Vaccines,
Vaccine Deployment, and “New Vaccines”
(LSF SPECIAL REPORT ON VACCINATION)
August 2025
Part 4 of 5 Thursday 28th August
Introduction to Part 4
Readers
who have followed the first three serials of this Special Report will by now
have gotten a fair grasp of the important differences between the three
concepts of Vaccines, Vaccine Deployment, and “New Vaccines”. Vaccines, just like any other human
invention, are never going to be perfect.
Nevertheless, this cannot detract from their huge benefits to mankind –
when appropriately deployed. So far, we
have seen consistently sharp differences in the formats for deploying vaccines
in the developed countries versus the developing ones, In general, the products
used in the developing countries are largely PROSCRIBED for use in the
developed ones. Worse still, developing
countries are compelled to be dependent on the West for even those products –
no matter the quality, no matter the asking price.
Malaria
vaccines, by the very nature of the problem they address, are obviously meant
for mass deployment in sub-Sahara Africa, specifically Nigeria, the infamous
malaria capital of the world. These
vaccines are one of the two case studies considered in this fourth and
penultimate serial.
Many
readers will be shocked to learn that despite well-advertised minimal efficacy
(of much less than 50%, and lasting only about 7 months); huge deployment cost
of between $12 – $20 per full dosage of 4-5 doses; and the scandalously
concealed safety concerns that cropped up during the clinical trials, the
manufacturers still insist that this product must be included in the routine
childhood schedule for mass deployment in Nigeria. Troubling, though not surprising, the
government has proudly announced her compliance with this “directive”.
The other
vaccine discussed in this serial is the HPV vaccine produced to address
cervical cancers. The vaccine is purposively designed to (proactively) help
women, who while very young, had been introduced to early sexual activities,
with multiple partners. In the best-case scenario therefore, this product can
only benefit a specific at-risk population.
It is therefore unwarranted that the inevitable health risk associated
with its use should be spread to the general population by administering it en
masse, indiscriminately. Sadly, the only
discrimination that persists, is that in the actual products used in Africa and
the rest of the western world. In short, we don’t use the same vaccines as the
countries producing the vaccines.
We expect every
literate Nigerian reading all these to be outraged as we are, concerning these
developments. There is nothing
“anti-vaxxer” in expressing these concerns and sharing this Report. Please do!
iv.
Malaria Vaccine
We wrote a
comprehensive article on the malaria vaccine at its debut in Nigeria in 2023. [24].
Interestingly, the NAFDAC had condemned the RTS,S vaccine endorsed by the
Federal Ministry of Health, rather routing for the R21 vaccine which had been
ignored by the Ministry. Both vaccines, however, are based essentially on the
same principles and materials. Both target the pre-erythrocytic
phase of malaria, using the same key antigen - the Circumsporozoite Protein
(CSP) - albeit in different concentrations, and with different adjuvants.
In the
article, it is shown from hard records that the newly touted malaria vaccines
were indeed developed for short-term visitors from the outside world to
malaria-endemic zones (specifically military personnel and
tourists). A strong market in sub-sahara Africa is however required
to make their production economically viable!
Stated efficacy
of the vaccine is generally between 30 – 40% with duration of less than 7
months. Particularly concerning were
safety issues. It is sad but noteworthy that the World Health
Organization was found culpable of hiding adverse effects observed during
clinical trials in a clearly desperate effort to promote this vaccine. The
adverse effects included “a ten times higher rate of meningitis, a higher
chance of cerebral malaria, and a doubling of deaths from all causes in girls
who had received the vaccine and not the placebo.”[25]. Sadly, these issues are yet to be
transparently resolved [26].
Notwithstanding
all these serious deficits, we still recognize that these products of
decades-long hard work by dedicated scientists might still be literally
life-savers for some categories of people.
