About Those First-Ever Covid-19 Vaccines Nearing Approval…

COVID-19; image courtesy of state.gov.

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.

My Concerns…

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.”

Terry’s advice:

“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).

Here’s part of their Q&A:

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?

Yes, yes.

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.

Annie

34 thoughts on “About Those First-Ever Covid-19 Vaccines Nearing Approval…

  1. Most interesting and my husband and I have been reading as much as possible about these vaccines. Neither one of us will hesitate when Dr. Fauci says “go”! A day or two of discomfort is worth everything to get this vaccine. The Dems will have to have a huge and effective publicity campaign to convince the skeptical public.

    Liked by 1 person

  2. This was somewhat reassuring. Thank you for collecting all this information.

    I remain concerned about the FDA until all the Trumplings are completely cleaned out of it. I won’t feel totally sure until the same vaccine gets approval from the equivalent agencies in other advanced countries.

    It seems that the effectiveness of the vaccines is not in question. And it’s true that we don’t know how long the immunity will last. But even if everybody needs to get a new shot every three or four months, that will still be a huge improvement over the current situation.

    As you point out, the main concern is long-term safety. If they’ve only been tested on humans for a few months, we don’t know what the long-term effects might be. Still, since the first recipients will be health-care workers and the elderly, it will be several months before vaccination is available to the general public, so we’ll have more time to be assured that it’s OK.

    But — all that being said, we need to be able to take yes for an answer. If it works and is safe, then yes, everybody should use it. It will be a textbook example of my conviction that it’s technology, not ideology or politics, is the greatest benefactor of humanity.

    Unfortunately we all know many Trumpanzees and religio-wingnuts will refuse the vaccine on various grounds. The red states and rural areas will likely remain a morass of diseases for years.

    Liked by 1 person

    1. Infidel: You’re welcome, and I understand the “somewhat” modifier. With regard to waiting for approval from other countries, I suspect that will happen close to US approval for the Pfizer-BioNTech vaccine, which is being distributed to other countries as well as within the US.

      I quite agree: despite the uncertainties, “we need to be able to take yes for an answer.”

      Hard for me to fathom what will happen in red states and rural areas; diehard governors may just have to wake up as hospitals and healthcare providers alike can’t handle the onslaught.

      Liked by 1 person

  3. Sally: It’s a fascinating story. If you and your husband haven’t read the Times article I linked to about the vaccine development, I think you will enjoy it.
    Yes, it’s one of the biggest of the zillion huge issues the Biden administration will face. It will be interesting to see the relevant appointments—all of whom I’m sure will be highly qualified people.

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    1. Right; fortunately, the efficacy data thus far is amazing, and the reported side effects have been things like headaches and fatigue. May those findings continue as the numbers of people involved increase significantly.

      Liked by 1 person

  4. Thanks again for a wonderful contribution, Annie. Your friend, Terry, gives a great explanation of how the mRNA-based vaccines work. I do have worries about the storage requirements, especially the one requiring -94 degreesC. Also, from what I’ve heard (I could be wrong), none of the vaccines so far have been tested in kids. In any case, I’ll certainly get one when I’m able to. Thanks again!
    George

    Liked by 1 person

    1. George: thanks very much. The storage is an issue; Pfizer has designed freezer boxes to ship the vaccine. But questions remain about the recipient providers who receive the boxes: what will they need?

      I don’t think there’s been any testing on children yet. Though there have been illness and deaths among young kids, the incidence appears lower in elementary school children. But I don’t think it’s clear whether/to what extent these kids can be asymptomatic and contagious to others.

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      1. Given that children are generally in less danger from the virus and the vaccines hasn’t been tested on them, it may be smarter to just vaccinate adults and count on that to protect children indirectly by causing the virus to disappear from circulation.

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  5. “I’ve done all this medical/scientific work armed with a master’s degree in English literature.” That’s a good thing Annie, as you then approach things with no bias and a fresh point of view. A good post, as we need to make educated decisions. We will be far down the list of any vaccines here, as Trudeau didn’t contract for any other than in China in the early days, and we don’t have any manufacturing facilities left. I’ll take whichever one I can get. I see Astra-Zeneca-Oxford is having problems with their dosing schedule, and having to redo part of their study, although I believe theirs will be the cheapest to make and easiest to store once they figure out the dose. With so many people all around the world to protect, all the companies will be needed. I watched W5 tonight and there was a half hour special on the polio epidemic in the 50’s and vaccine skepticism back then…an interesting look at the history of a devastating disease.

    Liked by 2 people

    1. I suspect Trudeau will find a way once vaccines are approved and available.

      Yes: the AstraZeneca-Oxford setback was most unfortunate. It will be cheaper and more convenient than the others, so there’s a lot of interest in their redoing the trials to correct the errors. I agree: the need will be great worldwide, and there will be a real need to ensure the poorest nations get what they need.

      Interesting about the polio epidemic: my understanding was that people were so terrified that they couldn’t wait for a vaccine.

