In February 2018, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to re-recommend the live virus nasal spray influenza vaccine, FluMist, for the 2018-19 “flu season” after a two-year hiatus.¹
FluMist, manufactured by MedImmune/AstraZeneca, was first licensed in the U.S. in 2003 as a trivalent vaccine and was approved for use in healthy children and adults between the ages of five to 49 years old.²
The live attenuated influenza vaccine (LAIV) is popular, particularly with children, since it is sprayed up the nose and does not require a needle for administration.

The ACIP voted against recommending the quadrivalent FluMist for the 2016-17 and 2017-18 influenza seasons due to the vaccine’s ineffectiveness in protecting against the H1N1 strain (Influenza A).²
According to the CDC:

While data from 2010-2011 through 2016-2017 indicated that LAIV lacked effectiveness among 2 through 17-year-olds against H1N1pdm09 influenza viruses (2009 H1N1) in the U.S., LAIV was effective against influenza B viruses, and was similarly effective against H3N2 viruses as inactivated influenza vaccines.³

Effectiveness of influenza vaccines varies every year because the influenza virus mutates rapidly and there are many strains.
Flu vaccines must be manufactured each “flu season” to match the circulating strains of influenza that health officials predict will be most prevalent. The CDC has stated:

How well the flu vaccine works (or its ability to prevent flu illness) can range widely from season to season and can be affected by a number of factors, including characteristics of the person being vaccinated, the similarity between vaccine viruses and circulating viruses, and even which vaccine is used.⁴

In 2017, data from a study published in The New England Journal of Medicine supported the federal recommendation that live virus FluMist should not be used on patients in the U.S.⁵
Brendan Flannery, PhD, author of the study and epidemiologist at the CDC’s Influenza Division discusses why the FluMist vaccine was ineffective during the 2015-16 season:

The simple explanation is that the vaccine virus in the live vaccine didn’t work the way it should have worked, whereas in the inactivated vaccine, that same virus worked well against the circulating viruses.”⁶

He adds that, “When the virus was killed in the inactivated vaccine, it worked. When it was a live vaccine, that live virus didn’t perform like a live virus. Something happened.”⁶

Live virus vaccines are known to cause vaccine strain virus infections, shedding and transmission.⁷
It is important to note that there are cases reported in the medical literature that FluMist has resulted in shedding and transmission of vaccine strain influenza virus.⁸

Why Did ACIP Reinstate FluMist for the 2018-19 “Flu Season”?

The ACIP meets three times a year to review and discuss new evidence on vaccines and make adjustments to the recommended vaccine schedule based on this evidence.²
In February 2018, the ACIP members voted 12-2 to include FluMist LAIV4 as an option for influenza vaccination for the 2018-19 influenza season for children and adults.
In a 14-0 vote, the vaccine was also added back into the Vaccine For Children Program (VFC),⁹ which is a federally funded program that provides vaccines at no cost to children who might not be vaccinated because of inability to pay.

Studies have shown that that effectiveness of LAIV in previous years was approximately 45 percent against Influenza A and B with 25 percent protection against Influenza A (H1N1pdm09) when compared with unvaccinated children.⁹
Researchers also found that although the inactivated influenza vaccine was “better” in all age groups against Influenza A (H1N1pdm09) when compared with LAIV, there was no statistically significant difference in protection between the two vaccines for the Influenza A (H3N2) and Influenza B viruses.⁹

This year, Raburn Mallory, MD, a representative from MedImmune/AstraZeneca attended the ACIP meeting to present information and data to the CDC’s vaccine policymaking committee on a new formulation of the nasal spray vaccine and the ways in which the manufacturer has corrected errors that were encountered in the prior version.⁹

According to the American Academy of Pediatrics (AAP):

On Wednesday, Raburn Mallory, M.D., senior director of clinical development for FluMist manufacturer MedImmune, told the committee it had changed to a new H1N1 strain (A/Slovenia) that is producing better antibody responses than the previous strain (A/Bolivia). He also presented data on shedding of the vaccine strain and on seroconversion. However, because there has been little circulation of influenza A/H1N1 in the past two years, there are no efficacy data for the new formulation against H1N1 which was the strain for which LAIV performed poorly in the 2013-’14 and 2015-’16 seasons.¹⁰

