New York State Public Health Law (PHL) § 2112 prohibits the administration of vaccines containing more than trace amounts of thimerosal, a mercury-containing preservative, to children less than 3 years of age and women who know they are pregnant, with certain exceptions described below. This law requires that the Commissioner of Health make a yearly determination of the adequacy of the supply of influenza vaccine that contains not more than 1.25 micrograms of mercury per 0.50 milliliter dose for women who know they are pregnant and not more than 0.625 micrograms of mercury per 0.25 milliliter dose for children less than 3 years of age. All single-dose preparations of influenza vaccine available in the United States are thimerosal-free, except for one brand which contains trace amounts of mercury (less than 1 microgram of mercury per 0.50 milliliter dose) which is below the thresholds established in PHL § 2112. For the purposes of this letter, seasonal influenza vaccine that is thimerosal-free or contains trace amounts of mercury (as described above) will be referred to as “vaccine that complies with PHL § 2112 (2) and (3).”
The Commissioner of Health has determined that it appears there will be an adequate supply of vaccine that complies with PHL § 2112 (2) and (3) for the 2017-2018 influenza season. Therefore, health care providers (physicians, nurse practitioners, physician assistants, nurse midwives) providing influenza vaccinations to pregnant women and children under 3 years of age should identify available sources of such vaccine and administer it to the extent it is available.
However, on occasion some influenza vaccine manufacturers may complete vaccine shipments later than other manufacturers, and some health care providers may not initially have an adequate supply of vaccine that complies with PHL § 2112 (2) and (3). Therefore, in accordance with PHL § 2112 (5), in instances when health care providers have in good faith sought out influenza vaccine that complies with PHL § 2112 (2) and (3), but such vaccine cannot be obtained or has been ordered but not yet received, children less than 3 years of age and pregnant women should be offered available influenza vaccine. There is no proven risk from thimerosal-containing vaccine, and the substantial risk of complications or death from influenza disease in these groups outweighs the risk of vaccination1-3. A parent/guardian of a child less than three years of age and a pregnant woman must provide informed consent prior to administration of vaccine that contains more than trace amounts of thimerosal. It is recommended that providers document such informed consent.