COVID-19 day 239: 📈 AstraZeneca profits up 20% compared to 2019, tells private investors what it wouldn't tell media about vaccine trial : 15 September 2020

US vaccine trial, which started 01 Sept, on pause & has most of the 50,000 participants; states that opened bars saw cases double; COVID-19 kills disproportionally more Hispanic and Black children

Tuesday was day 239 since the first case of coronavirus disease was announced in the United States. Today, I am comparing Monday and weekend data with Friday’s report.

Sections (no jump links, sorry!)
1, One big thing; 2, Recommendations; 3, Politics, economics & COVID; 4, Key metrics;
5, Resources

⓵ One big thing - the AstraZeneca vaccine

“The highest levels of NIH are very concerned,” said Dr. Avindra Nath, intramural clinical director and a leader of viral research at the National Institute for Neurological Disorders and Stroke, an NIH division. “Everyone’s hopes are on a vaccine, and if you have a major complication the whole thing could get derailed.”

As I noted on Sunday, the AstraZeneca vaccine trial paused on 06 September 2020 “after a participant in Britain became seriously ill.” AstraZeneca has resumed British clinical trials but they remain suspended in the United States.

The Food and Drug Administration has not yet decided whether to resume the US trial, which had only begun on 01 September. The US study “will account for most of the 50,000 participants on which the company intends to assess the vaccine.”

So a delay in the US is a big deal.

What is transverse myelitis?
Nath told KHN that he understood the patient had transverse myelitis although AstraZeneca has not confirmed this. Transverse myelitis is a rare inflammation of a cross-section of the spinal cord that can lead to pain, muscle weakness and paralysis.

AstraZeneca "need[s] to be more forthcoming with a potential complication of a vaccine which will eventually be given to millions of people," said Nath. "We would like to see how we can help, but the lack of information makes it difficult to do so."

In an earlier phase of the AstraZeneca trial, a participant experienced similar symptoms:

The pause is one of two that has occurred during the trial, AstraZeneca disclosed on Wednesday [emphasis added]. The company said “a brief pause” occurred in July after a volunteer participant “was confirmed to have an undiagnosed case of multiple sclerosis, which the independent panel concluded was unrelated to the vaccine.”

Transverse myelitis can be an initial symptom of MS.

Transverse myelitis often develops following viral infections such as varicella zoster (the virus that causes chicken pox and shingles), herpes simplex, cytomegalovirus, Epstein-Barr, influenza, echovirus, HIV, hepatitis A, and rubella.

Like many rare diseases, an MS diagnosis is largely one of elimination. No single set of symptoms, physical findings or laboratory tests lead to a diagnosis of MS, but central nervous system damage (the brain, spinal cord and optic nerves) is a prerequisite.

I think it would be prudent to review that July patient’s case in light of the September one. And for their data to be shared with research partners. (Spoiler: it’s not been shared with us.)

Public investment, private profits
The US government is supporting the development of six COVID vaccines.

Specifically, the US committed $1.2-billion to AstraZeneca for COVID-19 vaccine development in mid-May. European nations kicked in more than $1 billion.

In the first half of 2020, British-based AstraZeneca reported $3.6 billion in operating profit, more than 20% greater than in the first six months of 2019.

How? It raised prices on its existing dispensary.

According to research from the Los Angeles Times, “AstraZeneca hiked prices on some of its biggest-selling medicines by as much as 6% this year at a time when the overall inflation rate is hovering around 1%.”

Transparency, MIA
Despite public investment (we have invested billions in vaccine research and have pledged more to buy vaccines should be they be approved), the three companies with vaccines in advanced clinical trials in the United States have not publicly revealed their protocols and statistical analytical methods.

AstraZeneca has not been forthcoming about the cause of this latest pause. Instead, the company revealed more in a call with JP Morgan clients than it had revealed to the public, which is also funding the trial.

“Skepticism is rampant,” said Art Caplan, a bioethics professor at the New York University School of Medicine, “and a high standard of transparency is needed.”

