Inaktivierter SARS-CoV-2-Impfstoff (Vero-Zelle)

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SARS-CoV-2 Inactivated Vaccine (Vero Cell)

SARS-CoV-2 Inactivated Vaccine (Vero Cell) is composed

of novel coronavirus strain after Vero cell culture,

inactivation, purification and adjuvant adsorption.

Specification: 0.5 ml/PFS, 0.5 ml per dose

Storage condition: 2-8 ℃

Manufacturer: Beijing Institute of Biological Products Co., Ltd.; Wuhan Institute of Biological Products Co., Ltd.

Product Introduction

Eligible: This product is suitable for healthy people above 18 years old.(After clinical unblinding, the age

range of inoculation could be expan

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Produktbeschreibung

Product Name：SARS-CoV-2 Inactivated Vaccine (Vero Cell)

SARS-CoV-2 Inactivated Vaccine (Vero Cell) is composed

of novel coronavirus strain after Vero cell culture,

inactivation, purification and adjuvant adsorption.

Specification: 0.5 ml/PFS, 0.5 ml per dose

Storage condition: 2-8 ℃

Manufacturer: Beijing Institute of Biological Products Co., Ltd.; Wuhan Institute of Biological Products Co., Ltd.

Product Introduction

Eligible: This product is suitable for healthy people above 18 years old.(After clinical unblinding, the age

range of inoculation could be expan

STICHWORTE: BioNTech vaccine, Pfizer Vaccine , SARS-CoV-2 Inactivated Vaccine (Vero Cell) , Virus vaccine syringe , Vaccine syringe , Sinopharm Vaccine, Pre-clinical Trail for Vaccine, Clinical Trail Phase I/II for Vaccine, USA vaccine, CoronaVac ...

Produktmerkmale

Pre-clinical Trial

Immunogenicity study, including the comparative study of different dosage of antigen and adjuvant, as well as the comparative study of

different immunization schedule, doses and route of this Novel Coronavirus Inactivated Vaccine, has been conducted in Mouse, Rat, Guinea

Pig, Rabbit, Rhesus Monkey. The fore-said immunogenicity test results indicates that the vaccine has good immunogenicity in different

animals and could stimulate the production of high level titer neutralizing antibody in animals.

The safety evaluation in accordance with international guidelines has been carried out for the

vaccine. The Acute Toxicity and Repeated Administration Toxicity Observation was conducted in

Rat and Rhesus Monkey, the Allergy Observation was conducted in Guinea Pig, and the Animal

Protection Test Observation was conducted in Monkey. The results showed that the vaccine is

safe and effective with controllable quality.

The preclinical results shows that the vaccine has good immunogenicity in different animals, and it is safe and effective with controllable quality.

Clinical Trial Phase I/II

A total of 1120 participants in the phase I / II clinical trial completed 2-dose injections.

Result

1. There was no serious adverse reaction;

2. After different schedule and doses of vaccination, high titer

antibody has produced in the test;

3. After 28 days of inoculation, the positive rate of neutralizing

antibody reached 100%.

On June 23, Sinopharm launched the phase III clinical trial in

the United Arab Emirates. Up to now, more than 50,000

participant have been enrolled in clinical trial phase III.

Clinical Trial Phase III

Sinopharm has obtained the phase III clinical trial

approval of UAE at the first, and then successively

obtained the clinical trial approval of Bahrain, Egypt,

Peru, Morocco and Argentina.

The vaccine developed by WIBP entered phase I and phase II clinical trial.

BIBP built the first and only high-level biosafety production facility in China.

The vaccine developed by BIBP entered clinical trial.

WIBP released the results of phase blinding in clinical trials.

The UAE health minister issued the approval document of clinical trial to Sinopharm CNBG.

Beijing Institute of biological products released the first and second phase clinical results.

The study for the results of Phase I/II clinical trial on the vaccine was published on the Journal

of the American Medical Association.

The study for the results of Phase I/II clinical trial on the vaccine was published on the Lancet.

Timeline

2020.04.12

2020.04.15

2020.04.27

2020.06.16

2020.06.23

2020.06.28

2020.08.13

2020.10.15

Two SARS-CoV-2 Inactivated Vaccine (Vero Cell) from

Sinopharm CNBG are currently in the final stage of phase III

clinical trial, will be listed after national regulatory

approval.

Follow-up

The SARS-CoV-2 Inactivated Vaccine (Vero Cell) of

Beijing & Wuhan Institute of Biological Products Co.,

Ltd has an annual capacity of 300 million doses.