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Vaccines and Viral Variants: COVID-19 in the U.S. at One Year

On December 31, 2019, China first reported a cluster of viral pneumonia cases associated with the Huanan Seafood Market in Wuhan, China. About a week later, Chinese health authorities confirmed that these cases were associated with a novel coronavirus, SARS CoV-2. The first U.S. case of what we now know as COVID-19 was in a 35-year-old man who presented to an urgent care clinic in Snohomish County, Washington on January 19, 2020. The man had recently returned from visiting family in Wuhan, China.

The rest is history.

A little over a year later, we find ourselves living dramatically different lives as a result of COVID-19. The world has seen 106 million people infected with SARS CoV-2, and 2.3 million deaths as a result. The U.S. is the world’s unquestioned leader in both of these categories, with 27.5 million documented cases of COVID-19 and 475,000 deaths ( . The pandemic has resulted in lost employment, lost wages and massive disruption of industries such as bars, restaurants, travel and entertainment, all of which rely on in-person attendance for their success. We have all become self-styled experts in mask-wearing and hand sanitization, things we barely even thought about a year ago.

And yet, for the first time, it appears there may be a light at the end of the tunnel.

Two mRNA vaccines for COVID-19, those developed by Pfizer and Moderna, respectively, became available in the U.S. mid-December of 2020. A third vaccine, developed by Johnson and Johnson, has been submitted to the FDA for Emergency Use Authorization (EUA) and is expected to be approved this week. A fourth vaccine, developed by Novavax, is expected to be available in the U.S. by summer. As of this writing, 31.1 million people have received at least one dose of a vaccine, including 1.1 million in Georgia. The U.S. is averaging over 1.4 million vaccine doses per day at present. At this rate, it will take 10 months to cover 75-85% of the population with a two-dose vaccine. That’s the level of vaccination that Dr. Anthony Fauci, the nation’s top infectious disease specialist, has suggested will allow us to develop so-called “herd immunity” ( ). Such a timetable will have us wearing masks and engaging in social distancing throughout the remainder of 2021, although there is hope that the availability of newer vaccines and improved vaccine distribution will allow that goal to be achieved sooner.

Still, there are some issues on the horizon.

Viral replication inevitably leads to mutation, and while most of those mutations are harmless, some do lead to changes in a virus which can enhance its transmissibility, its virulence or both. The worldwide spread of SARS CoV-2 has allowed the virus a number of opportunities to develop favorable mutations. A few of these mutations, seen in the U.K. (variant B.1.1.7), South Africa (variant B.1.351) and Brazil (variant P.1), have commanded the most attention.

The emergence of these variants, which appear to be more transmissible than earlier versions of the virus and which may also be more resistant to the current vaccines, has put us into a vaccination horse race. The more infections there are, the more chances there are for these variants to spread or for new mutations to occur. On the other hand, if we can get the infection numbers down to very low levels, we can effectively mitigate the deleterious effects of the newer variants by eliminating them from circulation.

So what are the questions most people want answered now? Here are a few we’ve come across.

· How well do the current vaccines work? This is the most basic question, of course. The clinical trials used for Emergency Use Authorization suggested that the Pfizer and Moderna vaccines were about 95% effective at preventing infection. The Johnson and Johnson vaccine, expected to be approved under Emergency Use Authorization this week, was 66% effective in preventing moderate to severe disease from COVID-19 and 85% effective in preventing severe disease. Interestingly, the efficacy of the J&J vaccine varied by geographic region, as the vaccine was 72% effective in the U.S., 66% effective in Latin America and 57% effective in South Africa. The variant strains circulating in those latter two regions may be responsible for the reduced efficacy in those areas. Most importantly, the J&J vaccine was found to be 100% protective against hospitalization and death from multiple variants of COVID-19—including the B.1.351 variant in South Africa ( ).

Some of the post-marketing data on these vaccines are similarly encouraging. A recent laboratory study by Pfizer showed that blood from people who have been administered the Pfizer vaccine successfully warded off COVID-19 infection of cells in a petri dish by the U.K. and South African SARS CoV-2 viral variants. Data from Israel, which has been very successful in COVID-19 vaccine rollout, show positive real-world vaccine effects. Among people 60 years of age and older, who received the Pfizer vaccine early because of higher risk, it was found that the number of new COVID-19 cases dropped by 41 percent compared to three weeks earlier even though only about 50% of that population had been vaccinated at that time. Moreover, among 416,000 people who had received both doses of the vaccine, only 254 had gotten COVID-19 after their second dose—and all of the reported cases were mild, with no hospitalizations and no deaths. Compared to the general population, the researchers estimated that the Pfizer vaccine had a real-world efficacy in COVID-19 prevention of 91%. This is especially significant because the B.1.1.7 variant, first found in the U.K., now accounts for 80% of all COVID-19 cases in Israel ( ).

