Study describes health outcomes after co-vaccination with a monovalent primary series COVID-19 vaccine

In recent studies, vaccination, investigators described co-vaccination (SV) with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) primary series vaccine. They assessed 23 pre-determined health outcomes after SV in individuals aged 5 years or older with a Vaccine Safety Data Link (VSD).

Background

The 2019 coronavirus disease (COVID-19) is causing unprecedented morbidity and mortality worldwide, and in response, efforts are being made to mitigate the disease and reduce the number of cases worldwide. In 2019, anti-SARS-CoV-2 therapies were developed, including novel coronavirus disease (COVID-19) vaccines and monoclonal antibodies. Burden on medical institutions.

During the first two years of the United States (US) SARS-CoV-2 vaccination program, the United States Food and Drug Administration (US FDA) approved three monovalent SARS-CoV-2 vaccines for emergency use to provide primary vaccination. Licensed the vaccine. BNT162b2, Moderna’s mRNA-1273, and Janssen’s Ad.26.COV2.S.

Observational studies and clinical trials to date support simultaneous vaccination. However, several studies have reported an increased risk of adverse events in individuals receiving SV vaccination in combination with non-SARS-CoV-2 vaccines. Examples include Bell’s palsy and febrile seizures in individuals aged 11-21 years following meningococcal MenACWY-CRM conjugate vaccine. Pediatric recipients receiving concurrent trivalent inactivated influenza vaccine (IIV3) and 13-valent pneumococcal conjugate vaccine (PCV13). Further studies are needed to assess the safety of co-vaccination with a prime monovalent SARS-CoV-2 vaccine and a non-COVID-19 vaccine.

About research

In the present retrospective cohort study, the researchers described SV from the US-approved monovalent SARS-CoV-2 primary vaccine, targeting VSD-surveilled individuals aged 5.0 years and older, with monovalent novel coronavirus We assessed pre-determined adverse events after SV with infectious disease (COVID-19) primary vaccination.

The team analyzed data from VSD’s SARS-CoV-2 vaccine rapid cycle analysis (RCA) surveillance from December 11, 2020 to May 21, 2022. SV vaccination frequency was analyzed by comparing the vaccination outcomes of SV vaccinated and non-SV vaccinated individuals 3 weeks after SV vaccination. His 6 weeks after the first dose of the COVID-19 vaccine and his second dose depend on the type of SV received.

SV should receive a non-SARS-CoV-2 vaccine (≥1.0 vaccine) on the first or second dose of SARS-CoV-2 vaccine as per the Advisory Committee on Immunization Practices (ACIP). explained. guidelines. Vaccines were administered at different anatomical sites and were not mixed within the same syringe. Vaccines administered simultaneously were grouped to form mutually exclusive groups. For example, all types of influenza vaccines were grouped into the ‘all influenza’ group.

The research team used the International Classification of Diseases, Tenth Revision (ICD-10) codes to identify the results. Poisson regression modeling was performed to determine the adjusted rate ratio (aRR) for health outcomes ≥5.0 across both vaccine doses, and the odds ratio (OR) was calculated by logistic regression modeling to determine the number of patients who received SARS SV vaccination. We identified the factors associated with and without. – CoV-2 vaccine. Data included participants’ age, gender, COVID-19 risk status, and timing of COVID-19 vaccination (i.e., date of vaccination update by the Centers for Disease Control and Prevention (CDC) in 2021). around May 21). SV), and SARS-CoV-2 vaccination quarters.

result

Co-vaccination with SARS-CoV-2 vaccine was uncommon (0.70% of 8,455,037 after first dose, 0.3% of 7,787,013 after second dose). Most (72.0%) had received the SARS-CoV-2 vaccine by May 21, 2021. The most commonly co-administered vaccines were human papillomavirus (HPV), influenza, meningococcal, tetanus, diphtheria, and pertussis (Tdap) vaccines.

Adverse events after co-administration of the SARS-CoV-2 vaccine were rare, with only 56 outcomes reported after the first and second doses. Adverse event rates among SV recipients SV were not significantly different from those among non-SV recipients (6.50 vs. 6.80 per 10,000).

The research team found that the aRR for seizures or convulsions (aRR 2.8) and appendicitis (aRR 2.1) were significantly increased in ‘all SV’ recipients after the first vaccination, and in those who received ‘influenza SV’ after the second vaccination. observed that the aRR of Bell’s facial palsy (aRR 2.8) was significantly increased. . Participants were more likely to receive SV after the first dose of SARS-CoV-2 vaccine than after the second dose (OR 2.4).

The rate of SV was highest in children aged 5.0–11 years (OR 1.4), and individuals aged 5.0–29 years and ≥50.0 years were more likely to receive SV from the SARS-CoV-2 vaccine than individuals aged 30–49 years. significantly higher. . Additionally, non-Hispanic American Indians or Alaska Natives (OR 1.2) were more likely than non-Hispanic Caucasians to receive SV vaccination with SARS-CoV-2 vaccine.

Conclusion

Overall, the study results show that a combination of pre-determined events occurring among SV recipients are rare with the SARS-CoV-2 vaccine and significantly different from events occurring among non-SV recipients. showed no significant difference. aRR values ​​were significant for some results. However, the number of reported adverse events was limited and the data were not adjusted for multiple tests.