I think I’m like many Americans—probably many people worldwide—in my reactions to the news that two vaccines appear close to receiving FDA approval and the beginnings of distribution. A total of five are currently in phase 3 (safety trials).
With the numbers of people infected and dying seemingly out of control, we are clearly in dire conditions and in desperate need of effective interventions. No question.
But the Trump administration’s politicization of the process sullied it—in all likelihood even as the people at work were doing their best to follow the science.
The fact that one of the manufacturers, Moderna, is an upstart company that’s never brought a single product to market also gave me pause. (I learned in researching this piece, however, that Dr. Anthony Fauci, who has been director of the National Institute of Allergy and Infectious Diseases since 1984, had encouraged the NIH’s Vaccine Research Center to work with Moderna on their vaccine.)
And “Operation Warp Speed,” the title of the government’s effort, sounded scary to me when we know that safe vaccines have previously taken at least four years to develop and implement.
What’s more, though I am emphatically pro-science, I have skepticism due to my experiences. For decades, I worked as a medical writer and editor.
When the Human Genome Project was gathering steam, I was the project editor for a federally funded corollary study of “ELSI”: the Ethical, Legal, and Social Implications that were sure to arise from this exciting new direction in our scientific knowledge.
(I’ve done all this medical/scientific work armed with a master’s degree in English literature. Thus, I say with all humility that I have just enough knowledge to be a danger to myself and others—though I generally refrain from prescribing…)
But as I was teaching myself about genetics for the ELSI project, I was struck by what geneticists consistently referred to as “junk DNA.”
It seemed to me the height of arrogance that so many experts would just assume that because they hadn’t yet found a reason that portions of the DNA strands were non-coded for proteins, those parts must be “junk”—serve no function.
Eventually, the “junk DNA” was found to serve all sorts of important functions.
The skepticism I’d developed then returned when I learned that the two leading vaccines both use mRNA (messenger ribonucleic acid), which is a totally new approach to vaccine development.
Hundreds of millions of people worldwide could be inoculated—ASAP—with a substance that has never been applied before.
Previous vaccines have been made from weakened viruses or purified proteins found within the virus—in both cases designed to direct the immune system to attack the virus.
I needed to know more about this new approach.
My Scientist Friend Responds to My Concerns
I expressed my concerns to my friend Terry, a PhD biologist and gifted teacher who guided me/us through the role of phytoplankton in climate change, a post that you can read here.
UPDATE: I inadvertently switched two paragraphs in the description below, thereby throwing the sequence out of whack. The corrected version is below.
This is what Terry said about the mRNA vaccines:
“First of all, it is an extraordinarily brilliant idea—and so simple that I should have thought of it, and so should have many professional biochemical researchers long before me.
“Briefly: Genes, normally composed of DNA (more on this in a moment) copy their code in the form of mRNA (M=messenger) which joins with a cellular organelle [a structure within a cell that has a certain function] called a ribosome, which translates the code into a protein.
“A slight complication is that the COVID virus uses RNA as its ‘genes’ and therefore has no DNA. But now the complication simplifies: the virus ‘gene’ RNA copies its code into mRNA, which joins with a ribosome in the cell the virus has invaded, and the viral mRNA is translated into a protein.
“Now here is the basis for the brilliant idea: An intact virus inside a cell uses special proteins called ‘spike’ proteins (made from the instructions, or code, in the invading virus’s ‘gene’ RNA) to attach to the surface of the next cell to be invaded.
“This act is the sine qua non of viral infection and, ultimately, disease! If there’s no attachment, there are no new viruses to attack other cells. And no disease! [Emphases mine]
“The brilliant idea is to make loads of mRNA for the spike protein and inject millions of mRNA molecules coded for making this protein [or proteins] within a human being.
“The mRNA will then be taken up by and enter certain cells of the person’s body, attach to ribosomes, and produce hundreds of copies of this protein in each of the millions of cells in the body that now have the mRNA in them.
“Large amounts of these proteins will then be excreted by the many cells into the blood stream, where white blood cells will make huge amounts of powerful antibodies to the spike proteins.
“Any whole COVID virus that enters a person’s body will immediately become covered with antibodies that will prevent the virus from attaching to body cells (see sine qua non above). The infection chain will be broken, and disease spreading will stop.
“Now, consider that all of this is what normally happens to viruses and cells—except for the injection of the COVID mRNA for the spike proteins. So it is difficult to see where things could go wrong and produce some sort of problem in the body of the person being injected.
“But, of course that is not enough: we need to try it out in humans using the tried-and-true method of Phase I, Phase II, Phase III.“
Terry then discussed the trials that both Moderna and Pfizer-BioNTech (the small company that actually developed the Pfizer vaccine) have been doing for the past three or more months, with 30,000+ adult volunteers in each trial. (I just read the number 44,000 attributed to the Pfizer-BioNTech trials.)
“Nearly 95% of those receiving the MODERNA VERSION and 94% of those receiving the PFIZER VERSION have not gotten sick!
“The protocol for this experiment specifies that if the percent of people protected was small, the companies would have to carry out the experiment for many more months to be sure it was working.
“The fact that the effectiveness is so high permits them to stop the experiment now and get on with distributing the vaccine to the states. That is what they are now doing.
“Very few, if any, problems have been noted in the 60,000+ persons injected with the vac or they would have been reported already.”
