Results provide reassurance of vaccination schedule safety
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There was no significant difference in vaccine antigen exposure through the first 23 months of life between children with non–vaccine-targeted infections and controls between 24 and 47 months of age, according to results published March 6 in JAMA.

This was determined in a nested, matched case-control study of 193 infection cases and 751 controls, in whom estimated mean cumulative vaccine antigen exposure was 240.6 for cases of non–vaccine-targeted infections, and 242.9 for controls, reported Jason M. Glanz, PhD, of Kaiser Permanente Colorado, Denver, and his coauthors. The between-group difference was –2.3 (P = .55), a nonsignificant difference.

Using data from the Centers for Disease Control and Prevention-funded Vaccine Safety Datalink (VSD), the investigators identified children born between Jan. 1, 2003, and Sep. 31, 2013. Exclusion criteria were not having at least two well-child visits before the first birthday, medical contraindications to vaccination, or receiving vaccines not recommended by the Advisory Committee on Immunization Practices. Eligible children were followed through age 47 months or until disenrollment from their health care organization, the authors said.

ICD-9 and ICD-10 codes were used to identify non–vaccine-targeted infections, including upper and lower respiratory infections, gastrointestinal infections, and other viral and bacterial infections from ages 24to 47 months. A medical record review was performed to confirm case status. Cases were included only if it was confirmed that the infection occurred, that it was an incident outcome, that the outcome was the primary reason for the medical visit, that the outcome occurred in the inpatient or emergency department setting, and that there was no evidence that the child was diagnosed as having a vaccine preventable disease (VPD) on the same day as the infection. Controls did not have a VPD or record of a non–vaccine-targeted infection prior to the index date, Dr. Glanz and his colleagues said.

 

 

Antigen exposure was measured as the number of immunogenic proteins and polysaccharides in each vaccine, and was estimated from birth through age 23 months in both groups. Cumulative antigen exposure was estimated by adding the number of antigens in each non–vaccine-targeted infection and controls.

Estimated mean cumulative vaccine antigen exposure was 240.6 for cases of non–vaccine-targeted infections, and 242.9 for controls, the authors reported. The matched odds ratio (mOR) for estimated cumulative antigen exposure through age 23 months was not significant in children with infections, compared with controls (mOR = 0.94; 95% confidence interval, 0.84-1.07). The estimated maximum single-day antigen exposure was not significantly associated with non–vaccine-targeted infection (mOR = 1.07; 95% CI, 0.81-1.41).

The findings of this study “did not reveal any beneficial or detrimental associations with estimated cumulative vaccine antigen exposure in young children with non–vaccine-targeted infections in ED and inpatient settings,” wrote Dr. Glanz and coauthors. In addition, the study “did not find evidence that multiple vaccine exposure was associated with the risk for non-targeted infectious diseases.”

The CDC funded the study. The authors reported receiving contracts, grants, and other funding from the CDC.

SOURCE: Glanz JM et al. JAMA. 2018;319(9):906-13.

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These results provide “further reassurance about the safety of the U.S. child vaccination schedule,” said Sean T. O’Leary, MD, and Yvonne A. Maldonado, MD.


However, they added, more work must be done to strengthen the public’s trust and confidence in vaccines. Parents long have voiced concerns that vaccines might weaken their children’s immune systems.


“The small but vocal minority of anti-vaccine groups may not be satisfied by the evidence provided through VSD and other vaccine safety surveillance,” they wrote. “Simply providing scientific information and assuming parents will make the decision to vaccinate is not enough.


“Delivering evidence-based information to parents and clinicians in ways that inspire confidence in the robust and safe childhood immunization schedule is critical for maintaining the health of children,” they concluded.

Dr. O’Leary and Dr. Maldonado, both of the University of Colorado, Aurora, commented in an editorial accompanying the article by Glanz et al. (JAMA. 2018 Mar 6;319(9):870-1). Dr. Maldonado reported receiving personal fees for serving on a data and safety monitoring board for Pfizer. Dr. O’Leary reported no relevant financial disclosures.

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These results provide “further reassurance about the safety of the U.S. child vaccination schedule,” said Sean T. O’Leary, MD, and Yvonne A. Maldonado, MD.