We therefore endorsed the vaccines with the caution that it should be
deployed strictly in line with their actual characteristics. We particularly recommended that it be made
clear to people (particularly the press!) that at less than 50% efficacy, the
vaccines are no silver bullets; and that government should not attempt to
incorporate them into the list of essential vaccines to be vigorously
recommended for the masses – as the marketers had bluntly demanded! [27] Unfortunately, these counsels have gone unheeded,
and the malaria vaccine is now incorporated into childhood vaccine schedule in
several regions of Nigeria [28] A 2013
Report by the Parliament of India, investigating the deaths of several girls in
the shoddy clinical trials (dubiously dubbed “observational study”) of HPV
vaccine in India, noted that once a vaccine got included in the universal
immunization programme of a country, the manufacturer(s) are guaranteed
“windfall profit, … by way of automatic sale, year after year, without any
promotional or marketing expenses.” It
further noted that “once introduced into the immunization programme it becomes
politically impossible to stop any vaccination”.[29]
v. HPV Vaccine
It is generally held that cervical
cancer, causing an estimated 8,000 annual deaths in Nigeria, is associated with
infection by the human papillomavirus (HPV). However, although the infection by
HPV definitely leads to warts which could progress to cervical cancer after
about 15 - 20 years, if left untreated; the pathway is not at all
straightforward, and the rationale for mass vaccination as the solution for
cervical cancer has been vigorously challenged (30, 31).
In 2006 Gavi announced a $600
million HPV initiative with the goal of vaccinating 86 million girls in
low- and middle-income countries by 2025.
In the estimation of Gavi, the exercise will somehow avert “over 1.4 million future
deaths” (32). Several assumptions used to arrive
at these figures are clearly faulty.
First, HPV is a sexually
transmitted infection, with the virus present at some point in time in up to
90% of anyone who has ever had sex.
However, the infection is naturally cleared in over 99% of people who
get it. Progression to cancer only
occurs if this infection persists, is undetected, and consequently left
untreated for a period of over a decade.
A number of simple laboratory tests, including the pap smear test,
regularly taken every three years could however reveal such HPV infection and
available effective treatments applied.
This looks like the straightforward approach to dealing with cervical
cancer, rather than the global mass vaccination solution concocted by the GAVI.
This is especially so, since there have
been numerous serious adverse effects associated with the vaccine. The medical
literature from across various regions of the world is full of these adverse
effects, which can be summarized under two broad categories: premature ovarian failure (leading,
of course, to various reproductive issues) (33); and serious neurological and autoimmune disorders
(34). Other, rarer adverse effects
include veinous blood clots,
kidney issues, and even death (35). In
the US, the federal Vaccine Injury Compensation Program has paid
out more than $70 million to
people making claims regarding for injuries arising from HPV vaccines (36).
These adverse events are
known to be inevitable. Deliberately embracing them in mass vaccination events
offering spurious benefits is therefore quite incredible. According to Lyons-Weiler of the Institute for Pure and Applied Knowledge (37):
“In
2009, we were told the Severe Adverse Event [SAE] rate of HPV vaccines was
6.5%. But a study we published in Science, Public Health
Policy & The Law showed that the adverse events
profile of the HPV vaccine is far worse than has been reported…..Unleashing
this vaccine on millions of girls and young women will lead to a mass casualty
event these countries do not now have, and do not need. SAE’s will occur at the
rate of 65,000 per million women vaccinated, and the claimed net benefits of
the vaccine are just not there.”
Then again come the very concerning
technical issues surrounding the vaccine types itself. First of all, as is
becoming the trend, the particular vaccines shipped for use in LMIC are
different from those in use in the first-world countries. Actually, they are essentially products that
have been tested and discarded (or even proscribed) in the first-world
countries, but are expected to be managed by LMICs – supposedly for an interim
period - due to economic reasons. There are about 150 strains of HPV, with two of
them, strains 16 and 18, responsible for about 70% of warts that could lead to
cervical cancer, globally. However, the
contribution of the different strains to cervical cancer is not uniform all
across the globe, and there are significant regional variations. [In Nigeria,
the major strains are 16,18,31,35,51,52, with the first two responsible for
about 67% of cancerous warts].