As AstraZeneca’s Dr. Mallory has clearly pointed out, the problem is that there is no vaccine efficacy data available on the new formulation of LAIV4 and it is unknown whether FluMist will be effective this flu season.
Lisa Grohskopf, MD at the CDC acknowledged this by stating that, “effectiveness is likely to remain unknown until the next H1N1-predominant season” and that decisions to recommend influenza vaccines “is not generally based upon effectiveness comparisons to other products.”¹⁰

News reports highlight that ACIP’s discussion was centered on giving FluMist another try.⁹
One of the “No” votes was that of Henry Bernstein, DO, at Zucker School of Medicine at Hofstra/Northwell. Berstein expressed his concerns by stating the following:

The part that really worries me the most is the fact if we reinstate LAIV4 without knowing its vaccine effectiveness during an H1N1 season and then we have an H1N1 season and it results in increased morbidity and mortality … that is likely to undermine administration of flu vaccine for the public, potentially lowering all coverage rates and negatively impacting the country’s overall flu vaccine program.¹⁰

The second “No” vote was from David Stephens, MD, at Emory University School of Medicine. Stephens stated, “I’m really concerned about what message this [approval] sends.”⁹

Interestingly, the AAP has expressed the strongest concerns regarding the reinstating of FluMist. According to an article published on MedPage Today:

AAP liaison member David Kimberlin, MD, of the University of Alabama Birmingham, pointed out that the CDC meta-analysis was “too blended” to pull out strong consideration that LAIV has the kind of effectiveness they are hoping for. Also, the shedding data presented by the manufacturer does not correlate with effectiveness, he said.⁹

Dr. Kimberlin further added, “If we have an H1N1 year, and this vaccine has been recommended for use again and it doesn’t work, that’s a sobering sentence for me.”⁹

In response, ACIP committee member Edward Belongia, MD, at the Center for Clinical Epidemiology and Population Health in Wisconsin pointed out that decisions to recommend influenza vaccines are generally based on immunogenicity and not effectiveness.
He stated, “Given what we know, this is a reasonable approach. We always have to make the decision based on the best science available at the time, and I do think the manufacturer has made a good faith effort to understand the root causes of what was going on.”⁹

Despite the fact that the efficacy and effectiveness of this vaccine is unknown, another ACIP member Cynthia Pellegrini, senior vice president of public policy and government affairs for March of Dimes stated, “I think the evidence is pretty clear this vaccine is better than not being vaccinated and there are kids who will not be vaccinated without this option…”¹⁰

The ACIP also voted against giving preferential treatment to the inactivated influenza vaccine and the recombinant influenza vaccine over LAIV4.8
According to Laura Riley, MD, at Massachusetts General Hospital in Boston, the reason cited for voting against giving the other influenza vaccines preference over LAIV4 is, “We need to give people as many options to be vaccinated, because being vaccinated is better than not being vaccinated.”⁹

The assumption that using FluMist is better than not being vaccinated given the lack of data on the efficacy of LAIV4 is not rational because it is not based on scientific evidence.

The AAP is Encouraging Parents to Opt for Other Influenza Vaccines Instead of FluMist

Given the AAP’s objection to reinstating FluMist, the organization is recommending that children should be vaccinated with injectable influenza vaccines rather than FluMist. (It is important to note that injectable influenza vaccines also have their own set of problems that the CDC and AAP choose to ignore.)
This recommendation conflicts with that of the CDC’s recommendation of FluMist. ACIP member Henry Bernstein, MD said:

The AAP feels that the flu shot should be the primary vaccine choice for all children.” He goes on to add, “There’s no question that ideally we would like for the CDC and the AAP to be completely harmonized. Both groups are harmonized in wanting as many children to receive flu vaccine as possible each and every year. When recommendations are not perfectly harmonized, it does pose the possibility for confusion.¹¹

The fact that FluMist (LAIV4) is reinstated back into the CDC’s recommended influenza vaccine schedule for children and adults, despite lack of data that it actually works to prevent influenza, calls into question the CDC’s commitment to ensuring that all recommended vaccines are safe and effective.

