New Study Assessing Safety Profile of BNT162b2 Vaccine in New Zealand

In a recent study posted on Lancet preprint*Ser, Researchers Determined Associations Between Adverse Events of Special Interest (AESI) After Vaccination with BNT162b2, a Messenger Ribonucleic Acid (mRNA) Technology-Based Coronavirus Disease 2019 (COVID-19) Vaccine .

Background

New Zealand used a passive reporting system developed by Medsafe, its Medicines and Devices Safety Agency, to monitor the safety of the BNT162b2 COVID-19 vaccine with voluntary participation by medical professionals and the public. .Signal was properly detected, but underreporting or reporting bias must have prevented efficacy of this system. Therefore, the government later adopted an aggressive system of assessing his risk of AESI after BNT162b2 vaccination using the Electronic Health Record (EHR).

Approximately 95% of the eligible New Zealand population have received at least one dose of BNT162b2, making the real-world setting unique and ideal for assessing its safety profile, which is critical for severe acute respiratory syndrome coronavirus. 2 (SARS-CoV-2) represents a naïve population.

Additionally, New Zealand’s demographic is unique in that it has three main minority groups: Maori (indigenous New Zealanders), Pacific Islanders, and Asians. It will be important to evaluate the safety profile of BNT162b2 in a New Zealand-specific context that could not be deciphered in clinical trials.

Mass deployment of a COVID-19 vaccine using the BNT162b2 vaccine began in New Zealand in February 2021. Clinical trials have shown that BNT162b2 has a favorable efficacy and safety profile, but with limited results. They often failed to detect rare adverse events after vaccination (AEFI) due to small sample sizes, inadequate patient selection criteria, and short follow-up or study durations. AEFI responses to vaccines may vary among population subsets, depending on age, sex, and representation of minority groups.

About research

In the current retrospective cohort study, researchers compared the incidence of each prespecified AESI within 0 to 21 days after BNT162b2 vaccination with the predicted rate based on historical incidence from 2014 to 2019. compared. The study surveillance period began on February 19, 2021 with the vaccine. Rolled out and finished on February 10, 2022.

The study population consisted of New Zealanders aged 5 years and older who received their first dose of adult and pediatric BNT162b2 formulations. The study included age, age group, gender, ethnicity, etc.

Investigation result

The risk of myocarditis and pericarditis was low in those under 19 years of age, with ≥5 and 2 events per 100,000 after the second and first vaccinations, respectively. The benefits continue to offset the risk of disease, as studies have shown that the risk of myocarditis after COVID-19 is much higher than after vaccination with mRNA vaccines.

In addition, the researchers noted a statistically significant increase in the incidence of acute kidney injury (AKI) after the first and second doses of BNT1262b in all age groups except ages 5 to 19 years . Most patients who reported AKI were over the age of 65, and more than 50% of them had pre-existing conditions (such as diabetes) that could have contributed to her AKI. Therefore, more studies alone can justify the observed associations, if any.

Among patients who received the second dose, researchers noted 1.3 and 1.2 events of thrombocytopenia and venous thromboembolism (VTE). Although the observed events were higher than expected, the rate increase was small and the confidence interval (CI) was close to 1, suggesting minimal difference between the two events. There was a slight increase in VTE after the first dose of BNT1262b at ages 40–59, but no significant increase in thrombocytopenic events in any subgroup. cases have been reported. However, large-scale real-world studies have not confirmed the likelihood of thrombocytopenia or VTE following BNT162b2 vaccination.

The researchers also observed an increased risk of single-organ cutaneous vasculitis after the first dose of BNT162b2 at ages 20-39. However, observed and expected events remained below 6, leading to wider CIs. Due to lack of scientific data, further studies are needed to establish a link between single organ cutaneous vasculitis and her BNT162b2 vaccine. Finally, the researchers found no significant associations between the BNT162b2 vaccine and other outcomes of interest or AESI.

Conclusion

This national cohort study includes over 4 million vaccinated New Zealanders representing all ethnic groups. The results of this post-marketing vaccine safety study reconfirmed the overall safety profile of the BNT162b2 vaccine. There were no associations between BNT162b2 vaccination and most other AESIs, except for an increased risk of myo/pericarditis after BNT162b2 vaccination. For myocarditis/pericarditis, the association was highest in recipients younger than 39. In general, risk was highest after her second dose and in the youngest age group. In conclusion, the study results confirmed the safety profile of his BNT1262b from New Zealand’s unique context.

*Important Notices

The Lancet preprints publish non-peer-reviewed, preliminary scientific reports and therefore should not be considered definitive, to guide clinical practice/health-related actions, or to be treated as established information. should not be