10/20/20: AGE 17-&-UNDER GROUP ACCOUNTS FOR MORE THAN 40 PERCENT OF LATEST COVID-19 CASES IN DARE; PLUS, A VACCINE WILL NOT BE A PANACEA.

Young people age 17 and under living in Dare County accounted for six of the 14 COVID-19 cases reported locally during the past three days. Among the Dare County resident cases, they accounted for more than 50 percent.

Just as the 13 COVID-19 cases reported last Friday by the Dare County Dept. of Health and Human Services skewed older, the latest cases skew younger, with none in the higher-risk 65 and older age group and only two in the 25-49 age group.

Eleven of the 13 COVID-19 cases reported from Saturday through yesterday were Dare County residents. Since March, the DCDHHS has reported 637 COVID-19 cases, 355 in Dare County residents and 282 in nonresidents.

N.C. Health and Human Services Secretary Mandy Cohen has emphasized at recent press briefings that the risk of contracting COVID-19 is greatest in indoor locations where people gather closely together and do not take safety precautions, such as wearing masks and maintaining social distancing.

People are “letting their guard down,” said Governor Roy Cooper in support of her message at last week’s briefing. They are coming into close unprotected contact with friends and extended family members who do not live in their households, he said.

Such contact is most likely to occur in restaurants and bars and in private residences. Any reception, party, shower, or other indoor event gathering, in which public-health protocols are not observed, is cause for concern, Dr. Cohen said.

The Governor is expected to address the extension of North Carolina’s Phase 3 in its reopening, which is set to expire at 5 p.m. Friday, at a briefing tomorrow.

With State COVID-19 data metrics, such as the number of daily case reports and hospitalizations, trending upward in October, it is unlikely that the Governor will loosen any of the current restrictions in place.

EVENTUAL COVID-19 VACCINES WILL NOT BE PANACEA

With so much loose talk politically about a COVID-19 vaccine and the time of its availability, we thought we would pass along some facts. Regardless of the nature of the vaccines that are eventually licensed, they will not be panaceas, much like seasonal influenza vaccines do not prevent all recipients from getting the flu.

There currently are four COVID-19 vaccine candidates in Phase 3 studies now. If the studies yield positive results, one of more vaccines “may become available within a few months,” write two physicians and a scientist in the article, “Answering Key Questions About COVID-19 Vaccines,” published last week by the Journal of the American Medical Assn. (JAMA).

See “Answering Key Questions about COVID-19 Vaccines,” JAMA: https://jamanetwork.com/journals/jama/fullarticle/2772138?utm_source=silverchair&utm_campaign=jama_network&utm_content=covid_weekly_highlights&utm_medium=email.

The authors explain that the U.S. Food and Drug Administration, which licenses vaccines, “set as an expectation for licensure” of a COVID-19 vaccine that it would prevent disease or decrease the severity of the disease in at least 50 percent of the people who are vaccinated.

Because of the margin of error in estimating the percentage of cases or complications prevented, they explain, a study that shows a 50 percent reduction in illness may have efficacy (effectiveness) as low as 30 percent or as high as 80 percent.

Further, it is important to understand that individuals who are more likely to experience more severe cases of COVID-19, such as older people and people with chronic illnesses, are underrepresented in vaccine trials because of the obvious risks posed to them.

It will not be possible to extrapolate the experience of subjects in the clinical trials to all people, at large. Not only will at-risk individuals not be included in most trials, but untested individuals will not necessarily have the same responses to the vaccine as individuals who were tested.

We are just scratching the scientific surface here, and we are doing so only because politicians are touting an imminent vaccine, as if it will be 100 percent effective and guaranteed safe for all people. This simply is not so.

Pfizer, which has a two-dose vaccine in Phase 3 trials, is considering applying to the FDA for “Emergency Use Authorization” of its product. “EUA” is the only way that a vaccine would be available this year—on an expedited basis in an emergency situation.

If Pfizer’s as-yet-unapproved vaccine were made available through an EUA, the FDA would be representing only that the vaccine may be effective, and its benefits are likely to outweigh its risks. There would be no proven safety and effectiveness required for this authorization, as there would be for licensure.

See “Emergency Use Authorization of Covid Vaccines—Safety and Efficacy Follow-up Considerations’ in the New England Journal of Medicine: https://www.nejm.org/doi/full/10.1056/NEJMp2031373?query=C19&cid=DM101106_NEJM_Registered_Users_and_InActive&bid=282344754.

The other pharmaceutical companies with vaccines in Phase 3 trials are Moderna, AstraZeneca, and Johnson & Johnson. The latter two have paused their trials for safety reasons related to participants’ health. Pfizer is definitely the frontrunner.

Someone asked me not long ago if I would be willing to be vaccinated for COVID-19.

I am comfortable with mask wearing, social distancing, eating only outdoors at restaurants, restricting my time in public space, and otherwise minimizing my risk of exposure to the disease by observing well-known public-health protocols. I can work at home and have always been introverted, so I enjoy solitude. I am not now inclined to view a vaccine as a desirable add-on to my regimen.

Before I would consent to a vaccine, however, I would research the clinical trial results thoroughly for evidence of both safety and efficacy. Even then, I would be inclined to wait and see how millions of people respond to a vaccine after it is distributed widely, knowing that the responses of subjects in trials do not predict all of the responses in a vastly larger and more heterogeneous population. Wider use means a wider response. The same is true of a new drug.  

The JAMA article authors conclude: “Many individuals are hesitant about receiving COVID-19 vaccines. Reasons include the novelty and rapid development of the vaccines, as well as the politicization of the pandemic and inconsistent messages from scientists and government leaders.

“It is critical that clinicians [your primary care doctor] stay well informed about emerging data so that they can help patients make sound decisions about the vaccines needed to help end the pandemic.”

The key word here is “emerging.” Emerging data require time to emerge, something that all political candidates run out of.

Ann G. Sjoerdsma, 10/20/20

One thought on “10/20/20: AGE 17-&-UNDER GROUP ACCOUNTS FOR MORE THAN 40 PERCENT OF LATEST COVID-19 CASES IN DARE; PLUS, A VACCINE WILL NOT BE A PANACEA.

  1. I cannot comprehend the reluctance of people to be vaccinated once a vaccine is approved. The FDA is not a fly by night political organization. If you get a flu shot each year there is no reason not to get the COVID vaccine once approved. I will be one of the first in line.

    Like

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