Iona Munjal, MD
Executive Director, Vaccine Research & Development, Pfizer
Maternal immunization is a crucial health intervention because it can help protect newborn infants — whose immune systems are not yet sufficiently developed — from day one.
Iona Munjal is a doctor who has experienced infant illness firsthand. She’s also a mother. Both roles inform the work she does as Executive Director, Vaccine Research and Development at Pfizer. She is passionately committed to researching and developing breakthrough maternal vaccines that have the potential to protect and make a life-changing difference in the health of newborn babies.
Babies may benefit from maternal immunization
Maternal immunization — vaccinating pregnant women to help protect the health of their babies from their very first breath — is a vital intervention, explains Dr. Munjal. “Infants are most vulnerable to sickness when they’re first born, because they don’t have a developed immune system and may not be able to capably fight off infections,” she says.
“Infant immunization schedules typically begin when a child is two months old. But maternal immunization is a gift that can help protect the infants before they are fully immunized.”
Sometimes, nature steps in and equips infants with immunity against certain illnesses while they are still in the womb. Dr. Munjal points out that women who have had infections and have sufficiently high levels of antibodies naturally pass those antibodies (‘the fighting skills, so to speak’) via their placentas to their babies, thereby providing protection from becoming sick with those same infections.
With maternal immunization, modern medicine is simply taking a page out of Mother Nature’s playbook. “At Pfizer, we want to capitalize on the concept of passive protection transference by giving pregnant women vaccines for common infections that their babies might experience,” notes Dr. Munjal. “It’s a lovely idea for scientific research that piggybacks on a very important piece of evolutionary design and helps to protect the infant from illness from day one.”
Take advantage of existing maternal vaccines
Maternal vaccination is not new, however. The Tdap vaccine (tetanus, diphtheria, and pertussis) is already given to women to protect their newborns against pertussis (whooping cough), an illness that can have life-threatening complications.
Flu and COVID vaccines are also offered to protect the health of the mother. “We’re starting to head into winter and the flu season,” says Dr. Munjal. “So, if a flu vaccine is available and recommended by her doctor, then the vaccine has a dual role of protecting her — which is critical — and subsequently providing antibody protection to her unborn infant.”
I can’t think of anything more meaningful than bringing change via new vaccines.
Providing protection against pernicious illnesses
At Pfizer, Dr. Munjal and her team have been working on maternal vaccines to help protect infants against respiratory syncytial virus (RSV) and group B streptococcus (GBS). These are two particularly pernicious conditions, she explains. RSV is a contagious lower respiratory tract illness that is both extremely prevalent and potentially life-threatening for young infants. In the United States, approximately 500,000 to 600,000 infants experience lower respiratory tract disease due to RSV each year, and it is a leading cause of hospitalization in children less than one year of age. Meanwhile, GBS can cause potentially devastating diseases in infants, including sepsis, pneumonia, and meningitis. Pfizer hopes that maternal vaccination will help protect newborns and young infants from disease.
Recently, the U.S. Food and Drug Administration (FDA) approved the company’s RSV vaccine, for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth through six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age. The European Commission (EC) also granted marketing authorization for the company’s RSV vaccine for passive protection against LRTD caused by RSV in infants from birth through six months of age following maternal immunization during pregnancy. Additionally, the FDA and EC also approved the vaccine for active immunization of individuals 60 years of age and older for the prevention of LRTD caused by RSV.
Pfizer’s GBS vaccine candidate is currently in a Phase 2 clinical trial, and in July, positive efficacy and safety data from the study were published.
Bringing meaningful change
It’s no exaggeration to say that these immunizations — if they are both successfully developed and approved— could reduce parental and child misery and potentially prevent unnecessary deaths. Frankly, it’s about time that children were protected from such potentially devastating conditions says Dr. Munjal. “I can’t think of anything more meaningful than bringing change via new vaccines.”
It’s not just pregnant individuals and children in the first world who stand to benefit. In 2022, Pfizer announced a partnership with leaders from Rwanda, Ghana, Malawi, Senegal, Uganda, and the Bill & Melinda Gates Foundation to work towards sustained, equitable access to medicines and vaccines for 1.2 billion people living in 45 lower-income countries. The Bill & Melinda Gates Foundation has also provided support for the development and accessibility of the maternal RSV vaccine and GBS vaccine candidate in lower-income countries with grants totaling nearly US$128 million, including the development of a multidose vial for potential delivery of these vaccines in lower-income countries.
Infants are most vulnerable to sickness when they’re first born, because they don’t have a developed immune system and may not be able to capably fight off infections.
Maintaining a commitment to patient safety
Naturally, wherever in the world they are, mothers-to-be may be worried about the risks of maternal vaccinations. “We don’t want to negate the fact that shots can cause some discomfort at the site of the vaccination,” says Dr. Munjal. “No one likes getting shots. But what we’ve seen with maternal vaccines, is that reactogenicity — the way vaccines are tolerated — is quite good. So, most of the reactions that pregnant individuals tend to have are mild to moderate.”
During the research and development of vaccines, patient safety is the number one priority. “For this reason, Pfizer uses a three-tiered system in our clinical trials,” says Dr. Munjal. “First, we as a company, make sure that there are measures in place to record all safety events in the study.
Second, we work with clinical or academic researchers who actively monitor patient safety. Third, all patient data we collect are independently sent to and analyzed by outside groups, including regulators, like the FDA in the United States, so they can make their own safety assessment. Patient data are also sent to an independent external data monitoring committee, an advisory group of experts in the field which ensures all safety data is collected and duly analyzed.”
Tackling disease for pregnant individuals and infants
Vaccine development is the very opposite of easy, admits Dr. Munjal. But when the results are successful, ‘gratified’ doesn’t even begin to cover how she and her team feel. “Clinical studies of maternal and child populations, particularly infants, is a time-consuming and challenging thing to accomplish, but we’re committed to researching and developing innovative maternal vaccines,” she says.
“I’m proud to say that there’s now an option out there that could help reduce the burden of RSV. Then there’s our GBS study. If the vaccine candidate is successfully developed and approved, we could see it changing lives globally. That’s what we’re here for: to develop breakthroughs that change people’s lives.”
