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Advisers to the Centers for Disease Control and Prevention (CDC) last week recommended newly approved vaccines for respiratory syncytial virus (RSV) — despite concerns about the efficacy and safety of the new vaccines, potentially harmful interactions with the flu and COVID-19 vaccines and the unspecified cost for the vaccines.
- Recommended a new pneumococcal conjugate vaccine as an “option” for children.
- Discussed COVID-19 bivalent vaccines and vaccines for meningitis, polio, dengue, monkeypox and chikungunya vaccines.
- Discussed proposals regarding the vaccine schedule.
- Suggested the removal of egg allergies as a contraindication to vaccines made in eggs.
For Dr. Meryl Nass, an internist, biological warfare epidemiologist and member of the Children’s Health Defense (CHD) scientific advisory committee, last week’s proceedings lacked the due diligence needed to fully ascertain the safety of the vaccines and treatments being reviewed.
Writing on her blog, Nass stated:
“The mission of CDC and the ACIP members is to sign off on all possible vaccines as safe and effective, and to never turn over any stones that could reveal anything different. Then to roll all vaccines out to as broad a group of humans as humanly possible.”
ACIP says seniors ‘may’ get RSV vaccine, but overlooks other safety concerns
According to MedPage Today, ACIP recommended the new RSV vaccines for older adults on Wednesday “but opted not to give their strongest endorsement,” instead recommending “a talk with [a] medical provider first.”
STAT reported that ACIP recommended “anyone 60 and over should be able to get one of the new [RSV] vaccines … if they and their physicians think it would be worthwhile.”
According to STAT, ACIP was initially slated to vote on a broader recommendation that would have “urged all people 65 and older to get vaccinated” for RSV.
However, “that recommendation was watered down” after “several members of the committee expressed serious concerns about the decisions they were being asked to make based on the data the companies had provided.”
Reuters reported that while some committee members wanted to stick with the broader recommendation, “others had concerns that there was not enough data about how effective the vaccines are in people over the age of 75 and other high-risk groups.”
Two votes followed. In one, ACIP was asked whether “adults 65 years of age and older are recommended to receive a single dose of RSV vaccine.” The committee voted 9-5 to recommend that those age 65 and over “may” get an RSV vaccine after consultation with a doctor or pharmacist.
The other vote asked ACIP’s members whether “individual adults ages 60-64 may receive a single dose of RSV vaccine, using shared clinical decision-making” — that is, consultation with a doctor or pharmacist. Here, the result was 13-0 in favor, with one abstention.
ACIP’s recommendations are headed to the desk of outgoing CDC Director Rochelle Walensky, who is expected to sign off on them early this week. Her last day as head of the CDC is June 30. However, ACIP recommendations are not considered final until they are published in the Morbidity and Mortality Weekly Report.
The FDA recently approved the two vaccines — Pfizer’s Abrysvo and GSK’s Arexvy.
According to STAT, “It is expected both companies will provide vaccines to the market in time for the next RSV season.” However, the mild recommendations from ACIP “will likely lead to a lower uptake of the new vaccines than the manufacturers might have expected.”
Nass noted that data presented to ACIP indicated that out of 40,000 participants in the RSV vaccine clinical trials, six developed Guillain-Barré syndrome (GBS), a rare disorder in which the immune system attacks the nerves or a GBS-type illness. This was compared to no GBS cases in the control group.
According to CNN, some ACIP members expressed concern that few adults over 75 and older were enrolled in the Pfizer and GSK clinical trials, even though they represent the group most at risk from RSV.
The immunocompromised and those living in “settings such as nursing homes are also at elevated risk but were not enrolled in the studies,” STAT reported.
In addition, according to MedPage Today, approvals of the two RSV vaccines “were based on efficacy data spanning a single RSV season.” At the ACIP meeting, Pfizer and GSK representatives “presented data showing that vaccine efficacy largely held up through the first part of the second RSV season, but did drop slightly.”
Some concerns were also raised regarding the concurrent administration of RSV vaccines alongside flu and COVID-19 shots.
According to STAT, “these vaccines will likely be given at the same time of the year … and it’s not yet clear if giving the vaccines at the same time undermines the immune responses they generate” because studies of concomitant administration of COVID and RSV vaccines are still underway.
GSK claimed that when its RSV vaccine was administered along with a flu vaccine, “It was safe and well-tolerated,” CNN reported.
The cost of the vaccine also drew criticism. According to MedPage Today, Pfizer and GSK proposed a range of prices spanning between $180 and $295, but according to STAT, “Both companies resisted strong pressure from the committee to commit to a firm price.”
According to Reuters, “Pfizer and GSK have said they expect RSV vaccines to eventually become multibillion-dollar sellers.” However, Fierce Pharma reported that ACIP’s “tepid endorsement for the vaccines could hinder sales.”
For 2023, GSK “expects the U.S. market to be in the range of 10 million to 15 million people, a fraction of the size of the expected flu or COVID-19 market,” Reuters stated.
Pneumococcal vaccine approved as ‘option’ for infants as young as 2 months old
ACIP voted unanimously in favor of adding Pfizer’s new 20-valent pneumococcal conjugate vaccine (Prevnar, or PCV20) — currently administered only to adults — as an “option” for children, MedPage Today reported.
According to the AAP, “Pfizer’s PCV20 adds serotypes 8, 10A, 11A, 12F, 15B, which are not covered in PCV15,” a previously existing vaccine.
ACIP voted in favor of:
- Routine use of either PCV20 or PCV15 in children aged 2-23 months.
- Administration of either PCV15 or PCV20 in children aged 24-59 months with incomplete PCV vaccination status, and in children aged 24-71 months with certain underlying conditions and incomplete PCV vaccination status.
- Vaccination of children between 2 and 18 years of age with PCV20, or with pneumococcal polysaccharide vaccine (PPSV23) if they previously had only received PCV13 or PCV15.
- A single dose of PCV15 or PCV20 to children between 6 and 18 years of age with any risk condition who have not received any dose of PCV13, PCV15 or PCV20. If PCV15 is administered, the committee said it should be followed by a dose of PPSV23 at least eight weeks after the initial vaccination.
According to Nass, PPSV23 is “very inflammatory” and it is “unclear how well/if it works.”
Moreover, according to MedPage Today, ACIP expanded its definition of high-risk children to include conditions such as moderate persistent and severe persistent asthma, chronic kidney disease (excluding dialysis patients), chronic liver disease and those with renal failure on maintenance dialysis.
Some committee members “expressed concern over the lack of clinical data for the new vaccines,” MedPage Today reported, including “no effectiveness and no efficacy data on either PCV15 or PCV20.”
Nass noted that “the CDC presented no good data on these new vaccines,” instead presenting “economic models” in lieu of this data, adding, though, that “reliable data to plug into the models” is lacking.
Despite this missing data, an ACIP member quoted by Nass said, “Our CDC colleagues are masters at epidemiology surveillance that will give us the answer in [the] future” — “In other words,” Nass said, “‘we won’t know if it works unless we give it to millions of children, so what are we waiting for?’”
Third monkeypox vaccine dose not recommended — for now
ACIP considered, but rejected, recommending a third dose of the Jynneos vaccine for monkeypox.
However, the committee did encourage “2-dose vaccinations among persons who do not have immunity and optimizing immune function … ideally before mpox exposure.”
ACIP also recommended “persons eligible for vaccination, particularly those with advanced HIV and other immunocompromising conditions, should receive two doses of Jynneos vaccine,” adding that “Additional research on the durability of Jynneos vaccine-induced immunity is needed.”
In response, Nass remarked, “Let me remind you that monkeypox is essentially like shingles … It is a mild disease and there is no need for a vaccine for 99.9% of people; and if you get it, you will probably have real immunity afterwards.”
“CDC is willing to give it along with COVID vaccines, even though that probably magnifies the risk of myocarditis,” Nass added.
The committee also discussed, but did not act on, proposals to expand the use of Jynneos to children and pregnant and breastfeeding women.
Other vaccines also on ACIP’s agenda, but no decisions made
According to APP, “ACIP members reviewed data on Friday regarding the safety of aluminum in vaccines,” reviewing the results of a study finding a possible link between aluminum and childhood asthma.
However, it was determined that the study had “important limitations” and that its findings “do not prove causation,” although “a follow-up study with a larger group of children and longer follow-up time” will subsequently be performed. Ultimately, ACIP “did not recommend changing the vaccine schedule.”
Nass noted that links between aluminum, and diabetes and eczema, were also discussed, with a “small positive association” found in the case of eczema and asthma.
ACIP members also examined the possibility of “simplifying COVID vaccine recommendations for children ages 2-4 years,” according to the APP, looking “at the possibility of requiring only one dose for this group instead of two to three.”
ACIP’s COVID-19 vaccine work group said “it would support a single, potentially annual, dose for children ages 2 years and older, while maintaining multiple doses for those under 2.” However, no vote was taken.
Some committee members argued that “Simplifying the recommendations also may lead to more children getting vaccinated,” citing low uptake in children under age 2.
A new pentavalent meningococcal vaccine, combining two existing vaccines into one, was also discussed — a vaccine which, according to Nass, “is not needed.” No discussion of the safety of the existing meningitis vaccines took place at the meeting, Nass said.
Also on ACIP’s agenda was a recommendation under consideration for a single polio shot for all individuals who are unsure whether they were fully vaccinated as children or who expect to visit high-risk environments. Again, no decisions were made.
Vaccines for dengue and chikungunya — two mosquito-borne diseases which are rare in the U.S. — were also discussed by ACIP, with no outcome arising from the meeting.
Reactogenicity got magically turned into safety, and safety got thrown away’
ACIP also voted 14-0 that it is no longer necessary for individuals with egg allergies to receive their flu vaccine in a medical setting, noting that “immunization best practice guidelines already call for all vaccine providers to be equipped to handle anaphylaxis,” as reported by the American Academy of Pediatrics (AAP).
“Any flu vaccine appropriate for the person’s age and health status can be used regardless of whether it is egg-based,” AAP stated. This decision awaits CDC approval.
“CDC has been trying to get rid of vaccine contraindications for the past five years, despite lack of supportive evidence,” Nass said. Following ACIP’s vote, “egg allergies as a contraindication or precaution for flu shots is about to disappear.”
Nass told The Defender that while “there used to be three things a vaccine had to be tested for — purity, potency and safety,” safety has now “morphed into sterility” — meaning it doesn’t contain “outside germs,” according to a new definition from the U.S. Department of Health and Human Services.
“There used to be a word — reactogenicity — for acute reactions to a vaccine,” Nass said, referring to the physical manifestation of the body’s inflammatory response to vaccination. She also noted that “safety” was “primarily concerned with longer-term or non-resolving side effects,” including “serious side effects.”
“But reactogenicity got magically turned into safety, and safety got thrown away.”