by: David Gutierrez, staff writer
The industry is working with the FDA to create new rules to test and develop vaccines designed to be given to pregnant women, in order to pass antibodies on to their unborn infants. The fact that this protection would only be short-term is not viewed as a problem.
Indeed, the industry is elated at the possibility to start vaccinating – via their mothers – babies too young to receive traditional vaccines.
Industry senses new opportunity
The concept of maternal vaccination targeting the infant immune system is not a new one. As far back as the 1960s, researchers were working on such a vaccine against respiratory syncytial virus (RSV) – a common and mostly harmless infection that nearly everyone gets by age 2, and that is usually only dangerous for premature infants or babies with other health problems. Companies had soured on the idea of developing an RSV vaccine for newborns after the original RSV vaccine was actually found to increase children’s vulnerability to the disease, and caused two deaths.
But companies also worried that vaccinating pregnant women would not go over well with the public.
“The companies had some concerns about the use of maternal vaccines in a litigious society,” said immunization researcher Ruth Karron of Johns Hopkins University.
In recent years, however, pregnant women seem to have become more accepting of getting vaccines.
“We really had a sea change in the U.S. in terms of pregnant women getting the flu vaccine,” said Anne Schuchat of the Centers for Disease Control and Prevention (CDC).
The industry traces the start of this trend to the 2009 swine flu pandemic, and to later vaccination campaigns during pertussis (whooping cough) outbreaks.
In spite of CDC recommendations, most vaccines – including flu and Tdap vaccines – have not been proven safe for pregnant women. Just take a look at the FDA package inserts.
FDA colluding with shady research
The industry is looking to change that, by lobbying the FDA for a change in regulations that have made it difficult to test drugs on pregnant women.
“We are open to discussing alternative trial designs and alternative endpoints,” said Marion Gruber, director of the FDA’s Office of Vaccines Research and Review.
Now major vaccine companies, including GlaxoSmithKline, Novavax and Pfizer are working on various maternal vaccines, including for RSV and for Group B Strep (GBS). They hope that these vaccines will someday be administered routinely during pregnancy.
Research for a GBS vaccine has posed problems, since pregnant women in the United States are regularly given antibiotics if they test positive for GBS – even though research has shown that this practice contributes to antibiotic resistance, may harm children’s developing microbiomes, and provides little or no health benefit to the babies it is meant to help. This means that there isn’t much of a population to test a GBS vaccine on.
So, GlaxoSmithKline is instead carrying out trials on women in sub-Saharan Africa. The FDA has promised to accept the results, even though the followup methodology has been blasted as flawed.
“Many of [these women] don’t deliver in a hospital,” said Laura Riley, vice chair of obstetrics at Massachusetts General Hospital. “You can’t just go vaccinating people and not know the outcome.”
While pregnant women have a strong and understandable desire to protect their infants, the evidence still shows that the single best way to protect a child from disease is to breastfeed (or to feed pumped breast milk out of a bottle). Breast milk contains antibodies, immune factors, enzymes and white blood cells that help a child fight off infection. Breastfeeding is even linked to lower lifetime rates of non-infectious diseases, including leukemia and diabetes.
Of course, a mother should be sure to keep her own immune system in top shape to provide maximum protection through her milk. One way to support whole-body health is by consuming superfoods such as spirulina.
Sources for this article include: