Trial review board raises concerns about AstraZeneca vaccine data

In an unusual statement released early Tuesday, the National Institute of Allergy and Infectious Diseases said the independent board that reviews data from m...

Posted: Mar 23, 2021 9:10 AM
Updated: Mar 23, 2021 3:00 PM

In an unusual statement released early Tuesday, the National Institute of Allergy and Infectious Diseases said the independent board that reviews data from multiple Covid-19 vaccine candidates has raised concerns about AstraZeneca's announcement of efficacy data from its vaccine 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'The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,' said the NIAID statement released early Tuesday.

'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.'

On Monday, AstraZeneca had issued a press release saying its Covid-19 vaccine showed 79% efficacy against symptomatic disease and 100% efficacy against severe disease and hospitalization, citing long-awaited US trial data. The latter figure was based on five total cases of severe disease or hospitalization in people who received the placebo, NIAID Director Dr. Anthony Fauci said during a coronavirus briefing Monday.

In a statement Tuesday, AstraZeneca said the numbers shared Monday were based on a pre-specified interim analysis with a data cutoff of February 17. It said it has reviewed an early assessment of its primary analysis, and those results were consistent with the interim analysis.

'We will immediately engage with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up to date efficacy data,' the statement said. 'We intend to issue results of the primary analysis within 48 hours.'

The DSMB is an independent expert group that sees trial data before the pharmaceutical companies, the doctors running the trials, or even the US Food and Drug Administration. It has the power advise a company of positive interim findings, or to halt a trial over safety concerns. That's what happened to the AstraZeneca trial in September after a study participant developed neurological symptoms, for example.

Last year, the National Institutes of Health appointed a common DSMB to monitor Covid-19 vaccine clinical trials that were being funded by the federal government -- including AstraZeneca, Moderna and Johnson & Johnson. This DSMB has 10 to 15 members with specialties including vaccine development, statistics and ethics.

Fauci said on Good Morning America on Tuesday that when the DSMB saw AstraZeneca's press release, 'they got concerned and wrote a rather harsh note to them -- and with a copy to me -- saying that in fact they felt that the data that was in the press release were somewhat outdated and might in fact be misleading a bit, and wanted them to straighten it out.'

'Unforced error' could create doubt about vaccine

The press release from AstraZeneca was 'an unforced error' that may create doubt about what 'is very likely a very good vaccine,' Fauci said. The data are 'really quite good, but when they put it into the press release, it wasn't completely accurate.'

The fact that the DSMB picked up on the discrepancy was an example of a safeguard around vaccines, Fauci said.

But having seen the monitoring board's letter, 'we could not just let it go unanswered.'

'We just felt we could not remain silent,' Fauci told STAT on Tuesday. 'Because if we did remain silent, we could be understandably accused of covering something up. And we definitely didn't want to be in that position.'

Still, a public statement questioning AstraZeneca's data is unusual.

DSMBs sometimes disagree with investigators over the interpretation of trial results, Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said in a statement to the Science Media Centre in the UK. But that's usually done in private, he said, 'so this is unprecedented in my opinion.'

Dr. Peter Hotez, a vaccine expert and dean of tropical medicine at Baylor school of medicine, told CNN the NIAID statement was 'totally strange.'

'I can barely understand the dispute or why they would make it so public,' Hotez said. 'My concern is that this will further erode public confidence in the AZOX vaccine, especially for low and middle income countries. And we don't have many options for Africa and Latin America at this point.'

This is not the first time AstraZeneca has faced questions about its Covid-19 vaccine. In November, it was revealed that a mistake was made in the trial and some participants received the wrong dose.

More recently, a number of European countries including Norway, France and Denmark temporarily suspended their AstraZeneca vaccine rollouts due to reports of blood clotting in patients.

An emergency investigation by the European Medicines Agency concluded the benefits of the vaccine outweigh the risks, saying the vaccine is 'safe and effective' in preventing coronavirus and 'not associated with an increase in the overall risk of thromboembolic events, or blood clots.'

There's no indication the DSMB concerns noted in the NIAID statement were linked to safety issues with the AstraZeneca vaccine.

