Source: ChildrensHealthDefense.org
It’s been less than a year since the Centers for Disease Control and Prevention (CDC) recommended two new respiratory syncytial virus (RSV) vaccines — yet CDC data and the Vaccine Adverse Event Reporting System (VAERS) already show reports of 34 deaths, 302 serious adverse events and according to news reports this week, a safety signal for Guillain-Barré syndrome (GBS).
Reported cases include several instances of severe adverse events in newborns, including the death of a 27-day-old baby who was wrongly administered the vaccine, and in pregnant women and people in age groups for which the RSV vaccines were not approved.
The U.S. Food and Drug Administration (FDA) approved Pfizer’s Abrysvo and GSK’s Arexvy RSV vaccines for adults ages 60 and older — but not for children or babies.
Abrysvo is also approved for pregnant women, targeting RSV prevention in babies. The FDA approved Abrysvo and Arexvy in May 2023.
According to CDC data, approximately 9.65 million RSV vaccine doses — 6.58 million Arexvy doses and 3.06 million Abrysvo doses — were administered as of Feb. 16.
Members of the CDC’s Advisory Committee on Immunization Practices (ACIP) presented the data on deaths and adverse events related to the RSV vaccines at a Feb. 29 meeting.
Yet, ACIP — and news media reports — primarily focused on GBS safety signals, glossing over deaths and the administration of the vaccines to unauthorized age groups.
Instead, CDC officials claimed it’s too early to determine if the RSV vaccines caused the adverse events and reiterated that the shots are safe, according to The Associated Press (AP).
Experts who spoke with The Defender disputed the CDC’s reassurances. Brian Hooker, Ph.D., chief scientific officer for Children’s Health Defense (CHD), said “34 deaths in 10 months should be sufficient to pull the RSV vaccines from the market. But the FDA will not do that — nor will there be full investigations regarding these deaths.”
“I am greatly concerned with the excessive application of the RSV vaccine,” said cardiologist Dr. Peter McCullough. “We are beginning to see the tip of the iceberg in terms of serious side effects.”
CDC creating ‘illusion of safe and effective’
According to the CDC data presented at the Feb. 29 ACIP meeting, of the 34 deaths reported as of Feb. 16 following RSV vaccination, 22 were linked to Arexvy and nine to Abrysvo. In three instances, the report listed “no brand name.”
Yet, discrepancies in the data are evident, as the public-facing VAERS database indicates only 29 RSV vaccine-related deaths as of Feb. 23. And according to Albert Benavides, founder of VAERSAware.com, three more “hidden” deaths reported after RSV vaccines are listed in VAERS, but the vaccine name is unlabeled.
Benavides, who identified discrepancies and contradictions in VAERS data and has called attention to the existence of two parallel VAERS databases — one that is public-facing and one that is not — said, “It is simply gross and despicable the CDC and FDA are allowed to pass off this data obfuscation as pharmacovigilance.”
He added: “VAERS administration is simply not publishing all legitimate reports received.”
One of the deaths recorded in VAERS involved a 27-day-old baby from New York — even though the RSV vaccines are not approved for children. According to the report, which was entered into the VAERS database on Jan. 8, the newborn was vaccinated at a doctor’s office “and he passed away right there.” The date of death was unspecified.
Other RSV vaccine-related death reports included:
- A report involving a foreign woman of “unknown” age but who was pregnant. She received Abrysvo Dec. 27, 2023, and died Jan. 1, 2024.
- A 67-year-old New Jersey man who received Arexvy Oct. 14, 2023, and died two days later — a death acknowledged by GSK as “related to Arexvy.”
- A 69-year-old Florida man who received Arexvy concurrently with the Pfizer COVID-19 vaccine Sept. 28, 2023, and died two days later. According to the VAERS report, an EKG on the date of his death was “grossly ‘abnormal’” despite no known cardiac history and an “unremarkable” cardiac exam two months prior.
- A 70-year-old California man who received Arexvy concurrently with a flu vaccine on Sept. 5, 2023. Increased coughing and fever began “less than 24 hours later” and lasted for four days, until “the patient was found deceased at home.”
- A 73-year-old Virginia male who received Arexvy Jan. 24 and was diagnosed with GBS. Symptoms began 11 days after vaccination. He died Feb. 15.
