Covid-19: Treatments, Cures, and Vaccines

l_boy · May 5, 2021

Covid-19 Live Updates: Studies Indicate Pfizer-BioNTech Vaccine Protects Against the Most Severe Outcomes of Some Virus Variants

Pfizer vaccine highly effective against variants in 2 new studies. Great news.

RIP · May 5, 2021

l_boy said: ↑

Covid-19 Live Updates: Studies Indicate Pfizer-BioNTech Vaccine Protects Against the Most Severe Outcomes of Some Virus Variants

Pfizer vaccine highly effective against variants in 2 new studies. Great news.
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That is freaking awesome.

tampagtr · May 5, 2021

Such a disconnect listing to this episode about various nation states using donations or sales of Covid vaccine to other countries to curry favor and influence geopolitics. Such immense global demand and here we have people who won't take it. I know it's the story of history but it's just such a disconnect listening to tales of frustrated nations seeking the vaccine for their people.

The Jab: Might vaccine diplomacy misfire? - Economist Radio

ncargat1 · May 7, 2021

Pfizer and BioNTech initiate the next step towards securing full FDA approval of their mRNA based vaccine against SARS-CoV-2 for all individuals 16 and older.

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID-19 Vaccine
NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. Data to support the BLA will be submitted by the companies to the FDA on a rolling basis over the coming weeks, with a request for Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA will be set once the BLA is complete and formally accepted for review by the agency.

The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. under an Emergency Use Authorization (EUA) granted by the FDA on December 11, 2020. Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S. Submission of a BLA, which requires longer-term follow-up data for acceptance and approval, is the next step in the rigorous FDA review process.

“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.”
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Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID-19 Vaccine

G8trGr8t · May 7, 2021

Publix now offering walkin vaccines with no appointments required in SW Florida

ncargat1 · May 10, 2021

Following through on what everyone had expected, the FDA granted approval for the Pfizer/BioNTech mRNA vaccine to be used in children between the ages of 12 -15.

FDA permits use of the Pfizer-BioNTech Covid vaccine in kids ages 12 to 15
The Food and Drug Administration on Monday approved Pfizer and BioNTech’s request to allow their Covid-19 vaccine to be given to kids ages 12 to 15 on an emergency use basis, allowing states to get middle school students vaccinated before the fall.

The U.S. agency granting use of the shot in adolescents will also accelerate the nation’s efforts to drive down infections, public health officials and infectious disease experts say.

The two-dose vaccine is already authorized for use in people 16 and older. The Centers for Disease Control and Prevention’s vaccine advisory committee has scheduled a meeting Wednesday to review the shots for kids. If approved by the CDC as expected, it could be distributed to adolescents as soon as this week.
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https://www.cnbc.com/2021/05/10/pfizer-covid-vaccine-fda-clears-use-in-kids-ages-12-to-15.html

ncargat1 · May 14, 2021

The Brits have lead most of the research into extending the time between shots. They have shown that by extending the period of time between Pfizer shot 1 and 2 out to 12 weeks that the anti-body response in older adults showed a 3.5x increase.

Delaying second Pfizer vaccines to 12 weeks significantly increases antibody responses in older people, finds study
he study, supported by the UK Coronavirus Immunology Consortium, of 175 people who were aged over 80 and living independently is the first direct comparison of the immune response in any age group between those who are given the second Pfizer vaccine at a three-week interval and those at a 12-week interval. The Pfizer vaccine was originally authorised for a three-week interval between doses; however several countries, including the UK, chose to expand this to a 12-week interval to allow a higher percentage of the population to receive one vaccine dose quicker.

The research found that extending the second dose interval to 12 weeks increased the peak SARS-CoV-2 spike specific antibody response 3.5-fold compared to those who had the second vaccine at three weeks. Although the peak cellular immune responses were lower after the delayed second vaccine, responses were comparable between the groups when measured at a similar time point following the first dose.

