SARS-CoV-2 vaccine

Overview

SARS-CoV-2 vaccine is an adjuvanted recombinant protein-based COVID-19 vaccine candidate being developed collaboratively by GlaxoSmithKline (GSK) and Sanofi. This vaccine candidate is composed of a spike protein antigen which aims to stimulate immune system production of antibodies against SARS-CoV-2; it uses technology previously employed for a recombinant influenza vaccine.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 Vaccine (SARS-CoV-2 [COVID-19] and Influenza) in Adults ≥50 Years of Age	2024/11/19	NCT06694389	Phase 3	Active, not recruiting	ModernaTX, Inc.
IMPACT OF KIDNEY FAILURE ON THE REGULATION OF HUMORAL RESPONSE TO VACCINATION	2024/10/10	NCT06635525	N/A	Not yet recruiting	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Vaccine Responses in Cancer	2024/09/20	NCT06605625	N/A	Recruiting	Abramson Cancer Center at Penn Medicine
Humoral and Cellular Immunity Against SARS-COV-2 Vaccine in HIV-infected Patients Immunosuppressed	2022/12/01	NCT05633927	N/A	Completed	Hospitales Universitarios Virgen del Rocío
COVID-19 Vaccines Associated Malaise	2022/02/10	NCT05234333	N/A	Completed	University Hospital, Caen
Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) Immune Kidney Transplant Study (COVID-19)	2021/02/10	NCT04747522	N/A	Active, not recruiting	Oslo University Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Nuvaxovid	Novavax CZ, a.s.,Bohumil 138,Jevany, 28163,Czechia	Authorised	12/20/2021

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
NUVAXOVID DISPERSION FOR INJECTION COVID-19 VACCINE 5 µg/dose (RECOMBINANT, ADJUVANTED)	Serum Institute Of India Private Limited	SIN16886P	INJECTION, SUSPENSION	5 µg/dose	10/17/2023

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
NUVAXOVID	novavax inc.	02543656	Suspension - Intramuscular	5 MCG / 0.5 ML	12/8/2023
NUVAXOVID	novavax inc.	02525364	Suspension - Intramuscular	5 MCG / 0.5 ML	3/31/2022

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

AI-Powered Research

Premium Access