Vaxzevria Archives - Medical Design Sourcing

AstraZeneca abandons plans to launch Vaxzevria COVID-19 vaccine in U.S.

AstraZeneca (LON:AZN) was among the first companies to develop a COVID-19 vaccine, but the firm has given up on marketing its Vaxzevria vaccine in the U.S. The company’s CEO, Pascal Soriot, announced that it had asked the FDA to withdraw its regulatory paperwork for Vaxzevria.

The vaccine developed jointly with Oxford University saw considerable success in Europe and elsewhere. But the replication-deficient chimpanzee adenovirus ChAdOx1/AZD1222 has seen waning use as mRNA-based vaccines have come to dominate the market.

In the third quarter of 2022, sales of the vaccine dropped 83% to $173 million. Earlier this year, developing countries refused tens of millions of vaccine doses.

After giving up on plans to market its COVID-19 vaccine in the U.S., AstraZeneca will focus on the monoclonal antibody cocktail Evusheld (tixagevimab/cilgavimab).

AstraZeneca developed Evusheld in collaboration with researchers at Vanderbilt University. Dr. James E. Crowe…

AstraZeneca’s Vaxzevria COVID-19 vaccine wins full authorization in Europe

Although not available in the U.S., AstraZeneca’s (LON:AZN) Vaxzevria COVID-19 vaccine has won full marketing authorization in the European Union.

European authorities initially granted conditional marketing authorization to the vaccine for individuals at least 18 years old in early 2021. However, in April, the European Medicines Agency (EMA) noted that the vaccine had a possible link to rare cases of blood clots with low platelet levels. Johnson & Johnson’s COVID-19 vaccine was linked to similar reports.

European regulators’ decision to grant full authorization to the AstraZeneca vaccine follows a positive recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP).

The marketing authorization covers the use of the vaccine for primary vaccination and as a heterologous or homologous booster.

European regulatory authorities decided to provide full authorization for the vaccine after reviewing data…

SK Bioscience and GSK seek regulatory nod for COVID-19 vaccine in South Korea

SK Bioscience (KRX:302440) and GSK (NYSE:GSK) have filed a biologics license application with the Korean Ministry of Food and Drug Safety for their SKYCovione, a recombinant protein-based COVID-19 vaccine candidate.

The self-assembled nanoparticle vaccine candidate is adjuvanted with GSK’s pandemic adjuvant.

SKYCovione fared well in a Phase 3 study involving more than 4,000 adults in Thailand, Vietnam, New Zealand, Ukraine, the Philippines and South Korea.

In the study, the vaccine candidate performed better in terms of neutralizing antibody levels than AstraZeneca’s Vaxzevria COVID-19 vaccine. SKYCovione also had a good safety profile in the study. In particular, it generated neutralizing antibody titers almost three times more than the control vaccine two weeks after administering the second dose.

“At this point in time, when countries around the world are developing strategies to respond to the endemic phase of the COVID-19 gl…