You’re about to find out whether you’re vaccinated against one of the 20 most common and deadly childhood diseases. That’s because the Federal Drug Administration on Tuesday said it will begin accepting applications for clinical trials that will evaluate whether certain forms of so-called “cell-based” vaccine should be recommended for use against mumps, rubella, and chickenpox.
Although vaccines for those three diseases are routinely used in the United States, a study from the Pew Research Center released on Monday showed only about one-third of Americans now routinely receive the shots.
“The urgency with which the FDA is reacting underscores just how serious this situation has become,” the study’s lead author Jessica Schmalz said in a statement. In another part of the survey, Pew found that just 47 percent of Americans know it is legal for adults to buy all of the personal-use unapproved drugs available. Another 43 percent are unaware of the availability of those “unapproved drugs.”
About eight in 10 people said they support vaccinating children against the mumps, rubella, and chickenpox. They also have a high opinion of the safety of the rubella and mumps vaccines, and of chickenpox vaccine. Schmalz said people’s opinions regarding vaccination will be important when the FDA starts accepting vaccine applications next week.
The new cell-based vaccine is based on human cells created in a laboratory and injected into a person’s mouth. “It’s pretty simple,” says Dr. William Schaffner, professor of preventive medicine at Vanderbilt University. However, the method of vaccination has two problems.
First, it only works with certain diseases. For rubella, it should only be given to children, teens, and adults born before 1946. For varicella, chickenpox, children, teens, and adults who were born before 1957 should not get the vaccine. Schaffner says it is difficult to get an exact number of people living in the United States born before 1957. In addition, it can be difficult to test people for the varicella virus, which causes chickenpox, in large numbers to make sure the vaccine is working.
Second, cell-based vaccines are expensive, costing about $2,000 per dose. That’s much more expensive than the $80 to $120 cost of intramuscular vaccines. It’s easy to understand why the population as a whole is not consistently getting the mumps, rubella, and chickenpox vaccinations.
Nevertheless, Schaffner believes the cell-based vaccines could actually work better than intramuscular. In large trials that led to the vaccine approval for mumps, rubella, and chickenpox, one in four people received the vaccine despite having low immunity from previous infections. Schaffner says scientists have gotten pretty good at detecting if a person has an immunological response to a certain virus, even if a single infected person might present with one virus, or you might not detect immune response if a person develops colds.
The research indicates that an active response to the cell-based vaccine would show up, but Schaffner says that doesn’t mean the cell-based vaccine will be a good option. He thinks doctors will mostly want to go with intramuscular, since it comes with a unique ability to identify someone when they’re sick. It will have a more rapid response to infectious diseases and can be used in the community — perhaps more quickly than a cell-based vaccine.
Schaffner worries that mob mentality could result in unanticipated reactions by the medical community. “When they see an epidemic that isn’t predicted, they expect to have to chase,” he says. “They’re going to have to care about life-and-death situations.” Schaffner also worries that people not in the medical field will be lurching forward with vaccines without understanding the risks. “Many medical personnel are very careful, but they’re not thinking about this,” he says. “This is happening without asking the right questions.”
For a few more years at least, vaccinating children against the three diseases will be necessary. Vaccination programs that require children to get their shots at a specific time are not allowed under state or federal law. These rules would need to be waived for children in the study, but for the first time after nearly four decades of vaccines, decisions about the best method of vaccination against each of these diseases will be made by the FDA.