However, they added, more work must be done to strengthen the public’s trust and confidence in vaccines. Parents long have voiced concerns that vaccines might weaken their children’s immune systems.


“The small but vocal minority of anti-vaccine groups may not be satisfied by the evidence provided through VSD and other vaccine safety surveillance,” they wrote. “Simply providing scientific information and assuming parents will make the decision to vaccinate is not enough.


“Delivering evidence-based information to parents and clinicians in ways that inspire confidence in the robust and safe childhood immunization schedule is critical for maintaining the health of children,” they concluded.

Dr. O’Leary and Dr. Maldonado, both of the University of Colorado, Aurora, commented in an editorial accompanying the article by Glanz et al. (JAMA. 2018 Mar 6;319(9):870-1). Dr. Maldonado reported receiving personal fees for serving on a data and safety monitoring board for Pfizer. Dr. O’Leary reported no relevant financial disclosures.

Body

These results provide “further reassurance about the safety of the U.S. child vaccination schedule,” said Sean T. O’Leary, MD, and Yvonne A. Maldonado, MD.


However, they added, more work must be done to strengthen the public’s trust and confidence in vaccines. Parents long have voiced concerns that vaccines might weaken their children’s immune systems.


“The small but vocal minority of anti-vaccine groups may not be satisfied by the evidence provided through VSD and other vaccine safety surveillance,” they wrote. “Simply providing scientific information and assuming parents will make the decision to vaccinate is not enough.


“Delivering evidence-based information to parents and clinicians in ways that inspire confidence in the robust and safe childhood immunization schedule is critical for maintaining the health of children,” they concluded.

Dr. O’Leary and Dr. Maldonado, both of the University of Colorado, Aurora, commented in an editorial accompanying the article by Glanz et al. (JAMA. 2018 Mar 6;319(9):870-1). Dr. Maldonado reported receiving personal fees for serving on a data and safety monitoring board for Pfizer. Dr. O’Leary reported no relevant financial disclosures.

Title
Results provide reassurance of vaccination schedule safety
Results provide reassurance of vaccination schedule safety

There was no significant difference in vaccine antigen exposure through the first 23 months of life between children with non–vaccine-targeted infections and controls between 24 and 47 months of age, according to results published March 6 in JAMA.

This was determined in a nested, matched case-control study of 193 infection cases and 751 controls, in whom estimated mean cumulative vaccine antigen exposure was 240.6 for cases of non–vaccine-targeted infections, and 242.9 for controls, reported Jason M. Glanz, PhD, of Kaiser Permanente Colorado, Denver, and his coauthors. The between-group difference was –2.3 (P = .55), a nonsignificant difference.

Using data from the Centers for Disease Control and Prevention-funded Vaccine Safety Datalink (VSD), the investigators identified children born between Jan. 1, 2003, and Sep. 31, 2013. Exclusion criteria were not having at least two well-child visits before the first birthday, medical contraindications to vaccination, or receiving vaccines not recommended by the Advisory Committee on Immunization Practices. Eligible children were followed through age 47 months or until disenrollment from their health care organization, the authors said.

ICD-9 and ICD-10 codes were used to identify non–vaccine-targeted infections, including upper and lower respiratory infections, gastrointestinal infections, and other viral and bacterial infections from ages 24to 47 months. A medical record review was performed to confirm case status. Cases were included only if it was confirmed that the infection occurred, that it was an incident outcome, that the outcome was the primary reason for the medical visit, that the outcome occurred in the inpatient or emergency department setting, and that there was no evidence that the child was diagnosed as having a vaccine preventable disease (VPD) on the same day as the infection. Controls did not have a VPD or record of a non–vaccine-targeted infection prior to the index date, Dr. Glanz and his colleagues said.

 

 

Antigen exposure was measured as the number of immunogenic proteins and polysaccharides in each vaccine, and was estimated from birth through age 23 months in both groups. Cumulative antigen exposure was estimated by adding the number of antigens in each non–vaccine-targeted infection and controls.

Estimated mean cumulative vaccine antigen exposure was 240.6 for cases of non–vaccine-targeted infections, and 242.9 for controls, the authors reported. The matched odds ratio (mOR) for estimated cumulative antigen exposure through age 23 months was not significant in children with infections, compared with controls (mOR = 0.94; 95% confidence interval, 0.84-1.07). The estimated maximum single-day antigen exposure was not significantly associated with non–vaccine-targeted infection (mOR = 1.07; 95% CI, 0.81-1.41).

