 21, 2022.
5 The COVID Tracking Project. Mar. 7, 2021.
6 Abutaleb Y, Sun LH. How CDC data problems put the U.S. behind on the delta variant. The Washington Post Aug. 19, 2021.
7 Feldmann L. The trouble with transparency: How pandemic is challenging the CDC. The Christian Science Monitor Aug. 5, 2021.
8 Fox M. Analysis: CDC fails to publish data needed to judge risk of breakthrough infection CNN July 28, 2021.
9 Pollard MS, Davis LM. Decline in Trust in the Centers for Disease Control and Prevention During the COVID-19 Pandemic. RAND 2021.
10 Simmons-Duffin S. CDC is criticized for failing to communicate, promises to do better. NPR Jan. 7, 2022.
12 Cáceres M. CDC Intentionally Undercounting COVID-19 “Breakthrough Cases” in Vaccinated Persons. The Vaccine Reaction May 23, 2021.
13 CBSN. CDC Lacking Data on Breakthrough COVID-19 Infections. The Vaccine Reaction Sept. 6, 2021.
14 CNVC. CDC Pressured to Track Breakthrough COVID Cases Among the Vaccinated. The Vaccine Reaction July 26, 2021.
15 Miltimore J. What is the True Vaccine Breakthrough Rate? The CDC Doesn’t Want You to Know. The Vaccine Reaction Oct. 11, 2021.
16 Putka S. CDC Hasn’t Updated COVID Vax Breakthrough Data. MedPage Today Nov. 11, 2021.
17 Banco E. Biden officials trying to recalculate U.S. Covid-19 hospitalizations. Politico Feb. 7, 2022.
18 Cáceres M. U.S. Hospitals May ‘Recalculate’ How They Report COVID Cases. The Vaccine Reaction Feb. 13, 2022.
Original post from https://speakingaboutnews.com/its-the-biggest-fda-scandal-in-history-interview-with-whistleblower-linda-martin-ph-d/
Ingredient Lists: The FDA Admits They Can’t Do Their Job
Ingredient Lists: The FDA Admits They Can’t Do Their Job
How many times have you heard the argument that the ingredients in our food are safe to eat, simply because they are “Approved” by the FDA. I’ve heard this statement many times in the media recently, and I’m sure you have, too. I wasn’t going to let the opportunity slide to tell you what I really think when someone says that an ingredient has been rubber stamped by the FDA and is automatically safe to eat.
There’s an implication out there that everything allowed in processed food – preservatives, artificial sweeteners, thickeners, stabilizers, emulsifiers – have gone through some sort of rigorous testing by the FDA proving they’re okay to eat – but in most cases they haven’t!
Given the FDA’s mission to “protect the public health by assuring the safety, efficacy and security of…our nation’s food supply”, it would only make sense that they would be front and center in approving new food ingredients before they hit the market – however – this is not necessarily the case.In fact, the FDA is sometimes not even aware that a new ingredient has been introduced into our food.
New food ingredients are often approved by the manufacturer themselves, and not by the FDA.
While there are some food additives that the FDA has approved before they hit the shelves, this has proven to be a burdensome process. The FDA claims that so as not to waste government resources, they will just let the manufacturer decide whether an ingredient is safe to eat or not.
That’s right – all an ingredient manufacturer has to do is hire their own experts to claim under “reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use” and the manufacturer may deem it as “GRAS”, which stands for “Generally Recognized as Safe”. This is the green light to start adding it to food products.
A manufacturer can then voluntarily send their GRAS determination to the FDA, but this is not mandatory. Even worse, if the FDA raises questions about an ingredient received in a voluntary GRAS notice, the manufacturer can just withdraw their noticeand still use the ingredient in food products! This practice is nothing short of alarming, and is allowing companies to skirt around the FDA and essentially put whatever they want into our food.
This issue has become a monster that’s impossible to control. Back when Congress gave the FDA authority over food additives (in 1958), there were about 800 additives. Today, the number of known ingredients has swelled to about 10,000 and continues to grow. The National Resources Defense Council estimates that roughly 1,000 food chemicals have been secretly added without notification to the FDA, and say that GRAS should really stand for “Generally Recognized As Secret”. Even the FDA’s Deputy Commissioner, Michael Taylor, recently confessed:
“We simply do not have the information to vouch for the safety of many of these chemicals… we do have questions about whether we can do what people expect of us”.
You can’t put your confidence in the FDA, when it comes to food additives.
While some additives may be safe in small quantities, the FDA cannot regulate cummulative consumption when particular additives are being added to an insurmountable number of foods without any post-market oversight. For instance, even if you think you’re eating healthy you could easily be eating the ingredient carrageenan (that is linked to intestinal issues) at every meal: in your morning coffee and yogurt at breakfast, soup and deli-meat sandwich for lunch, and Lean Cuisine frozen dinner. What is the cumulative amount of carrageenan in this diet? No one is evaluating that. The FDA readily admits:
“We do not know the volume of particular chemicals that are going into the food supply so we can diagnose trends. We do not know what is going on post-market.”
