by Sharon Rondeau
(Feb. 4, 2022) — On January 29, 2022, The Post & Email published a response received from a spokesman for the U.S. Food and Drug Administration (FDA) regarding the abrupt withdrawal of two monoclonal antibody products used to combat COVID-19 in higher-risk individuals as well as the safety and efficacy of the COVID vaccines administered under Emergency Use Authorizations (EUA).
The article was prompted by the FDA’s Center for Drug Evaluation and Research’s January 24 press release contending:
In light of the most recent information and data available, today, the FDA revised the authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) – to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments…
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses, like SARS-CoV-2. And like other infectious organisms, SARS-CoV-2 can mutate over time, resulting in certain treatments not working against certain variants such as omicron. This is the case with these two treatments for which we’re making changes today.
The press release went on to say that while treatment methods against the coronavirus are important, “the authorized treatments are not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended. Data has clearly demonstrated that the available, safe and effective vaccines can lower your risk of developing COVID-19 and experiencing the potential associated serious disease progression, including hospitalization and death.”
Thus far, the government has not publicly addressed the more than one million reports of adverse events to the VAERS database, including more than 22,000 deaths, believed to have stemmed from the COVID-19 vaccines manufactured in the U.S.
While the mainstream media generally does not raise the issue of vaccine injuries in keeping with the government narrative, a relatively small group of physicians and scientists claim there are inexpensive, effective ways to manage COVID-19 successfully, particularly if done early, and that adverse events are a definitive risk, especially for children, which must be weighed via “informed consent.”
According to mainstream media sources, the survival rate of U.S. individuals who contract the coronavirus is over 98%. The AP, which says it conducts an “ongoing effort to address widely shared misinformation, including work with Facebook and other platforms to add context to misleading content and reduce its circulation online,” reported in July, “As of July 23, there were more than 34.3 million known cases of COVID-19 in the United States and 610,370 deaths, according to data from Johns Hopkins University. That means the case fatality ratio — or the portion of known cases that result in death in the country — is 1.8%. In other words, on average, 98.2% of known COVID-19 patients in the U.S. survive. Because the true number of infections is much larger than just the documented cases, the actual survival rate of all COVID-19 infections is even higher than 98.2%.”
One of our questions directed to the FDA last week concerned “Comirnaty,” a reportedly fully “approved” COVID-19 vaccine made by Pfizer and BioNTech which White House occupant Joe Biden touted in August as justification to impose mandates on various sectors of the population.
“Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine,” the FDA wrote in an August 23, 2021 press release. “The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.”
Since then, “booster” shots, which are third injections for the Pfizer and Moderna vaccines and second injections for the Johnson & Johnson product, have been approved for adults as well as for “everyone 12 years and older” who was given the Pfizer injection.
The approval of the BLA Biologics License Application for Comirnaty required the submission of certain information by BioNTech on a schedule to conclude December 31, 2022 with data on “the incidence of subclinical myocarditis following administration of a third dose of COMIRNATY in a subset of participants 16 to 30 years of age.”
According to a dedicated Comirnaty website, “Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID‑19) in individuals 5 years of age and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.”
The Department of Health and Human Services (DHHS) has not revoked the “public health emergency” it declared on February 4, 2020 due to COVID-19.
In a press release issued August 23 or later, the FDA wrote in a question-and-answer format:
Does the emergency use authorization (EUA) for Pfizer-BioNTech COVID-19 Vaccine remain in effect after the approval?
Yes. Pfizer-BioNTech COVID-19 Vaccine is authorized for emergency use and is available under the EUA as a two dose primary series in individuals 5 years of age and older, as a third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise, and as a single booster dose for individuals 12 years of age and older at least 5 months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine or Comirnaty.
In response to the question, “How is Comirnaty (COVID-19 Vaccine, mRNA) related to the Pfizer-BioNTech COVID-19 Vaccine authorized for emergency use?” the FDA said:
The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA) and the FDA-emergency use authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older, when prepared according to their respective instructions for use, can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns. Therefore, providers can use doses distributed under EUA to administer the vaccination series as if the doses were the licensed vaccine. For purposes of administration, doses distributed under the EUA are interchangeable with the licensed doses. The Vaccine Information Fact Sheet for Recipients and Caregivers provides additional information about both the approved and authorized vaccines.
Whether or not Comirnaty is available for administration in the United States is as yet unclear. Some have suggested that legal liability for injuries from the product would apply if Comirnaty were given in the United States, a liability which does not exist for the EUA-authorized product.
