The world’s largest global health conference is expected to be full of optimism, but as the first major vaccine trial in more than a decade enters its final stages, a growing chorus of Western medical experts is warning that the vaccine may not work as promised.
“I think it’s safe to say that there are some issues with the study,” said Dr. Robert Lustig, a gastroenterologist and president of the American Academy of Family Physicians.
“The vaccine itself was well-designed, but there were some things that we didn’t understand, and I think there’s going to be a lot of questions that are going to emerge,” he said.
In a letter to the American Public Health Association, the World Health Organization, the European Union, the U.S. Centers for Disease Control and Prevention, and others, Lustig says a study he led showed that the ULA vaccine produced no significant increase in the incidence of vaccine-preventable disease in patients.
That study, which was completed in 2012 and was published in the New England Journal of Medicine, found that the average number of doses administered to patients during the trial was roughly 4.6, compared to the 6.4 doses administered during the previous year.
The average number administered during a previous year was 3.3, but the researchers reported that the vaccinated population increased in size from 3.1 million in 2013 to 4.4 million in 2015.
Lustig said he and his colleagues didn’t want to be “shocked and confused” if the vaccine actually did work.
“If the study showed that there was some positive effect, then I would have thought that there would be an increased number of patients,” Lustig told Newsweek.
But that’s not what the study reported.
Instead, Lustigs study found that while the vaccinated group showed an average increase in mortality of 0.05 per 100,000 doses administered, the vaccinated patients showed an increase of 0 (or, to be more precise, 0.12 deaths per 100 vaccinated patients) per 100.
The number of deaths is a measure of the incidence that occurs during the course of a disease, and the number of infections.
So, the difference between the two groups was very small, but it was still statistically significant.
Lustigs data was based on the population of a hospital in the United Kingdom, and it was based off the same cohort of patients who received the UMA vaccine.
But because the vaccine was designed in a way to be administered to all patients at the same time, the study included only the vaccinated subjects.
In order to obtain the results that the study report, Lustiger and his team took two years of follow-up data from each of the 523,000 patients in the trial.
They also gathered information from the patient’s physician and other health professionals who evaluated them, and also from the hospitals that treated the patients.
Lustiger said that he’s confident that the results were reliable.
“We didn’t use any randomization, we just looked at the data that we had,” Lustiger told Newsweek via email.
“As you can imagine, it’s very difficult to compare outcomes across different studies.
So I am confident that we could get a statistically significant result, but I think it would be hard to say at this point if it’s going, or not going, to show up in a larger population.”
The study that Lustig and his coauthors analyzed showed that among the vaccinated, the average dose of the vaccine increased the risk of death by 0.3 percent.
But among the unvaccinated, the overall risk of deaths increased by just 0.1 percent.
While the vaccine itself wasn’t significantly associated with any increase in death, Lustigen and his fellow researchers concluded that the safety and efficacy of the UmaS vaccine was “not well established.”
They added that they were concerned that the overall vaccine safety was still being evaluated, and that “we would expect to see the effect of the vaccination decline with age and as a consequence of the increasing number of vaccines.”
Lustig’s letter was published Monday in the journal PLOS ONE.
Lustigen told Newsweek that he did not receive any compensation for his work on the Umas vaccine, and he has not been compensated by the American or European vaccine makers.
In response to the letter, the American Society of Gastroenterology issued a statement saying, “The World Health organization recognizes that the trial of the Vaccine for All is the first step toward the first phase of a vaccine trial.”
The statement also called on the vaccine makers to publish more information about the safety of the trial, and called for more public awareness of the study, as well as increased funding for vaccine safety studies.
A number of studies have been published since Lustig conducted his study, but Lustig maintains that he was not involved in any of them.
In an email to Newsweek, Lustige said that his study was “considered in a scientific context and the authors and I agreed to publish our findings in order to avoid controversy