Moreover, according to Nath, the NIH has not yet received tissue or blood samples from AstraZeneca.

Dr. Jesse Goodman, a Georgetown University professor and physician who was chief scientist and lead vaccine regulator at the FDA during the Obama administration, said the agency will review the data and possibly consult with British regulators before allowing resumption of the U.S. study, which had just begun when the injury was reported…

If it determines the injury in the British trial was caused by the vaccine, the FDA could pause the trial.

In a STAT News column last week, Ed Silverman, the pharmaceutical industry columnist, criticized AstraZeneca for its lack of transparency:

“The entire public has an interest in, and is deeply affected by, how quickly these vaccine trials are moving and whether they’re ultimately safe and effective,” Holly Fernandez Lynch, an assistant professor of medical ethics at the Perelman School of Medicine at the University of Pennsylvania, told me.

Andy Slavitt, former Obama Acting Administrator of the Centers for Medicare and Medicaid Services, notes:

The pause of a vaccine trial is not, in itself, newsworthy.

It would be unusual for a vaccine trial not to have pauses; yet with the lack of transparency, we have no way to know if this is the first trial to have pauses.

Remember that healthy people get vaccines to reduce the risk of contracting a disease in the future. Thus vaccines are not zero risk endeavors (neither is taking a shower).

It is the comparative risk, vaccine versus disease, that we must assess. And for that, the vaccine trials must provide exemplary transparency; politicians need to keep their mouths zipped; and news media need to provide full context rather than clickbait headlines and snappy sound bites.

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⓶ Recommendations

🤓 Recommended reading

😱 AFP Factcheck has been debunking COVID-19 disinformation as it emerges and now has 638 fact checks.

Busting coronavirus myths. AFP Factcheck, 11 September 2020 (update)

“You know, this has been a mismanaged situation every step of the way,” Gates said in the wide-ranging interview. “It’s shocking. It’s unbelievable — the fact that we would be among the worst in the world.”

He leveled his harshest criticism at Food and Drug Administration Commissioner Stephen Hahn, who mischaracterized findings from a Mayo Clinic study on Covid-19 and said researchers had seen a 35% survival benefit with the use of convalescent plasma. “Many of you know I was a cancer doctor before I became FDA commissioner,” Hahn said at the time. “And a 35% improvement in survival is a pretty substantial clinical benefit.”

“This is third grade math. I mean, are you kidding?” Gates said. “The head of the FDA got up and said it was a 35% death reduction where it’s not even a 3% reduction based on just a tiny little subset that was nonstatistical. This is unheard of.”

Bill Gates slams ‘shocking’ U.S. response to Covid-19 pandemic. STAT News, 14 September 2020.

[W]orld leaders had never before “been so clearly forewarned of the dangers of a devastating pandemic”, and yet they had failed to take adequate action.

Pandemic preparedness panel slams collective failure to heed warnings. Reuters, 13 September 2020.
A World in Disorder: Global Preparedness Monitoring Board. WHO & The World Bank, 14 September 2020.

‼️ On Sunday, I told you about Michael Caputo, the HHS communications official accused of interfering with CDC reports. On Sunday, he posted “a bizarre, paranoid video on Facebook claiming he might be assassinated by seditious forces.”

C.D.C. scientists “haven’t gotten out of their sweatpants except for meetings at coffee shops” to plot “how they’re going to attack Donald Trump next.”

On Monday he announced he might be taking medical leave.

Tuesday, STAT News reported that on the most recent Caputo-produced HHS podcast, the head of the Substance Abuse and Mental Health Services Administration “strongly echoe[d] the president’s talking points on reopening schools and businesses, angering current and former agency officials who say she is politicizing the office and reinforcing administration arguments about Covid-19 that aren’t supported by sound scientific evidence.”

In the latest podcast, McCance-Katz says reopening schools and businesses is essential for people’s mental health…Caputo tells McCance-Katz that the opposition to reopening schools is political, to which she responds, “It makes no sense.”

Top health official echoes Trump’s Covid-19 views, drawing accusations of politicizing U.S. mental health agency. STAT News, 15 September 2020.

