â Vir and GSK plan to immediately seek Emergency Use Authorization in the U.S. and authorizations in other countries ââ Additional new in vitro studies indicate VIR-7831 maintains activity against major circulating COVID-19 variants âSAN FRANCISCO and LONDON, March 10, 2021 (GLOBE NEWSWIRE) â VirBiotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK)today announced that an Independent Data Monitoring Committee (IDMC)recommended that the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody EfficacyTrial - Intent to Care Early) trial evaluating VIR-7831 (GSK4182136) asmonotherapy for the early treatment of COVID-19 in adults at high risk ofhospitalization be stopped for enrollment due to evidence of profoundefficacy.The IDMC recommendation was based on an interim analysis of data from 583patients enrolled in the COMET-ICE trial, which demonstrated an 85% (p=0.002)reduction in hospitalization or death in patients receiving VIR-7831 asmonotherapy compared to placebo, the primary endpoint of the trial. VIR-7831was well tolerated. As the trial remains ongoing and blinded with patientscontinuing to be followed for 24 weeks, additional results, includingepidemiology and virology data, will be forthcoming once the trial iscompleted.Based on these results, Vir and GSK plan to submit an Emergency UseAuthorization (EUA) application to the U.S. Food and Drug Administration (FDA)and for authorizations in other countries. Data from this registrational trialwill also form the basis for a Biologics License Application (BLA) submissionto the FDA.The companies also announced today the results of a new study submitted andpending online publication in bioRxiv, demonstrating that VIR-7831 maintainsactivity against current circulating variants of concern, including the UK,South African and Brazilian variants, based on in vitro data from pseudotypedvirus assays. In contrast to other monoclonal antibodies, VIR-7831 binds to ahighly conserved epitope of the spike protein, which may make it moredifficult for resistance to develop.
That does sound good. Was wondering where GSK has been on this. Great development, especially regarding the variants.
– Vir and GSK plan to immediately seek Emergency Use Authorization in the U.S.
and authorizations in other countries –
– Additional new in vitro studies indicate VIR-7831 maintains activity against
major circulating COVID-19 variants –
SAN FRANCISCO and LONDON, March 10, 2021 (GLOBE NEWSWIRE) — Vir
Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK)
today announced that an Independent Data Monitoring Committee (IDMC)
recommended that the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy
Trial - Intent to Care Early) trial evaluating VIR-7831 (GSK4182136) as
monotherapy for the early treatment of COVID-19 in adults at high risk of
hospitalization be stopped for enrollment due to evidence of profound
efficacy.
The IDMC recommendation was based on an interim analysis of data from 583
patients enrolled in the COMET-ICE trial, which demonstrated an 85% (p=0.002)
reduction in hospitalization or death in patients receiving VIR-7831 as
monotherapy compared to placebo, the primary endpoint of the trial. VIR-7831
was well tolerated. As the trial remains ongoing and blinded with patients
continuing to be followed for 24 weeks, additional results, including
epidemiology and virology data, will be forthcoming once the trial is
completed.
Based on these results, Vir and GSK plan to submit an Emergency Use
Authorization (EUA) application to the U.S. Food and Drug Administration (FDA)
and for authorizations in other countries. Data from this registrational trial
will also form the basis for a Biologics License Application (BLA) submission
to the FDA.
The companies also announced today the results of a new study submitted and
pending online publication in bioRxiv, demonstrating that VIR-7831 maintains
activity against current circulating variants of concern, including the UK,
South African and Brazilian variants, based on in vitro data from pseudotyped
virus assays. In contrast to other monoclonal antibodies, VIR-7831 binds to a
highly conserved epitope of the spike protein, which may make it more
difficult for resistance to develop.
"Cat's claw" extract inhibits replication of SARS-CoV-2 in vitro
Researchers in Columbia and Peru have shown that Uncaria tomentosa â a woody vine native to South America known of as "Cat's claw" â exerts in vitro antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the agent that causes coronavirus disease 2019 (COVID-19).
Handy guide for a herbal approach to treating SARS-COV-2 (COVID-19) Particularly useful for those who might be dealing with chronic issues.
PLANT-BASED INTERVENTIONS FOR CORONAVIRUS (SARS-COV-2) (And the Necessity for Sophisticated, Organ-Specific Treatments) Stephen Harrod Buhner
The illness went on and on. The symptoms changed, it was like an advent calendar, every day there was a surprise, something new. A muggy head; acutely painful calf; upset stomach; tinnitus; pins and needles; aching all over; breathlessness; dizziness; arthritis in my hands; weird sensation in the skin with synthetic materials. Gentle exercise or walking made me worse â I would feel absolutely dreadful the next day. Paul Garner, Professor of Infectious Diseases, Liverpool School of Tropical Medicine
Had my second Pfizer shot last Saturday, should be fully vaccinated by next weekend. Nonetheless, mask / social distancing / hand washing will continue until this thing is beaten.
TaniaMiami March 13 Times Pick I live in Miami, and I would not call this a "middle ground." Every time over this past year, whenever we started to come down slightly from a peak, Desantis would push too quickly. .........
I lost an aunt and uncle to covid just last month, when my Trump loving cousin took her dad out to lunch for his birthday. He was dead less than two weeks later, followed three days after that by his wife, who never learned of his death bc she was already intubated. The cousin was unrepentant, glad to have gotten her dad out and about.
If that's middle ground, I'd have preferred a true lockdown. Instead, it's idiocy.
.... and then read the comments and cry. âIâd Much Rather Be in Floridaâ Floridians are out and about and pandemic restrictions have been lifted. Thereâs just one problem: The virus never went away.
Time for a vacation!
shepjacksonville 8h ago Times Pick I live in Florida. Next week, I will not be able to attend the funeral of my 74 year old friend who just died of Covid. Her only exposure was a trip to the grocery store; after months of being at home, she just wanted to have a normal day. She wore her mask and thought she had done everything right. Sadly, she was wrong.
Ron DeSantis could care less about my friend. She is the "cost of doing business" to him. Instead, he gives thousands of vaccines to the rich and well-connected. If you live at The Villages or a million dollar retirement community, you're already vaccinated, courtesy of DeSantis' blatant corruption of the vaccination procedure. The rest of us are own our own.
It is a beautiful late winter/early spring day chez nous but I want to share some incredibly sad, depressing reading with you.
Go to this New York Times article, read it and wince, and then read the comments and cry. âIâd Much Rather Be in Floridaâ Floridians are out and about and pandemic restrictions have been lifted. Thereâs just one problem: The virus never went away.
qualified to have my blind broken this morning (scheduled to have pfizer jab next tuesday so astrazeneca had to let me know)
turns out i did get vaccinated (first shot mid dec, second shot mid jan)
so i've been walking around for months building immunity
And I thought you were a super spreader
Sorry, what is âblind brokenâ?
He participated in a double-blind vaccine test. They don't tell the participants whether they got the vax or the placebo. Now that he is/was signed up for the real thing, he is allowed to know whether he's already been vaccinated.
It is a beautiful late winter/early spring day chez nous but I want to share some incredibly sad, depressing reading with you.
Go to this New York Times article, read it and wince, and then read the comments and cry. âIâd Much Rather Be in Floridaâ Floridians are out and about and pandemic restrictions have been lifted. Thereâs just one problem: The virus never went away.
