Prof. Lade Wosornu
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22nd November, 2011
“FIRST RESULTS OF PHASE 3 TRIAL OF MALARIA VACCINE IN AFRICAN CHILDREN”
Readers are aware that whenever it becomes needful for us to administer stiff dose of book-long stuff, we do not hesitate to do so. Today, we’ll sum up an article from NEJM, New England Journal of Medicine. It is one of the most prestigious journals on the planet.
The article in question was published by the journal on October 18, 2011. The results are on trial being conducted at 11 centers in seven African countries.
WHAT WE ALREADY KNOW
The article’s abstract opens like so. “Each year, malaria occurs in about 225 million persons worldwide. Of these, about 780,000 die. Most of the dead are African, and, children.” We know all that.
It continued. During the past decade, authorities have pulled up their collective socks to control the malaria scourge. So, surprise, surprise! Fewer kids are now dying from malaria in parts of Africa. But, malaria is not a flea to be swatted with a single broom. Big guns are required. We know that also.
Malaria vaccine re-enters the fray.
AN EXEMPLAR
The study itself is a model of excellence in terms of any measure of excellence in scientific research. Examples are: The design: randomised, controlled and “double-blind” trial. Blessings were received from ethical authorities, both national and institutional. Green light in the form of written consent received from the kids’ parents or guardians. Statistical analyses were sound.
Definition of terms were agreed. The job which the vaccine was designed to do is called the “primary efficacy end point”. It is “attacks of clinical malaria and severe malaria.” Clinical malaria was defined as follows: An illness in a child with fever of 37.5°C or higher, and in whom a certain number of malaria parasites were found. Severe malaria, safety features and complications were defined. Verbal autopsies were held. Laboratory and radiologic procedures were prescribed.
NO ORPHAN
The trial was a spoiled child. It was not at all an impecunious orphan. It received close supervision. [Known in some quarters as “study oversight”]. A rich company, Glaxo-Smith-Kline Biologicals (GSK) was the father of the project. GSK developed and manufactured the vaccine.
Next, the trial was sponsored and funded by GSK and wealthy agencies: Program for Appropriate Technology in Health (PATH) and the “Malaria Vaccine Initiative [MVI]. As if that was not enough, an even wealthier big hitter weighed in. The name is the Bill and Melinda Gates Foundation. That is wealth indeed!
KEEP ALL JOINTS OILED
All study centers received dough from the MVI. It also provided cash for authors’ travel as well as their board and lodging. Finally, ethically, the manuscript was squeaky clean.
MURPHY’S 11TH COMMANDMENT
However, we had a fly in the ointment. The mythical 11th commandment did its thing: “If it can go wrong, it will go wrong.” So, believe it or not, check out these three facts. (1) This study had been the most pampered. (2). It was conducted with rigorous standardization among the research centers. (3) It provided a high standard of clinical care.
All the same, in one of the research centers, the vaccines were exposed to the wrath of the African sun. They met temperatures outside the recommended range! Some of the data were thrown out of the window.
DOES THE VACCINE WORK?
And, so we come to the results. The first 6000 children 5 to 17 months of age at enrollment were included in this report.
Please read with care. This is how the NEJM put it in its abstract. The vaccine, “deployed in combination with current malaria-control tools, could play an important role in future control and eventual elimination of malaria in Africa”.
COMPLICATIONS
Complication occurred. Examples are fits or seizures, high fever, and muscle infection. All children who had seizures related to the vaccine recovered from the acute event. However, epilepsy subsequently developed in one child.
Meningitis was reported more frequently in the vaccine group than in the control group.
DEATH?
Similar proportions of children died in each study group. The vaccine failed to make a difference in the number of deaths.
INITIAL EUPHORIA
The malaria vaccine reduced clinical episodes of malaria and severe malaria by half during the 12 months after vaccination in the kids was reported. These findings are robust. They are consistent with earlier results. So far, so good.
BUT, WILL IT LAST?
An inconvenient truth emerged. The level of protection provided by vaccine to these 6000 kids was lower at the end of the 12-month than shortly after vaccination. This truth erected a tower of Babel. Some studies suggest that the protection given by the vaccine lasts and lasts. Others say that the protection evaporates like dew at sun rise!
HIDDEN MEANING
Firstly, the vaccine is designed to attack in a pack. It will be used “in combination with malaria-control tools.” Secondly, it is not expected to be rushed into service here and now. It “could play role in future control.” Thirdly, please note the apologetic word: “could”. Fourthly, there is “decreasing protection over time.” Fifthly, will lives be saved?
WILL IT SAVE LIVES?
Here is the NEJM version of the truth concerning malaria-specific death. “Despite the vaccine efficacy against severe malaria, we did NOT observe a reduction in the rate of death from malaria or from any cause in the vaccine group.”
