mRNA vaccines against SARS-CoV-2 are remarkably effective. Limited information exists about the incidence of adverse events following immunization (AEFI) with their use. We conducted a prospective observational study including data from 704,003 first-doses recipients; 6536 AEFI were reported, of whom 65.1% had at least one neurologic AEFI ( non-serious 99.6%). Thirty-three serious events were reported; 17 (51.5%) were neurologic (observed frequency, 2.4/100,000 doses). At the time of writing this report, 16/17 cases had been discharged without deaths. Our data suggest that the BNT162b2 mRNA COVID-19 vaccine is safe; its individual and societal benefits outweigh the low percentage of serious neurologic AEFI. This information should help to dissipate hesitancy towards this new vaccine platform.
Because measles causes an estimated 2 million deaths per year among children in developing countries, including a substantial proportion of infants less than nine months old--the age at which vaccination is recommended--there has been interest in using different strains of vaccine and higher doses to achieve immunization of younger infants. We conducted a randomized trial of three different doses of Edmonston-Zagreb and of Schwarz measles vaccines in infants to evaluate the effect of the strain and dose of vaccine on the serologic response and acute adverse reactions to vaccination. Six-month-old infants received a standard, medium, or high dose of one of the vaccines, and nine-month-old infants received a standard dose. Antibody levels were measured before and after vaccination, by means of a plaque-reduction neutralization assay, in 1061 six-month-olds and 299 nine-month-olds. Edmonston-Zagreb vaccine produced higher rates of seroconversion and seropositivity than comparable doses of Schwarz vaccine. Among the six-month-old infants, the seroconversion rate 18 weeks after vaccination with the standard dose of Edmonston-Zagreb vaccine was 92 percent, that with the medium dose was 96 to 97 percent, and that with the high dose was 98 percent; the rates for the corresponding doses of Schwarz vaccine were 66 percent, 76 percent, and 91 percent, respectively. Higher seroconversion rates were observed with an increase in the dose of either Edmonston-Zagreb (P less than 0.01) or Schwarz (P less than 0.001) vaccine. The seroconversion rates produced by high and medium doses of Edmonston-Zagreb vaccine in six-month-olds were equal to or significantly higher than the rate produced by a standard dose of Schwarz vaccine in nine-month-olds (87 percent). Clinical adverse reactions were not associated with the strain or dose of a vaccine. We conclude that Edmonston-Zagreb vaccine is more immunogenic than Schwarz vaccine in infants and can induce effective immunization against measles at six months of age.
Background. Despite the success of the Dominican Republic's National Immunization Program, homogenous vaccine coverage has not been achieved. In October 2012, the country implemented a study on missed opportunities for vaccination (MOVs) in children aged <5 years. Methods. A cross-sectional study of 102 healthcare facilities was implemented in 30 high-risk municipalities. Overall, 1500 parents and guardians of children aged <5 years were interviewed. A MOV is defined as when a person who is eligible for vaccination and with no contraindications visits a health facility and does not receive a required vaccine. We evaluated the causes of MOVs and identified risk factors associated with MOVs in the Dominican Republic. Results. Of the 514 children with available and reliable vaccination histories, 293 (57.0%) were undervaccinated after contact with a health provider. Undervaccinated children had 836 opportunities to receive a needed vaccine. Of these, 358 (42.8%) qualified as MOVs, with at least one MOV observed in 225 children (43.7%). Factors associated with MOVs included urban geographic area (OR = 1.80; p = 0.02), age 1–4 years (OR = 3.63; p ≤ 0.0001), and the purpose of the health visit being a sick visit (OR = 1.65; p = 0.02). Conclusions. MOVs were associated primarily with health workers failing to request and review patients' immunization cards.
Background and objectives:Information on stroke among SARS-CoV-2 vaccines remains scarce. We report stroke incidence as an adverse event following immunization (AEFI) among recipients of 79,399,446 doses of 6 different SARS-CoV-2 vaccines (BNT162b2, ChAdOx1 nCov-19, Gam-COVID-Vac, CoronaVac, Ad5-nCoV, and Ad26.COV2-S) between December 24, 2020, and August 31, 2021, in Mexico.Methods:Retrospective descriptive study analyzing stroke incidence per million doses among hospitalized adult patients (≥18 years) during an 8-month interval. According to the World Health Organization, AEFIs were defined as clinical events occurring within 30 days following immunization and categorized as either non-serious or serious depending on severity, treatment, and hospital admission requirements. Acute ischemic stroke (AIS), intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH), and cerebral venous thrombosis (CVT) cases were collected through a passive epidemiological surveillance system in which local health providers report potential AEFI to the Mexican General Board of Epidemiology. Data were captured using standardized case report formats by an ad-hoc committee appointed by the Mexican Ministry of Health to evaluate potential neurologic AEFI against SARS-COV-2.Results:We included 56 patients (female, 31 [55.5%]) for an overall incidence of 0.71 cases per 1,000,000 administered doses (95% confidence interval [CI] 0.54–0.92); median age was 65 years (interquartile range 55–76); median time from vaccination-to-stroke (of any subtype) was 2 days (interquartile range 1–5); in 27 (48.2%) patients, the event was diagnosed within the first 24 hours following immunization. The most frequent subtype was AIS in 43 patients (75%; 0.54/1,000,000 doses, 95% CI 0.40–0.73) followed by ICH in 9 (16.1%; 0.11/1,000,000 doses, 95% CI 0.06–0.22), and SAH and CVT, each with 2 cases (3.6%; 0.03/1,000,000 doses, 95% CI 0.01–0.09). Overall, the most common risk factors were hypertension in 33 (58.9%) patients and diabetes mellitus in 22 (39.3%); median hospital length of stay was 6 days (IQR 4–13); at discharge, functional outcome was good (modified Rankin Scale of 0–2) in 41.1% of patients; in-hospital mortality rate was 21.4%.Discussion:Stroke is an exceedingly rare AEFI against SARS-CoV-2. Pre-existing stroke risk factors were identified in most patients. Further research is needed to evaluate causal associations between SARS-COV-2 vaccines and stroke.
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