European drug regulators said on Tuesday it began a real review of the Covid-19 vaccine developed by French medicine for French Sanofi and GlaxoSmithkline England, the fifth shot is currently under the reviews.
The decision to start the “review review” of the vaccine, VidPrevtyn, is based on the initial results of the Lab study and the initial clinical trial in adults, the European Medicine Agency (EMA).
The final stage global trial for protein-based coronavirus vaccine candidates began in May.
Sanofi and GSK hope to get approval at the end of 2021 after the results of the initial stage indicate a vaccine produces a strong immune response.
“EMA will assess the compliance of VidPrevtyn with ordinary EU standards for effectiveness, security and quality,” said the regulator, without providing details on data that has been received so far and the timeline is expected for approval.
Rolling EMA Review is intended to accelerate the approval process by allowing researchers to submit real-time findings before the final trial data is available.
Sanofi said the other rolling reviews from the vaccine would also begin in the UK, Canada and Singapore, as well as with the World Health Organization.
VidPrevtyn uses the same technology as one of the seasonal sanofi influenza vaccines.
This will be combined with adjuvant, a substance that acts as a booster against shot, made by GSK.
Other Covid-19 Vizine Candidates in Rolling UE reviews are they from Curevac, Novavax, Sinovac and Sputnik V.
Russia
The EU started a real-time review of the covid-19 sanofi-gsk vaccine
