Tuesday, August 18, 2020

Chinese vaccine looking good

Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes: Interim Analysis of 2 Randomized Clinical Trials

Shengli Xia et al.


Importance:  A vaccine against coronavirus disease 2019 (COVID-19) is urgently needed.

Objective:  To evaluate the safety and immunogenicity of an investigational inactivated whole-virus COVID-19 vaccine in China.

Interventions:  In the phase 1 trial, 96 participants were assigned to 1 of the 3 dose groups (2.5, 5, and 10 μg/dose) and an aluminum hydroxide (alum) adjuvant–only group (n = 24 in each group), and received 3 intramuscular injections at days 0, 28, and 56. In the phase 2 trial, 224 adults were randomized to 5 μg/dose in 2 schedule groups (injections on days 0 and 14 [n = 84] vs alum only [n = 28], and days 0 and 21 [n = 84] vs alum only [n = 28]).

Design, Setting, and Participants:  Interim analysis of ongoing randomized, double-blind, placebo-controlled, phase 1 and 2 clinical trials to assess an inactivated COVID-19 vaccine. The trials were conducted in Henan Province, China, among 96 (phase 1) and 224 (phase 2) healthy adults aged between 18 and 59 years. Study enrollment began on April 12, 2020. The interim analysis was conducted on June 16, 2020, and updated on July 27, 2020.

Main Outcomes and Measures:  The primary safety outcome was the combined adverse reactions 7 days after each injection, and the primary immunogenicity outcome was neutralizing antibody response 14 days after the whole-course vaccination, which was measured by a 50% plaque reduction neutralization test against live severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Results"  Among 320 patients who were randomized (mean age, 42.8 years; 200 women [62.5%]), all completed the trial up to 28 days after the whole-course vaccination. The 7-day adverse reactions occurred in 3 (12.5%), 5 (20.8%), 4 (16.7%), and 6 (25.0%) patients in the alum only, low-dose, medium-dose, and high-dose groups, respectively, in the phase 1 trial; and in 5 (6.0%) and 4 (14.3%) patients who received injections on days 0 and 14 for vaccine and alum only, and 16 (19.0%) and 5 (17.9%) patients who received injections on days 0 and 21 for vaccine and alum only, respectively, in the phase 2 trial. The most common adverse reaction was injection site pain, followed by fever, which were mild and self-limiting; no serious adverse reactions were noted. The geometric mean titers of neutralizing antibodies in the low-, medium-, and high-dose groups at day 14 after 3 injections were 316 (95% CI, 218-457), 206 (95% CI, 123-343), and 297 (95% CI, 208-424), respectively, in the phase 1 trial, and were 121 (95% CI, 95-154) and 247 (95% CI, 176-345) at day 14 after 2 injections in participants receiving vaccine on days 0 and 14 and on days 0 and 21, respectively, in the phase 2 trial. There were no detectable antibody responses in all alum-only groups.

Conclusions and Relevance:  In this interim report of the phase 1 and phase 2 trials of an inactivated COVID-19 vaccine, patients had a low rate of adverse reactions and demonstrated immunogenicity; the study is ongoing. Efficacy and longer-term adverse event assessment will require phase 3 trials.



She's 'Unbeatable?': WSJ Columnist Shreds the Liberal Media's New Kamala Harris Narrative With One Tweet

This is a case of identity poliics redounding in favour of conservatives. Because of identity politics, Biden had to choose a female, even if it was a real one.  Had he been free to choose the most helpful Veep he would have chosen Bernie Sanders and romped in.  Sanders has a huge personal following among the clueless so adding that to the effect of being on the Donk ticket would have probably wiped out Trump

Actually, it’s a series of tweets, but one particular observation from The Wall Street Journal’s Kimberley Strassel sticks out— and it’s a brutal one. I mean, do these liberal media types don’t know that we can harness the power of Google. These publications have archives like the rest of us. And there is a trove of articles about the collapse of Kamala Harris’ 2020 run.

