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. 2023 Jul 19;41(32):4658-4665.
doi: 10.1016/j.vaccine.2023.06.042. Epub 2023 Jun 15.

Safety of simultaneous vaccination with COVID-19 vaccines in the Vaccine Safety Datalink

Tat'Yana A Kenigsberg  1 , Kayla E Hanson  2 , Nicola P Klein  3 , Ousseny Zerbo  3 , Kristin Goddard  3 , Stanley Xu  4 , W Katherine Yih  5 , Stephanie A Irving  6 , Laura P Hurley  7 , Jason M Glanz  8 , Robyn Kaiser  9 , Lisa A Jackson  10 , Eric S Weintraub  11
Affiliations

Safety of simultaneous vaccination with COVID-19 vaccines in the Vaccine Safety Datalink

Tat'Yana A Kenigsberg et al. Vaccine. .

Abstract

Introduction: Safety data on simultaneous vaccination (SV) with primary series monovalent COVID-19 vaccines and other vaccines are limited. We describe SV with primary series COVID-19 vaccines and assess 23 pre-specified health outcomes following SV among persons aged ≥5 years in the Vaccine Safety Datalink (VSD).

Methods: We utilized VSD's COVID-19 vaccine surveillance data from December 11, 2020-May 21, 2022. Analyses assessed frequency of SV. Rate ratios (RRs) were estimated by Poisson regression when the number of outcomes was ≥5 across both doses, comparing outcome rates between COVID-19 vaccinees receiving SV and COVID-19 vaccinees receiving no SV in the 1-21 days following COVID-19 vaccine dose 1 and 1-42 days following dose 2 by SV type received ("All SV", "Influenza SV", "Non-influenza SV").

Results: SV with COVID-19 vaccines was not common practice (dose 1: 0.7 % of 8,455,037 persons, dose 2: 0.3 % of 7,787,013 persons). The most frequent simultaneous vaccines were influenza, HPV, Tdap, and meningococcal. Outcomes following SV with COVID-19 vaccines were rare (total of 56 outcomes observed after dose 1 and dose 2). Overall rate of outcomes among COVID-19 vaccinees who received SV was not statistically significantly different than the rate among those who did not receive SV (6.5 vs. 6.8 per 10,000 persons). Statistically significant elevated RRs were observed for appendicitis (2.09; 95 % CI, 1.06-4.13) and convulsions/seizures (2.78; 95 % CI, 1.10-7.06) in the "All SV" group following dose 1, and for Bell's palsy (2.82; 95 % CI, 1.14-6.97) in the "Influenza SV" group following dose 2.

Conclusion: Combined pre-specified health outcomes observed among persons who received SV with COVID-19 vaccine were rare and not statistically significantly different compared to persons who did not receive SV with COVID-19 vaccine. Statistically significant adjusted rate ratios were observed for some individual outcomes, but the number of outcomes was small and there was no adjustment for multiple testing.

Keywords: COVID-19 vaccine; Simultaneous vaccination; Vaccine Safety Datalink.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Kayla E. Hanson reports a relationship with Seqirus that includes: funding grants. Nicola P. Klein reports a relationship with Pfizer that includes: funding grants. Nicola P. Klein reports a relationship with Merck & Co Inc that includes: funding grants. Nicola P. Klein reports a relationship with GlaxoSmithKline that includes: funding grants. Nicola P. Klein reports a relationship with Sanofi Pasteur that includes: funding grants. W. Katherine Yih reports a relationship with Pfizer that includes: funding grants.

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