Tag: coronavirus

Vaccine Safety to Remain Unclear Until Millions Get Their Shots

Monitoring Covid-19 vaccines for safety issues will fall to a group of U.S. health agencies that also will have a hand in their rollout, a potential hurdle in persuading skeptics to get the shots, say former government officials who helped control an outbreak a decade ago.

The Centers for Disease Control and Prevention, the Food and Drug Administration, the Department of Veterans Affairs and other health agencies all have separate systems to track side effects and safety in people who get the first shots. But there are concerns the groups advising the agencies on all aspects of a vaccine may face public skepticism over their safety assessments at a time when vaccine hesitancy is a major concern.

“The same advisory committee that told them to get it are telling them it’s OK,” said Daniel Salmon, the director of vaccine safety for the National Vaccine Program Office during the 2009 H1N1 swine flu outbreak. “What are the optics of that?”

There’s also worry that a lack of unified oversight could make it more difficult to document and quickly act on safety issues. Meanwhile, the stalled presidential transition could complicate efforts even further, said Jesse Goodman, who led the FDA office that handled vaccines during the 2009 H1N1 outbreak.

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The FDA is outsourcing COVID-19 testing to China

After reviewing the 161 emergency use authorizations granted by the FDA since February, I found that at least 10 Chinese companies were delivered the FDA stamp of approval to deliver diagnostic tests in the United States for SARS-CoV-2, which causes COVID-19.

These China-based companies have received FDA EUAs that grants them the ability to test for the coronavirus in America (including date of approval and link to FDA approval document):

  1. Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (9/9/20). 
  2. ZhuHai Sinochips Bioscience Co., Ltd (8/17/20)
  3. Xiamen Zeesan Biotech Co., Ltd. (7/31/20)
  4. Jiangsu CoWin Biotech Co., Ltd. (7/24/20)
  5. Jiangsu Bioperfectus Technologies Co., Ltd. (6/18/20)
  6. Genetron Health (Beijing) Co., Ltd. (6/5/20)
  7. Sansure BioTech Inc. (5/4/20)
  8. Seasun Biomaterials (4/27/20)
  9. Fosun Pharma (4/17/20)
  10. BGI Genomics Co. Ltd. (3/26/20)

China is the United States’ greatest adversary, and Beijing has not been forthcoming about the role it played in potentially negligently unleashing the novel coronavirus. These factors may cause many to raise concerns about the FDA’s decision to continue to authorize Chinese labs and companies to deliver U.S. coronavirus testing. Moreover, China’s one-party, top-down totalitarian system demands that corporations based in China are completely subservient to the state. There are no truly independent companies in China. All are ultimately beholden to the needs of the Chinese Community Party (CCP).

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For The First Time Ever, Millions Of Working-Poor Americans Forced To Turn To Food Banks

Feeding America, a nationwide network of more than 200 food banks, was overwhelmed with demand as 20% of the organization’s food banks were at severe risk of running out of food earlier this year.

Demand at food banks has been so high, that Feeding America handed out 4.2 billion meals from March through October, the most ever.

The organization reported a 60% average increase in food bank users during the pandemic – and at least 30% are first-timers.

Data from Feeding America showed 181 food banks in its network distributed nearly 57% more food in the third quarter than the same period in 2019.

Estimates from the food bank suggest 1 in 6 Americans, from 35 million in 2019 to more than 50 million by the end of this year, will have food insecurity problems. The problem is worse for children – nearly 1 in 4 will go hungry as the pandemic deeply scarred the economy.

Shockingly, Feeding America found that 1 in 5 residents in Mississippi, Arkansas, Alabama, and Louisiana could not put food on the table.

AP interviewed Donna Duerr, 56, who said she must “either pay bills or get food.” She said food bank donations have greatly helped her as she struggles to survive.

Many of the folks attending food bank lines are the working poor who once had jobs in the service industry. Because of permanent job loss, many of their jobs will be completely wiped out.

