Controversy Over Booster Shots

 

Booster shot or not? If you follow this blog regularly, you know I’m in favor of Covid booster shots, especially for the most vulnerable. (Booster Shot or Not? Declining Vaccine Effectiveness) But the Biden administration is giving mixed signals on this important issue.

The CDC came out with recommendations in August to begin a Covid booster shot program beginning September 20th. Much of the data to support this decision comes from studies in Israel, but I also reported a recent study from the University of California San Diego. In response, I got my third Pfizer vaccine booster shot two weeks ago when it was offered to medical staff and their families based on the following eligibility:

  • Age 65 or older
  • Active cancer treatment for tumors or cancers of the blood
  • Organ transplant recipients taking medicine to suppress the immune system
  • Stem cell transplant within the last 2 years or those taking medicine to suppress the immune system
  • Moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome)
  • Advanced or untreated HIV infection
  • Active treatment with high-dose corticosteroids or other drugs that may suppress your immune response.

Anyone in any of these categories is at higher risk and adding a third shot increases their protection from infection.

The controversy broke out in today’s media when a group from the U.S. Food and Drug Administration (FDA) as well as the World Health Organization (WHO) objected to the CDC recommendations. In a review article published in The Lancet, a British medical journal that often embroils itself in controversy, these scientists concluded that current vaccine regimens were still very effective at protecting against severe disease from viral variants, including Delta. They prefer using current vaccine supplies to save more lives by vaccinating more of the unvaccinated population. “Even if some gain can ultimately be obtained from boosting, it will not outweigh the benefits of providing initial protection to the unvaccinated,” said Ana-Maria Henao-Restrepo, the study’s leading author and researcher at the WHO.

In other words, these scientists are more concerned with spreading the supply of vaccines around to give initial vaccinations to the unpopulated parts of the world, rather than increasing the protection of the most vulnerable in America. This is not a difference in science; it is a difference of opinion in medical ethics and the setting of priorities. Also, it assumes there is a limited supply of vaccines to go around. With three vaccines approved in the U.S., and at least five others being used world-wide, this is a difficult argument to make.

No one is saying there is evidence it is harmful to get a booster shot. No one is suggesting the booster shots will not increase protection in those who got their initial vaccinations more than six months ago. Some are suggesting the increased number of vaccinations may increase adverse reactions, but there is no proof of that happening.

Support for the booster shots has been widespread apart from this study group published in The Lancet. Robert Wachter, chair of the Department of Medicine at the University of California San Francisco, says there is enough data showing a third dose of the Pfizer vaccine can help protect those who are at risk of worse outcome, such as people over age 60, as well as those at risk of spreading it to vulnerable people, such as nursing home employees and healthcare workers. “If you got Pfizer more than six months ago, as I did, and you’re at more than a moderate risk of a bad outcome if you got infected, I think it’s a pretty clear call,” Dr. Wachter says.

The decision is yours to make – at least at this time! If you’re in a high-risk category, I recommend the booster shot. If you’re not, perhaps you don’t need the extra protection, though it would improve your chances of remaining virus free.

(Note: A panel of FDA advisors has just recommended booster shots for those in the high risk categories, but not for others.)

Covid Impacting Younger Americans

 

The 2020 pandemic year impacted mostly the elderly. From early on it became clear the most vulnerable were those over age 65, especially those with co-morbidities such as heart disease, lung disease, diabetes, and obesity. Those in their eighties or older were especially vulnerable. The risk of death in this age category was roughly one thousand times higher than in the very young.

The 2021 pandemic year is shaping up as very different. While the elderly are still vulnerable, most of them by now have been vaccinated. Vaccination rates are highest in this demographic, as they should be. The surge in positive tests for Covid and hospitalizations is now mostly in a younger population. How are these younger people doing?

Jon Kamp and Paul Overberg, writing in The Wall Street Journal, tell us, “Federal data show Covid-19 deaths among people under 55 have roughly matched highs near 1,800 a week set during last winter’s surge. These data show weekly tallies for overall Covid-19 deaths, meanwhile, remain well under half of the pandemic peak near 26,000 reached in January.”

The predominant strain of the virus circulating today in the U.S. is the Delta variant. The first surge last year was the Alpha variant. Though this is still being researched, most scientists today believe the Delta variant is more contagious, but less virulent. That means more people will test positive, but fewer will die from the Delta variant. These differences could be related to other factors such as vaccination rates, a younger infected population, and others.

The seven-day average for newly reported Covid-19 deaths each day recently eclipsed 1,600, up from an average that briefly moved below 220 a day in early July. With roughly 660,000 known Covid-19 deaths to date, the U.S. is on track to soon top the estimated 675,000 deaths that the Centers for Disease Control and Prevention has linked to the 1918-19 flu pandemic.