EUA application expected in April

AstraZeneca says it plans to apply for emergency use authorization from the US Food and Drug Administration in early April. At that time, its vaccine data will go through a rigorous review and evaluation process.

On Tuesday, White House senior adviser for Covid response Andy Slavitt attempted assure the public that any vaccine that's authorized will be safe and effective.

'We're talking about now a fourth vaccine that's not yet approved by the FDA. And the reason we have an FDA process is exactly so that we don't have to wonder about data. We don't have to take a company's word for it, with all respect to the companies,' Slavitt said during an interview on CNN Tuesday.

'The public should rest assured that nothing will get approved unless the FDA does a thorough analysis of this data, and when it does that thorough analysis, it will render a judgment on both what the data says, or what it's saying, and also whether or not it will be approved.'

Mississippi Coronavirus Cases

Data is updated nightly.

Cases: 501652

Reported Deaths: 10024
CountyCasesDeaths
Harrison34353540
DeSoto32162408
Hinds31977631
Jackson24508383
Rankin22015390
Lee15596235
Madison14597280
Jones13867243
Forrest13461252
Lauderdale11998317
Lowndes11065188
Lamar10522136
Pearl River9547237
Lafayette8557140
Hancock7740127
Washington7443160
Oktibbeha7147133
Monroe6787178
Warren6706176
Pontotoc6677104
Neshoba6642206
Panola6542131
Marshall6476135
Bolivar6323150
Union605794
Pike5824152
Alcorn5676102
Lincoln5439135
George497479
Scott473098
Tippah470381
Prentiss469182
Leflore4663144
Itawamba4640105
Adams4592119
Tate4592111
Copiah448792
Simpson4448116
Yazoo444887
Wayne440072
Covington429094
Sunflower4240105
Marion4232108
Coahoma4168107
Leake408688
Newton381779
Grenada3711108
Stone360664
Tishomingo360092
Attala331789
Jasper330165
Winston314691
Clay308977
Chickasaw301067
Clarke292594
Calhoun279447
Holmes267987
Smith264150
Yalobusha234547
Tallahatchie228251
Greene219449
Walthall218764
Lawrence213140
Perry205956
Amite205256
Webster203046
Noxubee186840
Montgomery179657
Jefferson Davis172243
Carroll169338
Tunica160039
Benton149239
Kemper141941
Choctaw133326
Claiborne132837
Humphreys129638
Franklin120328
Quitman106528
Wilkinson105139
Jefferson94734
Sharkey64220
Issaquena1937
Unassigned00

Alabama Coronavirus Cases

Cases: 820312

Reported Deaths: 15407
CountyCasesDeaths
Jefferson1148731924
Mobile726221339
Madison52362697
Shelby37640350
Baldwin37266552
Tuscaloosa35120612
Montgomery34123740
Lee23540246
Calhoun22236488
Morgan20958378
Etowah19838500
Marshall18381304
Houston17394412
St. Clair16078339
Cullman15468293
Limestone15354199
Elmore15271286
Lauderdale14323295
Talladega13851283
DeKalb12664261
Walker11221370
Blount10207176
Autauga10048148
Jackson9877184
Coffee9211191
Dale8904185
Colbert8877201
Tallapoosa7093198
Escambia6778134
Covington6715183
Chilton6648162
Russell637559
Franklin5969105
Chambers5612142
Marion5010127
Dallas4979200
Pike4796106
Clarke475884
Geneva4575127
Winston4522103
Lawrence4327117
Bibb425386
Barbour357876
Marengo338390
Monroe331664
Randolph329864
Butler326796
Pickens316584
Henry312866
Hale311688
Cherokee302960
Fayette294180
Washington251651
Cleburne247760
Crenshaw245375
Clay243368
Macon234863
Lamar224847
Conecuh186353
Coosa180340
Lowndes175464
Wilcox168939
Bullock151744
Perry138940
Sumter133238
Greene126744
Choctaw88527
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High pressure will dominate our weather forecast for our Tuesday. This means we will see some good weather for our Tuesday. However, some rain and thunderstorms will be in our weather forecast down the line with some more low pressure in our area.
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