31 minutes ago, mr_hunt said:

aaaaaaaaand one of my co-workers who i deal with every day is out because her son's gf has tested positive & is always at her house.   

Did they swab the gf’s throat to see if he has it?

33 minutes ago, mr_hunt said:

aaaaaher son's gf has tested positive & is always at her house.   

They sound like smart people.

Dumb question for the more informed:

 

This vaccine..... It seems to be a bit all over the place when it comes to people having reactions.  (By reactions, I mean chills, fever.  Not sore arm)  What I'm reading so far it seems that most people who have reactions is on the second dose.  Which makes sense.  Your body has started to build up antibodies, so at the second dose your body recognizes the proteins and ramps up to fight it, making you feel like crap. 

 

And there are people who have no reaction to the vaccine.  This makes sense too because there are people who are asymptomatic.  It stands to reason that you can get both doses and not have any symptoms, especially since its such a low dose of the protein and no where near what you would have if you were fighting off an actual COVID infection.

 

But what about the people who get a reaction after the first shot?  If you are the type of person to be asymptomatic, its too small of a dose (IMO) to have an adverse reaction. (again, IMO)  Is it possible that the people who are getting the vaccine and getting chills\fever\etc actually had COVID but were asymptomatic and fought it off so that when they get the shot the body is like "F no, not this crap again" and going into hyperdrive?

10 hours ago, vikas83 said:

I am sitting in a hotel room in San Francisco. 

My god.  I am so sorry.  Please get out of that awful city safe  

2 hours ago, EaglesRocker97 said:

I figured that was a sarcastic comment from Doc. I've been casually in and out of this thread. Is he actually pushing the "masks don't work" narrative?

No I’ve never once said that they don’t work. I’ve always from day one said they were one important part of the equation and that the overall policy was complex because there were multiple factors to consider, e.g, deaths #1, mental health, education, jobs, economy, sustainability of approach over time, local context, etc etc. 

So yeah that was 100% sarcastic. A push against the narrative that says "just wear a mask and wash your hands” or equivalent and everything will be fine. 

17 minutes ago, paco said:

My god.  I am so sorry.  Please get out of that awful city safe  

Flying home this morning. Thank God. 

1 minute ago, vikas83 said:

Flying home this morning. Thank God. 

Where do you stay when you go there?

6 minutes ago, DrPhilly said:

Where do you stay when you go there?

Yeah. Not going to advertise my location on here. 
 

It is a boutique hotel that moves a Peloton into my room for me. 

4 minutes ago, vikas83 said:

Yeah. Not going to advertise my location on here. 
 

It is a boutique hotel that moves a Peloton into my room for me. 

35 minutes ago, paco said:

Dumb question for the more informed:

 

This vaccine..... It seems to be a bit all over the place when it comes to people having reactions.  (By reactions, I mean chills, fever.  Not sore arm)  What I'm reading so far it seems that most people who have reactions is on the second dose.  Which makes sense.  Your body has started to build up antibodies, so at the second dose your body recognizes the proteins and ramps up to fight it, making you feel like crap. 

 

And there are people who have no reaction to the vaccine.  This makes sense too because there are people who are asymptomatic.  It stands to reason that you can get both doses and not have any symptoms, especially since its such a low dose of the protein and no where near what you would have if you were fighting off an actual COVID infection.

 

But what about the people who get a reaction after the first shot?  If you are the type of person to be asymptomatic, its too small of a dose (IMO) to have an adverse reaction. (again, IMO)  Is it possible that the people who are getting the vaccine and getting chills\fever\etc actually had COVID but were asymptomatic and fought it off so that when they get the shot the body is like "F no, not this crap again" and going into hyperdrive?

This is a distinct possibility - among others...

 

4 minutes ago, vikas83 said:

Yeah. Not going to advertise my location on here. 
 

It is a boutique hotel that moves a Peloton into my room for me. 

Complimentary Polos as well, I assume?

8 minutes ago, vikas83 said:

Yeah. Not going to advertise my location on here. 
 

It is a boutique hotel that moves a Peloton into my room for me. 

hope you enjoyed "dinner" at the blue oyster, loretta!   

3 minutes ago, EaglesRocker97 said:

Complimentary Polos as well, I assume?

I don’t take handouts. 
 