      Liked by 1 person

      1. Apparently there was a bad batch of polio vaccine in the US made by Cutter Labs (200,00 doses) and thousands got infected and died so it was halted for awhile….you can imagine the fear then. But Canada kept vaccinating because ours was made by Connaught Labs in Toronto (the original makers of Insulin). I found the segment on the iron lungs interesting – an early version of a ventilator. Trudeau won’t have a choice as we are 7 or 8 countries down the list on most of them and I suspect they will go by when the contracts were signed. They may give us enough doses to immunize the front line staff and nursing homes, but the rest – I think will be summer.

        Liked by 1 person

      2. I’m not sure we’ll get vaccine much before summer either.

        Interesting/tragic story about polio vaccine. I’m now remembering it somewhat. Must fervently hope nothing like that occurs this time!

        Liked by 1 person

  6. there will be a real need to ensure the poorest nations get what they need

    The developers will need to sell or otherwise provide manufacturing rights to anyone else with the capacity. For example, India has a huge vaccine-manufacturing industry, I think the largest in the world. That will take care of a big chunk of the world’s poorest people all by itself.

    Liked by 1 person

  7. Great article. I cleared up a lot of things. I am eager to take the vaccine. But only after Trump leaves office. Bottom line. Everything has become so politicized at this point that I do not trust the leadership of any government organizations under Trump’s control. If the new people under Biden and Fauci say it is safe, I will gladly join in. But not until then.

    Liked by 1 person

    1. Joseph: Thank you. Fortunately, the timing will mean you won’t be faced with that dilemma. It’s a relief that Biden’s team now has access to the info—and trump knew he could hide Fauci, but he couldn’t fire him. So he’s been very much in the midst of it all.

      Liked by 1 person

  8. I always learn so much from you. (Keeping it in my head, well, that’s another matter.) I had figured that when Dr. Fauci says “Go,” I’m going to get up and go get my vaccine. Scary? Of course. Less scary after reading this post? Yes. So let me amend this: When Dr. Fauci and Annie say “Go,” I’ll do it. Thanks for the info. And yes, still scary. But not as scary maybe as the idea of missing out on the rest of my days, however long or short they may be. Thanks, Annie.

    Liked by 2 people

    1. Denise: Thank you! I’m very glad. I should note that Annie the English major added a little update because I somehow messed up the sequence by transposing two paragraphs. The description makes more sense now.

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  9. “But the fact that the mRNA concept has been studied for a decade also reassured me” – this sort of thing reassures me too. While this Covid19 may be new, and the spikes may pose a challenge, there other other aspects of this whole process (coronaviruses generally, mRNA, making & testing vaccines even) that are not. We have some reassurance is the known. I’d be concerned by Moderna being an upstart too. Funnily enough that’s never been brought up in British media. Where Pfizer is concerned, I’m weary of their distinct lack of morals. The lawsuits, the dodgy marketing, the backhanders to doctors, it’s all detrimental to how we view a company, but I think the same could probably be said for many (most?) pharmaceutical companies. In the UK, the focus has been on Oxford/AstraZeneca, who found they could get over 90% effectiveness rather than below 70% because they made an error – an error in the dosage they gave to participants! Something as simple as that and they don’t get it right concerns me. I get that accidents can lead to great discoveries but come on, they can’t dose a syringe? Yikes! Rant over. Many of us, myself and my parents included, have waited for this time to come and now the worries about the effectiveness, let alone the safety, are a bit deflating.

    Caz xx

    Liked by 1 person

  10. I understand, Caz.
    I think one major issue in response to your concerns about Pfizer particularly and big Pharma generally is that “the whole world is watching.” I was quite worried about trump’s influence, but Biden will demand transparency and following the science. And Fauci’s reputation and knowledge are impeccable. We’ll be getting data from all over the world. Finally, we’ll all be in this together. So I hope you’ll try not to worry.
    Annie xx
    PS: As my post was so long, I decided not to go into the AstraZeneca-Oxford story, since they have work ahead of them. But for the reasons you’re aware of, that one could become the most feasible. Time will tell.

    Liked by 1 person

  11. I’m getting the vaccine the minute it’s at CVS! Thank you for all this valuable information. I’ve been watching segments related to vaccine development on “60 Minutes”. I find this topic fascinating.
    My daughter took a class at college this semester called “Plagues and Contagions” We both learned a lot about Polio & AIDS. The timing to take this class could not have been better for 2020’s virus.

    Liked by 1 person

    1. You’re most welcome, Roberta! I think we have some time ahead of us til it reaches your CVS, but we’ll see. I can imagine it was helpful learning about “plagues and contagions” at this point. Thanks for commenting.

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  12. I’ll certainly be getting my vaccine as soon as it’s available. I think the skill and dedication of those developing the various versions across the globe is continually understated, perhaps due to a mistrust of experts. What an achievement! Really interesting discussion as usual!

    Liked by 1 person

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