It wasn’t a little car crash either. It was a thermonuclear explosion. She was wiped out before the California primary. She had no message, no plan, and an organization that was rudderless. It was a s**t show. Yet, now that Joe Biden has decided to pick her, though she was not his first choice, Harris has undergone this rebirth as some master tactician and campaign ace who will inject steroids into the Democrats’ 2020 hopes. Really?

Here’s the observation Strassel noted that’s both true and damning:

Everyone from Julian Castro to Cory Booker to Deval Patrick to Tulsi Gabbard to Elizabeth Warren to Pete Buttigieg, to Amy Klobuchar to Andrew Yang to Tom Steyer to Michael Bennet had more appeal and staying power than Harris. But now we are told she is unbeatable?


Yet, while Strassel notes how Harris is an unremarkable VP pick, could that be also to her advantage. Just playing devil’s advocate here, when you can’t pin down your opponent and define her in an election—isn’t that a problem? Maybe. Though I would say her opening speech when she was first introduced shows a person who cannot go off-script. The speech was terrible to start, loaded with inaccuracies and lies about the Trump White House, and was entirely predictable. It was as if the entire production staff of MSNBC jotted down the annotations.

Strassel added that now more than ever, Harris will be put under the microscope due to Biden’s apparent mental degradation and her “do no harm” checkbox that she supposedly filled when the Biden camp was forced to pick her could open up the Democratic ticket to what engulfed her first campaign: total disaster (via WSJ):

If commentators are now struggling to define Ms. Harris, it’s because she offers little that is truly defining. The party establishment quickly closed ranks around her 2016 Senate race, allowing her to run a standard liberal campaign that the Los Angeles Times described as “carefully orchestrated” and “overly cautious and scripted.” In her 3½ Senate years, she’s done little by way of legislation, preferring to showboat at hearings. The lack of an animating agenda helps a explain a presidential campaign in which she bounced from left to far-left position, whatever she thought most helpful at the moment. She twice called to eliminate private health insurance—and twice reversed herself the next day after backlash. As Vox noted, the “combination of policy reversals and botched rollout . . . undermined faith in her ability to govern on the issue Democrats rate as most important.”

The campaign was a mess, rocked by infighting, leaks, restarts and financial problems. After the campaign announced layoffs in early November, its veteran Iowa operations manager wrote a scathing resignation letter in which she said she’d “never seen an organization treat its staff so poorly” and expressed dismay at its ability to make “the same unforced errors over and over.” Ms. Harris didn’t even make it to the first contest, dropping out—broke and with embarrassing poll numbers—two months before the Iowa caucuses. The only other “top tier” candidate to implode as quickly or spectacularly was Beto O’Rourke. The Washington Post campaign obituary bluntly called Ms. Harris an “uneven campaigner” who was “engulfed by low polling numbers, internal turmoil and a sense that she was unable to provide a clear message.” The Post this week lauded Ms. Harris as “vibrant and energetic” and a “vessel for Democratic hopes.”

Biden watchers insist the nominee fulfilled the cardinal rule of veep picks: First, do no harm. Possibly, but it’s pretty clear it did no good either. Mr. Biden’s biggest concern remains his lagging enthusiasm numbers. Polls consistently show the majority of Democratic voters notably unexcited about his candidacy. One fix would have been a running mate hailed as a fresh and rising Democratic star. Ms. Harris has alienated key elements of her party, in particular progressives who despise her as a “top cop” from her six years as California’s attorney general. In a poll this week by the Economist/YouGov, Ms. Harris was viewed favorably by only half of African-Americans and very favorably by only 26% of liberals. Will that keep people from pulling a Biden-Harris lever? Maybe not, but she won’t likely be a poll driver.

And there’s still a possibility she’ll do harm. Mr. Biden’s age and questions about his mental acuity guarantee an outsize focus on his running mate, who could end up president. Ms. Harris’s own presidential run proves she has a propensity to make mistakes—potentially big ones. The Trump campaign is eager to define her as a Bernie Sanders liberal, and she’s got a track record that helps—having endorsed Medicare for All, the Green New Deal and gun bans. Many Americans will also remember her leading role in the character assassination of Justice Brett Kavanaugh, matched only in political theater by Cory “Spartacus” Booker. This has the potential to turn off some suburban and independent voters. Even if they don’t rush into Mr. Trump’s arms; they may simply not vote.

