Two especially important and impactful events related to our fight against the COVID-19 virus have occurred within the last few days. Three days ago (4/24/2021) the CDC Director signed off on the restart of Johnson & Johnson COVID-19 vaccination after approximately an 11 day pause. The fact that this pause was recommended should give us confidence that the monitoring systems, designed to provide long-term information regarding the safety and efficacy of these vaccines which have been given Emergency Use Authorization, are working efficiently. During this pause, the CDC was able to identify 15 people with the thrombosis/thrombocytopenia syndrome. There were three deaths and six hospitalizations out of nearly eight million people injected. All patients were between 19 and 58 years old with the vast majority being ages 18-48. This pause also allowed for physicians to be cautioned about the nuances of treating this rare complication. The committee responsible for the monitoring the result of ongoing vaccine safety and efficacy (Advisory Committee on Immunization Practices (ACIP)) decided that the benefits of the vaccine far outweigh the risks. The restart of the vaccine was implemented with a warning that this rare complication can occur. The FDA’s new guidance places emphasis on J&J vaccinees seeking immediate medical attention if they develop severe headaches, shortness of breath, severe leg, or abdominal pain, or petechiae (tiny brownish red dots/rash from bleeding beneath the skin) away from the site of vaccination. The new advisory also emphasizes to healthcare providers that non-heparin blood thinners should be used to treat this disorder when recognized.
The second impactful event pertains to the upgrading of policies for those Americans who are fully vaccinated. COVID-19 cases have slowed to approximately 51,000 per day, hospitalizations remain high at about 86,000 daily, and death rates have slowed to under a thousand per day, with a total of 574,313 since the beginning of the pandemic. Vaccinations represent our way out of this COVID-19 peril. So many Americans have responded to the call resulting in 232 million doses having been administered since Dec. 14, 2020. Over 96 million Americans have been fully vaccinated, representing nearly 29% of the total population and 70% of citizens over age 65. We are now getting more of our just rewards as the CDC announced that fully vaccinated people do not need to wear masks when outdoors, except when in crowded venues or settings. This means that fully vaccinated individuals from different households can gather or dine together outdoors. They can also attend a small gathering outdoors with unvaccinated individuals. Recall that several weeks ago the CDC declared that fully vaccinated people did not need masks when visiting another unvaccinated household of low-risk individuals without masks. Previously, two households of vaccinated individuals could also meet indoors without masks. There is also great news that Americans wanting to travel to the European Union can do so without testing or quarantine if they have been fully vaccinated. It should be noted that most indoor activities still are safest, even for the fully vaccinated, when masks are being worn. There is a myriad of specific guidelines available at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.
The two issues detailed above should have effect on vaccine hesitancy. We need to get 80-85% of Americans vaccinated to reach levels of immunity that makes spread of the virus problematic. Unfortunately, the J&J pause may give additional “pause” to the reluctant. As time goes on and safe utilization continues, the advantages of this one-dose vaccine will outweigh the perceived risks. There are other rational and irrational reasons for not taking one of the vaccines. Among these is political leaning, typified by 40% of Republicans saying they will never get vaccinated. Curiously, half of frontline healthcare workers declare unwillingness to get the shot. The new CDC guidance has given incentives to the bunch that asks “Why should I get a COVID-19 shot if my lifestyle activities will not change? Sensitive and understanding information must be provided to influence those still resistant that protecting lives, livelihoods and lifestyles will be achieved by getting vaccinated.
The happiness on the face and relief in the eyes of the newly vaccinated is a sight to behold! Join their ranks if you have not already.
Clyde E. Henderson, MD
Cincinnati Medical Association