fog.png
Wednesday September 22nd, 2021 10:08AM

AstraZeneca confirms strong vaccine protection after US rift

By The Associated Press
Related Articles
  Contact Editor

AstraZeneca insisted that its COVID-19 vaccine provides strong protection even after counting additional illnesses in its U.S. study, as the drugmaker responded to concerns raised by American officials in an unusually public rebuke that threatened to further erode confidence in the shot.

In a late-night news release Wednesday, AstraZeneca said it had analyzed more data from that study and concluded the vaccine is 76% effective in preventing symptomatic COVID-19, instead of the 79% it had reported earlier in the week.

Some experts called the new analysis reassuring and said the updated details didn’t look substantially different from what was announced earlier. A peek at the full data won't come for at least another few weeks, once the Food and Drug Administration begins its own stringent review. For now, it's not clear if the new figures will be sufficient to repair the credibility in a vaccine that, despite being widely used in Britain, Europe and other countries, has had a troubled rollout.

Earlier this week, an independent panel that oversees the U.S. trial of the vaccine had accused AstraZeneca of cherry-picking data to tout the protection offered by its shot. The panel, in a harsh letter to the company and to U.S. health leaders, said AstraZeneca had left out some COVID-19 cases that occurred in the study.

The drugmaker responded that the results it reported included cases up to mid-February, as agreed in the study rules, and that it was preparing a fuller analysis of cases that had occurred since then — which it released Wednesday.

“AstraZeneca may have just been too hasty in submitting the earlier, incomplete interim analysis rather than waiting to analyze and submit the full dataset,” said Julian Tang, a virologist at the University of Leicester who was not connected to the research. He said the updated details were likely solid enough for U.S. regulators to authorize the vaccine.

Before the new results were released, Dr. Anthony Fauci, the top U.S. infectious disease expert, told reporters he hoped that when all the data was publicly vetted by the FDA, it would dispel any hesitancy caused by the spat. He predicted it would “turn out to be a good vaccine.”

AstraZeneca had been counting on findings from a predominantly U.S. study of 32,000 people to help rebuild confidence in its shot, which is crucial to global efforts to end the coronavirus pandemic since it is cheap, easy to store and a pillar of the COVAX initiative aimed at bringing vaccines to low- and middle-income countries. Despite evidence from trials and in real-world use that it does protect, previous studies have turned up inconsistent data about the degree of effectiveness.

Then last week a scare over blood clots had some countries temporarily pausing inoculations. Most have since restarted after the European Medicines Agency said the vaccine doesn’t increase the overall incidence of blood clots, though it did not rule out a connection to some rare clots. On Thursday, Denmark announced it would continue its suspension of the vaccine.

AstraZeneca's newest effectiveness calculations were based on 190 COVID-19 cases that occurred during the U.S. study, 49 more than it had included earlier in the week. The vaccine appears especially protective against the worst outcomes, with no severe illnesses or hospitalizations among vaccinated study volunteers compared to eight severe cases among those given dummy shots, the company said. It didn't provide a breakdown of the rest of the cases.

Some European authorities have questioned how protective the vaccine is in older adults. In the U.S. study, it was 85% effective in volunteers 65 and older, the company said. The study didn't turn up safety concerns.

The updated information “confirms that our COVID-19 vaccine is highly effective in adults, including those aged 65 years and over,” AstraZeneca research chief Mene Pangalos said in a statement. He said the company looks forward to "the rollout of millions of doses across America.”

The study hasn't ended, so additional COVID-19 cases could still accrue. AstraZeneca cautioned that 14 additional possible cases already are being examined and that could lead to further changes in the data.

The company intends to seek FDA clearance of the vaccine within a few weeks. The agency will publicly debate all the evidence with its outside advisers before making a decision.

Stephen Evans, a vaccines expert at the London School of Hygiene and Tropical Medicine, said it was difficult to understand why the dispute between AstraZeneca and U.S. officials spilled into the public. Such rifts during ongoing studies typically remain confidential.

“Given the details given here, it seems an unnecessary action to have raised concerns in public,” he said. “Results fluctuate as data accumulate ... what counts will be the FDA assessment and that will be done based on scrutiny of the full data and not press releases.” He said any vaccine with an efficacy rate higher than 60% is useful.

He said it was unclear why there was “a breakdown in relations” between AstraZeneca and the independent U.S. data experts monitoring the trial and worried that could undermine confidence in the vaccine.

“This vaccine is so important for global health, and the disputes do not promote global health,” he said. “At least in the short term, (this) will undermine confidence both in the U.S. and more importantly in the rest of the world.”