References:

 

2. Children’s Health Defence (Kennedy News & Views): Infant Deaths Following Vaccination: The Numbers Don’t Lie—Or Do They?

National and international health agencies such as the Centers for Disease Control and Prevention (CDC), the European Medicines Agency (EMA) and the World Health Organization (WHO) routinely and emphatically claim that serious adverse events following vaccination are rare.
Nowhere is officialdom’s minimization of vaccine risks more apparent than in these agencies’ position on vaccine-related deaths.
The WHO, for example, states that “so few deaths can plausibly be attributed to vaccines that it is hard to assess the risk statistically.
” Nevertheless, once regulators have deemed that a given vaccine is safe enough to be licensed and widely marketed, vaccine manufacturers are supposed to do just that—that is, continue to statistically assess a vaccine’s risks, including the risk of death—and regulators are supposed to carefully review the post-licensure data that pharmaceutical companies submit.

A 2017 commentary by India-based physicians Jacob Puliyel and C. Sathyamala in the Indian Journal of Medical Ethics describes a shocking dereliction of duty on the part of regulators who were presented with vaccine data carefully tailored to obscure serious risks.
Tackling concerns about infant deaths that have occurred following hexavalent vaccination in several European countries, the authors of the commentary show that GlaxoSmithKline (GSK) neglected to report to regulatory authorities that there was a statistically significant increased risk of sudden infant death in the four days after administration of its hexavalent vaccine—and the regulatory agency in question (the EMA) ignored the omission and accepted GSK’s apparently whitewashed data at face value.

Problematic hexavalent vaccines and problematic analyses
Among world regions, European countries have taken the lead in incorporating hexavalent vaccines into their childhood vaccine schedules.
Hexavalent vaccines are potent six-in-one combination shots covering diphtheria, tetanus, pertussis, hepatitis B, polio and Haemophilus influenzae type B.
In 2000, the European Union (EU) approved two hexavalent vaccines—GSK’s Infanrix hexa and Sanofi Pasteur’s Hexavac—but suspended Hexavac five years later after a detailed analysis suggested that children who received the vaccine in their second year of life had an elevated risk of sudden death.
The analysis by Drs. Puliyel and Sathyamala suggests that Infanrix hexa may be just as problematic as the discredited Hexavac vaccine.

In Europe, vaccine manufacturers routinely provide the EMA with pharmacovigilance documents called periodic safety update reports (PSURs).
The PSURs are intended to be critical medical analyses that evaluate “new or changing safety data,” and the EMA relies on them to make or uphold its vaccine-related policies.
In its PSURs for Infanrix hexa, GSK typically compares “expected” and “observed” deaths following hexavalent vaccination.
If the observed deaths were to significantly exceed the expected deaths, GSK would be forced to report “an increased risk of sudden infant death following vaccination with Infanrix hexa.”

According to Drs. Puliyel and Sathyamala, GSK’s analyses have been marred by statistical maneuvers and flawed assumptions that enable the company to mask probable risks.
For example, GSK’s calculation of expected deaths relies on assumptions that overestimate expected deaths, while the company gleans its figures for observed deaths through passive surveillance reports that are not actively solicited or investigated and are notorious for underestimating the true magnitude of adverse events.
In the U.S., the Food and Drug Administration (FDA) estimates that passive surveillance captures about one percent of vaccine-related adverse events.
A study in Africa that compared passive with active surveillance found that passive surveillance “failed to identify half of all AEFIs [adverse events following immunization] that were identified through active surveillance, including all of the serious AEFIs.”

Reviewing and reanalyzing GSK’s sudden death data from five PSURs (numbers 15-19), Drs. Puliyel and Sathyamala start with the earliest PSUR (number 15) and note a “clustering” of sudden deaths among infants (under age one) in the first three days following vaccination—with 72% of the deaths (42/58) taking place in that time frame and nearly all (93% or 54/58) occurring within 10 days of vaccination. The authors state:

“The fact that the rate of death decreases rapidly with the passage of time following immunization suggests that the deaths could be related to vaccination.”