The team concluded that extending administration of the second Pfizer vaccine to 12 weeks potentially enhances and extends antibody immunity, which is believed to be important in virus neutralisation and prevention of infection.
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Delaying second Pfizer vaccines to 12 weeks significantly increases antibody responses in older people, finds study

exiledgator · May 14, 2021

I'd love to hear some non political, scientific thoughts on mRNA vaccines on the 12-16 age group.

Anyone have info for pro vax parents that may be waffling on such a shot for a low risk demographic?

Not herd immunity theory stuff, but what the current literature says about this age group.

BLING · May 15, 2021

ncargat1 said: ↑

The Brits have lead most of the research into extending the time between shots. They have shown that by extending the period of time between Pfizer shot 1 and 2 out to 12 weeks that the anti-body response in older adults showed a 3.5x increase.

Delaying second Pfizer vaccines to 12 weeks significantly increases antibody responses in older people, finds study
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That’s interesting since most of the reason for not “extending” the doses (accelerating out more 1st doses, and delaying the 2nd) was concern over undermining the vaccine response. Sounds like it would have been a non issue, and it actually worked against intuition to actually improve vaccine response.

I guess the downside is in that extra 4-8 weeks you’d have more “partially vaccinated” people waiting around, and maybe some potential issues around that (esp in older people if they got themselves infected before completing their course).

ncargat1 · May 17, 2021

New research (pre-print, not peer reviewed yet) confirmed previous results from Pfizer and UT Austin that both mRNA vaccines promote a strong T-Cell response, even against "scary variants" such as the B.1.1.7 (UK) and the B.1.351 (South African). If I understand this correctly, it is still possible to become infected, but the T-Cells quickly overwhelm the virus which is part of the reason why so many "break through cases" are mild or even asymptomatic.

A second finding of the research was that if you already had COVID, a single shot of the mRNA vaccine was sufficient for a quality T-Cell response.

More really good news for this technology.

In the battle against COVID-19, the mRNA vaccines from Moderna and Pfizer-BioNTech have passed virtually every test for efficacy and safety. Now comes more positive news.

Researchers at the University of California and the Gladstone Institute of Virology in San Francisco have found that both vaccines induce strong T cell responses against two important coronavirus variants.

The T cell responses elicited by the two mRNA vaccines were identical against the B.1.1.7 (British) and B.1.351 (South African) variants and matched those against the original strain of the disease, the team found. In a pre-print version of the report, which has yet to undergo peer review, researchers said they'd found a "reassuringly unaltered T cell response against the variants."

A second dose of either vaccine affected the quantity but not the quality of T cells, the study found. This response, which was consistent against the original strain and the variants, shows the value of a second shot.
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Pfizer, Moderna COVID-19 vaccines induce responses against 2 key variants, small study finds

ncargat1 · May 21, 2021

Not sure what proof that there was offered if any at the time of the statement, but Ugur Sahin has earned a lot of credit throughout the pandemic with his predictions and estimations of how effective his mRNA product is/would be, so I will roll with him. Basically saying the Pfizer/BioNTech vaccine will be just as effetive against the latest variant of concern from India as it was against all of the other variants. Meaning, we will very likely be just fine.

BioNTech's BNTX, -0.83% chief executive has said that the COVID-19 vaccine it developed with U.S. pharmaceutical group Pfizer PFE, 0.25% is likely to be effective against the Indian variant of coronavirus. The German biotechnology company's CEO, Ugur Sahin, said on Thursday in a meeting with the Turkish health minister that the vaccine's effectiveness against the Indian variant was likely to be in the same range as for the South African variant, according to BioNTech. Sahin said that BioNTech and Pfizer's COVID-19 vaccine has shown real-world effectiveness of 75% against the South African variant of the coronavirus, and that efficacy against the Indian variant might be in the same range.
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BioNTech says COVID-19 vaccine likely to be effective against Indian coronavirus variant

G8trGr8t · May 21, 2021

ncargat1 said: ↑

Not sure what proof that there was offered if any at the time of the statement, but Ugur Sahin has earned a lot of credit throughout the pandemic with his predictions and estimations of how effective his mRNA product is/would be, so I will roll with him. Basically saying the Pfizer/BioNTech vaccine will be just as effetive against the latest variant of concern from India as it was against all of the other variants. Meaning, we will very likely be just fine.

