Finance

EU begins real-time review of Sanofi-GSK COVID-19 vaccine By Reuters

2/2
© Reuters. FILE PHOTO: A Sanofi logo is seen during the company’s annual results news conference in Paris, France, February 6, 2020. REUTERS/Benoit Tessier

2/2

(Reuters) -Europe’s drug regulator said on Tuesday it had started a real-time review of the COVID-19 vaccine developed by French drugmaker Sanofi (NASDAQ:) and Britain’s GlaxoSmithKline (NYSE:), the fifth shot currently under such a review.

The decision to start the “rolling review” of the vaccine, Vidprevtyn, was based on preliminary results from lab studies and early stage clinical trials in adults, the European Medicines Agency (EMA) said https://www.ema.europa.eu/en/news/ema-starts-rolling-review-covid-19-vaccine-vidprevtyn.

Late-stage global trials for the protein-based coronavirus vaccine candidate began in May.

Sanofi and GSK hope to get approvals by the end of 2021 after early-stage results showed the vaccine produces a robust immune response.

“EMA will assess the compliance of Vidprevtyn with the usual EU standards for effectiveness, safety and quality,” the regulator said, without giving details on data it had received so far and an expected timeline for approval.

EMA’s rolling reviews are aimed at speeding up the approval process by allowing researchers to submit findings in real time before final trial data is available.

Sanofi said other rolling reviews of its vaccine were also about to start in Britain, Canada and Singapore, as well as with the World Health Organization.

Vidprevtyn uses the same technology as one of Sanofi’s seasonal influenza vaccines. It will be coupled with an adjuvant, a substance that acts as a booster to the shot, made by GSK.

Other COVID-19 vaccine candidates in EU’s rolling review are those from CureVac, Novavax (NASDAQ:), Sinovac and Russia’s Sputnik V.

Disclaimer: Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. All CFDs (stocks, indexes, futures) and Forex prices are not provided by exchanges but rather by market makers, and so prices may not be accurate and may differ from the actual market price, meaning prices are indicative and not appropriate for trading purposes. Therefore Fusion Media doesn`t bear any responsibility for any trading losses you might incur as a result of using this data.

Fusion Media or anyone involved with Fusion Media will not accept any liability for loss or damage as a result of reliance on the information including data, quotes, charts and buy/sell signals contained within this website. Please be fully informed regarding the risks and costs associated with trading the financial markets, it is one of the riskiest investment forms possible.


Most Related Links :
Business News Governmental News Finance News

Need Your Help Today. Your $1 can change life.

[charitable_donation_form campaign_id=57167]

Source link

Back to top button