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Doctors are free to prescribe ivermectin to treat COVID-19, a lawyer representing the U.S. Food and Drug Administration (FDA) said this week.
“FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID,” Ashley Cheung Honold, a Department of Justice lawyer representing the FDA, said during oral arguments on Aug. 8 in the U.S. Court of Appeals for the 5th Circuit.
ABRYSVO consists of 120 mcg of lyophilized, recombinant antigen derived from the RSV fusion (F) surface glycoproteins of the two RSV subgroups, RSV-A (60 mcg) and RSV-B (60 mcg) stabilized in the pre-fusion trimeric conformation (RSVpreF) and is administered intramuscularly (IM) as a single dose (0.5 mL).
But troubled by side effect data from Pfizer’s trials and by another big drugmaker’s abandonment of a similar vaccine given during pregnancy, the panel split on the question of the vaccine’s safety, with multiple members concerned that it may increase the rate of premature births.
GlaxoSmithKline (GSK) last year stopped a late-stage clinical trial of its RSV vaccine in pregnant people over an elevated risk of premature birth and associated neonatal deaths in the babies born prematurely. In the GSK trial, premature birth was 38% more likely in the vaccinated pregnancies than in the placebo group. And there were hints of excess premature births as well in Pfizer’s data presented to the panel yesterday. The FDA advisers expressed frustration that the company’s final phase 3 trial wasn’t large enough to know whether the increased rate in the vaccinated group compared with the placebo group—5.7% versus 4.7%—was a real effect as the difference wasn’t statistically significant.
FDA will need to consider the split vote in deciding whether to license the vaccine, called RSVpreF and which the company has branded Abrysvo for use in pregnant people. The agency’s decision is due in August.
What, if anything, have you been hearing?
originally posted by: angelchemuel
Here's another bit of good news, Ivermectin has now been authorised to treat covid.
Doctors are free to prescribe ivermectin to treat COVID-19, a lawyer representing the U.S. Food and Drug Administration (FDA) said this week.
“FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID,” Ashley Cheung Honold, a Department of Justice lawyer representing the FDA, said during oral arguments on Aug. 8 in the U.S. Court of Appeals for the 5th Circuit.
Link
Rainbows
Jane
originally posted by: angelchemuel
Here's another bit of good news, Ivermectin has now been authorised to treat covid.
Doctors are free to prescribe ivermectin to treat COVID-19, a lawyer representing the U.S. Food and Drug Administration (FDA) said this week.
“FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID,” Ashley Cheung Honold, a Department of Justice lawyer representing the FDA, said during oral arguments on Aug. 8 in the U.S. Court of Appeals for the 5th Circuit.
Link
Rainbows
Jane
The US Department of Health and Human Services on Wednesday suspended funding to EcoHealth Alliance, a virus research organization tied to controversy about the origins of the virus that causes Covid-19. The agency also proposed the group be blocked from receiving federal funds in the future, possibly for years.
originally posted by: kwaka
For some good news:
US government suspends funding for virus research group at center of Covid-19 origin controversy
The US Department of Health and Human Services on Wednesday suspended funding to EcoHealth Alliance, a virus research organization tied to controversy about the origins of the virus that causes Covid-19. The agency also proposed the group be blocked from receiving federal funds in the future, possibly for years.