AstraZeneca's COVID-19 Vaccine Vaxzevria Granted Full Marketing Authorization in the EU

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News on November 3, 2022 /BioValleyBIOON/ -- AstraZeneca recently announced that itsCOVID-19Vaccine Vaxzevria (ChAdOx1-S [Recombinant], formerly known as AZD1222)Has obtained European MedicinesManagementBureau (EMA) grantedFull Marketing Authorization（full marketing authorization）。

In the EU, due to the urgency of COVID-19, Vaxzevria was initially granted a conditional marketing authorization (cMA).Due to continued sufficient evidence of safety and efficacy confirming the benefits of Vaxzevria, the EMA has now granted it a full Marketing Authorization (MA).. This decision follows the positive recommendation of the EMA's Committee for Medicinal Products for Human Use (CHMP) regarding full MA.

Full MA covers Vaxzevria in the foundationImmunity(Primary series), as well as a heterologous (with an approved mRNACOVID-19The use of a third booster dose, whether heterologous (different vaccine) or homologous (same vaccine).

Clinical studies and real-world evidence suggest that,Vaxzevria is effective against all forms of COVID-19, from mild symptoms to severe disease, including hospitalization and death.This includes expert reviews of 52 real-world research data, which show that,Vaxzevria Provides Equally Effective Protection Against COVID-19 Hospitalization and Death After Three Doses Compared to Available mRNA COVID-19 Vaccines。There is also substantial evidence supporting the use of Vaxzevria as a booster shot following all primary immunization schedules tested to date.

Iskra Reic, Executive Vice President of AstraZeneca's Vaccines and Immune Therapies, stated: "The transition of Vaxzevria from conditional marketing authorization to full marketing authorization is an important affirmation by the EMA of Vaxzevria's safety and efficacy, indicating that its benefits continue to outweigh potential risks. It is estimated that in the first year of vaccination, Vaxzevria has helped save more than six million lives, reflecting the strong evidence of Vaxzevria’s protective effect against severe disease and death caused by COVID-19."

Vaxzevria (ChAdOx1-S [Recombinant], formerly known as AZD1222) was invented by the University of Oxford. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the spike protein of the novel coronavirus (SARS-CoV-2). After vaccination, the surface spike protein is produced, stimulating the immune system to attack the SARS-CoV-2 virus.

Vaxzevria is a "viral vector" vaccine, which means a version of a virus that does not cause disease is used as part of the vaccine to teach the body how to fight it if exposed to the real virus later.Over the past 40 years, scientists have used this vaccine technology to combat other infectious diseases, such as influenza, Zika virus, Ebola virus, and HIV.

To date, AstraZeneca and its global partners have distributed more than 3 billion doses of Vaxzevria to over 180 countries, with approximately two-thirds of the vaccine doses delivered to low- and middle-income countries.It is estimated that in its first year of launch, Vaxzevria has helped save more than 6 million lives globally.

Based on clinical studies and real-world evidence from tens of millions of people globally, Vaxzevria has an acceptable safety profile. Common adverse reactions reported among millions of people vaccinated with Vaxzevria include headache, nausea, myalgia, arthralgia, tenderness/pain/fever/itching at the injection site, fatigue, malaise, pyrexia, and chills. The severity of most adverse reactions is mild to moderate and typically resolves within a few days after vaccination. (Bioon.com)

Source of Original Text:Vaxzevria receives full Marketing Authorisation in the EU for the prevention of COVID-19