![]() Similarly, mRNA-1273 efficacy, among 28,207 participants evaluated after 14 days post-dose 2, was 94.1%, higher in those aged 18–64 years compared to ≥65 years old. Among 34,922 participants evaluated at 7 days after the second dose, BNT162b2 was effective at 95.0% in preventing symptomatic COVID-19, and the protective effect was consistent among age groups ( Figure 1A) while the efficacy of a single dose was 52% (95% CI 30–68). The efficacy and safety of COVID-19 vaccines were evaluated by Phase 3 randomized controlled trials, whose primary endpoint was the symptomatic infection. Īll vaccines are administered intramuscularly. Both BNT162b2 and mRNA-1273 are based on nucleoside-modified mRNA encoding for the full-length SARS-CoV-2 spike (S) glycoprotein encapsulated in lipid nanoparticles, while ChAdOx1-S and Ad26.COV2-S are monovalent, recombinant, replication-incompetent chimpanzee and type 26 adenovirus vectors, respectively, encoding the S glycoprotein. A review of at least 6 weeks post-vaccination safety data should be available however, a median follow-up duration of 2 months after completion of the full vaccination regimen was considered sufficient by EMA to provide adequate information in the Dossier to assess a vaccine’s benefit-risk profile.ĮMA, using the rolling review regulatory tool to speed up the assessment process during a public health emergency, granted four conditional approvals for COVID-19 vaccines that met a positive benefit-risk balance: BNT162b2 (Comirnaty), mRNA-1273 (COVID-19 Vaccine Moderna), ChAdOx1-S (Vaxzevria), and Ad26.COV2-S (COVID-19 Vaccine Janssen) ( Table 1). ![]() ![]() Moreover, the pivotal trial should include individuals with pre-existing comorbidities and aged ≥65 years. ![]() According to the clinical requirements for COVID-19 vaccines for obtaining a conditional marketing authorization in the European Union (EU), at least one well-designed large-scale phase III efficacy trial should be conducted, with the primary endpoint defined as laboratory-confirmed COVID-19 disease of any severity in study participants seronegative for SARS-CoV-2 at baseline the point estimate of vaccine efficacy was set at least 50% with a lower bound of the 95% confidence interval >20% (preferably >30%), and it was recommended to assess vaccine efficacy against severe disease, hospitalization, and death as secondary endpoints. The European Medicines Agency (EMA) to confirm that a vaccine is safe, provides adequate protection, and is of suitable quality, recommends approval after a thorough evaluation. Clinical trials data: efficacy and safety ![]()
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