>> Advisors divided on one aspect of new RSV vaccine
>> Blood test for a pregnancy complication
The Med & Mic™ 05.19.23
MED NEWS blog post from Dr. Maria ON Speaking, LLC
RSV Vaccine: Advisors Split on Safety
The FDA’s advisory panel voted unanimously that a new RSV vaccine given to pregnant mothers to protect babies is effective. However, the committee split 10-4 on safety. More premature births were noted in the vaccine arm of Pfizer's studies, but the difference was not statistically significant. The four members who voted no did not think Pfizer had generated enough data to answer the safety question. Rival drug company Glaxo Smith Klein stopped its work on a maternal RSV vaccine because of an increased rate of preterm births. (Source: STAT News, H. Branswell, 5.18.23)
Blood Test for Preeclampsia
The FDA has cleared a blood test to detect preeclampsia, a complication of pregnancy. The condition is marked by high blood pressure in the second half of pregnancy and affects 1 in 25 pregnancies. The clearance is based on data from more than 700 pregnant women in 18 U.S. hospitals. (Source: Reuters, K. Mandowara, 5.19.23)
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