There’s a lot of hype here—no doubt. But I don’t think “top cop” Kamala brings much to the ticket. She’s being buoyed by a lot of media-manufactured hot air, flanked by her friends in the Senate. Let’s see how things go in a few weeks. Maybe she’ll hide in the bunker with Joe to avoid making errors because they’re both two peas in a pod when it comes to that.



Depression and anxiety are skyrocketing in young adults amid pandemic

Anxiety, depression and suicidal thoughts are skyrocketing amid the COVID-19 pandemic, a new study suggests. The study, from the Centers for Disease Control and Prevention (CDC), found that young adults were particularly prone to these increases.

The study researchers analyzed information from more than 5,400 U.S. adults ages 18 and older who completed an online survey in late June.

The percentage of Americans reporting symptoms of anxiety disorder increased about threefold and the percentage reporting symptoms of depressive disorder increased about fourfold, compared with levels seen in a survey conducted around the same period in 2019, the study found.

Overall, in the 2020 survey, about 41% of participants reported symptoms of at least one mental health condition; with 31% experiencing symptoms of anxiety or depression, 13% initiating or increasing use of substances (including alcohol or marijuana) to cope wtih stress tied to the pandemic, and nearly 11% reporting that they had seriously considered suicide in the past 30 days.

The toll was particularly striking among adults ages 18 to 24. In this group, about 63% reported symptoms of anxiety or depressive disorder, 25% reported starting or increasing use of substances, and 25% reported seriously considering suicide in the past 30 days. For comaprision, in a national survey conducted in 2018, about 14% of young adults reported an episode of major depression and 11% reported serious thoughts of suicide in the past year.

The new findings "highlight the broad impact of the pandemic and the need to prevent and treat these conditions," the authors wrote in their study, published Thursday (Aug. 13) in the journal Morbidity and Mortality Weekly Report.

The study could not determine the reason for the rise in mental health conditions, but factors relating to the pandemic, such as social isolation, school and university closures, unemployment and other financial worries, as well as the threat of the disease itself, may play a role, the authors said. Future studies will be needed to determine the specific drivers poor mental health in the pandemic.

Why young adults seem particularly affected by the pandemic is not known. After all, studies have found that young people are less likely to experience serious illness from COVID-19 compared with old adults. But older adults in the study had the lowest prevalence of mental health symptoms: Among those ages 65 and older, 8% reported experiencing symptoms of anxiety or depression, 3% reported starting or increasing use of substances and 2% reported seriously considering suicide in the past 30 days.

One idea is that people's ability to accept uncertainty may be tied to their mental health response, according to The New York Times. "Now there are so many questions, especially for young people, about relative risk, duration of the pandemic and what their futures will look like," study lead author Mark Czeisler, a psychology researcher at Monash University in Melbourne, Australia, told the Times. A longer life experienced may help older adults better tolerate these uncertain times.

There is an urgent need to address the mental health consequences of the pandmeic, such as through increased access to resources for diagnosis and treatment of mental health conditions and expanded use of telehealth, the authors said.



Rapid economic recovery Trump predicted continues as unemployment claims drop

Americans for Limited Government President Rick Manning today issued the following statement on the latest unemployment insurance claims published by the Department of Labor:

“President Donald Trump predicted a fast recovery from the COVID-19, and now it is continuing at a rapid clip with fewer than 1 million new jobless claims for the first time since March, and another 624,000 came off continued claims the week of Aug. 1.

“As a reminder, in Feb. 2020, unemployment was at a 50-year low with fewer than 6 million Americans unemployed and it was the unleashing of the Chinese coronavirus that drove those numbers through the roof. Now, the President’s balanced approach to reopening America while continuing to battle the virus has led to an unprecedented recovery, with 9 million to 10 million jobs recovered in the past three months.

“No President has been as focused on private sector job creation in generations, and it stands in stark contrast to the Obama-Biden so-called shovel-ready jobs promise that paid off public employee unions but did little for Americans who were actually out of work.”



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