Please see:
US - FDA Authorizes Emergency Use of JYNNEOS Vaccine to Increase Vaccine Supply ( FDA approved dose split into 5 parts) - August 9, 2022
FDA Information page on JYNNEOS vaccine for smallpox and monkeypox - August 7, 2022
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hat tip Lance
ACAM2000 and JYNNEOS comparison
CDC presentation slides at ACIP meeting June 2022
https://www.cdc.gov/vaccines/acip/me...tersen-508.pdf
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How effective is the monkeypox vaccine? Scientists scramble for clues as trials ramp up
Logistical and ethical challenges are complicating the design of studies
So far, there’s scant data on how well the vaccine is working in the current outbreak. Among 276 individuals who received a shot at a Paris hospital as post-exposure prophylaxis (PEP) after reporting a high-risk contact, 12 developed a monkeypox infection, French scientists reported in a recent preprint, 10 of them within 5 days of vaccination and two after more than 20 days. (That some people would develop monkeypox a few days after being infected is not surprising, says Jade Ghosn of Bichat Hospital, who led the study. “The vaccine is not a miracle, it needs time to be effective.” But the two cases occurring 22 and 25 days after vaccination are a surprise, especially because no additional high-risk contact could be established.) The study had no control group, however, making it impossible to tell how many people would have developed monkeypox if no one had been vaccinated. And people eager to be vaccinated may have lied about having had a high-risk contact. “That makes results from these studies on PEP really hard to evaluate,” says immunologist Leif Erik Sander of the Charité clinic in Berlin, who’s setting up a vaccine study in Germany.
A randomized trial—in which one group receives the vaccine and the other does not—would avoid such problems. Without a randomized study, “you can end up in this evidence limbo and find that if you had just done the trial, you would have been in a much better situation,” says biostatistician Natalie Dean of the University of Florida.
Giving a control group a placebo instead of a presumably effective vaccine is ethically dicey, many researchers say. But University of Oxford epidemiologist Richard Peto sees another way. Because demand for the vaccine is so much higher than supply, “Why not randomize the order in which people in the highest risk group are called in?” Peto asks. So far, however, no one seems to have taken up that idea.
more....
US - FDA Authorizes Emergency Use of JYNNEOS Vaccine to Increase Vaccine Supply ( FDA approved dose split into 5 parts) - August 9, 2022
FDA Information page on JYNNEOS vaccine for smallpox and monkeypox - August 7, 2022
------------------------------------------------------------------------------------------------
hat tip Lance
ACAM2000 and JYNNEOS comparison
CDC presentation slides at ACIP meeting June 2022
https://www.cdc.gov/vaccines/acip/me...tersen-508.pdf
------------------------------------------------------------------------------------------------
How effective is the monkeypox vaccine? Scientists scramble for clues as trials ramp up
Logistical and ethical challenges are complicating the design of studies
- 10 AUG 2022
- 12:30 PM
- BYKAI KUPFERSCHMIDT
So far, there’s scant data on how well the vaccine is working in the current outbreak. Among 276 individuals who received a shot at a Paris hospital as post-exposure prophylaxis (PEP) after reporting a high-risk contact, 12 developed a monkeypox infection, French scientists reported in a recent preprint, 10 of them within 5 days of vaccination and two after more than 20 days. (That some people would develop monkeypox a few days after being infected is not surprising, says Jade Ghosn of Bichat Hospital, who led the study. “The vaccine is not a miracle, it needs time to be effective.” But the two cases occurring 22 and 25 days after vaccination are a surprise, especially because no additional high-risk contact could be established.) The study had no control group, however, making it impossible to tell how many people would have developed monkeypox if no one had been vaccinated. And people eager to be vaccinated may have lied about having had a high-risk contact. “That makes results from these studies on PEP really hard to evaluate,” says immunologist Leif Erik Sander of the Charité clinic in Berlin, who’s setting up a vaccine study in Germany.
A randomized trial—in which one group receives the vaccine and the other does not—would avoid such problems. Without a randomized study, “you can end up in this evidence limbo and find that if you had just done the trial, you would have been in a much better situation,” says biostatistician Natalie Dean of the University of Florida.
Giving a control group a placebo instead of a presumably effective vaccine is ethically dicey, many researchers say. But University of Oxford epidemiologist Richard Peto sees another way. Because demand for the vaccine is so much higher than supply, “Why not randomize the order in which people in the highest risk group are called in?” Peto asks. So far, however, no one seems to have taken up that idea.
more....
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