Pregnant women are at about three times increased risk of ending up in the hospital in an ICU, and about twice as high chances of being on a ventilator when they get COVID, compared to non-pregnant women.So, it's serious.
The other thing that can happen with COVID during pregnancy is the illness itself can induce preterm delivery and then you'd have a premature baby, which could have complications. So we think it's very important for pregnant women to be protected against COVID.
So in the clinical studies, the large Phase 3 studies that were performed prior to the data being submitted to the FDA for the Emergency Use Authorization, all the manufacturers did these studies and they tried to exclude women who were pregnant or breastfeeding just because there wasn't any data on that. And there was little known and everybody's scared of things that could happen during pregnancy or during breastfeeding.
However, during those studies, some women, either the screening missed them and they were enrolled in the studies or they became pregnant during the study. So there are a handful of women that did become pregnant and some who were breastfeeding during those vaccine studies, and what all the manufacturers found is; no signal that there was any danger to the fetus, nothing unusual between the vaccine group and the placebo groups in terms of the pregnancies and the pregnancy outcomes. In addition to that, the manufacturers have done studies in animals who were pregnant or getting pregnant. And again, giving even twice the equivalent dose, the human equivalent dose, to animals did not result in any dangers that occurred during pregnancy.
So theoretically, these vaccines are very similar to inactivated vaccines that women already get. So we know that they're novel technology with the messenger RNA (mRNA) and the adenovirus DNA vector, but the end result is just a protein-based vaccine, which is very similar to what women already receive during pregnancy, Tdap vaccine (Tetanus, Diphtheria, Pertusis) and influenza vaccine, which are recommended. They protect the mother and they protect the newborn too. So we can say that the CDC, who is very conservative and has recommendations that are considered permissive, that women who have the vaccine available to them, who are pregnant or breastfeeding, may choose to be vaccinated.
It's important, not only for those women to be studied to make sure that it's safe and effective, but on balance, that since COVID can be more serious in women who are pregnant, it is recommended that they should be vaccinated. And that's what one should counsel women, is to strongly consider getting vaccinated. So, researchers don't think that any of the current vaccines will be transmitted through the placenta to the baby. So the baby won't have an immune response. And they don't think that it's going to be dangerous to the baby either. But the mother, of course, we hope that she forms antibodies, and in response to being vaccinated, and those antibodies are transmitted across the placenta and they may protect the baby.
It is not necessary that vaccinated women would have the vaccine itself, any part of the vaccine, be transferred via breast milk to the breastfeeding infant. However, if this does occur, presumably it would be totally degraded in the child's stomach, with the acid and digestive enzymes. So the child wouldn't get exposed to it in a meaningful way. It can be assumed that the child would benefit either from being exposed to a mother who's breastfeeding and been vaccinated, so they won't get any of that vaccine dose.