This has been already more than a half of a year that COVID-19 vaccine is available (Comirnaty). There appears robust data suggesting its safety as obtained from medical event reports from vaccinated people (https://www.ema.europa.eu/en/documents/covid-19-vaccine-safety-update/covid-19-vaccine-safety-update-comirnaty-14-july-2021_en.pdf). However, majority of data is observational and this is difficult to suggest causality. Meanwhile, the randomised controlled trial (RCT) paper, that reported the initial data on Comirnaty (Article Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine
), declared a two-year follow-up safety monitoring. And RCT would be indeed an ideal research setting to investigate causality.Is there any report of long-term safety of Comirnaty (or other) COVID-19 vaccine that is based on RCT results?
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-publication-results-landmark - Pfizer - BioNTech .
Thanks @Jaydip Datta, but this is the report dated December 2020 with initial release of RCT data and I'm looking for follow-up data
Data published in NEJM 2020 are Phase 3 clinical study results submitted for approval with up to 2 months/person follow-up. They are in accordance with the FDA Briefing Document, Pfizer-BioNTech COVID-19 Vaccine, December 10, 2020.
The regulatory package also includes the Risk Management Plan (RMP, comirnaty-epar-risk-management-plan_en.pdf, comirnaty-risk-management-plan_en.pdf), where missing facts have been requested from the manufacturer. By the end of 2023, the missing results have to be submitted to the EMA.
Vaccine-associated enhanced disease (VAED), including vaccine-associated enhanced respiratory disease (VAERD), was considered a major potential risk.
They are among the subjects of several post-approval studies (in the EU: ACCESS/VAC4EU, C4591010, globally: C4591001).
No long-term RCT findings have been reported to date. Extensive experiences have been gained since the start of the marketing. These have significantly expanded the side effect profile, pl. see Table 6 of the EudraVigilance data basis of the related vaccine. For example, many suspected cardiovascular adverse reactions (cardiac arrest, cardiac death, strokes, CNS haemorrhage, acute left vetricular failure, AMI, acute coronary syndrom, angina pectoris, myocarditis, rhythm disturbaces, blood pressure increase or hypertensive crisis. chest pain, thrombosis, embolism ...etc) have been reported. They are in accordance with the expected side effects of these vaccine spikes due to ACE2 downregulation.