BioNTech says COVID-19 vaccine likely to be effective against Indian coronavirus variant
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Thankful that I got the pfizer and not the J & J.

ncargat1 · May 22, 2021

Monoclonal cocktails continue to show excellent results for the people who meet the qualifications for treatment. The latest from Regeneron showed a 70% reduction in the risk of serious disease and death when given to non-hospitalized patients presenting mild or moderate symptoms.

Also this week, the FDA expanded the EUA for the monoclonal cocktails to cover more people, and including the lowering the minimum BMI value down to 25 to qualify for treatment.

Phase 3 Data Presented at ATS 2021 Show REGEN-COV™ (casirivimab with imdevimab) Reduced Risk of Hospitalization or Death by 70% in Non-hospitalized COVID-19 Patients
The Phase 3, randomized, double-blind, placebo-controlled trial evaluated REGEN–COV in 4,567 high-risk outpatients with COVID-19. Two REGEN-COV doses were studied in the trial – the currently authorized 2,400 mg dose and a 1,200 mg dose under evaluation with the U.S. Food and Drug Administration (FDA). All patients evaluated for efficacy had at least one risk factor for severe COVID-19, such as chronic lung disease (including asthma), obesity, cardiovascular disease or being at least 50 years of age.

Positive topline results from the trial were announced in March 2021, showing REGEN–COV met its primary and all secondary endpoints, with similar efficacy observed for both doses. These data demonstrated patients treated with 1,200 mg or 2,400 mg REGEN–COV experienced:

70% (p=0.0024) and 71% (p<0.0001) reduced risk of hospitalization or death through day 29, compared to placebo.

4-day shorter time to symptom resolution, with a median of 10 days with both REGEN-COV groups compared to a median of 14 days with placebo.

Reduced viral load by 0.71 log10 copies/mL and 0.86 log10 copies/mL in seven days, compared to placebo (p<0.0001 for both).

A safety assessment in 5,531 patients was conducted up to day 169, and the safety profile was consistent with previously reported data. Serious adverse events (SAEs) were largely related to COVID-19 and occurred in 1.1% of patients in the 1,200 mg group, 1.3% in the 2,400 mg group and 4.0% in the placebo group. There was 1 death in the 1,200 mg group (n=827), 1 death in the 2,400 mg group (n=1,849) and 5 deaths in the placebo groups (n=1,843).
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https://www.prnewswire.com/news-rel...hospitalized-covid-19-patients-301292557.html

ncargat1 · May 25, 2021

Moderna's trial for children 12-18 produced a result that showed 100% efficacy in Phase 3 trial. They will immediately file with the FDA to expand its EUA down to 12 year old children. Let the debate continue.....

Moderna's COVID-19 vaccine aces trial in teens, teeing up back-to-school FDA approval
In a phase 3 trial in kids ages 12 to 18, Moderna’s vaccine posted 100% efficacy after two doses. Investigators enrolled 3,700 participants and randomly assigned two-thirds to receive two doses of the Moderna vaccine. The remaining third received two doses of placebo.

Investigators recorded zero COVID-19 cases in the vaccinated group 14 days after the second dose, and four in the placebo group. They didn't identify any new safety concerns.

The results set Moderna up for an FDA filing in the age group next month. Under that timeline, the vaccine could score an authorization in teens sometime this summer and play a role in a back-to-school vaccination push.

But Moderna won’t be the first COVID-19 vaccine maker to score an authorization in children. After Pfizer’s vaccine aced its own trial in participants ages 12 to 15, an emergency authorization followed—and, now, Pfizer's vaccine is authorized for people 12 and up.
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ncargat1 · May 29, 2021

Additional Monoclonal Antibody approved by the FDA for EUA from GlaxoSmithKline. Note, not mentioned in the article, this MAB drug showed equal efficiency against all know variants, including the triple-mutation Indian variant.

