More AstraZeneca notes:
AstraZeneca CEO says participant had neurological symptoms, could be discharged today
SEPTEMBER 9, 2020
“Soriot also confirmed that the clinical trial was halted once previously in July after a participant experienced neurological symptoms. Upon further examination, that participant was diagnosed with multiple sclerosis, deemed to be unrelated to the Covid-19 vaccine treatment, he said.“
[...]
“The new disclosures made by Soriot were heard by three investors participating on the call and were shared with STAT. An AstraZeneca spokesperson did not respond to an email request for further comment.
BBM:
One investor on the call said Soriot’s comments were intended to reassure investors that the company was taking the possible vaccine safety event seriously, and to reverse any damage to the company’s stock price. “A vaccine that nobody wants to take is not very useful,” said Soriot.
To date, AstraZeneca’s public statements on the pause have been sparse with details. For instance, the company has not publicly confirmed that this is the second time its trials have been stopped to investigate health events among participants.“
NIH ‘Very Concerned’ About Serious Side Effect in Coronavirus Vaccine Trial / Sept. 14, 2020
What is transverse myelitis, the illness that paused Oxford COVID vaccine trials?
Sept. 10, 2020
“However, an AstraZeneca statement claimed that Soriot's statements on "transverse myelitis" were misinterpreted. “He stated that there is no final diagnosis and that there will not be one until more tests are carried out,” AstraZeneca’s spokesperson said. “Those tests will be delivered to an independent safety committee that will review the event and establish a final diagnosis."
Also, any worry on the vaccine safety front is premature and unwarranted. Such symptoms, which may or may not be caused by the vaccine, are quite common. Temporary holds of large medical studies aren't unusual, and investigating any serious or unexpected reaction is a mandatory part of safety testing. AstraZeneca pointed out that it is possible the problem could be a coincidence; illnesses of all sorts could arise in studies of thousands of people. Adequate and stringent safety measures will taken in every possible department before the vaccine is released.”
What is transverse myelitis? Google searches up after reported link to Astrazeneca coronavirus vaccine Trial
Sept. 9, 2020
“Following the publication of
The New York Times report, there was a huge spike in Google searches for transverse myelitis.“
AstraZeneca Pauses Vaccine Trial for Safety Review
Published Sept. 8, 2020 Updated Nov. 25, 2020
“President Trump has repeatedly pushed for the approval of a vaccine by Election Day, Nov. 3. On Tuesday nine companies, including AstraZeneca, made a joint pledge to “stand with science” on coronavirus vaccines, reaffirming that they would not move forward with such products before thoroughly vetting them for safety and efficacy.“
[...]
““If there are two cases, then this starts to look like a dangerous pattern,” said Mark Slifka, a vaccine expert at Oregon Health and Science University. “If a third case of neurological disease pops up in the vaccine group, then this vaccine may be done.”“
[...]
“The company said it was “working to expedite the review of the single event to minimize any potential impact on the trial timeline,” and reaffirmed its commitment “to the safety of our participants and the highest standards of conduct in our trials.”
A spokeswoman for the Food and Drug Administration declined to comment.
A person familiar with the situation, who spoke on the condition of anonymity, said that the participant who experienced the suspected adverse reaction had been enrolled in a Phase 2/3 trial based in the United Kingdom. The individual also said that a volunteer in the U.K. trial had received a diagnosis of transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections. However, the timing of this diagnosis, and whether it was directly linked to AstraZeneca’s vaccine, is still unknown.
Transverse myelitis can result from a number of causes that set off the body’s inflammatory responses, including viral infections, said Dr. Gabriella Garcia, a neurologist at Yale New Haven Hospital. But, she added, the condition is often treatable with steroids.
AstraZeneca declined to comment on the location of the participant and did not confirm the diagnosis of transverse myelitis. “The event is being investigated by an independent committee, and it is too early to conclude the specific diagnosis,” the company said.“
AstraZeneca Covid-19 vaccine study is put on hold
Sept. 8, 2020
“An individual familiar with the development said researchers had been told the hold was placed on the trial out of “an abundance of caution.” A second individual familiar with the matter, who also spoke on condition of anonymity, said the finding is having an impact on other AstraZeneca vaccine trials underway — as well as on the clinical trials being conducted by other vaccine manufacturers.“
Safety Review Underway of AstraZeneca’s Vaccine Trial
Sept. 11, 2020
AstraZeneca, Under Fire for Vaccine Safety, Releases Trial Blueprints
Experts are concerned that the company has not been more forthcoming about two participants who became seriously ill after getting its experimental vaccine.
Sept. 19, 2020
“AstraZeneca revealed details of its large coronavirus vaccine trials on Saturday, the third in a
wave of rare disclosures by drug companies under pressure to be more transparent about how they are testing products that are the world’s best hope for ending the pandemic.
Polls are finding Americans increasingly wary of accepting a coronavirus vaccine. And scientists inside and outside the government are worried that regulators, pressured by the president for results before Election Day on Nov. 3, might release an unproven or unsafe vaccine.
“The release of these protocols seems to reflect some public pressure to do so,” said Natalie Dean, a biostatistician and expert in clinical trial design for vaccines at the University of Florida. “This is an unprecedented situation, and public confidence is such a huge part of the success of this endeavor.”