🔬 Research and medical news

Adolescents and young adults, Hispanic, Black, and AI/AN persons, and persons with underlying medical conditions are disproportionately represented among deaths associated with SARS-CoV-2 in persons aged <21 years reported to CDC.

SARS-CoV-2–Associated Deaths Among Persons Aged <21 Years — United States, February 12–July 31, 2020. CDC, 15 September 2020.
Coronavirus kills far more Hispanic and Black children than White youths, CDC study finds. Washington Post, 15 September 2020.

The first six months of the pandemic saw the number of people living in extreme poverty around the globe rise by 7%, after declining year after year for the past two decades…

Indirectly, COVID will cause more women than men to suffer and die, in large part because the pandemic has disrupted health care before, during, and immediately after childbirth.

New report says Covid-19 pandemic has caused historic setbacks in global health. STAT News, 14 September 2020.
COVID-19, A Global Perspective. Gates Foundation 2020 Goalkeepers Report, September 2020.

⓷ Politics, economics and COVID-19

⚾️ MLB postseason will feature neutral-site 'bubbles' and World Series in Texas – along with strict protocols.

✈️ For the second time in two months, a Delta flight returned to the gate in Detroit after a passenger refused to wear a mask. (Bravo!)

🍺States that reopened bars had COVID-19 cases double three weeks later. Who would guess that, right? The research showed “a statistically significant national relationship between foot traffic to bars one week after they reopened and an increase in cases three weeks later.”

🆘 White House increasingly at odds with public health advice as deaths rise.

⓸ Key metrics

🦠 Monday, Johns Hopkins reported 6,553,399 (109,656 new, average 36,552/day) cases and 194,489 (1,510 new, average 503/day) deaths since Friday.

  • Monday
    - cases 🔻6% compared to seven-day average; deaths 🔻45%
    - seven-day average: 36,111 cases and 754 deaths 
    - 2.97% cases leading to death
    - case rate, 198.0 per 10,000; death rate, 5.9 per 10,000

  • One week ago
    - cases 🔻37% compared to seven-day average; deaths 🔻67%
    - seven-day average: 38,576 cases and 802 deaths 
    - 3.00% cases leading to death
    - case rate, 190.4 per 10,000; death rate, 5.7 per 10,000

Note: the seven-day average is important because dailies vary due to factors other than actual case numbers, particularly over a weekend.

🇺🇸 14 September 

  • CDC: 6,503,030 (35,549 new) cases & 193,705 (510 new) deaths
    One week ago: 6,226,879 (34,337 new) cases & 188,051 (462 new) deaths

  • State data*:  6,523,075 (65,017 new) cases & 186,578 (742 new) deaths
    One week ago: 6,299,262 (22,650 new) cases & 181,440 (363 new) deaths
    KS reports only M-W-F; CT and RI report only M-F

  • WHO: 6,426,958 (40,126 new) cases & 192,612 (803 new) deaths
    One week ago: 6,189,488 (45,350 new) cases & 187,541 (878 new) deaths

🌎 14 September 

Johns Hopkins interactive dashboard (11.00 pm Pacific)

  • Global: 29,190,588 (287,835 new) cases & 927,245 (4,508 new) deaths
    One week ago: 27,332,433 (228,588 new) cases & 892,443 (9,104 new) deaths

* Johns Hopkins data, ~11.00 pm Pacific.
State data include DC, Guam, the Northern Mariana Islands, Puerto Rico and the US Virgin Islands

The virus was not created in a lab and the weight of evidence is that it was not released intentionallyAlthough early reports tied the outbreak to a market in Wuhan, China, analyses of genomic data have suggested that the virusdeveloped elsewhere.

⓹ Resources

👓 See COVID-19 resource collection at WiredPen.
📝 Subscribe to Kathy’s COVID-19 Memo :: COVID-19 Memo archives
🦠 COVID-19 @ WiredPen.com
📊 Visualizations: USWorld
🌐 Global news (at WiredPen)

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