Opinion: The COVID-19 vaccine and you
Contrary to everything I learned in college and writing experience, I’ll start with the bottom line: The COVID-19 vaccine that dominated the news cycles this week will not be available to you this winter, and possibly not until after summer. Or later. The reason, put simply, is that scientists don’t know very much about its ultimate effectiveness, side effects, and other important matters.
Earlier this month, Pfizer and its partner (BioNTech of Germany) announced preliminary results that show their vaccine is more than 90 percent effective. That’s great news, but the operative word is “preliminary.” Research on vaccines — regardless of “warp speed” contingencies — takes years to do properly.
First on all, after being reasonably sure that their serum will work and cause no harm, scientists must submit their concoction to double-blind testing procedures. This means that half of the volunteers get an injection of the vaccine, and half get a saline solution. The subjects don’t know which shot they get, and neither do the medical personnel who give the shots. Only members of an independent IRB (Institutional Review Board), composed of experts in the field, know which is which.
The Pfizer sample was made up of 44,000 volunteers, and only 94 of the participants became ill with coronavirus. However, we don’t know at this point how many of those 94 people received the real vaccine. Nevertheless, that’s a fantastic result. The standard flu shot that many of us get every year has only a 40- to 50-percent rate of effectiveness. So, even if all of the people who got sick received the vaccine, that’s still within acceptable limits. But, it raises serious questions, the obvious one being: Why didn’t the people who got shots of salt water get sick? And that leads to many other questions, like: What factors were present in the study that prevented the un-vaccinated subjects from getting sick?
Preliminary testing with four versions of the vaccine began early this year, and Pfizer picked the one that produced the fewest cases of mild side effects, such as fever and fatigue, for further testing. Clinical trials with that version began in May, and so far there have been no serious concerns about its safety.
The current study will continue regardless of the preliminary results until 164 of the volunteers become ill with the virus. At that point, the results will be analyzed again. Scientists will then report the efficacy, an estimate of effectiveness, of the vaccine.
After the preliminary results are reviewed and approved by the Food and Drug Administration (FDA), the double-blind portion of the trials end. Then, the vaccine will be distributed to millions of people. Those who receive the injections will be monitored for two years by the FDA and the Centers for Disease Control and Prevention (CDC).
Who will then receive immunization? Given what we know about the virus, it’s likely that medical personnel, first responders, and the elderly will receive doses of the initial batch of the vaccine. People with certain medical conditions, like diabetes, who are most susceptible to the virus may also be included.
Pfizer can produce 30 million to 40 million doses before the end of this year. Because the vaccine is administered in two injections, 3 weeks apart, that’s enough for 15 million to 20 million people, a very small percentage of our total population of about 230 million.
How the vaccine works in not important to us, but it’s very important to other and continuing research. The Pfizer vaccine is based on a genetic molecule called RNA (ribonucleic acid). It’s different from DNA (deoxyribonucleic acid) in that DNA forms as a double helix (like our chromosomes) and does not easily replicate itself. RNA forms as a single strand and readily replicates. The RNA in the Pfizer vaccine replicates quickly, causing our immune system to make antibodies and immune cells that can deliver a swift attack on the virus.
Knowing that this strategy is effective encourages further research. For example, Moderna is in late-stage trials with an RNA vaccine and, according to the New York Times, other RNA studies are being carried out in China, England, India, Singapore, South Korea, and Thailand.
Dark winter ahead
Although the Pfizer announcement is very encouraging, we need to remain vigilant now and probably in the foreseeable future. COVID-19 is spiking all around the world, and it will get worse as winter comes to the northern hemisphere. Outdoor gathering will move indoors, where the virus can spread more easily.
Even if the vaccine were available, it would not vitiate the importance of wearing masks, washing our hands well, keeping our contacts to a minimum, and maintaining social distancing. The New York Times cited Dr. Paul Offit, a member of the FDA’s vaccine advisory panel as having said, “This (the vaccine) will not replace hygienic measures, it will be an adjunct to hygienic measures. You owe it to others to make sure you wear a mask.”
However, there is a less altruistic reason to maintain the precautions that we’ve observed for the past several months. On an MSNBC telecast, Dr. Anthony Fauci was asked about the importance of wearing a mask. He said that there is evidence that face masks both protect others and protect ourselves. Let’s keep it in mind that COVID-19 is a serious public health threat.
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Jim Glynn is Professor Emeritus of Sociology. He may be contacted at email@example.com.