NPR’s Scott Simon asks FDA advisor Dr. Paul Offit about Johnson & Johnson’s vaccine and other advancements in the pandemic.
SCOTT SIMON, HOST:
The panel that recommends the Food and Drug Administration unanimously states, go for it. License the Johnson & Johnson COVID-19 vaccine for emergency situation use. An FDA analysis has discovered it to be 66%reliable overall and to have a, quote, “beneficial safety profile.” Dr. Paul Offit has actually advised the FDA throughout the vaccine-approval procedure. He’s director of the Vaccine Education Center at the Kid’s Health center of Philadelphia.
Dr. Offit, thanks so much for being with us.
PAUL OFFIT: Thank you.
SIMON: The Moderna and Pfizer vaccines have a much greater effective rate – don’t they? – in the mid-90 s. What makes the Johnson & Johnson version a good concept at just 66%?
OFFIT: Well, the Moderna and Pfizer vaccines were checked in the U.S. just. The Johnson & Johnson vaccine was likewise evaluated in a number of nations in South America, as well as Mexico and South Africa. It’s not precisely the exact same population. So it’s sort of comparing apples to oranges. Also, the stress that were flowing in South Africa is mostly the South African variation, and the pressure flowing in Brazil is mostly the Brazilian variation. There were different stress, really, that this vaccine was checked versus.
SIMON: I gather from reports that a few of your fellow panelists asked whether Johnson & Johnson’s vaccine may be more efficient if it were offered as two shots, not just one, and that the business is studying this. What’s your view on that?
OFFIT:. So if you take a look at the research studies they did, the preclinical studies they did in non-human primates as well as the Phase 1– 2a research studies they carried out in individuals, what they discovered was that second dosage did increase the titer or the amount of virus-specific neutralizing antibodies, suggesting that it might be more reliable. It’s really reliable, however, at preventing extreme disease after a single dose. And it causes the type of reaction, so-called cellular immune response, that looks like it’s going to have relatively long-lived memory, which is all good.
However that second dose may be more effective. I think we’ll probably understand that by the second half of this year, in which case, then one might get a booster dosage. This definitely provides defense versus what you care about, which is hospitalization, ICU admission and death. And it’s essentially 100?fective at doing that.
SIMON: And if authorization follows soon, when might the vaccine pertained to drug stores and other vaccination websites, and how much?
OFFIT:. And then it goes to the CDC, which then makes their recommendations about which group or groups may best benefit from this vaccine.
SIMON: Dr. Offit, you’re a pediatrician. What do you inform moms and dads who are very excited for a vaccine for their kids and who are worried, for example, about the obvious increase in multisystem inflammatory syndrome in children, which is unusual, however a severe disease that’s connected to COVID?
OFFIT: Well, it’s definitely worth trying to avoid this disease in kids.
But right now, we still require to figure out what the best dosage is. It’s not going to be the same kinds of studies you simply saw for Pfizer and Moderna and Johnson & Johnson, which were studies of 30 to 45,000 people to see whether it was effective, since kids do not get that sick, so it would be difficult to do those studies.
SIMON: Let me ask you about the AstraZeneca-Oxford University vaccine.
OFFIT: Yes. The excellent news is right now, the AstraZeneca item is being tested as a two-dose vaccine in the United States.
SIMON: Dr. Paul Offit is a member of the FDA’s vaccine advisory panel. Thanks a lot for being with us.
OFFIT: Thank you.
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