Closer to home, the Center for Medicaid and Medicare Services (CMS) has reported a recent significant decrease in COVID 19 infections in nursing homes and assisted living centers as those very vulnerable populations have begun to undergo mandatory vaccination. Since 36% of the total U.S. pandemic death toll (153,000 persons) has come from that group, these results are very encouraging ( ).

One thing seems to be clear: The vaccines are all quite effective (close to 100%) in preventing severe disease of the sort that could result in hospitalization and death, even with the newer strains. That’s the most significant finding we’ve seen to date—and one which gives us great hope for a way out of this mess in the coming months.

· Are the vaccines safe? The gist of the entire vaccination issue has boiled down to the entire safety versus efficacy discussion. We’re hearing less of the absurd nanobot and/or tracking device absurdity now that I referenced in my last blog post. Now, people just want to know if the vaccine is safe.

The reasons for public mistrust are numerous. Most vaccines take years to develop; Moderna, Pfizer, J&J and Astra-Zeneca have all brought products to market in less than a year. There are suspicions about political motivations and other non-medical issues, as seems to be the case with just about anything these days. But while the vaccines may be new, the technology behind them isn’t. The mRNA vaccines (Pfizer and Moderna, for example) were developed for the 2003 SARS pandemic but never fully utilized. In addition, the medical scientific community has become much more sophisticated at biotechnology in recent years. When you think of the internet in 2003 versus today, the differences are astonishing. Biotechnology has made similar advances in that same time frame. We’re just better at this sort of science now—and that enhanced expertise has showed up in a very public way in the development of COVID-19 vaccines.

The adverse effects reported with COVID vaccination have largely been mild: Injection site soreness (84%), fatigue (63%), headache (55%), muscle aches (38%), chills (32%) and fever (14%). Anaphylactic reactions—true allergic reactions—have been seen in a under a hundred persons, but none of these reactions have been lethal, and nearly all have occurred within 15 minutes of vaccine administration. Interestingly, nearly all (96%) of the anaphylactic reactions have been in women.

The most critical point in vaccine safety is, of course, the life-or-death one: Can the vaccine kill me?

It is inevitable that some people will die after COVID-19 vaccination. After all, people die all the time. The truly important point here is whether there is a cause-and-effect relationship demonstrable in the event. Baseball great Hank Aaron is one recent very public example. Aaron had received the Pfizer vaccine two weeks before his recent death, raising concerns about causation—but Aaron, who was 86 years old, was found to have died of natural causes. A handful of deaths shortly after vaccine administration have been investigated in Norway, Germany, Spain, and Belgium, and none have been linked to the administration of COVID-19 vaccine. Some of the vaccinated individuals actually died of COVID infections contracted during the week or so after vaccine administration when there is no protection. Others were quite old and had numerous underlying illnesses. The incidence of deaths in these cases did not exceed the expected number of deaths among those populations during that time frame.

The Vaccine Adverse Events Reporting System (VAERS), a voluntary health reporting system administered by the U.S. Department of Health and Human Services, keeps extensive data on adverse events, including deaths, after vaccination. VAERS database reported 196 deaths nationwide within 30 days after COVID-19 vaccination through January 18, 2021. The median age of the deceased was 79. Over 66% of these individuals were residents of a long-term care facility. Numerous studies of the deaths in these nursing home populations showed no cause-and-effect relationship between COVID-19 vaccination and death among nursing home residents in the U.S.

Among community-dwelling individuals aged less than 65, there were 28 individuals among 13.7 million persons vaccinated as of January 18 who had died within 0-30 days of vaccine administration. Autopsy reports were available for 11 of those 28 individuals. In none of the 28 cases was the vaccine felt to be a contributing cause of the person’s death.

So, in summary, there is ample evidence that the currently available COVID-19 vaccines are very effective, and they appear to be quite safe, as well.