Experts have been particularly concerned about
AstraZeneca’s vaccine trials, which began in April in Britain, because of the company’s refusal to provide details about serious neurological illnesses in two participants, both women, who received its experimental vaccine in Britain. Those cases spurred the company to halt its trials twice, the second time earlier this month. The studies have resumed in Britain, Brazil, India and South Africa, but are still on pause in the U.S. About 18,000 people worldwide have received AstraZeneca’s vaccine so far.
“AstraZeneca’s 111-page trial
blueprint, known as a protocol, states that its goal is a vaccine with 50 percent effectiveness — the same threshold that the Food and Drug Administration has set in its
guidance for coronavirus vaccines. To determine with statistical confidence whether the company has met that target, there will have to be 150 people ill with confirmed coronavirus among participants who were vaccinated or received placebo shots.
However, the plan anticipates that a safety board will perform an early analysis after there have been just 75 cases. If the vaccine is 50 percent effective at that point, it might be possible for the company to stop the trial early and apply for authorization from the government to release the vaccine for emergency use.“
[...]
“In allowing only one such interim analysis, AstraZeneca’s plan is more rigorous than the others that have been released, from
Moderna and Pfizer, Dr. Eric Topol, a clinical trials expert at Scripps Research in San Diego, said in an interview. Moderna allows two such analyses, and Pfizer four.
He said the problem with looking at the data too many times, after a relatively small number of cases, is that it increases the odds of finding an appearance of safety and efficacy that might not hold up. Stopping trials early can also increase the risk of missing rare side effects that could be significant once the vaccine is given to millions of people.
Dr. Topol said AstraZeneca’s plan, like those of Moderna and Pfizer, had a problematic feature: All count relatively mild cases of Covid-19 when measuring efficacy, which may hamper efforts to determine whether the vaccine prevents moderate or severe illness.
Such plans are not usually shared with the public “due to the importance of maintaining confidentiality and integrity of trials,” Michele Meixell, a spokeswoman for AstraZeneca, said in a statement.”
[...]
“Dr. Mark Goldberger, an infectious disease expert at the Global Antibiotic Research and Development Partnership and a former F.D.A. official, said he found the rapid restarting of trials abroad to be “a little disturbing,” especially given the lack of details around the patients’ symptoms and the ambiguity around their connection to the vaccine. “Maybe this is the best they could do — it may not be possible to get more certainty at this time,” he said. “It is a question mark as to what’s going on.”
The company did not immediately inform the public about the neurological problems of either participant. Nor did it promptly alert the F.D.A. that it was again pausing its trials after the second U.K. volunteer developed illness and an independent safety board called for a temporary halt, according to multiple people familiar with the situation. The company’s chief executive told investors about the problems but did not discuss them publicly until the information was leaked and
reported by STAT.
“The communication around it has been horrible and unacceptable,” said Dr. Peter Jay Hotez, a virologist with Baylor College of Medicine in Houston. “This is not how the American people should be hearing about this.”
Dr. Hotez also criticized obtuse statements released by government officials, including U.K. regulators who he said failed to supply a rationale for resuming their trials.“
[...]
“While other adenovirus-based products have seen some success in the past, they have also been linked to serious adverse events. The most famous was the case of 18-year-old Jesse Gelsinger, who died in 1999 after receiving gene therapy through an adenovirus that sparked a lethal inflammatory response from his immune system.
If a serious side effect was definitively linked to AstraZeneca’s vaccine, scientists would need to determine if its root cause stemmed from the adenovirus vector, or perhaps the coronavirus genes it carried — connections that could raise concerns about other companies’ products that rely on the same components.“
-more at link
—
Moderna and Pfizer Reveal Secret Blueprints for Coronavirus Vaccine Trials
The companies hope to earn the trust of the public and of scientists who have clamored for details of the studies.
Sept. 17, 2020
“The plan released by Moderna on Thursday morning included a likely timetable that could reach into next year for determining whether its vaccine works. It does not jibe with the president’s optimistic predictions of a
vaccine widely available to the public in October.
Moderna’s Covid-19 vaccine.]
Moderna’s 135-page plan, or protocol, indicated that the company’s first analysis of early trial data might not be conducted until late December, though company officials now say they expect the initial analysis in November. In any case, there may not be enough information then to determine whether the vaccine works, and the final analysis might not take place until months later, heading into the spring of next year.
Moderna’s timeline meshes with the cautionary estimates from many researchers, including Dr. Robert R. Redfield, the director of the Centers for Disease Control and Prevention, who told senators on Wednesday that a vaccine would not be widely available until the middle of next year. Hours later, Mr.
Trump sharply contradicted him, making unsubstantiated projections that a vaccine could become widely available weeks from now.
On Wednesday, Joseph R. Biden Jr., the Democratic presidential nominee,
said in Wilmington, Del., that the process used to evaluate and approve a vaccine would have to be “totally transparent” to win public confidence. He has said that Mr. Trump’s calls for companies and regulators to speed the process have shaken the public’s faith in vaccines and that politics has no place in vaccine development.“