Turning to the 19th PSUR (which should include all cumulative deaths reported in prior PSURs), Puliyel and Sathyamala note that the numbers in number 19 are not “consistent” with the numbers in the 16th PSUR; specifically, “the cumulative deaths reported are lower in the PSUR 19 than in the PSUR 16.”
After correcting the data by restoring the missing deaths, the two authors find that “the number of observed deaths is significantly higher than expected for the first four days after vaccination” [emphasis added]. They suggest that GSK owes consumers and regulators an explanation as to why it did not report this statistically significant increased risk of infant death.
They also caution:

“If one glosses over the deaths after vaccination, one can prevent/delay the evaluation of the vaccine’s safety profile and this has the potential to result in more, unnecessary deaths, which is difficult to justify ethically.”

Clinical evidence on hexavalent vaccines
Italian researchers have published clinical reports that suggest a relationship between Infanrix hexa and sudden infant death.
In one case report, a three-month-old female infant died within 24 hours of vaccination with Infanrix hexa due to a likely anaphylactic reaction.
The authors of the study suggest that anaphylaxis may be underreported as a vaccine-related outcome, given the difficulty of pinpointing which specific vaccine components were involved and the possibility that several ingredients (i.e., vaccine antigens, animal proteins, antibiotics) could be responsible.

Another analysis looked at 13 SIDS deaths that occurred one to seven days after administration of either Hexavac or Infanrix hexa (2000-2010) and likewise speculated that “vaccine components could have a direct role in sparking off a lethal outcome in vulnerable babies.” Elaborating on possible mechanisms, the authors stated:

“…Several compounds and…adjuvants of the hexavalent vaccine might easily go beyond the BBB [blood-brain barrier], that in the first months of life is still immature and quite permeable, inducing…molecular alterations [in the brain]…with consequent fatal disorganization of respiratory control in particularly predisposed infants.”

Making safety a priority
The WHO and government health agencies are quick to dismiss as a “myth” any possible link between vaccines and sudden infant death syndrome (SIDS) or other unexplained infant deaths—despite a landmark ruling by the U.S. Court of Federal Claims in 2017 that vaccines “caused or substantially contributed” to a 2011 SIDS death.
And, notwithstanding the worrisome reports of sudden infant deaths associated with hexavalent vaccines, the combination vaccines appear to be here to stay.
Following Hexavac’s withdrawal from the European market, the EU has gone on to grant marketing approval to two other hexavalent vaccines manufactured by Sanofi Pasteur (Hexyon and Vaxelis, in 2013 and 2016, respectively).
The EU also gave a scientific thumbs-up for rollout of Sanofi’s Hexaxim vaccine in non-EU regions.

Outside the EU, public health officials and agencies in low- and middle-income countries, including India, are eagerly embracing hexavalent vaccines as “the future of routine immunization,” primarily because of the six-in-one vaccines’ perceived potential to boost vaccine coverage while lowering program costs.
These same enthusiasts also view combination vaccines as a way to defuse the concerns of those who object that babies receive “too many shots too soon.”
A 2017 study funded by Merck and Sanofi Pasteur optimistically stated that incorporation of hexavalent vaccines into the U.S. vaccine schedule “could improve coverage rates and timeliness” and “reduce the ‘shot burden.’”

Vaccine researchers at the CDC admit that there is a need to invest in vaccine safety infrastructure “at a level commensurate with investments in vaccine development,” particularly through post-licensure studies that compensate for the “well-known limitations” of prelicensure clinical trials.
These CDC researchers also (somewhat understatedly) point out the “increasing emphasis…on proving, rather than assuming, that no problems are associated with a vaccine” [emphasis added]. What the commentary by Drs. Puliyel and Sathyamala shows is that the “proof” offered by vaccine manufacturers cannot be accepted uncritically and that regulatory agencies must scrutinize pharma-authored reports rather than simply rubber-stamping them. A
s a result of the EMA’s failure to perform due diligence on Infanrix hexa, say the two medical researchers, “numerous children were unnecessarily exposed to the risk of death.”

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