EUA granted for Glaxosmithkline-Vir COVID-19 treatment
There are now two FDA-backed monoclonal antibody COVID-19 treatments after the agency granted Glaxosmithkline plc (GSK) emergency use authorization (EUA) for single-dose sotrovimab to treat mild to moderate COVID-19 in adults and children as young as 12.

The GSK-Vir treatment group consisted of those with a positive SARS-CoV-2 test and at high risk for progressing to severe COVID-19, including hospitalization or death. The decision was based on data from an interim analysis of the phase III COMET-ICE study showing the treatment was 85% effective (p=0.002). The randomized, double-blind, placebo-controlled trial consisted of 583 non-hospitalized adults with mild-to-moderate COVID-19 symptoms and a positive SARS-CoV-2 test result. Roughly half of the patients received sotrovimab and the other half received a placebo within five days of onset of COVID-19 symptoms.

The study’s primary endpoint was COVID-19 progression, hospitalization for more than 24 hours for acute management of any illness or death from any cause through day 29. Hospitalization or death was found in 21 (7%) patients who received placebo compared to three (1%) patients who received sotrovimab.
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EUA granted for Glaxosmithkline-Vir COVID-19 treatment

ncargat1 · Jun 1, 2021

Moderna follows Pfizer's lead and applies for Full Authorization of their mRNA vaccine to prevent COVID-19 in 16 year olds and up.

Moderna applies for full F.D.A. approval for its Covid vaccine.
Moderna on Tuesday became the latest pharmaceutical company to apply to the U.S. Food and Drug Administration for full approval for its Covid-19 vaccine for use in people 18 and older. F.D.A. approval would allow the company to market the shot directly to consumers, and could also help raise public confidence in the vaccine.

Full approval could also make it easier for schools, employers, government agencies and the U.S. military, which has encountered resistance to coronavirus vaccines, to mandate vaccinations.

“We look forward to working with the F.D.A. and will continue to submit data from our Phase 3 study and complete the rolling submission,” Stéphane Bancel, Moderna’s chief executive, said in a statement.

Last month Pfizer and BioNTech applied to the agency for full approval of their vaccine for use in people 16 and older.
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Covid Live Updates: Moderna Applies to F.D.A. for Full Vaccine Authorization

ncargat1 · Jun 9, 2021

Molnupiravir - an oral drug in Phase 3 trials right now. Has proven to halt viral repliacation of SARS-CoV-2 within 5 days or less in small Phase1/2 trials and in the lab tests.

Saddest part.....this drug was developed 4 years ago to treat RNA base Corona viruses, but there was no money to bring this drug to Trials and Approval because it was believed taht there would never be any money to be made treating Corona viruses. Just imagine if we had a treatment that worked back in March/April of 2020?

U.S. government commits to purchase approximately 1.7 million courses of Molnupiravir upon issuance of Emergency Use Authorization or approval by the U.S. Food and Drug Administration

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced it has entered into a procurement agreement with the United States government for molnupiravir (MK-4482). Molnupiravir is currently being evaluated in a Phase 3 clinical trial, the MOVe-OUT study, for the treatment of non-hospitalized patients with laboratory-confirmed COVID-19 and at least one risk factor associated with poor disease outcomes. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics.

“Merck is pleased to collaborate with the U.S. government on this new agreement that will provide Americans with COVID-19 access to molnupiravir – an investigational oral therapy being studied for outpatient use early in the course of disease – if it is authorized or approved,” said Rob Davis, president, Merck. “In addition to this agreement with the U.S. government, we are actively engaged in numerous efforts to make molnupiravir available globally to fulfill Merck’s commitment to widespread access.”

