Vaccines…a Cautionary Tale

“Health officials are beginning to wonder whether it will be possible to contain a spreading killer if society does not take more aggressive, intrusive measures. ‘Right now, we are paralyzed,’ said [the] director of the Centers for Disease Control in Atlanta leading the Federal Government’s epidemiologists tracking the disease. ‘We don’t have the data to fight this epidemic,’ he said yesterday.  

Opponents of widespread mandatory testing argue that it is unnecessary and could prove self-defeating by frightening possibly infected people away from the medical system.” February, 10, 1987 (NY Times)

This quote is from a yellowing article folded up in a book called Ethics and Other Liabilities. I hadn’t looked at the book in decades though the title is one of my favorites. It must have been fate that led me back to it. 

The article’s concern is obviously not the current Covid-19 pandemic but the HIV/AIDS epidemic of the 1980s, though the language could have been taken from today’s paper.

In this ramped up election year, we have a pandemic laying waste to our citizens – and to populations worldwide. Last night, the death toll in America crossed the 200,000 mark. 200,000 innocent victims of an insidious, invisible, invasive, highly contagious virus.

Operation Warp Speed is the public-private partnership initiated by the Trump administration in March to fast track the development, manufacture and distribution of 300,000,000 doses of a Covid-19 vaccine to Americans. Trump has been telling us it will be ready “before a very important day. You know what I’m talking about…” Yes, election day.

No one – not Dr. Robert Redfield his CDC director, not Dr. Anthony Fauci his NIAID director, not Dr. Stephen Hahn his FDA commissioner, not Dr. Jerome Adams his Surgeon General – in the scientific community believes a vaccine will be vetted and ready for distribution by election day – nor should it be. But, that’s the golden ticket Trump is campaigning on.

Rarely have drugs been fast tracked without normal safety and effectiveness protocols, and then only when “it may be effective” and potential benefits outweigh its risks for emergency use. “But, for a vaccine, the agency has always demanded a higher level of assurance of safety, for a simple reason: The vaccine will be given to healthy people.” (William Schulz, deputy commissioner for policy at the FDA, 1994-1999).

After 40 years of research there is no vaccine for HIV/AIDS

Operation Warp Speed is the medical equivalent of the Manhattan Project that developed the nuclear bomb or the Apollo Project that put a man on the moon. Without a vaccine, Covid-19 could be as deadly as the 1918 Spanish Flu that killed 675,000 Americans and between 20-50 million worldwide.

What are the prospects? It’s hard to say. In response to a question by Nicolle Wallace today, Dr. Irwin Redlener, director of Columbia University’s National Center for Disaster Preparedness cited mumps as a the fastest developed vaccine in medical history. Four years. If a safe and effective vaccine for Covid-19 can be developed it is likely to come sooner than that, but there is no assurance that it can be found. Mumps might be the standard we should refer to for the creation, testing, certification and distribution of a viral vaccine. 

Something to think about: remember Ebola? It killed 11,310 people in three Guinea, Liberia, and Sierra Leone before it was contained. There is no vaccine or cure.

• Ebola, like Covid-19 is virus. There is no vaccine to combat it’s spread. There are only mitigating strategies to contain and limit the spread. 
• HIV/AIDS is another virus without a vaccine. There are mitigating therapies but no cure. 
• SARS (Severe Acute Respiratory Syndrome is the virus that appeared in February 2003 and mysteriously disappeared in July 2003. There is no vaccine for SARS.
• Same with MRSA, the antibiotic resistant staph infection. 

Donald Trump is trying desperately to jawbone the coronavirus. His strategy keeps changing. “It’ll go away.” “Testing only creates more cases.” “The US is doing better than any other country.” “Kids are immune.” It’s a patchwork of wishful thinking.

As we enter the stretch toward the November 3rd election, he’s sidelined the country’s best infectious disease experts and brought on board Dr. Scott Adams, a radiologist with no infectious disease credentials to tout what Mr. Trump calls “herd mentality” (he means herd immunity) i.e. letting the virus run its course to see who survives, believing (without proof) that those who survive will develop immunity – at the cost of millions of dead Americans.

I sincerely hope Donald Trump pulls this rabbit out of somewhere. Maybe “a very important” part of his anatomy. I want a vaccine even more than he does, but I want it to be “safe and effective.” That’s the CDC standard, and it won’t come next month. Let’s be realistic. Coronavirus is among us and the guy that cheated on his SAT’s, claimed bone spurs to avoid military service, cheated subcontractors out of their pay, and paid off a porn star to avoid spoiling his presidential run is not the person I trust to vet anything – much less a vaccine. Let the CDC do its work (without interference). Let the FDA certify its safety and effectiveness (without political pressure), and let medical professionals distribute and deliver it. Then I’ll take my dose.