Bulletin
Investor Alert

Coronavirus Update Archives | Email alerts

March 23, 2021, 2:23 p.m. EDT

Global case tally for COVID-19 nears 124 million as U.S. health experts question AstraZeneca trial data

new
Watchlist Relevance
LEARN MORE

Want to see how this story relates to your watchlist?

Just add items to create a watchlist now:

  • X
    AstraZeneca PLC (AZN)
  • X
    AstraZeneca PLC ADR (AZN)
  • X
    Pfizer Inc. (PFE)

or Cancel Already have a watchlist? Log In

Ciara Linnane

The global case tally for the coronavirus-borne illness COVID-19 crept closer to 124 million on Tuesday, as U.S. health officials raised concerns about results from a trial of AstraZeneca PLC’s vaccine less than a day after the data were released.

The company may have included “outdated information” in U.S. trial results for its COVID-19 vaccine, providing an “incomplete view of the efficacy data,” a U.S. federal health agency said in a highly unusual statement released after midnight.

AstraZeneca /zigman2/quotes/203048482/delayed UK:AZN +0.44% /zigman2/quotes/200304487/composite AZN +0.20% said Monday that interim data from a major late-stage trial found the vaccine was  79% effective  in preventing symptomatic COVID-19 and 100% effective at preventing people from falling seriously ill. The vaccine also proved safe, a key issue coming after some European countries temporarily halted its use last week after a small number of people reported blood clotting issues after getting a jab.

But the  National Institute of Allergy and Infectious Diseases  (NIAID) said it had been notified by the Data and Safety Monitoring Board (DSMB), an independent committee overseeing the U.S. trial, that it was “concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial.”

“The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the NIAID said. “We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.

AstraZeneca said in a statement that the numbers it published on Monday were based on a pre-specified interim analysis with a data cut-off of Feb. 17.

Read also: CDC changes school guidance, allowing K-12 students to sit 3 feet apart if wearing masks

“We have reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis. We are now completing the validation of the statistical analysis,” the company said. It added that it will “immediately” engage with the DSMB to share its primary analysis with the most up to date efficacy data. The company intends to issue results of the primary analysis within 48 hours.

The news casts a cloud on AstraZeneca’s other aim, which is to submit the vaccine for emergency use authorization in the U.S., where it would offer a fourth alternative, joining the vaccines developed by Pfizer Inc. /zigman2/quotes/202877789/composite PFE -0.15% and German partner BioNTech SE /zigman2/quotes/214419716/composite BNTX -1.92% , Moderna Inc. /zigman2/quotes/205619834/composite MRNA -0.56% and most recently Johnson & Johnson /zigman2/quotes/201724570/composite JNJ +0.04% .

Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, told ABC News that the AstraZeneca shot is “likely very good,” but that the data presented was questioned by independent medical experts at the National Institutes for Health.

He said the U.S. Food and Drug Administration will review the data when it submits its application for an EUA and “will independently go over every bit of data themselves.”

Others suggested the problem may lie with the company’s inexperience in dealing with U.S. regulators.

The U.S. is pushing to expand its vaccine program and get jabs into arms as quickly as possible, in an effort to avoid mass transmission of new variants of the virus that are creating spikes in cases in other places, notably Europe and Brazil.

German Chancellor Angela Merkel said Tuesday the variant that was first detected in the U.K. has now become the dominant strain in Germany and described it as a “new pandemic.”

“Essentially, we have a new virus… it is much deadlier, much more infectious and infectious for much longer,” she said as she announced a strict lockdown over the Easter holiday period.

In France, President Emmanuel Macron said his country’s vaccination drive will be greatly expanded in April, as it works to combat a third wave of infections. France should be vaccinating “morning, noon and evening,” Macron said on a visit to a vaccine site in the northern town of Valenciennes, as AFP reported. The army will set up 35 mass vaccination centers, he said.

/zigman2/quotes/203048482/delayed
UK : U.K.: London
7,930.00 p
+35.00 +0.44%
Volume: 1.90M
May 18, 2021 4:35p
P/E Ratio
34.66
Dividend Yield
2.61%
Market Cap
£103.64 billion
Rev. per Employee
£282,763
loading...
/zigman2/quotes/200304487/composite
US : U.S.: Nasdaq
$ 55.99
+0.11 +0.20%
Volume: 6.98M
May 18, 2021 4:00p
P/E Ratio
36.78
Dividend Yield
2.45%
Market Cap
$146.34 billion
Rev. per Employee
$365,423
loading...
/zigman2/quotes/202877789/composite
US : U.S.: NYSE
$ 40.05
-0.06 -0.15%
Volume: 15.81M
May 18, 2021 4:03p
P/E Ratio
20.38
Dividend Yield
3.90%
Market Cap
$223.74 billion
Rev. per Employee
$533,860
loading...
/zigman2/quotes/214419716/composite
US : U.S.: Nasdaq
$ 194.50
-3.80 -1.92%
Volume: 1.84M
May 18, 2021 4:00p
P/E Ratio
34.41
Dividend Yield
N/A
Market Cap
$47.89 billion
Rev. per Employee
$283,276
loading...
/zigman2/quotes/205619834/composite
US : U.S.: Nasdaq
$ 159.53
-0.90 -0.56%
Volume: 4.81M
May 18, 2021 4:00p
P/E Ratio
127.22
Dividend Yield
N/A
Market Cap
$64.42 billion
Rev. per Employee
$617,996
loading...
/zigman2/quotes/201724570/composite
US : U.S.: NYSE
$ 170.45
+0.06 +0.04%
Volume: 5.85M
May 18, 2021 4:00p
P/E Ratio
30.11
Dividend Yield
2.49%
Market Cap
$448.70 billion
Rev. per Employee
$613,918
loading...
1 2
This Story has 0 Comments
Be the first to comment
More News In
Industries

Story Conversation

Commenting FAQs »

Partner Center

Link to MarketWatch's Slice.