Coronavirus (COVID-19)

[ramssuperbowl99]

1 hour ago, seriously27 said:

I hate when they use words like this. The vaccine will not be ready for most public use until 2021 at the earliest, maybe late 2020 if things go perfectly. The vaccine will not be through FDA approval until after September and that doesn't factor in the EMA,ASEC, HC or the rest of the world's regulatory bodies. Not only will they need to get FDA approval for the drug itself, but the manufactring process will need to be approved as well. They have completed initial trials, but have yet to go into any sort of major production and that will take them past September just to get enough for a decent batch of drugs. They need to stop saying things like widely available. 

Presumably they are already sharing data with the FDA/[insert regulatory body of choice here] so that they get approval more quickly.

Edited July 20, 2020 by ramssuperbowl99

[Xenos]

More on the benefits of the extra $600 UI:

https://www.npr.org/sections/coronavirus-live-updates/2020/07/20/892476371/the-end-of-600-unemployment-benefits-will-hit-millions-of-households-and-the-eco

Quote

If the hit comes, it will be felt not only by the unemployed but by grocers, landlords and the broader economy. Cutting off benefits to so many people at once would reduce their collective spending power by nearly $19 billion per week. 

"However you slice these numbers, we're talking about very large amounts that mean quite a bit to workers and to the macroeconomy," said Ryan Nunn, who leads applied research at the Federal Reserve Bank of Minneapolis. 

In an interview last week, Nunn said the extra jobless benefits have acted as an important crutch for the economy. Without them, the U.S. would likely have experienced more defaults on car loans and credit card bills and more people falling behind on their rent.

 

[Mega Ron]

Protein treatment cuts the odds of patients developing severe disease by 79%

https://www.bbc.co.uk/news/health-53467022

Oxford vaccine appears to work (although 70% of those treated suffered headaches or fever

https://www.bbc.co.uk/news/uk-53469839

[BobbyPhil1781]

https://www.thelancet.com/lancet/article/s0140-6736(20)31604-4

Great news!!

Two vaccines that are extremely promising and more on the horizon that have shown potential as well.

Edited July 20, 2020 by BobbyPhil1781

[BobbyPhil1781]

2 minutes ago, Mega Ron said:

Protein treatment cuts the odds of patients developing severe disease by 79%

https://www.bbc.co.uk/news/health-53467022
 

Thank you for posting this. I just linked the PDF earlier which was unbeknownst to me. I need to pay attention to what's in my clipboard lol

[BobbyPhil1781]

Not to be outdone, the Chinese release Phase 2 data from their CanSino vaccine which look extremely promising as well.

https://www.thelancet.com/lancet/article/s0140-6736(20)31605-6

For the few science nerds in here:

"Summary

Background

This is the first randomised controlled trial for assessment of the immunogenicity and safety of a candidate non-replicating adenovirus type-5 (Ad5)-vectored COVID-19 vaccine, aiming to determine an appropriate dose of the candidate vaccine for an efficacy study.

Methods

This randomised, double-blind, placebo-controlled, phase 2 trial of the Ad5-vectored COVID-19 vaccine was done in a single centre in Wuhan, China. Healthy adults aged 18 years or older, who were HIV-negative and previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection-free, were eligible to participate and were randomly assigned to receive the vaccine at a dose of 1 × 1011 viral particles per mL or 5 × 1010 viral particles per mL, or placebo. Investigators allocated participants at a ratio of 2:1:1 to receive a single injection intramuscularly in the arm. The randomisation list (block size 4) was generated by an independent statistician. Participants, investigators, and staff undertaking laboratory analyses were masked to group allocation. The primary endpoints for immunogenicity were the geometric mean titres (GMTs) of specific ELISA antibody responses to the receptor binding domain (RBD) and neutralising antibody responses at day 28. The primary endpoint for safety evaluation was the incidence of adverse reactions within 14 days. All recruited participants who received at least one dose were included in the primary and safety analyses. This study is registered with ClinicalTrials.gov, NCT04341389.

