Is the FDA Blocking SAFE Vaccines?


There is another promising line of attack against the coronavirus. . .T-cells. This new line of attack was revealed in a new study published in Blood.

T-cells taken from the blood of people who recovered from a COVID-19 infection can be successfully multiplied in the lab. And these cells maintain their ability to effectively target proteins that are key to the virus’s function.  

Michael Keller, M.D., a pediatric immunology specialist at Children’s National Hospital, led the study.

He said, “We found that many people who recover from COVID-19 have T-cells that recognize and target viral proteins of SARS-CoV-2, giving them immunity from the virus because those T-cells are primed to fight it.”

Dr. Keller added, “This suggests that adoptive immunotherapy using convalescent T-cells to target these regions of the virus may be an effective way to protect vulnerable people, especially those with compromised immune systems due to cancer therapy or transplantation.”  

There has been evidence from previous phase 1 clinical trials that virus-targeting T-cells can be “trained” to target specific viruses.

So, the researchers in this study thought that COVID-19 virus-targeting T-cells could be ,infused into immunocompromised patients. This would help patients build an immune response before exposure to the virus. This should protect them from a serious or life-threatening infection.

The study also had other useful findings.

It identified that SARS-CoV-2 directed T-cells have adapted to predominantly target specific parts of the viral proteins found on the cell membrane. This revealed a new way the immune system responds to COVID-19 infection.

Most of the current vaccine research focuses on specific proteins found mainly on the ‘spikes’ of the coronavirus SARS-CoV-2.

This finding that T-cells are successfully targeting a membrane protein instead has opened researchers’ eyes. It adds another avenue for vaccine developers to explore when creating new vaccines to protect against the virus.  

The Big News

Covid Deaths Linked to Air Pollution

A study has concluded that long-term exposure to air pollution could be linked to 15% of Covid deaths. Researchers combined health and disease figures with data about exposure to particulate matter in the air. “If both long-term exposure to air pollution and infection with the COVID-19 virus come together then we have an adverse effect on health, particularly with respect to the heart and blood vessels,” said vascular biologist Thomas Munzel.

FDA Reluctant to OK Emergency Use of Vaccines

The FDA seems unlikely to fast-track the introduction of Covid-19 vaccines through an emergency use authorization (EUA). Such an FDA policy would allow vaccines to be given to certain high-risk groups and health-care workers before clinical trials have finished. But FDA officials are raising concerns that EUAs may make it difficult for clinical trials to provide reliable data. “If … we don’t get adequate enough information to understand how these vaccines compare with each other and perform in terms of their safety and efficacy, we don’t know how to use them in a public health context,” says former FDA chief scientist Jesse Goodman. 

Antoantibody ‘Friendly Fire’

A new study found that some survivors of Covid-19 show signs that their immune system has turned on the body. This is similar to lupus and rheumatoid arthritis. At some point, the body’s defense system shifted into attacking itself, rather than the virus. The patients are producing molecules called “autoantibodies” that target genetic material from human cells, instead of from the virus. This could be behind the “long hauler” phenomena with some Covid-19 patients.   

Lilly Antibody Treatment Dud

Eli Lilly said Monday that its antibody treatment was ineffective on patients hospitalized with advanced Covid-19. It discontinued the trial with these patients. The company did say that other trials of the treatment would continue. These involve people who are not as sick or who have been exposed to the virus. Lilly remained optimistic that the treatment could work if given early on in the course of the disease.     

Latin America, Covid and Politics

Latin America has one-third of all Covid-19 deaths. It has suffered more acutely from the virus than any other region of the world. Presidents Trump and Bolsonaro of Brazil have a shared disregard for science . . . and international organizations. The two presidents attacked the agency most capable of fighting the virus — the Pan American Health Organization. President Trump nearly bankrupted the agency by withholding promised funding at the height of the outbreak.            

The Coronavirus Numbers

Here are the numbers from Wednesday at 8 a.m. ET from Johns Hopkins University:

  • 44,059,551 Infected Worldwide
  • 1,168,568 Deaths
  • 8,779,839 Infected in the U.S.
  • 226,728 Deaths in the U.S.

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What’s Next

With the exception of U.S. Treasury securities, pretty much everything is down this morning.

The reason is straightforward: fears that Europe will be forced to impose a second lockdown. Cases and hospitalizations in Europe have spiked even higher than in the U.S.

But keep in mind, we are usually two to three weeks behind in the course of the virus than Europe. , the worst is yet to come here.

Futures this morning suggested a pretty decent selloff today.

And of course, there is the presidential election. . . . .

Yesterday, the White House Office of Science and Technology listed one of the Trump administration’s accomplishments to be this: “Ending the Covid-19 pandemic.”

I am left speechless. The pandemic is over? Someone please tell the virus.

By this time next week, the dust will be settling after the election. We hope we will have a winner announced.

Markets will be trying to make sense of either a second Trump term or a President Joe Biden.

Biden currently holds a 9.2% lead nationally, according to FiveThirtyEight polling.

As long as we get a winner, the markets will be happy. The removal of that uncertainty will remove one source of volatility.

That will still leave the virus, though. Will someone please tell it that it has been “defeated”?

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Yours in Health & Wealth,

Tony Daltorio

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