- A 75-year-old Virginia woman who received Arexvy Jan. 4, died two hours later.
- A 76-year-old Michigan man who received Arexvy Jan. 11, sustained tachycardia and difficulty breathing, and died of acute sepsis and pneumonia Jan. 15.
- A 77-year-old Pennsylvania man who received Arexvy Jan. 4 and soon experienced “seizure-like activity” despite no history of seizures. He died Jan. 6.
- An 81-year-old California man who received Arexvy and a flu vaccine Sept. 18, 2023. He sustained severe cardiopulmonary arrest and died five hours later.
- An 81-year-old New Mexico woman who received Arexvy concurrently with the Moderna COVID-19 vaccine, and pneumonia, adenovirus and flu vaccines, on Oct. 19, 2023. On Oct. 29, 2023, she sustained a hemorrhage and later died.
- An 85-year-old Colorado man who received Abrysvo and a flu vaccine on Sept. 11, 2023. Two days later, he “developed symptoms of shingles in his eye” and later “developed meningitis/encephalitis that led to a host of other complications that ultimately led to his death” on Dec. 21, 2023.
According to Benavides, other deaths likely related to RSV vaccination are “hidden” within VAERS, with details such as the vaccine name listed as “unknown” in some reports.
This includes the Jan. 8 death of a preterm newborn in Texas. According to VAERS, the baby was “not breathing” hours after vaccination and subsequently died. The vaccine lot number listed in the VAERS report corresponds with Abrysvo.
Benavides said mislabeled reports hide the true extent of adverse events:
“Not publishing legitimate reports is one of their Vegas tricks. They delete legitimate reports after publication, purposely delay published reports, allow reports to be published without critical data fields like age, date of vaccination or death, even when reports are properly documented in the summary narrative.
“It’s not a stretch to believe VAERS administration is systematically and actively scrubbing data fields that were present on initial submission to create the illusion of ‘safe and effective.’”
Two other RSV vaccine-related reports in VAERS list Beyfortus — a monoclonal antibody for RSV administered to babies — in the write-up.
These reports include a male born prematurely in New York who received Beyfortus and the hepatitis B vaccine at birth, and died of “fluid buildup in the lungs.” Another report lists an Arkansas male of “unknown” age who died of cardiac arrest on Feb. 14, although this was deemed unrelated to the “Beyfortus vaccine received” the prior day.
Although Beyfortus is not a vaccine, it is classified as such in some instances. The ACIP recommended adding Beyfortus to the childhood vaccine schedule — giving it a liability waiver — but excluding it from the National Vaccine Injury Compensation Program (VICP).
‘Startling’ number of Guillain-Barré cases following RSV vaccination
VAERS lists 3,834 adverse events relating to the RSV vaccines as of Feb. 23, with approximately two-thirds of the reports pertaining to Arexvy. A total of 302 reports are classified as serious adverse events, with slightly over half connected to Arexvy.
Yet, the ACIP meeting and subsequent news stories largely focused on a single safety signal: a higher-than-normal incidence of GBS in RSV vaccine recipients.
According to The New York Times, GBS causes the immune system to attack the nerves, leading to paralysis and death in severe cases. According to AP, “An estimated 3,000 to 6,000 people develop G.B.S. in the U.S. each year,” mostly older adults.
“Rare cases of Guillain-Barré syndrome have been linked to other vaccines, including those against influenza and shingles,” the Times reported. The Times did not mention incidences of GBS connected to COVID-19 vaccination.
AP reported that health officials estimate “About two cases of Guillain-Barré might be seen in every 1 million people who receive a vaccine.” CDC data indicate the GBS incidence rate for Abrysvo recipients was 4.6 cases per million people.
GBS incidences were lower for Arexvy, but according to AP, officials are also performing “follow-up tracking” in people who received this particular vaccine.
“These data suggest a potential increased risk” from the RSV vaccine, said Dr. Tom Shimabukuro, director of CDC’s Immunization Safety Office, in remarks quoted by AP.
“Given that the RSV vaccine was first approved in the U.S. on May 3, 2023, the number of VAERS reports for GBS, death and atrial fibrillation are indeed startling,” Hooker said.
