Sanofi, GSK Secure European COVID-19 Booster Approval, AstraZeneca Withdraws U.S. Application

As COVID-19 continues to circulate, the European Commission approved Sanofi and GSK’s COVID-19 booster. On a different note, AstraZeneca’s CEO said the company would withdraw its COVID-19 vaccine FDA approval application, ultimately pulling out of the U.S. COVID-19 market due to low demand.

Better Late than Never for Sanofi and GSK

After several years of clinical trials, lagging behind the competition, Sanofi and GSK’s VidPrevtyn Beta finally has the chance to enter the European market after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion of the vaccine based on trial data, leading to approval. 

Sanofi designed the monovalent, recombinant-protein vaccine modeled on the Beta variant and includes GSK’s pandemic adjuvant. The French pharma giant uses the same recombinant-protein technology in its approved seasonal flu vaccines. The booster can pair with initial mRNA or adenovirus COVID-19 vaccines. The companies said the vaccine protects against multiple strains of the virus.

Sanofi underwent two immunogenicity and safety studies before submitting the vaccine for approval. In the COVIBOOST immunogenicity and safety study, Sanofi said VidPrevtyn Beta elicited higher immune responses than Pfizer-BioNTech’s booster and Sanofi and GSK’s first-generation booster. In the VAT02 immunogenicity and safety study, the vaccine also showed positive results among a population with previous doses of an mRNA vaccine. 

The VAT08 Phase 3 Stage 2 study included over 23,000 participants and demonstrated a 64.7% efficacy rate among the population regardless of previous infection status. Among those who previously had COVID-19, the efficacy rate increased to 75.1%. Across all the studies, VidPrevtyn Beta demonstrated a tolerable safety profile.

Based on Advance Purchase Agreements, Sanofi said the vaccine is ready for distribution across Europe. Sanofi is the marketing authorization holder in the partnership with GSK.

Related Article: AstraZeneca’s Role in COVID-19 Slows Down as World Looks to mRNA Vaccines

AstraZeneca Removes COVID-19 Vaccine from FDA Consideration

After mulling around downsizing its COVID-19 vaccine efforts worldwide, AstraZeneca’s CEO, Pascal Soriot, said in a press briefing on Thursday that the company will withdraw its COVID-19 vaccine submission from the FDA. Soriot said the U.S. has an adequate supply of COVID-19 vaccines, and the vaccine demand is declining.

Even in its home country, AstraZeneca’s COVID-19 vaccine program lost momentum when the UK announced it would not purchase any more vaccines from the company. The UK cited superior real-world data from mRNA vaccines and said patients who cannot take mRNA vaccines could take advantage of Novavax’s vaccine. 

Still, the company plans to focus on COVID-19 prevention measures through its product Evusheld. The FDA granted Evusheld Emergency Use Authorization in May this year. AstraZeneca designed the product for immunocompromised individuals and those ineligible for any COVID-19 vaccine who either have not contracted COVID-19 or have not contracted it recently. Evusheld gained the European Commission’s approval in September, and AstraZeneca hopes it will gain the FDA’s full approval sometime next year.

With AstraZeneca’s COVID-19 vaccine revenue declining sharply worldwide as Moderna and Pfizer maintain billion-dollar profits with their mRNA vaccines, it was only a matter of time before AstraZeneca took a step back from the COVID-19 vaccine market.

With boosters being a primary focal point in the COVID-19 conversation, Sanofi and GSK’s European approval is big news for the two companies who worked so long to get a vaccine to the market. On the other end of the spectrum, AstraZeneca played a critical role in the early days of COVID-19 vaccines but, based on its competitors’ performance, will take a step back from the COVID-19 vaccine market. 

Author

Reed Slater