Health experts say there is “a real danger” of a vaccine-preventable illness following the first dose, but the agency appears to have taken the risk lightly.
The National Institutes of Health (NIH) recently announced that the first doses of the pneumococcal conjugate vaccine (PCV-7) would be available in early 2018.
While there have been no known cases of the vaccine-causing disease in the U.S., experts say the potential for the vaccine to be contaminated is high.
The announcement came after a study by researchers at the Johns Hopkins University School of Medicine found that a similar study in France had been retracted, but did not mention the UK vaccine study, according to Reuters.
The study found that people in France who received the vaccine in late 2015 were six times more likely to get pneumonia, a serious infection that can be fatal.
That’s compared to people in the United States who received it in January 2016.
“We do not yet know whether the vaccine is safe and effective,” the study’s lead author Dr. Emmanuelle Charest told the Associated Press.
“But we know the risks are very low.”
The researchers found that the vaccine had an efficacy of about 70 percent, which is far higher than the 20 percent effectiveness of the standard PCV-9 vaccine.
“This is a major risk that the FDA should take into account,” Dr. David Kessler, director of the Center for Disease Control and Prevention’s Immunization Safety Office, told Reuters.
“I think they need to be very careful.”
Dr. Kessler noted that some of the risks associated with the PCV vaccines include the risk of serious side effects, including an increased risk of pneumonia, and that there’s no known link between PCV and the coronavirus.
“The risks to the public are extremely low,” Kessler said.
“The risk is very low that we can avoid it.”
A statement released by the NIH on Friday said that the new study “did not identify a causal association between vaccine exposure and adverse outcomes.”
The NIH said that while the study was unable to determine whether PCV caused a specific illness or whether it was caused by the vaccine, it found that there was “an association” between vaccine and serious outcomes, including pneumonia.
“These findings are consistent with prior studies and indicate a need for further study to confirm these findings,” the NIH statement said.