Romano Law Nurse Corner #26
Center for Disease Control Statistics- Vaccine News
As of the date of this writing the death toll from the coronavirus has topped 895,000 worldwide and 190,000 in the United States. Last week, circulating on Facebook and on a certain political figures' Twitter account there was a claim the Centers for Disease Control and Prevention had “quietly updated the COVID number to admit that only 6%” of reported deaths — or about 9,000 — “actually died from COVID.”
The purported source appears to be a reference to the CDC’s update to its death data and resources page, which noted that in 6 percent of reported deaths, covid-19, the disease caused by the novel coronavirus, “was the only cause mentioned.” However, that does not mean only 6 percent of reported deaths are attributed to the virus — it means 94 percent of people had at least one additional factor contributing to their deaths. In addition, the information is no secret addendum: It’s been on the CDC site since at least May.
“Comorbidities” reported by the CDC include heart disease, obesity, diabetes and hypertension — conditions that can make a person more vulnerable to the virus. Each would be listed on a person’s death certificate, along with COVID-19. Death certificates may also list sepsis, respiratory arrest, kidney failure or other conditions as the immediate cause of death, but those are caused by the infection. The virus remains the reason that they died.
It is well known that many people with COVID have some other underlying condition, which increases their risk of dying from COVID and getting COVID to begin with. The CDC update provides a compilation of data on comorbidities, showing what other conditions are present in people who die of the coronavirus and helping reveal who might be most at risk. This is not any different from what the health agency or public health experts have said in the past. The CDC has said for months that people with underlying health issues are at greater risk of developing serious symptoms from the coronavirus.
When you see that ‘only 6%’ of people had COVID-19 as the sole reason listed on their death forms, what it means is that there was a small fraction of people who died of the disease who didn’t have any other underlying or immediate causes noted by the medical certifiers. This is not surprising, as it’s pretty rare that someone wouldn’t have at least one issue caused by coronavirus prior to their death, and all it means is that in 94% of cases people who had COVID-19 also developed other issues, or had other problems at the same time.
Conspiracy theories and misinformation have been a persistent problem amid the coronavirus pandemic, causing alarm among public health experts.
COVID-19 Vaccine News
Vaccines typically take years to develop and approve, through four phases that include human trials. But with Operation Warp Speed, rather than submitting all sections of the application after all four phases are done, approved projects can submit data to the FDA bit by bit. White House Operation Warp Speed is meant to cut through regulatory red tape to speed up vaccine development and have hundreds of millions of vaccine doses ready to distribute as soon as they receive FDA approval.
How is a vaccine trial considered effective?
By conducting a large trial, researchers hope to learn whether the vaccine is safe and whether it prevents infection. Initial safety studies were done by testing a small number of healthy volunteers. A large trial should reveal less common side effects. To determine whether the vaccine is working, researchers will compare the number of infections in the people receiving the active vaccine with the number of infections in the people receiving the inert placebo.
The Food and Drug Administration is the federal agency that will decide whether to authorize the use of the vaccine. It has said a vaccine must reduce infections in the vaccinated group by at least 50% to be considered.
How will we know if the vaccine is working?
These are what's called event-driven trials. "An event-driven trial means that the primary analysis of the trial happens when you get enough events," Janes says. "We don't know how long that's going to take."
By "events," Janes means laboratory-confirmed cases of COVID-19 disease. Janes says the trial now underway aims to get at least 150 events among the trial participants.
To make sure the researchers are unaware of who's getting the vaccine and who's getting a placebo, an independent body will track the data as they're collected. That data safety monitoring board is made up of experts in all aspects of clinical trial design and implementation.
Downsides to releasing a vaccine too soon
Of course, if a vaccine doesn’t work very effectively, people would continue to get sick and die. So, if a vaccine is only 40-50% effective, it will mean a lot of folks could get COVID-19, but even a partially effective vaccine would make the pandemic more manageable. However, releasing a vaccine with serious side effects, even “rare” side effects, would mean perfectly healthy people would put their health at risk if they got the vaccine.
If the vaccine is perceived as a flop by the public, it will undermine confidence in the government.
We all desire an end to this pandemic but we also want a safe and effective vaccine.
Susan Ramsey is both an attorney and an RN. Ms. Ramsey’s professional experience began as a Registered Nurse in the Intensive Care Unit at Yale New Haven Hospital. While pursuing her Bachelor’s Degree, she was a counselor with the New Haven Rape Crisis Program. During her time with the Program, Ms. Ramsey counseled sexual assault survivors and performed seminars for local police departments, universities, and high schools. During her time working as a registered nurse, Ms. Ramsey decided to attend law school. Ms. Ramsey graduated from CUNY Law School, and has practiced law in several different State and Federal Courts. She is a Florida Heath Care Risk Manager and a member of the Palm Beach County Sober Home Task Force. Ms. Ramsey actively litigates cases involving catastrophic injuries and wrongful death on behalf of survivors, cases include injuries suffered by victims of professional negligence, product liability and medical negligence.
Amie Goldberg is both an attorney and a certified APRN. After completing a Bachelor of Arts Degree at Whittier College, Ms. Goldberg attended nursing school at Emory University. Ms. Goldberg’s professional experience started as a Registered Nurse at Egleston Children’s Hospital taking care of children with congenital heart disease. After a few years, she continued working in all areas of the hospital while attending Kennesaw State University on weekends in order to get her Master’s Degree in Nursing with a specialty of Primary Care Nurse Practitioner/Family Nurse Practitioner. During her time as an APRN, Ms. Goldberg decided to attend law school at St. Thomas University in Miami, Florida. Since graduating, she has mainly practiced in the areas of personal injury and worker’s compensation, fighting for the rights of injured people. Since joining the Romano Law Group, Ms. Goldberg has been the Director of the Opioid Litigation Project. Ms. Goldberg also practices in the area of medical malpractice and nursing home negligence, bringing an inside perspective and knowledge to help get justice for our clients.