I just care about Peloton and room service breakfast. Not in the room otherwise. 

1 minute ago, vikas83 said:

I don’t take handouts.

Sorry to offend your sense of dignity. I assumed your elite digs would merely be included as part of the exorbitant room rate.

54 minutes ago, vikas83 said:

Flying home this morning. Thank God. 

Is it like playing hop scotch trying to avoid used needles, poop and heroin addicts nodding off in the streets?

58 minutes ago, vikas83 said:

Yeah. Not going to advertise my location on here. 
 

It is a boutique hotel that moves a Peloton into my room for me. 

Ahh ok.  Nice to get that Peloton in place.

I used to go thru there a lot.  I typically stayed at the Fairmont up on Nob Hill or at the Intercontinental.

1 hour ago, DrPhilly said:

Ahh ok.  Nice to get that Peloton in place.

I used to go thru there a lot.  I typically stayed at the Fairmont up on Nob Hill or at the Intercontinental.

Both great. I like the Mandarin Oriental. The Ritz is nice too. And the Le Meridien in the financial district. 

1 hour ago, rambo said:

Is it like playing hop scotch trying to avoid used needles, poop and heroin addicts nodding off in the streets?

It is impossible to go outside and not have someone beg for money within 10 feet of the hotel entrance. Such an awful, awful city. 

Novavax released some details of their Phase III trials in the UK and South Africa. Reporting 89% efficacy against a mix of  pre-existent sars-cov-2 strains and the infamous b1.1.7 strain. Efficacy in the South Africa trial was only 49% though, largely attributed to the b1.351 strain that is predominant there. Better than J&J, and likely on par with the two mRNA vaccines we already have when it comes to the pre-existent variants, but unknown on whether it'll fare better against b1.351. 

 

Quote

Novavax COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial

Jan 28, 2021 at 4:05 PM EST

Download PDF

First to Demonstrate Clinical Efficacy Against COVID-19 and Both UK and South Africa Variants

• Strong efficacy in Phase 3 UK trial with over 50% of cases attributable to the now-predominant UK variant and the remainder attributable to COVID-19 virus
• Clinical efficacy demonstrated in Phase 2b South Africa trial with over 90% of sequenced cases attributable to prevalent South Africa escape variant
• Company to host investor conference call today at 4:30pm ET

GAITHERSBURG, Md., Jan. 28, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that NVX-CoV2373, its protein-based COVID-19 vaccine candidate, met the primary endpoint, with a vaccine efficacy of 89.3%, in its Phase 3 clinical trial conducted in the United Kingdom (UK). The study assessed efficacy during a period with high transmission and with a new UK variant strain of the virus emerging and circulating widely. It was conducted in partnership with the UK Government’s Vaccines Taskforce. Novavax also announced successful results of its Phase 2b study conducted in South Africa.

"With today’s results from our UK Phase 3 and South Africa Phase 2b clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2 and 3 trials involving over 20,000 participants. In addition, our PREVENT-19 US and Mexico clinical trial has randomized over 16,000 participants toward our enrollment goal of 30,000. NVX-CoV2373 is the first vaccine to demonstrate not only high clinical efficacy against COVID-19 but also significant clinical efficacy against both the rapidly emerging UK and South Africa variants,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. "NVX-CoV2373 has the potential to play an important role in solving this global public health crisis. We look forward to continuing to work with our partners, collaborators, investigators and regulators around the world to make the vaccine available as quickly as possible.”

NVX-CoV2373 contains a full-length, prefusion spike protein made using Novavax’ recombinant nanoparticle technology and the company’s proprietary saponin-based Matrix-M™ adjuvant. The purified protein is encoded by the genetic sequence of the SARS-CoV-2 spike (S) protein and is produced in insect cells. It can neither cause COVID-19 nor can it replicate, is stable at 2°C to 8°C (refrigerated) and is shipped in a ready-to-use liquid formulation that permits distribution using existing vaccine supply chain channels.

UK Phase 3 Results: 89.3% Efficacy

The study enrolled more than 15,000 participants between 18-84 years of age, including 27% over the age of 65. The primary endpoint of the UK Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.

The first interim analysis is based on 62 cases, of which 56 cases of COVID-19 were observed in the placebo group versus 6 cases observed in the NVX-CoV2373 group, resulting in a point estimate of vaccine efficacy of 89.3% (95% CI: 75.2 – 95.4). Of the 62 cases, 61 were mild or moderate, and 1 was severe (in placebo group).