Through the agreement, if molnupiravir receives Emergency Use Authorization (EUA) or approval by the U.S. Food and Drug Administration (FDA), Merck will receive approximately $1.2 billion to supply approximately 1.7 million courses of molnupiravir to the United States government. Merck has been investing at risk to support development and scale-up production of molnupiravir and expects to have more than 10 million courses of therapy available by the end of 2021.Molnupiravir (EIDD-2801/MK-4482) is an investigational, orally bioavailable form of a potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV-2, the causative agent of COVID-19. Molnupiravir has been shown to be active in several models of SARS-CoV-2, including for prophylaxis, treatment and prevention of transmission, as well as SARS-CoV-1 and MERS. EIDD-2801 was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University, and with partial funding support from the U.S. government. Since licensed by Ridgeback, all funds used for the development of EIDD-2801 by Ridgeback have been provided by Wayne and Wendy Holman and Merck.
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Merck Announces Supply Agreement with U.S. Government for Molnupiravir, an Investigational Oral Antiviral Candidate for Treatment of Mild to Moderate COVID-19 - Merck.com

ncargat1 · Jun 14, 2021

Novavax reported data from US vaccine trial with 90% efficacy. This vaccine is a protein nano-particle based vaccine, very much different from the mRNA technologies and the more tradtional platform used by J&J. While late to the game for the first wave, the thought is that this technology much be perferct for immunity amplification and will be ideal for future booster shots.

Novavax, a small American company buoyed by lavish support from the U.S. government, announced on Monday the results of a clinical trial of its Covid-19 vaccine in the United States and Mexico, finding that its two-shot inoculation provides potent protection against the coronavirus.

In the 29,960-person trial, the vaccine demonstrated an overall efficacy of 90.4 percent, on par with the vaccines made by Pfizer-BioNTech and Moderna, and higher than the one-shot vaccine from Johnson & Johnson. The Novavax vaccine showed an efficacy of 100 percent at preventing moderate or severe disease.

By the time Novavax gets the green light from the U.S. government, it may be too late to contribute to the country’s first wave of vaccinations. But many vaccine experts expect that, with waning immunity and emerging variants, the country will need booster shots at some point. And the protein-based technology used in the Novavax vaccine may do a particularly good job at amplifying protection, even if people have previously been vaccinated with a different formulation.

Novavax will apply for authorization in the United States after it finishes developing a quality control test, according to its chief executive. “You have to test them every way from Sunday to show that under any conditions you get the same answer,” Mr. Erck said. “And that takes time.”
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Novavax Offers U.S. a Fourth Strong Covid-19 Vaccine

ncargat1 · Jun 21, 2021

Glaxo-Smith-Kline and Vir Bio are moving quickly to see full authorization of the monoclonal anti-body. Phase 3 showed an 85% reduction in the % of patients who died or where hospitalized more than 29 days after treatment. Further, the antibody appears effective against variants alpha-iota with the exception of the delta variant, which it has not been tested against. The companies are also testing an intra-muscular formulation to avoid the need for patients to receive an I-V for treatment.

With final phase 3 data in hand, Vir Biotechnology and GlaxoSmithKline are seeking full approval for their COVID-19 antibody by the end of the year. The study found that the treatment, sotrovimab, slashed hospitalizations and deaths by 79% in adults with mild to moderate COVID-19 who were at high risk of their disease becoming severe.

The duo scored an emergency nod from the FDA in May based on early data from nearly 600 patients. An interim analysis showed sotrovimab reduced the risk of hospitalization or death by 85% a month after treatment, prompting an independent data monitoring committee to recommend stopping enrollment in the study. The companies plan to submit the full data, from 1,057 patients, to a peer-reviewed journal.

the companies are working on a formulation of sotrovimab that can be given by intramuscular injection. It is in a phase 2 study due to read out by the end of the year and a phase 3 study with data expected in the first half of 2022. The partners are also planning a trial to test the intramuscular antibody’s efficacy at warding off COVID-19 infection.
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Vir, GSK unveil final data for COVID-19 antibody en route to 2021 filing

exiledgator · Jun 21, 2021

Just heard on NPR how two shot mRNA vax are highly effective against b117 delta variant, but only getting one shot is ~35% effective.

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