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The coronavirus vaccine comes with more side effects than a flu shot. Experts urge people to get it anyway

The first coronavirus vaccine authorized in the United States may cause more side effects than the flu vaccine, but the most common reactions — soreness at the injection site, fatigue and headache — are mild or moderate in most people and fade after a few days, according to analyses of clinical trial data.

Infectious disease experts say most people can safely get the vaccine, but they should be prepared for some of these potential side effects.

“Any robust vaccine may generate some discomfort but it is worth the mild side effects — these side effects are not extraordinary — to be immune against this circulating new pandemic,” said Dr. Monica Gandhi, an infectious disease physician at UCSF.

The FDA granted emergency use authorization late Friday to the first vaccine in the U.S., developed by Pfizer and German firm BioNTech, which has been shown to be 95% effective at preventing COVID-19 illness.

Health care workers and residents of long-term care centers will be first in line to receive the vaccine in California, followed by essential workers. Mass vaccinations of the general public are expected in spring or summer 2021.

The Pfizer vaccine’s most common side effects were fatigue, headache, muscle pain and chills, according to an FDA analysis of Pfizer’s clinical trial data. Less common were joint pain, fever, diarrhea and vomiting. The vast majority of those symptoms were mild or moderate.

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California’s Health Secretary Concedes There Is No Empirical Basis for the State’s Ban on Outdoor Dining

This week a Los Angeles County judge ruled that a local ban on outdoor dining at restaurants, ostensibly aimed at reducing transmission of the COVID-19 virus, was “not grounded in science, evidence, or logic.” Around the same time, California Health and Human Services Secretary Mark Ghaly admitted that the same thing is true of a state ban on outdoor dining that currently applies to all of Southern California, including Los Angeles County. Ghaly said that ban, which is one of many restrictions that are triggered when a region’s available ICU capacity drops below 15 percent, is “not a comment on the relative safety of outdoor dining” but is instead aimed at discouraging Californians from leaving home.

“The decision to include, among other sectors, outdoor dining and limiting that, turning to restaurants to deliver and provide takeout options instead, really has to do with the goal of trying to keep people at home,” Ghaly said during a briefing on Tuesday. He noted that “we have worked hard with that industry to create safer ways for outdoor dining to happen.”

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Sen. Bernie Sanders says Democrats delayed COVID-19 relief

Sen. Bernie Sanders admitted that fellow Democrats, led by House Speaker Nancy Pelosi, were responsible for delaying urgently needed coronavirus relief by walking away from the White House’s offer of a $1.8 trillion coronavirus package.

In an interview with CNN’s Jake Tapper Monday, the socialist two-time presidential candidate noted Pelosi’s hypocrisy in endorsing a smaller bipartisan $908 million deal last week after rejecting the twice-as-large proposal from President Trump in October.

“Democrats walked away from that deal because they wanted $2.2 trillion,” Tapper said.

“That’s right!” Sanders (I-Vt.) responded, confirming it was Democrats, not Republicans, who were to blame for months of inaction.

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HOLLYWOOD DEPLOYED LOBBYISTS TO WIN EXEMPTIONS TO STRICT CALIFORNIA LOCKDOWN

LAST MONTH, California Gov. Gavin Newsom was caught violating his own warnings against multiple households dining together indoors. The Democratic governor was spotted at the French Laundry, an exclusive restaurant north of San Francisco, where he was celebrating the birthday of longtime friend Jason Kinney.

The dinner controversy was more than just an opulent display of political double standards — it also highlighted the backroom efforts to maintain special treatment during the pandemic. Kinney, a veteran political operative, is a lobbyist for a number of interests seeking to shape the rules governing life under the pandemic, including what kind of economic activities are deemed essential in order to stay in business.

The inside track may have paid off. One of Kinney’s clients, Netflix, has been allowed to continue to operate during the latest round of forced closures that began last week as intensive care hospital capacity has dwindled across the state.

The entertainment industry has been given extensive leeway to operate during the pandemic, even as California now faces a stay-at-home order. The state has deemed the television and movie production industry as “critical infrastructure” and has allowed Hollywood studios to continue filming projects, including in Los Angeles, which is facing the most strict lockdown order.

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