Preliminary analysis indicates that the UK variant strain that was increasingly prevalent was detected in over 50% of the PCR-confirmed symptomatic cases (32 UK variant, 24 non-variant, 6 unknown). Based on PCR performed on strains from 56 of the 62 cases, efficacy by strain was calculated to be 95.6% against the original COVID-19 strain and 85.6% against the UK variant strain .

The interim analysis included a preliminary review of the safety database, which showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups.

"These are spectacular results, and we are very pleased to have helped Novavax with the development of this vaccine. The efficacy shown against the emerging variants is also extremely encouraging. This is an incredible achievement that will ensure we can protect individuals in the UK and the rest of the world from this virus,” said Clive Dix, Chair, UK Vaccine Taskforce.

Novavax expects to share further details of the UK trial results as additional data become available. Additional analysis on both trials is ongoing and will be shared via prepublication servers as well as submitted to a peer-reviewed journal for publication. The company initiated a rolling submission to the United Kingdom’s regulatory agency, the MHRA, in mid-January.

South Africa Results:   Approximately 90% of COVID-19 cases attributed to South Africa escape variant

In the South Africa Phase 2b clinical trial, 60% efficacy (95% CI: 19.9 – 80.1) for the prevention of mild, moderate and severe COVID-19 disease was observed in the 94% of the study population that was HIV-negative. Twenty-nine cases were observed in the placebo group and 15 in the vaccine group. One severe case occurred in the placebo group and all other cases were mild or moderate. The clinical trial also achieved its primary efficacy endpoint in the overall trial population, including HIV-positive and HIV-negative subjects (efficacy of 49.4%; 95% CI: 6.1 – 72.8).

This study enrolled over 4,400 patients beginning in August 2020, with COVID-19 cases counted from September through mid-January. During this time, the triple mutant variant, which contains three critical mutations in the receptor binding domain (RBD) and multiple mutations outside the RBD, was widely circulating in South Africa. Preliminary sequencing data is available for 27 of 44 COVID-19 events; of these, 92.6% (25 out of 27 cases) were the South Africa escape variant.  

Importantly in this trial, approximately 1/3 of the patients enrolled (but not included in the primary analyses described above) were seropositive, demonstrating prior COVID-19 infection at baseline. Based on temporal epidemiology data in the region, the pre-trial infections are thought to have been caused by the original COVID-19 strain (i.e., non-variant), while the subsequent infections during the study were largely variant virus. These data suggest that prior infection with COVID-19 may not completely protect against subsequent infection by the South Africa escape variant, however, vaccination with NVX-CoV2373 provided significant protection.

"The 60% reduced risk against COVID-19 illness in vaccinated individuals in South Africans underscores the value of this vaccine to prevent illness from the highly worrisome variant currently circulating in South Africa, and which is spreading globally. This is the first COVID-19 vaccine for which we now have objective evidence that it protects against the variant dominating in South Africa,” says Professor Shabir Maddi, Executive Director of the Vaccines and Infectious Diseases Analytics Research Unit (VIDA) at Wits, and principal investigator in the Novavax COVID-19 vaccine trial in South Africa. "I am encouraged to see that Novavax plans to immediately begin clinical development on a vaccine specifically targeted to the variant, which together with the current vaccine is likely to form the cornerstone of the fight against COVID-19.”

Novavax initiated development of new constructs against the emerging strains in early January and expects to select ideal candidates for a booster and/or combination bivalent vaccine for the new strains in the coming days. The company plans to initiate clinical testing of these new vaccines in the second quarter of this year.

"A primary benefit of our adjuvanted platform is that it uses a very small amount of antigen, enabling the rapid creation and large-scale production of combination vaccine candidates that could potentially address multiple circulating strains of COVID-19,” said Gregory M. Glenn, M.D., President of Research and Development, Novavax. "Combined with the safety profile that has been observed in our studies to-date with our COVID-19 vaccine, as well as prior studies in influenza, we are optimistic about our ability to rapidly adapt to evolving conditions.”

The Coalition for Epidemic Preparedness Innovations (CEPI) funded the manufacturing of doses of NVX-CoV2373 for this Phase 2b clinical trial, which was supported in part by a $15 million grant from the Bill & Melinda Gates Foundation.

