Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey

@article{Tanriover2021EfficacyAS,
  title={Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey},
  author={Mine Durusu Tanriover and Hamdi Levent Doğanay and Murat Akova and Hatice Rahmet G{\"u}ner and Alpay Azap and Sıla Akhan and Ş{\"u}kran K{\"o}se and Fatma Sebnem Erdinc and Emin Halis Akalın and {\"O}mer Fehmi Tabak and H{\"u}sn{\"u} Pullukçu and {\"O}zg{\"u}r Batum and Serap ŞİMŞEK YAVUZ and {\"O}zge Turhan and Mustafa Taner Yıldırmak and İftihar K{\"o}ksal and Yeşim Taşova and Volkan Korten and G{\"u}rdal Yılmaz and Mustafa Kemal Çelen and Sedat Altın and Ilhami Çelik and Yasar Bayindir and Ilkay Karaoğlan and Aydın Yılmaz and Aykut {\"O}zkul and Hazal G{\"u}r and Serhat Unal and Bircan İmran Ayça {\"O}mer G{\"u}le İrem Ahmet Çağkan Mehtap Hati Kayaaslan Hasanoğlu Dalkıran Aydos Çınar Akdemir-K and Bircan Kayaaslan and Imran Hasanoğlu and Ayça Dalkıran and {\"O}mer Aydos and Gule Cınar and İrem Akdemir-Kalkan and Ahmet Çagkan Inkaya and Mehtap Aydın and Hatice Kiran Çakir and Jale Yıldız and {\"O}zenir Kocabıyık and S. Aytac Arslan and Bayram Nallı and {\"O}mer Furkan Demir and Sarp Singil and Çiğdem Ataman-Hatipoğlu and Gunay Tuncer-Ertem and Sami Kınıklı and Uğur {\"O}nal and Bilgul Mete and G{\"o}zde Dalgan and Meltem Işikg{\"o}z Taşbakan and Tansu Yamazhan and Berna K{\"o}m{\"u}rc{\"u}oğlu and Enver Yalnız and Aysun Benli and Çağla Keskin-Sarıtaş and Mustafa Gokhan Ertosun and {\"O}zlenen {\"O}zkan and Salih Emre and Seçil G{\"u}nher Arıca and Ferit Kuşçu and Aslıhan Candevir and Buket Ert{\"u}rk-Şengel and Fadime Ayvaz and Firdevs Aksoy and Çiğdem Mermutluoğlu and Yakup Demir and G{\"u}lşah G{\"u}nl{\"u}oğlu and Seda Tural-{\"O}n{\"u}r and Ayşin Kılıç-Toker and Esma Eren and Barış Otlu and Ayse Mete and K{\"u}bra Koçak and Hale Ateş and İlkay Koca-Kalkan and Kurtuluş Aksu},
  journal={Lancet (London, England)},
  year={2021},
  volume={398},
  pages={213 - 222}
}

Figures from this paper

Safety and efficacy of two immunization schedules with an inactivated SARS-CoV-2 vaccine in adults. A randomized non-inferiority clinical trial.
TLDR
Both schedules of CoronaVac protected against COVID-19 hospitalizations, especially in over 60 years-old participants, and there were no significant differences for local and systemic AE between schedules.
Immunogenicity, Effectiveness, and Safety of Inactivated Virus (CoronaVac) Vaccine in a Two-Dose Primary Protocol and BNT162b2 Heterologous Booster in Brazil (Immunita-001): A One Year Period Follow Up Phase 4 Study
  • R. Grenfell, Nathálie BF Almeida, Priscila Fernanda S Maria Luysa C Jessica V Viviane CF Edua Martins Pedrosa de Assis dos Santos de Oliveira Si
  • Medicine
    Frontiers in Immunology
  • 2022
TLDR
The data approach the effectiveness of CoronaVac association with BNT162b2 from the clinical and biological perspectives, aspects that have important implications for informing decisions about vaccine boosters.
Safety and immunogenicity of a SARS-CoV-2 inactivated vaccine in patients with chronic hepatitis B virus infection
TLDR
The results demonstrated that SARS-CoV-2 inactivated vaccines had a favorable safety profile in CHB patients and the benefit of vaccination in compensated cirrhotic patients still outweighs the vaccine-related risk.
Heterologous AD5-nCOV plus CoronaVac versus homologous CoronaVac vaccination: a randomized phase 4 trial
TLDR
Heterologous boosting with Convidecia following initial vaccination with CoronaVac is safe and more immunogenic than homologousboosting, and the occurrence of adverse reactions and geometric mean titers of neutralizing antibodies against live wild-type SARS-CoV-2 virus after booster vaccination are suggested.
Immunogenicity of a Heterologous Prime-Boost COVID-19 Vaccination with mRNA and Inactivated Virus Vaccines Compared with Homologous Vaccination Strategy against SARS-CoV-2 Variants
TLDR
The immunogenicity of an mRNA-inactivated virus vaccine against the SARS-CoV-2 wild-type (WT) and variants was evaluated and a third dose of the vaccine is needed for these vaccines.
...
...

References

SHOWING 1-10 OF 38 REFERENCES
A randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of SARS-CoV-2 vaccine (inactivated, Vero cell): a structured summary of a study protocol for a randomised controlled trial
TLDR
The efficacy and safety of an inactivated and aluminium hydroxide adsorbed SARS-CoV-2 vaccine is evaluated in voluntary participants after 14 days of the second dose against RT-PCR confirmed symptomatic COVID-19 cases.
Efficacy and Safety of a COVID-19 Inactivated Vaccine in Healthcare Professionals in Brazil: The PROFISCOV Study
TLDR
A phase 3 clinical trial conducted in healthcare professionals in Brazil demonstrated that the inactivated CoronaVac vaccine has a good safety profile and is efficacious against any symptomatic SARS-CoV-2 infections and highly protective against moderate and severe COVID-19.
Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19
TLDR
A single dose of Ad26.COV2.S protected against symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection and was effective against severe–critical disease, including hospitalization and death, in an international, randomized, double-blind, placebo-controlled, phase 3 trial.
Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine
TLDR
The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease, and Aside from transient local and systemic reactions, no safety concerns were identified.
...
...