pcloudy.png
Tuesday May 18th, 2021 7:01PM

EU regulator is considering Oxford-AstraZeneca vaccine

By The Associated Press
Related Articles
  Contact Editor

LONDON (AP) — The European Medicines Agency said Tuesday that AstraZeneca and Oxford University have submitted an application for their COVID-19 vaccine to be licensed across the European Union.

The EU regulator said it received a request for the vaccine to be greenlighted under an expedited process and that it could be approved by Jan. 29 “provided that the data submitted on the quality, safety and efficacy of the vaccine are sufficiently robust and complete.”

The EMA, the drugs agency for the 27-nation EU, has already approved two other coronavirus vaccines, one made by American drugmaker Pfizer and Germany's BioNTech and another made by U.S. biotechnology company Moderna. Switzerland approved the Moderna vaccine on Tuesday and plans to immunize about 4% of its population using that and the Pfizer-BioNTech shot.

Britain gave its approval to the Oxford-AstraZeneca vaccine last month and has been using it. India approved it this month.

As part of its strategy to obtain as many different COVID-19 vaccines as possible for Europeans, the EU said it had concluded early talks with French biotech company Valneva to secure up to 60 million doses of vaccine.

Valneva previously signed a deal with Britain to provide tens of millions of doses of its shot, which is developed using similar technology to that used to make flu vaccines. The EU has sealed six vaccine contracts for up to 2 billion doses, many more than are necessary to cover its population of approximately 450 million.

The Oxford-AstraZeneca vaccine is expected to be a key vaccine for many countries because of its low cost, availability and ease of use. It can be kept in refrigerators rather than the ultra-cold storage that the Pfizer vaccine requires. The company has said it will sell it for $2.50 a dose and plans to make up to 3 billion doses by the end of 2021.

Researchers claim the Oxford-AstraZeneca vaccine protected against disease in 62% of those given two full doses and in 90% of those initially given a half dose because of a manufacturing error. However, the second group included only 2,741 people — too few to be conclusive.

Questions also remain about how well the vaccine protects older people. Only 12% of study participants were over 55 and they were enrolled later, so there hasn’t been enough time to see whether they develop infections at a lower rate than those not given the vaccine.

The U.S. Food and Drug Administration says it won't consider approving the Oxford-AstraZeneca vaccine until data are available from late state research testing the shot in about 30,000 people.

The World Health Organization is also examining a request from AstraZeneca and Oxford for an emergency use listing for its vaccine.

The U.N. health agency does not license or regulate vaccines itself, but typically evaluates vaccines once they have been approved by an agency such as the U.K. regulator or the European Medicines Agency. WHO experts conduct their own evaluation of whether or not the risks of a vaccine outweigh its benefits and then make a recommendation for the shots to be “pre-qualified” so they can be bought by donors for developing countries.

___

Lorne Cook in Brussels, and Jamey Keaten in Geneva, contributed to this report.

___

Follow AP’s pandemic coverage at:

https://apnews.com/hub/coronavirus-pandemic

https://apnews.com/hub/coronavirus-vaccine

https://apnews.com/UnderstandingtheOutbreak

  • Associated Categories: Associated Press (AP), AP National News, AP Online National News, Top General short headlines, AP Health, AP World News, AP Business, AP Business - Corporate News, AP Business - Industries, AP Business - Health Care
© Copyright 2021 AccessWDUN.com
All rights reserved. This material may not be published, broadcast, rewritten, or redistributed without permission.
Bodies pile up at crematorium in Germany's virus hot spot
A surge of coronavirus deaths in the eastern German state of Saxony has boosted business for Meissen crematorium, but no one is celebrating
5:00AM ( 5 minutes ago )
Ebola vaccines stockpiled against future outbreaks
The World Health Organization and partners say they are creating a global stockpile of Ebola vaccines to help stamp out future outbreaks
4:57AM ( 9 minutes ago )
EU regulator is considering Oxford-AstraZeneca vaccine
The European Medicines Agency said AstraZeneca and Oxford University have submitted an application for their COVID-19 vaccine to be licensed across the 27-nation European Union
4:52AM ( 14 minutes ago )
Associated Press (AP)
Gunmen kill policeman escorting polio workers in Pakistan
Pakistani police say two gunmen riding on a motorcycle killed a policeman escorting a team of polio workers
3:14AM ( 1 hour ago )
Should I get a COVID-19 vaccine if I've had the virus?
Health experts say people who have had the coronavirus should still plan on getting a COVID-19 vaccine once it's available to them
3:02AM ( 2 hours ago )
Asia Today: India starts shipping COVID-19 vaccine to cities
India has started shipping COVID-19 vaccines to multiple cities, four days ahead of the nationwide inoculation drive
2:27AM ( 2 hours ago )
AP Health
Probe highlights Vatican legal system's limited protections
A criminal investigation into a Vatican real estate investment is exposing weaknesses in the city state’s judicial system and its limited protections for those accused
2:16AM ( 2 hours ago )
Emergency imposed in Malaysia over virus is reprieve for PM
Malaysia’s king has approved a coronavirus emergency that will suspend parliament and hold off calls for elections in a political reprieve for embattled Prime Minister Muhyiddin Yassin
1:08AM ( 3 hours ago )
Divers sift debris, seabed mud for Indonesia plane devices
Indonesian navy divers are searching through plane debris and seabed mud for the black boxes of a Sriwijaya Air jet that crashed with 62 people aboard
12:51AM ( 4 hours ago )
AP World News
Asian stocks mixed as markets watch for Biden stimulus plan
Asian stocks are mixed as investors watch for details of President-elect Joe Biden's proposed economic stimulus plan
1:37AM ( 3 hours ago )
Asian stocks gain as markets watch for Biden stimulus plan
Asian stocks have gained as investors watch for details of President-elect Joe Biden's proposed economic stimulus plan
12:01AM ( 5 hours ago )
Airbnb banning rioters, hate groups ahead of inauguration
Airbnb says it’s reviewing reservations in the Washington, D
8:23PM ( 8 hours ago )
AP Business
Stocks slip as Wall Street takes a breather after 4-day run
Stocks closed lower on Wall Street Monday as trading cools in markets around the world following record-setting runs
4:08PM ( 12 hours ago )
Fox News shuffles daytime lineup; CNN makes changes
Fox News Channel has dramatically reshuffled its daytime lineup and is adding a new opinion hour at 7 p.m. Eastern
2:41PM ( 14 hours ago )
Meet the online gadget show, a hall of mirrors to the future
Every January, huge crowds descend on Las Vegas for the CES gadget show, an extravaganza of tech and glitz intended to set the tone for the coming year in consumer technology
10:44AM ( 18 hours ago )
AP Business - Corporate News
The Latest: Jordan receives first shipment of Pfizer vaccine
Jordan has received its first shipment of the Pfizer coronavirus vaccine before its vaccination drive kicks off this week
3:10PM ( 13 hours ago )
Lebanon plans 11-day, 24-hour curfew, hospital beds fill up
Lebanese authorities have announced a tightening of a nationwide lockdown, including an 11-day 24-hour curfew that starts later in the week
2:51PM ( 14 hours ago )
Aid agencies fear impact in Yemen after US terror decision
Aid agencies warn of a devastating impact on the humanitarian effort in Yemen from the U.S. decision to designate Iranian-backed rebels there as terrorists
2:38PM ( 14 hours ago )
AP Business - Industries
The Latest: Mexico sees record 16,105 new virus cases
Mexico has posted another daily record for newly confirmed coronavirus cases, with 16,105 new infections reported Saturday, and a near-record of 1,135 deaths related to COVID-19 in the latest 24-hour period
10:22PM ( 2 days ago )
The Latest: Montreal enacts curfew as virus cases spike
A curfew meant to curb a rising tide of COVID-19 cases took effect across Quebec on Saturday evening
9:55PM ( 2 days ago )
The Latest: Austin will treat patients at convention center
Health officials in Austin, Texas, say they will open space in the Austin Convention Center for COVID-19 patients because they expect that the area’s health care system will soon be overwhelmed
6:48PM ( 2 days ago )
AP Business - Health Care
Bodies pile up at crematorium in Germany's virus hot spot
A surge of coronavirus deaths in the eastern German state of Saxony has boosted business for Meissen crematorium, but no one is celebrating
5:00AM ( 5 minutes ago )
EU regulator gets request to approve Oxford COVID-19 vaccine
The European Medicines Agency said AstraZeneca and Oxford University have submitted an application for their COVID-19 vaccine to be licensed across the 27-nation European Union
4:47AM ( 19 minutes ago )
The Latest: WHO experts to arrive in Wuhan this week
China says World Health Organization experts will begin their fact-finding visit this week in the central city of Wuhan where the coronavirus was first detected in late 2019
4:18AM ( 48 minutes ago )
Divers search debris, seabed mud for Indonesia plane devices
Indonesian navy divers are searching through plane debris and seabed mud for the black boxes of a jet that crashed over the weekend with 62 people aboard
3:53AM ( 1 hour ago )
Global stocks rise as markets watch for Biden stimulus plan
Global stocks and U.S. futures are higher as investors watch for details of President-elect Joe Biden's proposed economic stimulus plan
3:44AM ( 1 hour ago )