Significant progress on PREVENT-19 Clinical Trial in US and Mexico

To date, PREVENT-19 has randomized over 16,000 participants and expects to complete our targeted enrollment of 30,000 patients in the first half of February.  PREVENT-19 is being conducted with support from the U.S. government partnership formerly known as Operation Warp Speed, which includes the Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response, and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at HHS. BARDA is also providing up to $1.75 billion under a Department of Defense agreement.

PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial | COVID-19) is a Phase 3, randomized, placebo-controlled, observer-blinded study in the US and Mexico to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M in up to 30,000 subjects 18 years of age and older compared with placebo. The trial design has been harmonized to align with other Phase 3 trials conducted under the auspices of Operation Warp Speed, including the use of a single external independent Data and Safety Monitoring Board to evaluate safety and conduct an unblinded review when predetermined interim analysis events are reached.

The trial’s primary endpoint is the prevention of PCR-confirmed, symptomatic COVID-19. The key secondary endpoint is the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints will be assessed at least seven days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2.

https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-demonstrates-893-efficacy-uk-phase-3

My wife and my covid tests from yesterday (day 5 since exposure) came back negative. I'm in day 6 now since exposure, still feel normal. The entire family of the guy who I was exposed to has tested positive. 

Gonna keep isolation for a few more days make sure symptoms don't show up late, but things are looking good thankfully.

https://www.cnn.com/2021/01/29/politics/pentagon-vaccination-agreement/index.html

 

Quote

 

(CNN)The Pentagon and the Federal Emergency Management Agency are negotiating the final terms of an agreement that could see the military provide around 450,000 Covid-19 vaccinations a day.

The figure is included in a draft agreement between the two agencies viewed by CNN that also calls for the deployment of 10,000 troops at 100 vaccination centers across the United States that would run through at least February 26 as a start.

 

Several officials emphasize details are still being worked out and could change before final approval for the deployment is given by Defense Secretary Lloyd Austin.

 

Since taking office, President Joe Biden has said his goal is to have as many as 1.5 million Americans vaccinated every day. The current average is 1.2 million a day since he took office so should the agreement be successfully implemented it could help exceed his goal.

 

 

Not sure why Trump never thought of this, since he's in the 90th percentile, but it's good to finally have a President who puts America First (tm).

"The company plans to initiate clinical testing of these new vaccines in the second quarter of this year. "

So since this spreads easier and may very well become the dominate strain,July at the earliest is when 360 million people will need to be vaccinated again, please tell me how the WHO will declare Pandemic over by end of year? Plus children won't even begin to get any vaccine until the fall, that is 70 million. Sure the current vaccine is 50% effective but not everyone will take it and we don't know who will be protected so everyone needs another vaccine and there is going to be  large group of people on top of the Anti Vaxers that will say forget it I am not getting another shot

https://apnews.com/article/donald-trump-malaria-coronavirus-pandemic-oklahoma-09e3f4db37dda112ecec70d780bc964d?fbclid=IwAR2CBuxZMuebkve_eYHum01blvVcINS--uLPPi_b-dW5CtsORp_X-pmSFiI

On 1/29/2021 at 10:43 AM, vikas83 said:

Yeah. Not going to advertise my location on here. 
 

It is a boutique hotel that moves a Peloton into my room for me. 

The Huntington? 

Appreciate the laughs.  Much needed.  Doc says that Claws are not yet approved by the FDA to combat COVID.  So she recommended pounding some Corona instead.  I can’t do the mexican piss though, so I’ll just suffer.

3 hours ago, bobeph said:

Appreciate the laughs.  Much needed.  Doc says that Claws are not yet approved by the FDA to combat COVID.  So she recommended pounding some Corona instead.  I can’t do the mexican piss though, so I’ll just suffer.

Hope you recover quickly. How about Guinness?

 

 

3 hours ago, bobeph said:

Appreciate the laughs.  Much needed.  Doc says that Claws are not yet approved by the FDA to combat COVID.  So she recommended pounding some Corona instead.  I can’t do the mexican piss though, so I’ll just suffer.

Sorry to hear that brother. Rest and lots of fluids. 

Like water and juice, not your boyfriend's nut juice.