Letter writer Jonathan Bakin (Leader, July 19) appears to acknowledge that there is a contradiction between the CDC [Centers for Disease Control and Prevention] recommendations regarding the flu …
Letter writer Jonathan Bakin (Leader, July 19) appears to acknowledge that there is a contradiction between the CDC [Centers for Disease Control and Prevention] recommendations regarding the flu vaccine and the MSDS (material data safety sheet) from the manufacturer, which sheet is vetted by the U.S. Federal Drug Administration. Then he suggests that accepting one set of materials over the other represents “believ[ing] in science … [or] in tin foil.”
If I choose to follow what the FDA has vetted and the manufacturer has stipulated, have I left the realm of science or has the CDC?
Here’s another example: The Jefferson County Community Health Improvement Plan, dated Oct. 21, 2016, page 12 (on page 19 of the printed plan) includes the immunization strategic results framework that calls for 100 percent of pregnant women to receive the Tdap in the third trimester of pregnancy by 2020.
I have reviewed four FDA-approved manufacturer Tdap package inserts that appear to be current. Each one includes some variation of the following: There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, (blank) product (blank) should be given to a pregnant woman only if clearly needed.
So, in the interest of informed consent, should Jefferson County promote the Tdap vaccine to 100 percent of pregnant women in the admitted absence of “adequate and well-controlled studies in pregnant women,” a statement agreed to by the manufacturer and vetted and approved by the U.S. FDA?