EU starts real-time review of Sanofi-GSK coronavirus vaccine | Coronavirus pandemic news
After early results showed that the vaccine produced a strong immune response, Sanofi-GSK hopes to be approved by the end of this year.
The European drug regulatory agency said on Tuesday that it has begun a real-time review of the COVID-19 vaccine developed by the French drugmaker Sanofi and GlaxoSmithKline in the United Kingdom. This is the fifth vaccine currently under review.
The European Medicines Agency (EMA) stated that the decision to start a “rolling review” of the vaccine Vidprevtyn was based on preliminary results from laboratory studies and early adult clinical trials.
Late-stage global trials of protein-based coronavirus vaccine candidates began in May.
Sanofi and GlaxoSmithKline hope to obtain approval by the end of 2021 after early results show that the vaccine produces a strong immune response.
“EMA will assess whether Vidprevtyn meets the EU’s usual effectiveness, safety and quality standards,” the regulatory agency Said in a statement, But did not provide details of the data received so far and the expected timeline for approval.
“After the vaccine’s marketing authorization application is submitted, EMA will further communicate.”
The agency’s rolling review aims to speed up the approval process by allowing researchers to submit survey results in real time before final trial data is available.
Sanofi said that other rolling reviews of its vaccines are also about to begin in the United Kingdom, Canada, Singapore, and the World Health Organization.
Vidprevtyn uses the same technology as a seasonal flu vaccine from Sanofi. It will be combined with an adjuvant, which is a booster made by GlaxoSmithKline.
The four vaccines authorized by the EMA in the EU are Pfizer BioNTech, Moderna, AstraZeneca and Johnson & Johnson.
Unlike Pfizer and Moderna and other mRNA vaccines that need to be stored at ultra-low temperatures, Sanofi injections can be kept at temperatures close to room temperature, which may help promote.
Like most other vaccines on the market, the jab requires two doses.
Other COVID-19 vaccine candidates in the rolling review of the EU are from CureVac, Novavax, Sinovac, and Russia’s Sputnik V.