‘Unexplained Illness’ Halts Testing Of Johnson & Johnson’s Vaccine

AP: 2nd COVID-19 Vaccine Trial Paused Over Unexplained Illness
A late-stage study of Johnson & Johnson’s COVID-19 vaccine candidate has been paused while the company investigates whether a study participant’s “unexplained illness” is related to the shot. The company said in a statement Monday evening that illnesses, accidents and other so-called adverse events “are an expected part of any clinical study, especially large studies,” but that its physicians and a safety monitoring panel would try to determine what might have caused the illness. The pause is at least the second such hold to occur among several vaccines that have reached large-scale final tests in the U.S. (10/13)

Stat: Johnson & Johnson Covid-19 Vaccine Study Paused Due To Illness
The study of Johnson & Johnson’s Covid-19 vaccine has been paused due to an unexplained illness in a study participant. A document sent to outside researchers running the 60,000-patient clinical trial states that a “pausing rule” has been met, that the online system used to enroll patients in the study has been closed, and that the data and safety monitoring board — an independent committee that watches over the safety of patients in the clinical trial — would be convened. (Herper, 10/12)

USA Today: Johnson & Johnson COVID-19 Vaccine Trial Paused By Unexplained Illness
It is not known if the unidentified illness is related to the vaccine, but clinical protocols require a pause while it is investigated. Johnson & Johnson's JNJ-78436735 vaccine is one of four large-scale, final-stage COVID-19 vaccine trials underway in the U.S. Another trial, run by AstraZeneca, was halted Sept. 8 after a second participant was diagnosed with a neurological condition. Johnson & Johnson said Monday it has paused further dosing in its trial while the participant's illness is reviewed and evaluated by an independent Data Safety Monitoring Board as well as the company's clinical and safety physicians. (Weise and Weintraub, 10/12)

In other development news —

The New York Times: Covid-19 Vaccines Are Chance At Salvation, Financial And Beyond, For Drug Makers
Now, with pharmaceutical companies racing to find vaccines to end the coronavirus pandemic, the industry is hoping to redeem itself in the public’s mind. The primary goal, of course, is to rescue the world from the grips of a vicious virus. But a big fringe benefit is to get public credit — and to use an improved image to fend off government efforts to more heavily regulate the industry. (Drucker, Gelles and Thomas, 10/13)

New York Post: Pfizer COVID-19 Vaccine Study To Include Kids As Young As 12
Pfizer plans to test its experimental coronavirus vaccine in kids as young as 12 in an effort to make its late-stage clinical trial more diverse. The US Food and Drug Administration cleared Pfizer this month to include adolescents ages 12 to 15 in its Phase 3 study of the COVID-19 vaccine it’s developing with German firm BioNTech, the company said on its website Monday. (Manskar, 10/13)

CNN: Experimental Covid Vaccine: Thousands Are Signing Up To Be Deliberately Exposed To The Virus
As most of us obsess with avoiding Covid-19 at all costs, a rapidly growing group of people around the world say they are prepared to deliberately take on the virus. Tens of thousands of people have signed up to a campaign by a group called 1 Day Sooner to take an experimental vaccine candidate and then face coronavirus in a controlled setting. (Krever, Black and Moisescu, 10/12)

Vaccine skepticism presents challenges —

Stat: Letter Urging Covid-19 Vaccine Trial Participation Sparks Backlash
The episode illustrates the challenges historically Black colleges and universities face as they seek to leverage their legacies of trust within African American communities to bolster lagging Black enrollment in Covid-19 vaccine clinical trials. Their recruitment efforts will need to overcome the deep-seated suspicions many Black Americans hold toward medical researchers, pharmaceutical companies, and the government that stem from long-standing racial injustices perpetrated by those institutions. Now, as the four HBCU medical colleges prepare to host Covid-19 vaccine trials on their campuses, there’s hope their efforts will have more success. (St. Fleur, 10/12)

Popular Science: A Taskforce Of Black Doctors Is Independently Evaluating COVID-19 Vaccine Candidates
As the COVID-19 pandemic shows no signs of waning in the US, researchers are working to develop a vaccine at historic speed. President Donald Trump has pushed for a vaccine to become available by Election Day, now less than a month away, causing many Americans to worry that a vaccine will be approved too hastily. Responding to these concerns, a taskforce of Black doctors has formed to independently vet COVID-19 vaccine candidates. The taskforce is organized by the National Medical Association, which was founded in 1895 to represent Black healthcare professionals at a time when organizations such as the American Medical Association restricted membership to white people. (Baggaley, 10/12)

Axios: Gallup: Americans' Willingness Get A Coronavirus Vaccine Has Dropped To 50% In September
According to the latest Gallup poll, Americans' willingness get a coronavirus vaccine has dropped to 50% in late September, a dramatic 11-point fall from the previous month. Why it matters: This steep drop is further evidence that the vaccine has been politicized. Republicans are now more willing to be vaccinated, while Democrats and independents have become increasingly uncomfortable. (Arias, 10/12)