Ethical Issues during Zika Epidemic in Puerto Rico and the Americas.

The Zika virus epidemic and the possible devastating teratogenic effects of the virus represent a challenge. Health authorities have the responsibility to create programs that provide adequate preventive, medical and psychological services to the affected population. The estimated risk of microcephaly in infants of mothers infected with Zika virus is 1 to 13% when the infection occurs in the first trimester of pregnancy. There is insufficient data to estimate the risk of microcephaly when infection occurs in the second or third trimester. Pregnant women and those in reproductive age are advised to avoid traveling to places where there is local transmission of the Zika virus. Human rights advocates have requested, comprehensive sexual and reproductive health services that include expanded access to contraceptive methods including emergency contraception and safe abortion services. These strategies created a debate between the abortion rights and the right of the disabled. The discussion rests on the assumption that there are lives that are not worth living. Most people focus on the most severely affected patients, but few consider that the spectrum of disabilities associated with congenital Zika infection is broad. The rights of children with disabilities and their dignity as individuals should be respected.

Safety and Immunogenicity of a Tetravalent Dengue Vaccine Candidate in Healthy Children and Adults in Dengue-Endemic Regions: A Randomized, Placebo-Controlled Phase 2 Study.

BACKGROUND: A safe, effective tetravalent dengue vaccine is a global health priority. The safety and immunogenicity of a live attenuated, recombinant tetravalent dengue vaccine candidate (TDV) were evaluated in healthy volunteers from dengue-endemic countries. METHODS: This multicenter, double-blind, phase 2 study was conducted in Puerto Rico, Colombia, Singapore, and Thailand. During stage I, 148 volunteers aged 1.5-45 years were sequentially enrolled into 4 age-descending groups and randomized at a ratio of 2:1 to receive TDV or placebo. In stage II (group 5), 212 children aged 1.5-11 years were randomized at a ratio of 3:1 to receive TDV or placebo. Participants received a subcutaneous injection of TDV or placebo on days 0 and 90 and were followed for analysis of safety, seropositivity, and neutralizing antibodies to DENV-1-4. RESULTS: Injection site pain, itching, and erythema (mostly mild) were the only solicited adverse events more frequently reported with TDV than with placebo in all age groups. After 2 TDV doses, seropositivity was >95% in all 5 groups for DENV-1-3 and 72.7%-100% for DENV-4; geometric mean titers ranged from 582 to 1187 for DENV-1, from 582 to 1187 for DENV-2, from 196 to 630 for DENV-3, and from 41 to 210 for DENV-4 among the 5 groups. CONCLUSIONS: TDV was well tolerated and immunogenic in volunteers aged 1.5-45 years, irrespective of prevaccination dengue exposure.