JAMA
October 20, 2015, Vol 314, No. 15
http://jama.jamanetwork.com/issue.aspx

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The Trans-Pacific Partnership Agreement and Implications for Access to Essential Medicines
Jing Luo, MD; Aaron S. Kesselheim, MD, JD, MPH
[Initial text]
This Viewpoint discusses the importance of patent protection and its role in the Trans-Pacific Partnership (TPP) Agreement.

After a difficult legislative battle, President Obama signed into law Trade Promotion Authority on June 29, 2015. The legislation allows for an up-or-down vote with no amendments in Congress for international trade agreements such as the Trans-Pacific Partnership (TPP) Agreement. The TPP Agreement includes 12 Asia-Pacific countries (United States, Canada, Mexico, Peru, Chile, Japan, Vietnam, Malaysia, Singapore, Brunei, Australia, and New Zealand) with a collective trading power amounting to 40% of the global gross domestic product. The TPP Agreement is still being negotiated; recently, in a meeting of trade ministers in Maui, Hawaii, negotiators failed to finalize the text of the Agreement due in large part to disagreement regarding intellectual property protections for pharmaceutical products.1

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Association of Tdap Vaccination With Acute Events and Adverse Birth Outcomes Among Pregnant Women With Prior Tetanus-Containing Immunizations
Lakshmi Sukumaran, MD, MPH; Natalie L. McCarthy, MPH; Elyse O. Kharbanda, MD, MPH; Michael M. McNeil, MD, MPH; Allison L. Naleway, PhD; Nicola P. Klein, MD, PhD; Michael L. Jackson, MPH, PhD; Simon J. Hambidge, MD, PhD; Marlene M. Lugg, DrPH; Rongxia Li, PhD; Eric S. Weintraub, MPH; Robert A. Bednarczyk, PhD; Jennifer P. King, MPH; Frank DeStefano, MD, MPH; Walter A. Orenstein, MD; Saad B. Omer, MBBS, MPH, PhD
Abstract
Importance
The Advisory Committee on Immunization Practices (ACIP) recommends the tetanus, diphtheria, and acellular pertussis (Tdap) vaccine for pregnant women during each pregnancy, regardless of prior immunization status. However, safety data on repeated Tdap vaccination in pregnancy is lacking.
Objective
To determine whether receipt of Tdap vaccine during pregnancy administered in close intervals from prior tetanus-containing vaccinations is associated with acute adverse events in mothers and adverse birth outcomes in neonates.
Design, Setting, and Participants
A retrospective cohort study in 29 155 pregnant women aged 14 through 49 years from January 1, 2007, through November 15, 2013, using data from 7 Vaccine Safety Datalink sites in California, Colorado, Minnesota, Oregon, Washington, and Wisconsin.
Exposures
Women who received Tdap in pregnancy following a prior tetanus-containing vaccine less than 2 years before, 2 to 5 years before, and more than 5 years before.
Main Outcomes and Measures
Acute adverse events (fever, allergy, and local reactions) and adverse birth outcomes (small for gestational age, preterm delivery, and low birth weight) were evaluated. Women who were vaccinated with Tdap in pregnancy and had a prior tetanus-containing vaccine more than 5 years before served as controls.
Results
There were no statistically significant differences in rates of medically attended acute adverse events or adverse birth outcomes related to timing since prior tetanus-containing vaccination. For example, local reactions occurred at a rate (per 10 000 women) of 4.2 in those who received Tdap in pregnancy less than 2 years before (adjusted risk ratio [RR], 0.49 [95% CI, 0.11-2.20]; P = .35) and 7.0 two to 5 years before (adjusted RR, 0.77 [95% CI, 0.31-1.95]; P  = .59) a prior tetanus-containing vaccine compared with 11.2 in controls. Preterm delivery occurred in 6.6% of women receiving Tdap in pregnancy less than 2 years before (adjusted RR, 1.15 [95% CI, 0.98-1.34]; P = .08) and 6.4% two to 5 years before (adjusted RR, 1.06 [95% CI, 0.94-1.19]; P  = .33) a prior tetanus-containing vaccine compared with 6.8% of controls. Small for gestational age delivery occurred in 9.0% of women less than 2 years before (adjusted RR, 0.99 [95% CI, 0.87-1.13]; P = .88) and 8.7% of women 2 to 5 years before (adjusted RR, 0.96 [95% CI, 0.87-1.06]; P = .45) a prior tetanus-containing vaccine compared with 9.1% of controls.
Conclusions and Relevance
Among women who received Tdap vaccination during pregnancy, there was no increased risk of acute adverse events or adverse birth outcomes for those who had been previously vaccinated less than 2 years before or 2 to 5 years before compared with those who had been vaccinated more than 5 years before. These findings suggest that relatively recent receipt of a prior tetanus-containing vaccination does not increase risk after Tdap vaccination in pregnancy.