According to VAERS, 34 GBS cases related to RSV vaccination were recorded. Most were in the 65-79 age group, but at least two cases were reported in people under age 60, even though the RSV vaccines are not approved for those age groups. CDC data presented at the Feb. 29 ACIP meeting said 23 GBS reports have been “verified.”
From these “verified” reports, 15 involved Abrysvo, 14 patients were male, seven received a COVID-19 vaccine at the same time they received the RSV shot, the median age was 71 and one patient died.
The ACIP presentation referred to one GBS report “in a non-pregnant female patient aged 50s years” who received Abyrsvo. VAERS includes reports of other GBS cases in patients in age groups not authorized to receive the RSV vaccines.
In one instance, a 6-month-old girl from California received Abrysvo and several other vaccines at a military site on Nov. 30, 2023. She sustained “life threatening” cardiac arrest. The RSV vaccine “was given by mistake,” according to her VAERS report.
And a 28-year-old Kentucky female who received Abrysvo on Dec. 1, 2023, soon developed “facial weakness,” despite “no history of similar symptoms.” She was hospitalized for seven days and diagnosed with GBS.
The ACIP also referenced 58 cases of atrial fibrillation, three cases of acute disseminated encephalomyelitis, two cases of transverse myelitis and one case of posterior reversible encephalopathy syndrome and acute encephalitis following RSV vaccination.
Risks of RSV vaccines evident during clinical trials
Despite the deaths and safety signals connected to the RSV vaccines, CDC officials at the Feb. 29 ACIP meeting adopted a reassuring tone regarding the vaccines’ safety.
“Due to the uncertainties and limitations, these early data cannot establish if there is an increased risk for GBS after vaccination,” Shimabukuro said, according to the Times.
According to AP, “CDC officials also presented estimates that the vaccines have prevented thousands of hospitalizations and hundreds of deaths from RSV, and that current data indicates the benefits of vaccination outweigh the possible risks.”
“R.S.V. vaccines may prevent an estimated 120 to 140 in-hospital deaths and about 25,000 outpatient visits per million doses administered,” the Times reported.
“Pfizer is committed to the continuous monitoring and evaluation of the safety of Abrysvo” and is conducting four safety studies examining the risk of GBS, said Reema Mehta, Pfizer’s vice president of risk assessment and safety, in remarks quoted by AP.
“There are limitations to all of these data, and further analysis by FDA, CDC and the vaccine manufacturers are needed to confirm and quantify any potential risk,” said Alison Hunt, a GSK spokesperson, in remarks quoted by the Times.
Experts noted the contradiction of CDC officials identifying safety signals from VAERS, after a Feb. 15 U.S. House of Representatives hearing where CDC and FDA officials downplayed the role of VAERS in the detection of safety signals.
Dr. Daniel Jernigan, director of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, claimed at the hearing that VAERS is “not intended to determine if a vaccine is causing an adverse event.”
Saying that such criticisms were “a ploy to remove emphasis” from adverse events, Hooker said, “VAERS inaccuracies are only in under-reporting, not misreporting.”
“The [2011] Lazarus study conducted at the request of CDC shows that perhaps 1% of all vaccine adverse events are captured by VAERS and that the true vaccine adverse event rate is around 1 in 39,” he said.
According to Dr. Meryl Nass, an internist and biological warfare expert, “The FDA and CDC have enormous amounts of data on well over 100 million Americans” but “refuse to study the data.”
According to AP, public health officials were aware of GBS instances identified during clinical trials and “different systems were watching for signs of problems.”
Nass said there is little evidence that RSV vaccines are saving lives in either babies or the elderly.” But, she said, “There was good evidence, even in the pre-marketing data, that the RSV vaccines caused neurologic complications, including GBS.”
“Why would anyone take an RSV vaccine that has a reasonable chance of causing a neurologic illness to prevent colds? The answer is that they are not being told the truth,” Nass said, calling for RSV vaccines to not be licensed or used until their safety is proven.
McCullough said RSV “is like a mild cold and easily treated at home.” He said the risk of “fatal paralysis, cardiac side effects and vaccine death far outweigh the occasional case of RSV, which we have been managing for many years in internal medicine.”
“I do not recommend the new RSV vaccine to older adults,” he said.