The findings of this study “did not reveal any beneficial or detrimental associations with estimated cumulative vaccine antigen exposure in young children with non–vaccine-targeted infections in ED and inpatient settings,” wrote Dr. Glanz and coauthors. In addition, the study “did not find evidence that multiple vaccine exposure was associated with the risk for non-targeted infectious diseases.”

The CDC funded the study. The authors reported receiving contracts, grants, and other funding from the CDC.

SOURCE: Glanz JM et al. JAMA. 2018;319(9):906-13.

There was no significant difference in vaccine antigen exposure through the first 23 months of life between children with non–vaccine-targeted infections and controls between 24 and 47 months of age, according to results published March 6 in JAMA.

This was determined in a nested, matched case-control study of 193 infection cases and 751 controls, in whom estimated mean cumulative vaccine antigen exposure was 240.6 for cases of non–vaccine-targeted infections, and 242.9 for controls, reported Jason M. Glanz, PhD, of Kaiser Permanente Colorado, Denver, and his coauthors. The between-group difference was –2.3 (P = .55), a nonsignificant difference.

Using data from the Centers for Disease Control and Prevention-funded Vaccine Safety Datalink (VSD), the investigators identified children born between Jan. 1, 2003, and Sep. 31, 2013. Exclusion criteria were not having at least two well-child visits before the first birthday, medical contraindications to vaccination, or receiving vaccines not recommended by the Advisory Committee on Immunization Practices. Eligible children were followed through age 47 months or until disenrollment from their health care organization, the authors said.

ICD-9 and ICD-10 codes were used to identify non–vaccine-targeted infections, including upper and lower respiratory infections, gastrointestinal infections, and other viral and bacterial infections from ages 24to 47 months. A medical record review was performed to confirm case status. Cases were included only if it was confirmed that the infection occurred, that it was an incident outcome, that the outcome was the primary reason for the medical visit, that the outcome occurred in the inpatient or emergency department setting, and that there was no evidence that the child was diagnosed as having a vaccine preventable disease (VPD) on the same day as the infection. Controls did not have a VPD or record of a non–vaccine-targeted infection prior to the index date, Dr. Glanz and his colleagues said.

 

 

Antigen exposure was measured as the number of immunogenic proteins and polysaccharides in each vaccine, and was estimated from birth through age 23 months in both groups. Cumulative antigen exposure was estimated by adding the number of antigens in each non–vaccine-targeted infection and controls.

Estimated mean cumulative vaccine antigen exposure was 240.6 for cases of non–vaccine-targeted infections, and 242.9 for controls, the authors reported. The matched odds ratio (mOR) for estimated cumulative antigen exposure through age 23 months was not significant in children with infections, compared with controls (mOR = 0.94; 95% confidence interval, 0.84-1.07). The estimated maximum single-day antigen exposure was not significantly associated with non–vaccine-targeted infection (mOR = 1.07; 95% CI, 0.81-1.41).

The findings of this study “did not reveal any beneficial or detrimental associations with estimated cumulative vaccine antigen exposure in young children with non–vaccine-targeted infections in ED and inpatient settings,” wrote Dr. Glanz and coauthors. In addition, the study “did not find evidence that multiple vaccine exposure was associated with the risk for non-targeted infectious diseases.”

The CDC funded the study. The authors reported receiving contracts, grants, and other funding from the CDC.

SOURCE: Glanz JM et al. JAMA. 2018;319(9):906-13.

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Key clinical point: No significant difference was found in vaccine antigen exposure between controls and children with infectious diseases not targeted by vaccines.

Major finding: Estimated mean cumulative vaccine antigen exposure was 240.6 for cases and 242.9 for controls.

Study details: A matched case-control study of 944 patients enrolled in six integrated health care organizations as part of the Vaccine Safety Datalink (VSD).

Disclosures: The Centers for Disease Control and Prevention funded the study. The authors reported receiving contracts, grants, and other funding from the CDC.

Source: Glanz JM et al. JAMA. 2018;319(9):906-13.

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