The FDA is asleep at the wheel and the Food Industry is in charge.
The big food industry has proudly taken it upon themselves to approve food ingredients… and why wouldn’t they? It’s the perfect opportunity for them to create chemicals that help them to make products cheaper and quicker, without 3rd party oversight into their safety. In August, the Grocery Manufacturers Association (an industry group comprised of over 300 big food brands such as Pepsico, General Mills, Kellogg’s and Kraft) announced they are unleashing an initiative to “improve the process and increase transparency for making Generally Recognized As Safe (GRAS) determinations” and will “take the lead in defining a standard that will provide clear guidance on how to conduct transparent state of the art ingredient safety assessments…”.
Who wants the Grocery Manufacturers Association to take the lead here? I know I don’t.
This was clearly a move to give the public a warm and fuzzy feeling about the safety of our food, without making any real progress and putting more power into hands of Big Food. According to the chief regulatory affairs attorney for the Center for Science In The Public Interest, Laura MacCleery, “That this is seen as a step forward neatly illustrates the dysfunction built into the current system. It is outrageous that FDA doesn’t already have the identity, much less the safety data, of all substances added to the nation’s food supply”. There is undeniable evidence of institutional corruption at the FDA, as they’ve allowed pharmaceutical companies to lobby for regulations that “serve their interests” and have minimized the role of the FDA. So, allowing the food corporations to take the lead in determining what ingredients are safe to eat is inexcusable.
The U.S. Government Accountability Office (GAO) has called out the FDA for its lax practices and asked them to strengthen their oversight of food ingredients. According to the GAO’s audit of the FDA in 2010 they found some huge problems with the way the FDA is running things. Although I think their entire report is required reading, I’ve summarized some highlights here for you.
The FDA is not aware of many GRAS determinations:
“FDA generally does not have information about other GRAS determinations because companies are not required to inform the agency… once a company concludes that a substance is GRAS, it may market the substance, even if FDA finds that the notice does not provide a sufficient basis for GRAS… Without information about all GRAS determinations, FDA has less awareness of substances in the nation’s food supply and less knowledge of the potential cumulative dietary exposure of GRAS substances… (This) makes it difficult, if not impossible, for public health authorities to attribute a food safety problem to a specific GRAS substance…. FDA’s oversight of their safety would be improved if companies were required to make the agency aware of their GRAS determinations”.
Companies can hire their own experts to determine their product is GRAS and there are no conflict of interest guidelines in place:
“While FDA has issued guidance to minimize the potential for conflicts of interest among it’s own staff who look at scientific issues and the safety of GRAS substances, it has not issued any guidance on the subject for companies to use with their own scientific experts… Expert panels can be comprised of a company’s own staff or outside experts hired by the company… FDA has not issued any conflict of interest guidance.”
Companies are not held accountable or required to keep records of their GRAS determinations:
“FDA has not taken certain steps to ensure companies maintain proper documentation to support their GRAS determinations… it intended to conduct random audits of data and information maintained by these companies. However, according to FDA officials, the agency has not conducted such audits”.
FDA has failed to conduct ongoing reviews of GRAS substances, including those that raised concerns over 30 years ago:
“FDA last engaged in a systematic reconsideration of the safety of GRAS substances in the 1970s and 1980s. This effort raised questions about the safety of almost three dozen GRAS substances…from about 1972 through 1982, the committee reviewed the safety of 422 substances directly added to food… In all, the committee questioned the safety of 35 of these substances… unless evidence was provided to FDA showing these substances safety, it expected FDA to revoke their GRAS status… As of December 2009, FDA had affirmed 17 of these 35 substances as GRAS…(and) FDA had not issued regulations on the remaining 18 substances and could not readily explain why, even though almost 30 years had passed”
The GAO concluded that there are GRAS ingredients currently on the market that may not be safe:
“questions have been raised about the safety of numerous GRAS substances over the last 50 years and some have been banned as a result. In the future, other substances now considered GRAS may also prove to be unsafe”.
For these reasons, I believe that we need to take responsibility for our own health and not rely on the FDA to protect us.
This may not be news to you, but so many people are relying on these antiquated regulations – so we need to spread the word! Please share this post with your friends and family, and with anyone who tries to tell you that an ingredient is safe just because it’s “approved” by the FDA!
Next time they say such a thing…you’ll be armed with the truth!
We must read the ingredient lists on the food we eat – if you don’t recognize the ingredient, put it down and run as fast as you can!
Xo,
Vani
P.S. Are you jumping from diet to diet and nothing seems to work? Are you sick of seeing contradictory health advice from experts? In my new book, Feeding You Lies, I blow the lid off the lies we’ve been fed about the food we eat – lies about its nutrient value, effects on our health, label information, and even the very science we base our food choices on. I guide you through a 48-hour Toxin Takedown to rid your pantry, and your body, of harmful chemicals – a quick and easy plan that anyone
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