By Don Rauf
In this episode of Track the Vax, Serena Marshall talks with Richard Nettles, MD, the vice president of U.S. medical affairs at Janssen, the subsidiary of Johnson & Johnson that developed the company's COVID-19 vaccine, which received emergency use authorization from the U.S. Food and Drug Administration (FDA) on February 27.
Following this green light from the FDA, vaccine supplies across the nation are expected to greatly increase in the weeks ahead. Dr. Nettles told Track the Vax that 4 million doses are shipping immediately, and 20 million more will be distributed by the end of March.
“We have enough to vaccinate 100 million Americans by the end of June,” he says. President Joe Biden announced in February that the United States will have sufficient vaccine doses (of different types) to inoculate 300 million Americans by the end of July; but this week he moved up that date by two months, to the end of May.
Supplies could very well increase at a faster rate, following the announcement on March 2 that the pharmaceutical giant Merck is teaming up with Johnson & Johnson to manufacture the product. Merck intends to dedicate two facilities in the United States to producing the Johnson & Johnson vaccine, a move that could sharply boost supplies.
Powerful Protection — Even Against Variants
Research has shown the single-dose vaccine to have a 72 percent efficacy rate in United States studies and 64 percent in South Africa, where a very contagious variant was first detected. The vaccine was demonstrated to be 85 percent effective at preventing severe disease, and it provided complete protection against COVID-related hospitalization and death.
Nettles adds that the vaccine also tested well in trial participants in South America.
“We showed after 28 days we had no deaths and no COVID-related hospitalizations, even in South Africa and in Brazil where those variants were predominant,” he says.
For public health authorities, this is encouraging news, as variants have been steadily gaining ground in the United States, and virus cases have recently been creeping higher after weeks in decline. USA Today reported on March 2 that infections were increasing again in 29 states.
While Pfizer and Moderna are both looking into tweaking their vaccines to take on the variants, Nettles is not so sure that the Johnson & Johnson product will need any adjustments, judging by the results so far.
“We’re always looking at our vaccine carefully and monitoring the variant status,” he says. “We are in a position where we could alter this vaccine if we would need to do that.”
The Single-Dose Advantage
Nettles highlights that one of the more appealing aspects of the J&J product is that it’s a one-and-done proposition. Some people will definitely prefer getting one shot rather than two, and a single dose eliminates a lot of scheduling logistics required when a second inoculation is needed.
For populations that have issues with travel, transient populations, and homeless populations, immunization is much easier with a single-shot system, according to Nettles.
“In rural populations where people have to travel long distances to get a second shot, this opens up the possibility of vaccinating [more] people like that,” he says.
A big question remaining for this vaccine, as well as for all the other COVID inoculations, is how long it will be effective.
“Do you need a booster shot six months later, a year later, two years later, five years later? We just don't know yet,” he says.
Although the single shot has proved itself to be remarkably protective, Johnson & Johnson has already initiated clinical trials to test a double dosing of its vaccine.
“We had planned a two-dose trial at the same time [as the single-dose study],” Nettles says. “That’s lagged somewhat behind — it’s a little bit more complicated and you have to bring individuals back for that second dose.”
With trial results still forthcoming, scientists may yet find advantages in a two-dose approach. For example, the immunization may last longer with two shots.
Looking Ahead: Testing on Children and Pregnant Women
Right now, the Johnson & Johnson vaccine has been tested and approved for use in individuals age 18 and older. Clinical trials so far have focused on older people because these populations have been most vulnerable to the virus.
With major research completed on this older population, Johnson & Johnson is now directing attention to those younger than 18. Nettles notes that J&J hopes to have information on vaccine efficacy in the 12 to 17 age group later this year, and then “hopefully sometime over the next year,” trials will be completed in even younger groups.
Another population yet to be studied is pregnant women. The National Institutes of Health (NIH) published a viewpoint in the Journal of the American Medical Association in February calling for greater inclusion of pregnant and lactating people in COVID-19 vaccine research. Also, a previous Track the Vax podcast with Mark Turrentine, MD, a professor at the Baylor College of Medicine in Houston and a cochair of the American College of Obstetricians and Gynecologists (ACOG), spotlighted vaccine safety concerns among pregnant women and new mothers owing to a lack of research among these populations.
Nettles says that J&J is moving forward in this area and currently initiating dosing with about 800 pregnant women. Later, he expects to begin a specific trial where they will vaccinate individuals who are immunocompromised.
“We'll move forward with these trials in a way that is as fast as we can, but also as safely as we can,” says Nettles.
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March 05, 2021 at 05:06AM
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Track the Vax: Behind the Scenes of Johnson & Johnson's Entry in the Race to Beat COVID-19 - Everyday Health
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