So, let us ask again. Will the vaccine reported in the prestigious NEJM save the life of your son or my grand child? In plain words, the answer is “N” ‘O”, no!
The article in question was published by the journal on October 18, 2011. The results are on trial being conducted at 11 centers in seven African countries.
WHAT WE ALREADY KNOW
The article’s abstract opens like so. “Each year, malaria occurs in about 225 million persons worldwide. Of these, about 780,000 die. Most of the dead are African, and, children.” We know all that.
It continued. During the past decade, authorities have pulled up their collective socks to control the malaria scourge. So, surprise, surprise! Fewer kids are now dying from malaria in parts of Africa. But, malaria is not a flea to be swatted with a single broom. Big guns are required. We know that also.
Malaria vaccine re-enters the fray.
AN EXEMPLAR
The study itself is a model of excellence in terms of any measure of excellence in scientific research. Examples are: The design: randomised, controlled and “double-blind” trial. Blessings were received from ethical authorities, both national and institutional. Green light in the form of written consent received from the kids’ parents or guardians. Statistical analyses were sound.
Definition of terms were agreed. The job which the vaccine was designed to do is called the “primary efficacy end point”. It is “attacks of clinical malaria and severe malaria.” Clinical malaria was defined as follows: An illness in a child with fever of 37.5°C or higher, and in whom a certain number of malaria parasites were found. Severe malaria, safety features and complications were defined. Verbal autopsies were held. Laboratory and radiologic procedures were prescribed.
NO ORPHAN
The trial was a spoiled child. It was not at all an impecunious orphan. It received close supervision. [Known in some quarters as “study oversight”]. A rich company, Glaxo-Smith-Kline Biologicals (GSK) was the father of the project. GSK developed and manufactured the vaccine.
Next, the trial was sponsored and funded by GSK and wealthy agencies: Program for Appropriate Technology in Health (PATH) and the “Malaria Vaccine Initiative [MVI]. As if that was not enough, an even wealthier big hitter weighed in. The name is the Bill and Melinda Gates Foundation. That is wealth indeed!
KEEP ALL JOINTS OILED
All study centers received dough from the MVI. It also provided cash for authors’ travel as well as their board and lodging. Finally, ethically, the manuscript was squeaky clean.
MURPHY’S 11TH COMMANDMENT
However, we had a fly in the ointment. The mythical 11th commandment did its thing: “If it can go wrong, it will go wrong.” So, believe it or not, check out these three facts. (1) This study had been the most pampered. (2). It was conducted with rigorous standardization among the research centers. (3) It provided a high standard of clinical care.
All the same, in one of the research centers, the vaccines were exposed to the wrath of the African sun. They met temperatures outside the recommended range! Some of the data were thrown out of the window.
DOES THE VACCINE WORK?
And, so we come to the results. The first 6000 children 5 to 17 months of age at enrollment were included in this report.
Please read with care. This is how the NEJM put it in its abstract. The vaccine, “deployed in combination with current malaria-control tools, could play an important role in future control and eventual elimination of malaria in Africa”.
COMPLICATIONS
Complication occurred. Examples are fits or seizures, high fever, and muscle infection. All children who had seizures related to the vaccine recovered from the acute event. However, epilepsy subsequently developed in one child.
Meningitis was reported more frequently in the vaccine group than in the control group.
DEATH?
Similar proportions of children died in each study group. The vaccine failed to make a difference in the number of deaths.
INITIAL EUPHORIA
The malaria vaccine reduced clinical episodes of malaria and severe malaria by half during the 12 months after vaccination in the kids was reported. These findings are robust. They are consistent with earlier results. So far, so good.
BUT, WILL IT LAST?
An inconvenient truth emerged. The level of protection provided by vaccine to these 6000 kids was lower at the end of the 12-month than shortly after vaccination. This truth erected a tower of Babel. Some studies suggest that the protection given by the vaccine lasts and lasts. Others say that the protection evaporates like dew at sun rise!
HIDDEN MEANING
Firstly, the vaccine is designed to attack in a pack. It will be used “in combination with malaria-control tools.” Secondly, it is not expected to be rushed into service here and now. It “could play role in future control.” Thirdly, please note the apologetic word: “could”. Fourthly, there is “decreasing protection over time.” Fifthly, will lives be saved?
WILL IT SAVE LIVES?
Here is the NEJM version of the truth concerning malaria-specific death. “Despite the vaccine efficacy against severe malaria, we did NOT observe a reduction in the rate of death from malaria or from any cause in the vaccine group.”
So, let us ask again. Will the vaccine reported in the prestigious NEJM save the life of your son or my grand child? In plain words, the answer is “N” ‘O”, no!
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