Cameroon this week launched a campaign to vaccinate 250,000 babies, beginning at age 6 months, with GlaxoSmithKline's malaria vaccine — a shot that even the Bill & Melinda Gates Foundation said won't work.
Cameroon this week became the world's first country
to routinely vaccinate children against malaria, using a shot that's only 30% effective and doesn't stop transmission.
The country plans to give the vaccine — known as Mosquirix
(RTS,S/AS01) — to about 250,000 children by the end of 2025. The GlaxoSmithKline-produced shot, recommended by the World Health Organization
(WHO), requires four doses and provides protection against severe illness caused by one type of malaria parasite.
Protection wanes over several months.
The first dose is given at age 6 months via an injection into the baby's thigh
. The second and third doses are given one and two months after the first injection, respectively. The fourth dose is given over a year later.Dr. Paul Thomas — a retired pediatrician who grew up in Africa — said eradicating malaria was a "worthy goal" but that this vaccine was "sure to fail.""You cannot eliminate malaria with a vaccine that does not prevent transmission and is only 30% effective," Thomas told The Defender. "Even Bill Gates — who loves vaccines and whose Gavi [the Vaccine Alliance] organization was behind the development of this vaccine — does not support this program."This vaccine will "clearly not protect or improve children's health," Thomas said. "[The rollout] is a futile and dangerous project that I feel strongly should be relegated to the scrap heap of failed ideas and programs."Shabnam Palesa Mohamed
, executive director of Children's Health Defense Africa, agreed, telling The Defender, "As an African, I am once again horrified at the colonialism of Africa through Big Pharma
, endorsed by the World Health Organization."
Mohamed pointed out that Mosquirix does not meet the WHO's goal
of having licensed malaria vaccines with efficacies of at least 75% by the year 2030. She said:"There is credible evidence to suggest that clean water and good sanitation, as well as medicines like artemesia and hydroxychloroquine are far more effective, safe and affordable in treating malaria.
"The African public and ethical leaders should take back health and sovereignty together."
After initially pouring more than $200 million to test the vaccine, the Bill & Melinda Gates Foundation
in July 2022 withdrew financial support because the shot had "a much lower efficacy than we would like," Philip Welkhoff, the Gates Foundation's director of malaria programs, told The Associated Press
.Although the Gates Foundation no longer funds the shot, it still funds Gavi, the organization providing the shot "free of charge" in Cameroon.
Roughly 19 other African countries
plan to follow Cameroon's lead by introducing the vaccine this year. With Gavi's help, those nations will likely immunize more than 6 million children through 2025, Gavi told NBC News.
Aurelia Nguyen, Gavi's chief program officer, said, "The vaccination will save lives. It will provide major relief to families and the country's health system."Will it save lives or increase mortality rates?There is no data supporting the assumption that Mosquirix will decrease, rather than increase, child mortality in Africa, according to Thomas, who analyzed the package insert describing the product's clinical trial results."The trials included the use of highly effective mosquito nets and all the vaccinated were also getting other vaccines. ... There was no placebo used," he said. "Side effects were extensive and this vaccine uses an adjuvant never before used for pediatric vaccines."
Based on what is reported in the package insert, it appears "They never bothered to look, or if they did, they have not reported the findings. It is clearly time we demand better clinical trials for vaccines," he said.
Given what is known and what remains unknown about the vaccine's safety, Thomas called it a "potentially dangerous product" that "should not be injected into any child.""All-cause mortality may actually increase for children who are given this vaccine.
We just don't have the data [from what the package insert makes public]," Thomas said.Clinical trials showed doubled female mortality
According to the package insert, Mosquirix's clinical trials showed kids who received three doses of the vaccine were more likely to get meningitis
:"In clinical studies, meningitis (any aetiology) has been reported more frequently in the group vaccinated with three doses of Mosquirix up to 20 months post dose 1 (27 cases out of 11,439 vaccinees) compared with the control group (4 cases out of 6,096 vaccinees). A causal relationship to the vaccine has not been established."
The control group for the Phase 3 trials was given a "comparator vaccine
," The Lancet
reported, but the report did not say what kind. A comparator
is "a specific drug ... with a similar indication and formulation as the treatment of interest."But the package insert failed to mention that the Phase 3 trials also found increased risk of cerebral malaria and doubled female mortality, as reported by the BMJ.Participants reported fever (27%), irritability (14%) and pain (16%) or swelling (7%) at the injection site after the third dose. Others (less than 10% but more than 1%) reported diarrhea and decreased appetite.A small fraction (0.1%) of trial participants fell into a febrile seizure within a week after getting one of the shots.
Moreover, a seven-year follow-up
in children who participated in the Phase 2 trial shows that the vaccine's efficacy had waned over time and that there was a rebound effect later on, especially in areas prone to malaria.WHO's earlier pilot lacked informed consent
Additionally, the WHO — in a pilot rollout of the vaccine in Malawi, Ghana and Kenya — committed a "serious breach
" of international ethical standards by failing to give informed consent to those involved, according to another BMJ report.
The BMJ said the WHO's randomized study involved 720,000 children, adding:
"WHO says the study is a 'pilot introduction' and not a 'research activity' — and that those children living in areas randomised to receive the new vaccine will do so as part of each country's routine vaccination schedule and that consent is 'implied.'
"An implied consent process means that recipients of the vaccine are not being informed that they are in a study.
"Instead, WHO says that information on vaccination is provided to the community and to parents through health talks and community outreach — among other methods — and parents who present for vaccination do so with the option to vaccinate their children or not."But Charles Weijer, a bioethicist at Western University in Canada, told The BMJ that the failure to obtain informed consent from parents whose children are taking part in the study violates the Ottawa Statement, a consensus statement on the ethics of cluster randomised trials."The vaccine's active substance is made up of proteins found in Plasmodium falciparum parasites and the hepatitis B virus, although the shot is not recommended for treating hepatitis B.
Upon vaccination, the child's immune system is expected to recognize the proteins from the parasite and virus as foreign and make antibodies against them.Plasmodium falciparum
parasites are commonly transmitted by mosquitoes.
More than 90% of all malaria cases
occur in sub-Saharan Africa, according to the WHO. The Centers for Disease Control and Prevention estimated 90% of deaths due to malaria
are in sub-Saharan Africa and that most of these deaths occur in children under 5 years of age.
The Gates Foundation co-founded Gavi and is one of its four permanent board members. UNICEF, the World Bank
and the WHO — whose second-largest donor is Gates
— hold the other permanent seats.
The Clinton Health Access Initiative
also sits on Gavi's board. The initiative last year teamed up with the Gates Foundation and the WHO to launch "The Big Catch-Up
," which they called the "largest childhood immunization effort ever."Suzanne Burdick, Ph.D., is a reporter and researcher for The Defender based in Fairfield, Iowa.