The 2005 PREP Act shields vaccine manufacturers from legal liability, with the federal government providing a means by which those claiming injuries might be compensated. In an updated post dated January 13, 2022, the Congressional Research Service (CRS) reported:
To encourage the expeditious development and deployment of medical countermeasures during a public health emergency, the Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (HHS) to limit legal liability for losses relating to the administration of medical countermeasures such as diagnostics, treatments, and vaccines. In a declaration effective February 4, 2020 (the HHS Declaration), the Secretary of HHS (the Secretary) invoked the PREP Act and declared Coronavirus Disease 2019 (COVID-19) to be a public health emergency
warranting liability protections for covered countermeasures. Under the HHS Declaration and its amendments, covered persons are generally immune from legal liability (i.e., they cannot be sued for money damages in court) for losses relating to the administration or use of covered countermeasures against COVID-19. The sole exception to PREP Act immunity is for death or serious physical injury caused by “willful misconduct.” However, individuals who die or suffer serious injuries directly caused by the administration of covered countermeasures may be eligible to receive compensation through the Countermeasures Injury Compensation Program.
On August 10, 2020, TheVaccineReaction wrote:
After passing the PREP Act in 2005, the next year Congress passed the Pandemic and All Hazards Preparedness Act. That law funded the creation of a public-private business partnership between the federal government and pharmaceutical companies that allowed HHS to provide federal money to drug companies for research and development of new bioterrorism and pandemic vaccines.8
…Under the 2020 coronavirus pandemic public health emergency declaration, “covered persons”—which includes vaccine administrators and manufacturers—are generally immune from legal liability (i.e., they cannot be sued for money damages in civil court) for harm or losses relating to the administration or use of “covered countermeasures” (COVID-19 vaccines and drugs) before or after licensure. The sole exception to immunity from civil liability under the PREP Act is for death or serious physical injury caused by “willful misconduct,” such as evidence of criminal fraud or gross negligence on the part of a company manufacturing the vaccine or a person who administered the vaccine.
On September 29, 2021, the CRS reported:
Although Comirnaty is fully approved by FDA for administration to individuals 16 years and older, an EUA remains in effect for the Pfizer-BioNTech COVID-19 vaccine. Among other things, the reissued EUA authorizes the Pfizer-BioNTech vaccine for uses that FDA had previously authorized but fall outside the scope of FDA’s approval of Comirnaty. Such uses include the administration of the vaccine to children aged 12 to 15 and third doses of the vaccine regimen for certain immunocompromised individuals. The EUA also authorizes use of Comirnaty for those purposes to allow for interchangeable administration of the two vaccines.
Under the heading, “What is Comirnaty,” the CRS wrote:
Comirnaty is the proprietary name (i.e., the brand name) under which the FDA-licensed vaccine that has been known as the Pfizer-BioNTech COVID-19 vaccine (or BNT162b2) will be marketed.16 The proprietary name is the exclusive name of a drug or vaccine that is owned by a company under trademark law. Pharmaceutical products are often marketed under a brand name, which the company selects and FDA approves as part of the BLA review process.17 In the BLA approval letter, FDA indicated that Pfizer and BioNTech may label and market the licensed vaccine as Comirnaty,18 which, according to the companies, “represents a combination of the terms COVID-19, mRNA, community, and immunity.”19
On September 7, 2021, Children’s Health Defense reported it sued the FDA for allegedly having “violated federal law when the agency simultaneously licensed Pfizer’s Comirnaty COVID vaccine and extended Emergency Use Authorization for the Pfizer-BioNTech vaccine.”
The article further states:
The lawsuit alleges once the FDA approved and licensed Pfizer’s Comirnaty vaccine, there was no further basis for the FDA to preserve the EUA status for the Pfizer-BioNTech vaccine that Pfizer acknowledges has the “same formulation” and is “interchangeable.”
There also is no basis to retain EUA status for other COVID vaccines for the same use and for the same population as Pfizer’s Comirnaty vaccine, according to the complaint.
“The FDA must justify its actions in open court,” said Mary Holland, CHD president and general counsel. “The language of its licensure is nearly incomprehensible, and the result of licensed and unlicensed vaccines for the same indication is arbitrary.”
According to the news outlet “Heavy” in response to its question regarding the FDA’s description of the two Pfizer-BioNTech products as “legally distinct,” a representative from Pfizer wrote, “The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the EUA authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series. The Pfizer-BioNTech COVID-19 EUA labeled product will still be shipped and usable until its expiry date, as long as authorized frozen storage conditions have been maintained.”
However, Comirnaty appears to be available in Europe.
The FDA’s response to The Post & Email’s inquiry on the availability of Comirnaty reads: “Please contact HHS regarding Comirnaty distribution.”
The Department of Health and Human Services contains a single reference to Comirnaty on its website appearing in a list of “COVID-19 Vaccine Milestones.”
On January 28, The Post & Email contacted HHS spokeswoman Kirsten Allen to ask, “I was referred to you by the spokesman for the FDA. Can you tell me whether or not Comirnaty is available in the U.S. currently? If not, why not, and when will it be available?”
The following day, on a Saturday, Allen responded:
Yes. You can visit vaccines.gov if you’d like to find and schedule an appointment.
Realizing we might have been unclear in our questioning, we followed up with, “Where is ‘Comirnaty’ being administered as opposed to its predecessor, the Pfizer COVID-19 vaccine approved under EUA? Has Comirnaty replaced the EUA product?”
To date, we have received no response.