Findings

603 volunteers were recruited and screened for eligibility between April 11 and 16, 2020. 508 eligible participants (50% male; mean age 39·7 years, SD 12·5) consented to participate in the trial and were randomly assigned to receive the vaccine (1×1011 viral particles n=253; 5×1010 viral particles n=129) or placebo (n=126). In the 1×1011 and 5×1010 viral particles dose groups, the RBD-specific ELISA antibodies peaked at 656·5 (95% CI 575·2–749·2) and 571·0 (467·6–697·3), with seroconversion rates at 96% (95% CI 93–98) and 97% (92–99), respectively, at day 28. Both doses of the vaccine induced significant neutralising antibody responses to live SARS-CoV-2, with GMTs of 19·5 (95% CI 16·8–22·7) and 18·3 (14·4–23·3) in participants receiving 1×1011 and 5 × 1010 viral particles, respectively. Specific interferon γ enzyme-linked immunospot assay responses post vaccination were observed in 227 (90%, 95% CI 85–93) of 253 and 113 (88%, 81–92) of 129 participants in the 1 × 1011 and 5 × 1010 viral particles dose groups, respectively. Solicited adverse reactions were reported by 183 (72%) of 253 and 96 (74%) of 129 participants in the 1×1011 and 5×1010 viral particles dose groups, respectively. Severe adverse reactions were reported by 24 (9%) participants in the 1 × 1011 viral particles dose group and one (1%) participant in the 5 × 1010 viral particles dose group. No serious adverse reactions were documented.

Interpretation

The Ad5-vectored COVID-19 vaccine at 5 × 1010 viral particles is safe, and induced significant immune responses in the majority of recipients after a single immunisation."

[ramssuperbowl99]

14 minutes ago, Mega Ron said:

Protein treatment cuts the odds of patients developing severe disease by 79%

https://www.bbc.co.uk/news/health-53467022

Oxford vaccine appears to work (although 70% of those treated suffered headaches or fever

https://www.bbc.co.uk/news/uk-53469839

Mild enough headaches or fever that they recommend Tylenol. Goddamn is good news sweet.

 

[BobbyPhil1781]

Big difference, as I understand (and holy hell I'm learning a lot about science w/ this ****) is the CanSino was extremely effective after one dose while the AZD1222 was more effective after a second, booster shot.

[seriously27]

1 hour ago, ramssuperbowl99 said:

Presumably they are already sharing data with the FDA/[insert regulatory body of choice here] so that they get approval more quickly.

So I presumably know that they are not very far along in the FDA portion on the manufacturing side and they haven't started the manufacturing process or even the approval process at this time. Timelines will be quicker than normal since AZ/Oxford is part of the governments handpicked, best chances for the vaccine and received a large part of the grant money(Along with J&J). ALs, don't forget that AZ is not an American company. They are a Swedish/British company. SO while getting the FDA approval is important, I don't think that is their only focus, and they won't have the same push with other agencies. (alhough to the US's credit, the FDA is more strict than most agencies) It's just bothersome because I get the hopeof it getting released in mass quantities in that time, all these articles will do is push for more people to talk about response failures when it doesn't come out until 2021. We have too many actual response failures to talk about without adding false ones. 

[ramssuperbowl99]

2 minutes ago, seriously27 said:

So I presumably know that they are not very far along in the FDA portion on the manufacturing side and they haven't started the manufacturing process or even the approval process at this time. Timelines will be quicker than normal since AZ/Oxford is part of the governments handpicked, best chances for the vaccine and received a large part of the grant money(Along with J&J). ALs, don't forget that AZ is not an American company. They are a Swedish/British company. SO while getting the FDA approval is important, I don't think that is their only focus, and they won't have the same push with other agencies. (alhough to the US's credit, the FDA is more strict than most agencies) It's just bothersome because I get the hopeof it getting released in mass quantities in that time, all these articles will do is push for more people to talk about response failures when it doesn't come out until 2021. We have too many actual response failures to talk about without adding false ones. 