One particular challenge for COVID-19 vaccination programs has been the inherent mistrust of the vaccines among people of color. The Kaiser Family Foundation has reported that 43% of Black adults and 37% of Hispanics in the U.S. are taking a “wait and see” approach to the vaccines, as opposed to 26% of the white population ( ). Lack of information about vaccine efficacy or concerns about vaccine risks have contributed to that reluctant stance. For example, 57% of the unvaccinated have concerns about vaccine safety, and 49% don’t have enough information about vaccine efficacy. Interestingly, a substantial proportion of the unvaccinated persons of color are concerned about getting COVID-19 from the vaccine (54% of Blacks and 50% of Hispanics), even though that is completely impossible. Part of this mistrust stems from prior government-sponsored experimentation upon Black populations, such as the infamous Tuskegee experiment, when hundreds of Black men with syphilis went untreated without their knowledge, or the local Operation Big Buzz, when Aedes Aegypti mosquitoes were dropped in the Carver Village neighborhood in Savannah and in similar Black neighborhoods in Avon Village, Florida in 1956 and 1958 to test the viability of mosquito vectors for germ warfare. Given that COVID-19 outcomes among Hispanic and Black people is worse than among other segments of the U.S. population, having adequate vaccination rates among these groups will be a crucial measure in gaining control of the pandemic in this country going forward.

What about the new SARS CoV-2 variants? Will the vaccine work against them, too? The development of variant strains of a virus is the natural consequence of viral replication: The more copies of the virus which are made, the more likely there will be a mutation. Many of these variant strains are not as effective as the parent strain, and do not propagate, but a few may develop characteristics which make them more easily transmissible, more deadly or more resistant to vaccination. There are currently 3 major variants which have been seen worldwide: The UK (Kent) variant, B 1.1.17, the South African variant (variant B.1.351) and the Brazilian variant (variant P.1). All three have been detected in the U.S., although the U.K. variant is the only one which has shown up so far in Georgia ( ). It should be noted that viral genomic sequencing efforts in the U.S. have significantly lagged behind similar efforts in the U.K., making it likely that these viral strains are circulating far more widely than is currently being seen. It is likely that other variants will emerge over time as the pandemic moves on. Both Moderna and Pfizer have said that they are working to develop “booster shots” which may be more effective against these emerging variants.

The U.K. (B 1.1.17) variant appears to be about 35-60% more easily transmitted than earlier versions of SARS CoV-2 and may be up to 35% more deadly, although there is some controversy about this. It does appear to have the same susceptibility to the current vaccines as the other variants. Viral sequencing among specimens taken from patients in the U.S. show that this viral strain is becoming exponentially more prevalent and will likely be the predominant strain in the U.S. by March. It already accounts for 80% of new COVID-19 cases in London ( ). In the U.S., most of the isolates of this strain have come from California and Florida.

The South African variant (B.1.351) is simultaneously more easily transmitted and more deadly than the original version of the virus. Unfortunately, it also has mutations which seem to make it more resistant to vaccine effects, although the current vaccines still seemed to protect against severe infections which lead to hospitalization or death ( ).. The recent trial of he Novavax vaccine, for example, was nearly 90% effective in Great Britain, but only 49% effective in South Africa. Nearly all of the after-vaccination cases seen in South Africa during the Novavax clinical trials involved the B.1.351 variant. The Oxford/Astra Zeneca vaccine recently stopped its South African clinical trials because its vaccine was shown to be “ineffective” in preventing even mild disease against the B.1.351 variant ( )

The Brazilian variant (P.1) seems similar to the South African variant, although less is known about it. It is likely that this variant is responsible for severe outbreaks in Latin America, including those seen in cities where prior exposure should have led to herd immunity. This viral strain has shown a propensity for re-infecting COVID-19 patients with prior exposure ( In the U.S., it has been found in Minnesota so far, but it almost certainly is more prevalent than we are currently seeing. The U.S. simply isn’t doing enough viral genomic sequencing work to see the spread as it is occurring. The CDC has vowed to change that in the near future.

· So what does the future hold? As the vaccines come out, will life return to normal? Unfortunately, the road back to normalcy will be a bumpy one, fraught with potholes and roadblocks we might not see coming. For while the rapid development of safe and effective vaccines in under a year’s time is unprecedented, bordering on the miraculous, the SARS CoV-2 virus has shown a remarkable propensity for adaptation. Moreover, reservations about vaccine administration and the reluctance of some to engage in such simple measures as mask-wearing and social distancing as well as simple “pandemic fatigue” will inevitably give the raging viral forest fire that is COVID-19 enough oxygen to keep going for a while now. The need to get vaccines to developing nations is also important, for as long as COVID-19 can replicate anywhere, it can mutate—and the next mutation, or the one after that, could be even more lethal and more contagious. Such mutations have even been seen to arise in a single individual with COVID-19 ( ). For now, we need to encourage the vaccination of as many people as possible. Since we cannot be certain if vaccinated persons can be asymptomatic carriers (no one has studied that yet), we must still engage in mask-wearing in public and in social distancing for the forseeable future—likely for the remainder of 2021. But we can, and will, beat this pandemic. How rapidly we do that is largely up to us ( ).

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