Currently, the only
vaccine used in the US is the nonavalent Gardasil-9 which targets 9 strains of
HPV, with two or three doses, according to ages of the recipients (38). In Nigeria however, the recommended vaccine is
the Gardasil-4 quadrivalent HPV vaccine targeting only 4 strains [6, 11, 16
and 18]. On roll-out, the vaccine was to be administered in three doses to
achieve the nominal efficacy indicated during its development. However, at the present time, the WHO has determined
that one dose will suffice (39). It is troubling that the main
reason for this new protocol seems to be a desire to enroll as many
participants from the LMICs into the vaccination programme, with little concern
for the health outcomes. Indeed, a WHO Press Release hailing the revised
protocols, specifically related them with a “goal of having 90 per cent of
girls vaccinated by the age of 15 by 2030.”
(40)
Apart from the safety issues previously
mentioned, there is also a big technical question on the long-term efficacy of
the vaccine solution for HPV infections and cervical cancer. This arises from studies indicating that
while the vaccine might indeed reduce the prevalence of the target strains of
HPV, they could end up increasing the prevalence of other more virulent,
previously non-target strains. These
also could end up contributing to cervical cancer! This phenomenon is known as HPV-type replacement (41).
It is therefore not
at all surprising reports indicating that despite two decades of global mass
HPV vaccination campaign, there is no significant reduction in incidences of
cervical cancers. Indeed, in some
populations, there are reports of increased incidences of cervical cancer in
the vaccinated compared with the unvaccinated (42).
An extensive review
of mass HPV vaccination written by the US-based Children’s Health Defense (CHD)
featured some specific comments on the programme in Nigeria. In the report (37), Michael
Baum, an attorney representing vaccine-injured plaintiffs in several lawsuits
against Merck in the US was quoted:
“U.S.
data makes it clear that vaccinating millions of Nigerian girls with Gardasil
will cause a staggering number of serious adverse events, including death.”
Similarly, Kim Mack Rosenberg, co-author of “The HPV Vaccine
on Trial” said:
“Having
studied the HPV vaccines in depth for several years, I am profoundly concerned
about Nigeria’s mass vaccination campaign. Instead of vaccinating millions of
girls, steps should be taken to reduce risk factors that may contribute to
cervical cancer, including early pregnancy and multiple pregnancies, poor
nutrition and poor nutritional status, lack of access to clean cooking fuels,
and others.”
Sexual intercourse at a young age, multiple sexual partners, and oral contraceptive use are other well-established risk
factors associated with cervical cancer. (43, 44, 45)
26. Benn
C.S. (2020) WHO’s rollout of malaria vaccine in Africa: can safety questions be
answered after only 24 months? https://www.bmj.com/content/368/bmj.l6920
27.
https://www.malariavaccine.org/resources/reports/rtssas01-malaria-vaccine-technical-brief
28.
https://www.instagram.com/nphcda/p/DC1ttnpItDy/?hl=en
29. Report 72, 2013: Seventy-Second Report on
Alleged Irregularities in the Conduct of Studies Using Human Papilloma Virus
(HPV) Vaccine by PATH In India. Published by the Department-Related
Parliamentary Standing Committee.
30. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5691619/
31. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3482043/#!po=37.5000
33.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4528880/
https://childrenshealthdefense.org/defender/hpv-vaccine-safety-concerns-part-1-et/
34
https://www.sciencedirect.com/science/article/pii/S0264410X17308071
36
https://childrenshealthdefense.org/defender/injured-merck-gardasil-hpv-vaccine-case/
37. https://childrenshealthdefense.org/defender/truth-hpv-vaccine-part-3-et/
38.
https://www.cdc.gov/vaccines/vpd/hpv/public/index.html].
41. https://www.tandfonline.com/doi/pdf/10.1080/21645515.2015.1066948
43. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2670004/
44. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7377087/