That's a bummer - can you share why they haven't gotten further along?

[Mega Ron]

If it meets our standards, it will more than meet yours.

[WizeGuy]

2 hours ago, seriously27 said:

I hate when they use words like this. The vaccine will not be ready for most public use until 2021 at the earliest, maybe late 2020 if things go perfectly. The vaccine will not be through FDA approval until after September and that doesn't factor in the EMA,ASEC, HC or the rest of the world's regulatory bodies. Not only will they need to get FDA approval for the drug itself, but the manufactring process will need to be approved as well. They have completed initial trials, but have yet to go into any sort of major production and that will take them past September just to get enough for a decent batch of drugs. They need to stop saying things like widely available. 

Yeah, I'm hoping a few vaccines to be widely available for the public in early 2021. If it's at the end of 2020- that'd be insane, but unlikely. 

The US will have around 200 million of the Oxford vaccine being delivered in the fall of 2020-early 2021. Moderna's vaccine may also be delivering doses in the fall and really ramping up at the end of the year. Of course, this is if everything goes PERFECTLY, but even vaccinating health care workers and those at high-risk will have a very positive impact.

There may be a light at the end of the tunnel here. We just need to stay diligent until then. Also, I'm keeping a keen eye on treatment in the coming months. Here's to hoping we start turning the tide of this war in the coming months. 

[seriously27]

11 minutes ago, ramssuperbowl99 said:

That's a bummer - can you share why they haven't gotten further along?

I talked about it in an earlier post when they first started talking about millions of doses being released to the public by October. It's simply a matter of scheduling and timing. No one is at fault really. The manufacturing side of the process just takes a long time. Assume the first couple of batches are engineering runs to test the process itself, you are talking about a month to a month and a half of process. That process has to be validated(including all equipment) That process will then  have to be released by the FDA and that will take a little bit of time as well.(but this will be the portion that will be fast-tracked) Then each run after that will take about two months from vial thaw to purification. This is only the first 2/3rds of the process as you have the fill finish or bottling/syringe phase as well. This process will also have to take place at an FDA approved facility and will have to have it's own sterile process approved. I think it's feasible to say they could have a lot of product on the market in early December but like I said, that's if everything goes perfectly. 

Edited July 20, 2020 by seriously27

[seriously27]

10 minutes ago, Mega Ron said:

If it meets our standards, it will more than meet yours.

If this is a critique about the standards of the FDA vs the EMA I think you'll find the EMA actually get's highly criticized for releasing drugs and medical device approvals too quickly, to the detriment of patient safety. Now don't get me wrong, the FDA sits on the other side of that coin and have neen notoriously slow to release things and that has caused issues with patient health and need. 

But to state the EMA has better standards than the FDA is simply just an idea that the US is a joke right now, so they must be the worst at everything. 

[WizeGuy]

12 minutes ago, seriously27 said:

I talked about it in an earlier post when they first started talking about millions of doses being released to the public by October. It's simply a matter of scheduling and timing. No one is at fault really. The manufacturing side of the process just takes a long time. Assume the first couple of batches are engineering runs to test the process itself, you are talking about a month to a month and a half of process. That process has to be validated(including all equipment) That process will then  have to be released by the FDA and that will take a little bit of time as well.(but this will be the portion that will be fast-tracked) Then each run after that will take about two months from vial thaw to purification. This is only the first 2/3rds of the process as you have the fill finish or bottling/syringe phase as well. This process will also have to take place at an FDA approved facility and will have to have it's own sterile process approved. I think it's feasible to say they could have a lot of product on the market in early December but like I said, that's if everything goes perfectly. 

Thank you for the insight! I'm still dumbfounded at how fast this is coming along.