“GET VACCINATED BY ONE OR THE OTHER OF THESE AS SOON AS IT IS POSSIBLE!”
I asked Terry whether there had been any concerns due to the vast amounts of antibodies created, as we know that in some instances, particularly in elderly patients, the virus caused their immune systems to go haywire, producing multiple organ failure and often death. He said he believed such instances would have shown up in the clinical trials, but none had.
Note: The results thus far are interim data that haven’t yet been subject to peer review.
Persuading Those in Greatest Need of the Vaccine
There have been glitches along the way. Both Pfizer and Moderna were asked to include more minority individuals in their trials.
This is and will be a difficult issue for both individuals and our society. Black and Latino people have borne the worst brunt of Covid, with the highest rates of death and disease. Thus, they should be considered among the earliest recipients of the vaccine.
But for very legitimate reasons, there’s considerable skepticism of such government efforts, dating back to the infamous Tuskegee experiment in which the US Public Health Service studied the effects of untreated syphilis on Black men. Though the study began in 1932 and continued for forty years, when penicillin became available in the 1940s as an effective treatment, it was not given to the ailing men, even though it could have cured them.
There will be a need for considerable outreach to encourage understandably reluctant people to take the vaccine—in these communities and others.
After I spoke with Terry, I did a little additional research. The CDC has its own mRNA website. Among its key points: mRNA technology, though new, has been studied for more than a decade; since mRNA vaccines don’t contain live virus, they don’t carry the risk of causing the disease in the vaccinated person; and “mRNA from the vaccine never enters the nucleus of the cell and does not affect or interact with a person’s DNA.”
The third point was particularly important to me: no messing around with the basis of our DNA. But the fact that the mRNA concept has been studied for a decade also reassured me. A lot of groundwork had been done.
Thus, after China had released the genetic sequence of the virus, the NIH Vaccine Center researchers had identified the particular gene for the virus’s “spike protein.” They sent it to Moderna, which had identified the same gene.
At that point, Moderna’s scientists plugged the data into its computers. Stephane Bancel, the company’s chief executive, told The New York Times that it then took two days to design the vaccine. “This is not a complicated virus,” he said.
The development of the vaccines is a fascinating story, which The Times ran under the headline “Politics, Science and the Remarkable Race for a Coronavirus Vaccine.” The link is above.
An Interview With Dr. Fauci
Elisabeth Rosenthal, a physician and former New York Times reporter, interviewed Dr. Anthony Fauci, the immunologist respected, even revered, worldwide (except in the eyes of Donald Trump).
There are a number of vaccine candidates that are promising. But there’s also a lot of skepticism because we’ve seen the F.D.A. come under both commercial and, increasingly, political pressure. When will we know it’s OK to take a vaccine? And which?
It’s pretty easy when you have vaccines that are 95 percent effective. Can’t get much better than that. I think what people need to appreciate — and that’s why I have said it like maybe 100 times in the last week or two — is the process by which a decision is made.
The company looks at the data. I look at the data. Then the company puts the data to the F.D.A. The F.D.A. will make the decision to do an emergency use authorization or a license application approval.
And they have career scientists who are really independent. They’re not beholden to anybody. Then there’s another independent group, the Vaccines and Related Biological Products Advisory Committee. The F.D.A. commissioner has vowed publicly that he will go according to the opinion of the career scientists and the advisory board.
You feel the career scientists will have the final say?
And will the decisions that are being made in this transition period — like the vaccine distribution plan — in any way limit the options of a new administration?
No, I don’t think so. I think a new administration will have the choice of doing what they feel. But I can tell you what’s going to happen, regardless of the transition…, is that we have people totally committed to doing it right that are going to be involved in this.
So I have confidence in that.
My Final Thoughts…For Now
Thus, my scientist friend Terry says it’s safe to get vaccinated. When I’d asked the endocrinologist who treats me for osteoporosis, who’s run many clinical trials, how we’d know when a vaccine was safe, she said: “When Dr. Fauci says it is.” And Dr Fauci says it’s safe to get vaccinated.
We won’t know for a while, of course, if there are any long-term problems, any unusual side effects that may pop up in individuals that weren’t seen in the trials, and the length of time the vaccines confer immunity.
But those appear to be tradeoffs that we must make in facing an out-of-control and sometimes fatal disease that is rampaging through our country and the world, leaving some people who survive with serious lingering effects (the “long haulers”), and decimating our economies.
So when Dr Fauci gives the green light, count me in. We’ll surely have more safety data by then. The availability, however, will be limited: Pfizer said the first 6.4 million doses will go out in December.
We do know that storage and delivery problems on the massive scale needed will have to be resolved.
To ensure the stability of an mRNA vaccine, it must be kept well below freezing—in Pfizer’s case, at minus 94 degrees Fahrenheit. If simply refrigerated above freezing, it will degrade in just five days.
Many are concerned that lack of proper storage due to insufficient planning and equipment may result in the need to discard some otherwise life-saving vaccine. Moderna’s must also be frozen, but at minus 4 degrees Fahrenheit, where it will be viable for 30 days.
It will be important when one of the other vaccines that doesn’t require such handling becomes available—especially for the poorer areas worldwide.
In preparing this post, my intention is to inform and evoke discussion—not to persuade. If you have concerns, questions, other information, please let me know.
AnnieContinue reading “About Those First-Ever Covid-19 Vaccines Nearing Approval…”