If you’ve been vaccinated, these numbers need not alarm you. But if you’re unvaccinated, you should be paying attention. Deaths have been concentrated among the unvaccinated, according to federal data. The CDC reported last week that unvaccinated Americans were 4.6 times more likely to get infected, 10 times as likely to be hospitalized, and 11 times as likely to die as those who have been vaccinated.

Tampa General Hospital, one of Florida’s largest, reports over 90% of hospitalized patients were unvaccinated. Most of the remaining 10%, who were vaccinated, had compromised immune systems due to organ transplants or cancer treatment. My local hospital, Orlando Health, is reporting similar statistics.

As a result of these demographic changes, most of the new deaths are occurring in a younger population. Age remains a major risk factor, even in a younger population. People in their 30s are four times as likely to die from Covid as people ages 18 to 29, according to the CDC. For people ages 75 to 84, however, the risk of death is 220 times as high. This emphasizes the importance of young people getting vaccinated. The table below reflects this growing number of deaths in a younger population.

The number of working-age adults dying of Covid has returned to levels reached last year during the winter surge. Older Americans still account for the most Covid-19 deaths, but their higher vaccination rates have helped hold down the numbers. About 54% of the overall U.S. population and 63% of eligible people ages 12 and above are fully vaccinated, while the average among nursing homes is 84% for their residents, federal data show.

Fortunately, the most vulnerable, our seniors in nursing homes, are not seeing the rise in cases and deaths we witnessed last year. This is mostly due to the high rates of vaccinations in this demographic, as well as new requirements for all nursing home personnel to be vaccinated.

However, there are still some disparities in infection and vaccination rates among racial groups. CDC data show blacks and Hispanics face almost three times the rates of hospitalization and more than twice the risk of death as non-Hispanic whites. Rates among Native Americans are even higher. However, rates among Asians are similar to non-Hispanic whites. The disparities reflect pre-existing conditions, access to healthcare and occupational exposure according to public health experts. Cultural reluctance to vaccination is also a factor.

Declining Vaccine Effectiveness

 

In a recent post I recommended a booster vaccination shot. I came to this conclusion based on reports from the Mayo Clinic that showed reduced effectiveness of both the Pfizer and Moderna vaccines, especially the Pfizer. Many friends who have been vaccinated also reported testing positive recently, although their illnesses were mild.

Now comes additional support for booster shots in a new study published in The New England Journal of Medicine (NEJM). This study is particularly important because it was done in healthcare workers at The University of California San Diego (UCSD). This well-documented study should convince everyone of the need for additional vaccinations.

UCSD began vaccinating healthcare workers in December 2020 with the mRNA vaccines. By March, 76% had been vaccinated and by mid-July 87%. Infections declined rapidly beginning in February, 2021. Between March and June, fewer than 30 healthcare workers tested positive each month. But this all changed in mid-June.

Coincident with the rise of the Delta variant and the end of the California mask mandate, the number of cases began rising. By the end of July, the Delta variant accounted for 95% of the UCSD isolates. The number of infections continued to rise, including cases among fully vaccinated persons. These changes are reflected in Figure 1 below.

Fortunately, UCSD has a low threshold for Covid testing, which is triggered by the presence of at least one symptom during daily screening or by an identified exposure, regardless of vaccination status. From March 1 to July 31, 2021, a total of 227 UCSD healthcare workers tested positive for Covid-19. Of these 227, 130 of these (57.3%) were fully vaccinated. Of these 130, symptoms were present in 109 or 84%. Symptoms were present in 80 of the 90 workers who were unvaccinated or 89%. No deaths were reported in either group and only one unvaccinated person was hospitalized.

Vaccine effectiveness was calculated for each month. Vaccine effectiveness exceeded 90% from March through June but fell to 65.5% in July. These changes are reflected in Table 1.

These same vaccines had previously demonstrated effectiveness of 94% for the Moderna vaccine and 95% for the Pfizer vaccine.

The authors conclude “. . .our data suggest that vaccine effectiveness against any symptomatic disease is considerably lower against the delta variant and may wane over time since vaccination. The dramatic change in vaccine effectiveness from June to July is likely to be due to both the emergence of the delta variant and waning immunity over time, compounded bby the end of masking requirements in California and the resulting greater risk of exposure in the community.”

This should be sufficient proof of the wisdom of getting a vaccine booster shot if your last vaccination shot was greater than six months ago. It is clear from this data that vaccine efficacy declined about six months after initial vaccination and coincident with the rise of the Delta variant. The annual season for influenza vaccinations is upon us and this would be a good time to get both. The CDC has already given us their blessing to get both the same day.