___

Associated Press Medical Writer Maria Cheng in London and Jan M. Olsen in Copenhagen contributed to this report.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

  • Associated Categories: U.S. News, Associated Press (AP), AP National News, AP Online National News, Top U.S. News short headlines, 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.
AstraZeneca confirms strong vaccine protection after US rift
AstraZeneca insisted Wednesday that its COVID-19 vaccine is strongly effective even after counting additional illnesses in its disputed U.S. study, the latest in an extraordinary public rift with American officials
11:26PM ( 3 minutes ago )
Stuck ship in Egypt's Suez Canal imperils shipping worldwide
At least 150 vessels are waiting to use the Suez Canal after a skyscraper-sized cargo ship wedged across the vital waterway
11:03PM ( 26 minutes ago )
North Korea test-fires ballistic missiles in message to US
North Korea has test-fired its first ballistic missiles since President Joe Biden took office as it expands its military capabilities and increases pressure on Washington while nuclear negotiations remain stalled
10:47PM ( 42 minutes ago )
Associated Press (AP)
Brighter outlook for US as vaccinations rise and deaths fall
More than three months into the U.S. vaccination drive, many of the numbers paint an increasingly encouraging picture
8:34PM ( 2 hours ago )
A first: US Senate confirms transgender doctor for key post
The U.S. Senate has confirmed former Pennsylvania Health Secretary Rachel Levine to be the nation's assistant secretary of health
8:26PM ( 3 hours ago )
Brazil becomes 2nd nation to top 300,000 COVID-19 deaths
Brazil has topped 300,000 confirmed COVID-19 deaths, becoming the second country to do so amid a spike in infections that has seen the South American country report record death tolls in recent days
7:56PM ( 3 hours ago )
AP National News
Virginia, with 2nd-most executions, outlaws death penalty
Virginia has become the 23rd state to abolish the death penalty
6:39PM ( 4 hours ago )
Conservationists sue to save spotted owl logging protections
Environmental groups have sued to preserve protections for 3.4 million acres of northern spotted owl habitat from the US-Canada border to California
6:38PM ( 4 hours ago )
Biden's dogs back at White House after ruff start
President Joe Biden’s dogs are roaming the White House again
6:34PM ( 4 hours ago )
Top U.S. News short headlines
Treasury sends out additional 37 million relief payments
The Treasury Department says it has sent out another 37 million economic impact payments over the past week, bringing the total disbursed in the past two weeks to $325 billion
9:03PM ( 2 hours ago )
Treasury sends out additional 37 million in relief payments
The Treasury Department says it has sent out another 37 million economic impact payments over the past week, bringing the total disbursed in the past two weeks to $325 billion
8:55PM ( 2 hours ago )
The Latest: US tops 30 million confirmed cases of COVID-19
The U.S. has now surpassed 30 million confirmed cases of COVID-19
8:44PM ( 2 hours ago )
AP Business
The Latest: Poland, church urge distancing during services
Amid a spike in new COVID-19 cases, Poland’s health care and Catholic Church authorities have appealed to all parish priests to strictly observe the limit of attendance and distancing at church services, and especially during next month’s Easter holiday
5:36PM ( 5 hours ago )
A late slide, led by Big Tech, leaves US stock indexes lower
Stocks gave up an early gain and wound up broadly lower on Wall Street, led by declines in tech heavyweights like Facebook and Apple
4:09PM ( 7 hours ago )
The Latest: Louisiana to open vaccines to age 16 and up
Louisiana will end its limits Monday on which adults can receive the coronavirus vaccine, giving access to anyone 16 and older who wants to schedule an appointment
4:05PM ( 7 hours ago )
AP Business - Industries
The Latest: Belgium heads to lockdown amid spike in cases
Belgium is reintroducing strict lockdown measures in response to a surge of new coronavirus infections
10:10AM ( 13 hours ago )
Hong Kong halts use of Pfizer vaccine, cites defective lids
Hong Kong has suspended vaccinations using Pfizer shots after the Chinese distributor informed the city that one batch had defective bottle lids
9:29AM ( 14 hours ago )
The Latest: EU moves to stricter export controls on vaccines
The European Union is moving toward stricter export controls to ensure there are more COVID-19 vaccine supplies for the bloc
8:42AM ( 14 hours ago )
AP Business - Health Care
Stuck ship in Egypt's Suez Canal imperils shipping worldwide
At least 150 vessels are waiting to use the Suez Canal after a skyscraper-sized cargo ship wedged across the vital waterway
11:03PM ( 26 minutes ago )
North Korea test-fires ballistic missiles in message to US
North Korea has test-fired its first ballistic missiles since President Joe Biden took office as it expands its military capabilities and increases pressure on Washington while nuclear negotiations remain stalled
10:47PM ( 42 minutes ago )
Nixon's overtime bank shot sends Texas A&M past Iowa State
Jordan Nixon banked in a short jump shot at the buzzer in overtime, giving her a career-high 35 points and lifting Texas A&M to an 84-82 victory over Iowa State in the second round of the women’s NCAA Tournament
10:05PM ( 1 hour ago )
Grocery store worker narrowly escaped gunman's notice
An employee of the Colorado supermarket where a gunman killed 10 people watched as the assailant opened fire and narrowly escaped his notice as she joined with others in a desperate scramble to get away
9:57PM ( 1 hour ago )
Nixon buzzer beater in OT lifts A&M over Iowa State 84-82
Jordan Nixon banked in a short jump shot at the buzzer in overtime, giving her a career-high 35 points and lifting Texas A&M to an 84-82 victory over Iowa State in the second round of the women’s NCAA Tournament
9:53PM ( 1 hour ago )