Johnson & Johnson First To Enter Final Trial Stage For A Single-Dose Vaccine
Four COVID-19 experimental vaccines are now in Phase 3 of clinical trial testing, but Johnson & Johnson's candidate is the only one that could be delivered in one shot instead of two.
The Wall Street Journal:
Johnson & Johnson Begins Final-Stage Testing Of Covid-19 Vaccine
Johnson & Johnson said Wednesday it started a 60,000-person clinical trial of its single-dose Covid-19 vaccine on three continents, becoming the fourth experimental Covid-19 shot to enter final-stage testing in the U.S. The New Brunswick, N.J., company said it could learn pivotal results from the trial by early next year, which if positive could lead to government authorization of the vaccine for emergency use soon afterward. J&J aims to enroll adult volunteers in the U.S. and several other countries, including Brazil and South Africa. (Loftus, 9/23)
CNBC:
Johnson & Johnson Enters Late-Stage Trial Testing Its Coronavirus Vaccine
J&J is the fourth drugmaker backed by the Trump administration’s Covid-19 vaccine program Operation Warp Speed to enter late-stage testing. The others are Moderna, Pfizer and AstraZeneca. The trial will enroll up to 60,000 adult volunteers across 215 locations in the U.S. and other countries, according to the National Institute of Allergy and Infectious Diseases. Participants will be randomly selected to receive a dose of the potential vaccine or a placebo, according to details of the trial, which will determine whether the vaccine is safe and effective. (Lovelace Jr., 9/23)
The Boston Globe:
Major Study To Start For COVID-19 Vaccine Developed By Johnson & Johnson, Beth Israel
Dr. Dan Barouch, head of Beth Israel’s Center for Virology and Vaccine Research in Boston, which helped develop the vaccine and tested it in laboratory monkeys, said a single-dose regimen has obvious advantages over a vaccine that requires a shot and a booster dose months or years later. “Think about yourself," he said in a phone interview. “It would be so much easier to go to your doctor for a one-and-done shot then to remember to go back for a booster shot. And, of course, on a global scale for a global vaccine campaign, it’s much easier. The amount [of vaccine] you make goes twice as far.” (Saltzman, 9/23)
Reuters:
Fujifilm's Avigan Shown To Be Effective In Japanese Phase-3 Trial For COVID-19
Fujifilm Holdings Corp said on Wednesday a late-stage study of its antiviral drug Avigan showed it reduced recovery times for COVID-19 patients with non-severe symptoms, boosting expectations for regulatory approval in Japan. The Phase 3 clinical study of 156 patients in Japan showed that those treated with Avigan improved after 11.9 days, versus 14.7 days for a placebo group. Results of the study, conducted by subsidiary Fujifilm Toyama Chemical, were statistically significant, the company said in a release. (9/22)
NPR:
The Paradox Of Being A Volunteer In A COVID-19 Vaccine Trial
More than 100,000 people are taking part in studies to see if one or more COVID-19 vaccine candidates actually work. Janssen Pharmaceutical Cos. of Johnson & Johnson is about to start wide-scale testing for its vaccine. It will involve as many as 30,000 volunteers. AstraZeneca, Pfizer and Moderna already have vaccine candidates in large studies in the United States. Novavax should start its study later this fall. (Palca, 9/23)
The Washington Post:
These Are The Top Coronavirus Vaccines To Watch
The worldwide effort to create a vaccine for the novel coronavirus kicked off in January, soon after scientists in China posted online the genome of a virus causing a mysterious pneumonia. Vaccine development usually takes years and unfolds step by step. Experimental vaccine candidates are created in the laboratory and tested in animals before moving into progressively larger human clinical trials. These steps are now overlapping in the race to find a vaccine for a global disease that has killed hundreds of thousands of people. Human testing began in some cases before animal studies were finished. As companies launch small Phase 1 trials intended to establish the correct dose, they already are planning the Phase 3 trials that evaluate whether the vaccines are effective and safe. (Steckelberg, Johnson, Florit and Alcantara, 9/21)
AP:
What A Gift: Russia Offers UN Staff Free Virus Vaccines
What do you do when Vladimir Putin offers you Russia’s new coronavirus vaccine, for free? United Nations staff in New York and around the world are now facing that choice, after the Russian president offered Tuesday to provide them the Sputnik-V vaccine in a speech to this year’s General Assembly marking the body’s 75th birthday. (9/22)
And more on how the public is viewing the vaccine race —
The Hill:
Interest In Immediately Getting First-Generation COVID-19 Vaccine Drops: Poll
The percentage of Americans who say they will seek a coronavirus vaccine as soon as it becomes available has dropped among Republicans, Democrats and independents, according to the latest Axios-Ipsos polling. Thirty-nine percent of respondents now say they will likely get a first-generation vaccine once it is available. This includes 43 percent of Democrats and independents and 33 percent of Republicans. The steepest drop is among Democrats, who were 13 percentage points less likely to get a vaccine immediately than in a previous poll. Interest among Republicans fell 8 points, and only 2 points among independents. (Budryk, 9/22)
NBC News:
Many Parents Are Hesitant To Give Their Kids A Covid-19 Vaccine. What If Schools Require It?
Michelle Vargas of Granite City, Illinois, has always vaccinated her 10-year-old daughter, Madison. They both typically get flu shots. But when a vaccine for the coronavirus eventually comes out, Vargas will not be giving it to her daughter — even if Madison's school district requires it. (Chuck, 9/23)
FiveThirtyEight:
How To Know When You Can Trust A COVID-19 Vaccine
Scientists around the world are currently undertaking one of the fastest vaccine-development programs in history, trying to get the novel coronavirus under control as quickly as humanly possible. But the vaccines being tested sit at a nexus of misinformation and mistrust. Between Trump’s apparent meddling in federal health agencies’ decision-making, skepticism about the seriousness of the disease, and long-standing culture wars around the safety of vaccines in general, it’s easy to find yourself floundering, unsure who you can trust. So I spoke with a handful of people who really know how vaccines, clinical trials and COVID-19 work to find out how to know when it’s a good idea to get the vaccine. They offered these four pieces of advice. (Koerth, 9/23)
