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FDA Expected to Authorize Pfizer and Merck Covid Pills This Week
Posted on 12/21/21 at 1:13 pm
Posted on 12/21/21 at 1:13 pm
LINK
quote:
The U.S. Food and Drug Administration is poised to authorize a pair of pills from Pfizer Inc. and Merck & Co. to treat Covid-19 as soon as this week, according to people familiar with the matter -- a milestone in the fight against the pandemic that will soon expand therapies for the ill.
An announcement may come as early as Wednesday, according to three of the people. They asked not to be identified ahead of the authorization and cautioned that the plan could change.
quote:
Pfizer’s pill, Paxlovid, and Merck’s molnupiravir are intended for higher-risk people who test positive for Covid. The treatments, in which patients take a series of pills at home over several days, could ease the burden on stretched hospitals with infections poised to soar through the winter in the U.S.
quote:
“It’s the biggest thing to happen in the pandemic after vaccines,” said Eric Topol, director of the Scripps Research Translational Institute. The timing of the announcement, so late in the year, is unusual for the FDA and reflects the urgency behind the medicines, he said.
FDA’s authorizations may include limitations for populations in which they could be used, one of the people familiar with the matter said. A Food and Drug Administration advisory committee narrowly recommended the Merck pill last month, with some members of the panel citing safety concerns including for pregnant women.
The U.S. government has ordered 10 million courses of the Pfizer pill and about 3 million courses of Merck’s, which isn’t as effective, clinical studies indicate, and may carry risks. However, the pills are likely to not be immediately available in widespread supply.
Posted on 12/21/21 at 1:14 pm to WPBTiger
Need to approve Novavax and then this thing is over...
Pills that are over 90% effective once you have it and then a protein based vaccine for those weary of the RNA vax.
/pandemic
Pills that are over 90% effective once you have it and then a protein based vaccine for those weary of the RNA vax.
/pandemic
Posted on 12/21/21 at 1:15 pm to WPBTiger
If you take the pills will you still be required to get the jab?
Posted on 12/21/21 at 1:16 pm to WPBTiger
Who wants their cell properties changed forever? Get in line here.
Posted on 12/21/21 at 1:17 pm to Lsut81
quote:
Pills that are over 90% effective
Lol
Posted on 12/21/21 at 1:18 pm to WPBTiger
is it a vaccine pill or a treatment pill?
Posted on 12/21/21 at 1:20 pm to finchmeister08
Treatment.
It was 90% effective in HIGH RISK people in trials, much more effective in low risk.
With this there should be very, very little reason to continue this whole charade.
But they will.
It was 90% effective in HIGH RISK people in trials, much more effective in low risk.
With this there should be very, very little reason to continue this whole charade.
But they will.
Posted on 12/21/21 at 1:24 pm to Lsut81
quote:
Need to approve Novavax
They are supposed to file with FDA before end of the year. Lets see how fast it gets approved.
Posted on 12/21/21 at 1:31 pm to Lsut81
quote:there you go not understanding. they don't want it over just like chemo drug makers don't want cancer "over".
Need to approve Novavax and then this thing is over...
Pills that are over 90% effective once you have it and then a protein based vaccine for those weary of the RNA vax.
Posted on 12/21/21 at 2:29 pm to WPBTiger
Pfizer and Merck will get authorization but Romark's NT-300 pill that completed phase 3 clinical trials in April 2021 and reduced progression to severe Covid-19 disease by 85% and has been working to get EUA but has not been able to.
Romark announces initial results of phase 3 clinical trial of NT-300 for the treatment of covid-19
Nitazoxanide is a broad-spectrum thiazolide antiparasitic agent that is approved by the Food and Drug Administration (FDA) for the treatment of Cryptosporidium parvum and Giardia duodenalis infections in children aged =1 year and adults. Nitazoxanide is rapidly metabolized to its active metabolite, tizoxanide, and has in vitro antiviral activity against a range of viruses, including influenza viruses, hepatitis B and C viruses, norovirus, rotavirus, Ebola virus, Middle East respiratory syndrome coronavirus (MERS-CoV), and SARS-CoV-2.1-3
NIH Covid-19 Treatment Guidelines - Nitaxoxanide
Romark announces initial results of phase 3 clinical trial of NT-300 for the treatment of covid-19
Nitazoxanide is a broad-spectrum thiazolide antiparasitic agent that is approved by the Food and Drug Administration (FDA) for the treatment of Cryptosporidium parvum and Giardia duodenalis infections in children aged =1 year and adults. Nitazoxanide is rapidly metabolized to its active metabolite, tizoxanide, and has in vitro antiviral activity against a range of viruses, including influenza viruses, hepatitis B and C viruses, norovirus, rotavirus, Ebola virus, Middle East respiratory syndrome coronavirus (MERS-CoV), and SARS-CoV-2.1-3
NIH Covid-19 Treatment Guidelines - Nitaxoxanide
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