Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Settings
Settings
Dynamic quotes 
OFFON

MarketScreener Homepage  >  Equities  >  London Stock Exchange  >  AstraZeneca PLC    AZN   GB0009895292

ASTRAZENECA PLC

(AZN)
  Report
SummaryQuotesChartsNewsCalendarCompanyFinancialsConsensusRevisions 
SummaryMost relevantAll NewsPress ReleasesOfficial PublicationsSector newsMarketScreener StrategiesAnalyst Recommendations

AstraZeneca : Covid-19 Vaccine Trial From AstraZeneca, Oxford Can Resume in U.S. -- Update

10/23/2020 | 02:42pm EST

By Thomas M. Burton

Federal health regulators have decided to allow the resumption of U.S. studies of a leading Covid-19 vaccine candidate from AstraZeneca PLC and the University of Oxford, according to a person familiar with the matter and materials reviewed by The Wall Street Journal.

The U.S. Food and Drug Administration has wrapped up its examination of two cases of a possible neurological side effect that emerged in two people testing the shot. The agency told AstraZeneca on Friday that the late-stage trial in the U.S. can resume, according to the person and materials.

The FDA didn't find the vaccine was responsible for the two cases, though it couldn't rule out a link either, the person said.

The agency plans to require researchers to inform study subjects of the cases and monitor them for any related neurological events, such as numbness, the person said.

AstraZeneca declined to comment.

The vaccine is among the most advanced in development. If it proves to work safely, it could be one of the first, if not the first, greenlighted by regulators for widespread use.

The vaccine had been on track to be authorized for widespread use before year's end, if it proved to work safely in the late-stage testing.

Last month, however, AstraZeneca paused trials testing the shot around the world, including in the U.S., after a U.K. woman developed a mysterious neurological illness. A U.S. health official had said the event involved a spinal cord problem.

The illness followed a pause in testing, in July, after an unexplained illness of a trial subject. Researchers initially told subjects in the study the case involved a neurological disorder known as transverse myelitis. AstraZeneca later said the case turned out to be multiple sclerosis unrelated to the vaccine, and the testing resumed.

Studies testing the vaccine around the world later resumed after regulators outside the U.S. determined it was safe to do so, except a late-stage trial in the U.S. because the FDA was still investigating the two events.

The FDA has spent weeks exploring whether the two cases involved transverse myelitis and whether the vaccine was responsible for the illness, the person said.

An AstraZeneca spokesman has said the company was working with the FDA so it can evaluate whether the U.S. trial can resume. All the studies testing the shots are being closely watched for safety, including by health regulators in various countries, the spokesman said.

Reuters had earlier reported the U.S. trial could resume this week.

Transverse myelitis is a known side effect of vaccines but is rarely linked to the shots. Other times, it is an early symptom of the nerve-system disease multiple sclerosis, and unrelated to getting a shot.

The condition refers to inflammation of the spinal cord involving the destruction of a fatty white material, known as myelin, that insulates nerve cell fibers. It impedes the ability of nerves in the spinal cord to send messages to the rest of the body.

Cases are rare, with only about 1,400 diagnosed annually in the U.S. The cause is unknown. It can trigger a variety of symptoms, including weak arms and legs, along with sharp pains, numbness and tingling.

It can sometimes also lead to paraplegia that necessitates wheelchair use.

Experimental vaccines undergo study, in trials that progressively test the shots in increasing numbers of volunteers, both to test effectiveness and to look for any side effects that could harm people if regulators greenlighted the vaccines and they were then given widely.

To protect trial subjects, independent researchers who didn't play a role in the vaccine's development, or at the company that would sell it, look for any signs that the shot could be harmful. This data-safety monitoring board evaluates side effects in subjects.

Side effects often emerge in trials evaluating drugs and vaccines, and the studies are frequently paused for researchers and regulators to make sure it is safe to go on.

Since the trial for the vaccine from AstraZeneca and Oxford was put on hold, studies of Johnson & Johnson's Covid-19 vaccine candidate and of a combination of Eli Lilly & Co.'s antibody and Gilead Sciences Inc.'s antiviral remdesivir w ere paused.

AstraZeneca was among the drugmakers that pledged to not seek regulators' permission for widespread use of their Covid-19 vaccines until the shots proved to work safely in late-stage testing.

--Joseph Walker contributed to this article.

Write to Thomas M. Burton at tom.burton@wsj.com

(END) Dow Jones Newswires

10-23-20 1441ET

Stocks mentioned in the article
ChangeLast1st jan.
ASTRAZENECA PLC 0.28% 7770 Delayed Quote.2.14%
GILEAD SCIENCES, INC. 0.89% 60.03 Delayed Quote.-7.62%
All news about ASTRAZENECA PLC
11:22aSerum Institute CEO sees AstraZeneca's COVID-19 vaccine as "very good" candid..
RE
11:18aSerum Institute CEO sees AstraZeneca's COVID-19 vaccine as "very good" candid..
RE
10:59aUK regulator set to approve COVID-19 vaccine next week - FT
RE
10:31aIndia's Modi visits key vaccine facilities as COVID-19 cases surge
RE
08:22aUK appoints vaccines minister to oversee COVID inoculations
AQ
08:05aIndia's Modi visits key vaccine facilities as COVID-19 case load surges
RE
03:32aOil prices post weekly gain ahead of OPEC+ meeting
RE
11/27SALESFORCE, DELTA AIR LINES, BEST BU : Stocks That Defined the Week
DJ
11/27Stocks at record high but yields fall, dollar under pressure
RE
11/27Oil prices post weekly gain ahead of OPEC+ meeting
RE
More news
Financials (USD)
Sales 2020 26 512 M - -
Net income 2020 2 998 M - -
Net Debt 2020 13 181 M - -
P/E ratio 2020 43,5x
Yield 2020 2,72%
Capitalization 136 B 136 B -
EV / Sales 2020 5,62x
EV / Sales 2021 4,89x
Nbr of Employees 70 600
Free-Float 95,7%
Chart ASTRAZENECA PLC
Duration : Period :
AstraZeneca PLC Technical Analysis Chart | MarketScreener
Full-screen chart
Technical analysis trends ASTRAZENECA PLC
Short TermMid-TermLong Term
TrendsBearishBearishBullish
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus OUTPERFORM
Number of Analysts 26
Average target price 121,49 $
Last Close Price 103,45 $
Spread / Highest target 50,3%
Spread / Average Target 17,4%
Spread / Lowest Target -36,2%
EPS Revisions
Managers
NameTitle
Pascal Soriot Chief Executive Officer & Executive Director
Leif Valdemar Johansson Non-Executive Chairman
Pam P. Cheng Executive VP-Operations & Information Technology
Marc Pierre Jean Dunoyer Chief Financial Officer & Executive Director
Menelas N. Pangalos EVP-Biopharmaceuticals Research & Development
Sector and Competitors
1st jan.Capitalization (M$)
ASTRAZENECA PLC2.14%135 908
DAIICHI SANKYO COMPANY, LIMITED56.60%72 682
JIANGSU HENGRUI MEDICINE CO., LTD.17.92%69 850
YUNNAN BAIYAO GROUP CO.,LTD7.23%18 673
ORION OYJ-3.10%6 712
SWEDISH ORPHAN BIOVITRUM AB1.42%5 440