AstraZeneca CEO hopeful COVID-19 vaccine may still have role in U.S.
Reuters
Published Jul 29, 2021 10:59
LONDON (Reuters) - AstraZeneca (NASDAQ:AZN) still plans to seek U.S. approval for its COVID-19 vaccine even though the process there is taking longer than expected, because it may still be used in the country in the future, CEO Pascal Soriot said on Thursday.
"The simple answer is, it's an important vaccine. And we believe it may play a role in the future, so we want to file and get approval for it," he told a media briefing, when asked why the drugmaker was pursing approval even though the United States has enough supply to inoculate its population without it.
Soriot said the company does not need U.S. approval to boost credibility of the vaccine, Vaxzevria, around the world. Some 170 countries have given the go-ahead for its use, but AstraZeneca wants to be ready for a time when it could be needed.
The company's plans to submit applications for approval have been pushed to the second half of this year, however, after repeated delays because of requests for large data from U.S. authorities.
"The (U.S.) FDA (Food and Drug Administration) are requesting, an awful lot of information ... and we're having to submit all of those data sets, clinical trial tables analyses, etc. to have that pre-BLA meeting," senior executive Mene Pangalos said on the call.
The company is also exploring booster doses for people who have already been vaccinated with two doses of either their own shot or mRNA-based vaccines.
"We hope to have that data in the third quarter, suitable for submission with an authorisation requests in the UK at least before the end of the year," Pangalos added.
Get The App
Written By: Reuters
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.