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Tue Mar 2, 2021, 09:02 AM

Biden to announce 'historic partnership': Merck will help make Johnson & Johnson coronavirus vaccine

Last edited Tue Mar 2, 2021, 09:33 AM - Edit history (1)

Source: Washington Post

President Biden will announce Tuesday that pharmaceutical giant Merck & Co. will help make Johnson & Johnson’s single-shot coronavirus vaccine — an unusual pact between fierce competitors that could sharply boost the supply of the newly authorized vaccine, according to senior administration officials. The officials, who spoke on the condition of anonymity to discuss a matter that has not been announced, said they began scouring the country for additional manufacturing capacity after they realized in the first days of the administration that Johnson & Johnson had fallen behind in vaccine production.

They soon sought to broker a deal with Merck, one of the world’s largest vaccine makers, which had tried and failed to develop its own coronavirus vaccine. Under the arrangement, Merck will dedicate two facilities in the United States to Johnson & Johnson’s shots. One will provide “fill-finish” services, the last stage of the production process during which the vaccine substance is placed in vials and packaged for distribution. The other will make the vaccine itself, and has the potential to vastly increase supply, perhaps even doubling what Johnson & Johnson could make on its own, the officials said.

“It’s a historic partnership,” said one of the officials, adding that the companies “recognize this is a wartime effort.” He praised their sense of “corporate citizenship.” The officials declined to provide details about how Merck’s involvement will affect the projected supply of the Johnson & Johnson vaccine and the timetable for distributing it. It could easily take two months to get the “fill-finish” plant ready and a few more months to equip the other facility to make the vaccine, according to a person familiar with the process who spoke on the condition of anonymity because he was not authorized to discuss the issue.

The Biden administration’s efforts to ramp up production of the Johnson & Johnson vaccine suggest that it sees the vaccine playing a bigger role in addressing the challenges ahead, such as the eventual need for children’s vaccine and possibly for boosters to counter virus variants, said a person familiar with the situation who spoke on the condition of anonymity because he was not authorized to discuss it. Johnson & Johnson is conducting a trial of a two-shot vaccine, with the doses given two months apart, with results not expected until at least May. Johnson & Johnson did not respond to a request for comment. Merck did not comment on the deal but said it “remains steadfast in our commitment to contribute to the global response to the pandemic.''

Read more: https://www.washingtonpost.com/health/2021/03/02/merck-johnson-and-johnson-covid-vaccine-partnership/



Full headline: Biden to announce ‘historic partnership’: Merck will help make Johnson & Johnson coronavirus vaccine, officials say

This is interesting. As far as I know, Merck has sat this out...

ETA - here is an article I found that indicated that back in January, Merck was looking at getting into the action as a partner - https://www.fiercepharma.com/pharma/merck-after-canning-covid-19-vaccine-programs-talks-to-help-shot-production

Pharma
Merck canned its own COVID-19 vaccines. Now, it's in talks to manufacture other companies' shots

by Eric Sagonowsky | Feb 11, 2021 10:00am


After Merck & Co. got off to a late start in the COVID-19 vaccine race and made an early exit, the drug giant is in talks to aid the global vaccine manufacturing effort. The drugmaker is “actively involved” in discussions with governments, health agencies and other pharmaceutical companies to “identify the areas of pandemic response where we can play a role, including potential support for production of authorized vaccines," a spokesman said via email.

News of the talks comes about two weeks after Merck abandoned both its coronavirus vaccine candidates—one it acquired through its Themis buyout and the other it was studying in partnership with IAVI. Merck said the two shots had produced immune responses weaker than those prompted by natural infections as well as by other COVID-19 vaccines.Still, the company believes it has an “important responsibility to contribute to the pandemic response," the spokesman said, and remains "at the ready to do so."

While Merck hasn't indicated which companies it could help with production, there has been industry talk about a potential tie-up with Novavax. After the vaccine biotech last month presented positive phase 3 data on its candidate, Evercore ISI analyst Josh Schimmer said he suspected Merck might "step up" as Novavax's manufacturing partner. Novavax CEO Stan Erck then told CNBC's Meg Tirrell that Merck "could be a good partner for us as they don't have a competing product." He also named GSK as a company with those capabilities. At the time, Merck told Tirrell it was focused on therapeutics.

(snip)

Also this week, Teva said it was in talks to help with COVID-19 vaccine production. The company has sites in Israel, Europe and the U.S. that could be used in the global effort, CEO Kåre Schultz said, according to The Wall Street Journal.

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Reply Biden to announce 'historic partnership': Merck will help make Johnson & Johnson coronavirus vaccine (Original post)
BumRushDaShow Mar 2021 OP
Auggie Mar 2021 #1
BumRushDaShow Mar 2021 #2
Auggie Mar 2021 #4
2naSalit Mar 2021 #3
NJCher Mar 2021 #5
BumRushDaShow Mar 2021 #7
lkinwi Mar 2021 #6
Arkansas Granny Mar 2021 #8
Botany Mar 2021 #9
bucolic_frolic Mar 2021 #10
Post removed Mar 2021 #11
BumRushDaShow Mar 2021 #12
Bear Creek Mar 2021 #13
BumRushDaShow Mar 2021 #14
Bear Creek Mar 2021 #16
BumRushDaShow Mar 2021 #19
tinrobot Mar 2021 #23
Post removed Mar 2021 #35
tinrobot Mar 2021 #42
TwilightZone Mar 2021 #63
FBaggins Mar 2021 #26
Bear Creek Mar 2021 #37
FBaggins Mar 2021 #48
TwilightZone Mar 2021 #65
lagomorph777 Mar 2021 #30
Deminpenn Mar 2021 #47
SheltieLover Mar 2021 #15
Bear Creek Mar 2021 #17
SheltieLover Mar 2021 #18
BumRushDaShow Mar 2021 #21
SheltieLover Mar 2021 #22
BumRushDaShow Mar 2021 #28
Post removed Mar 2021 #24
ForgoTheConsequence Mar 2021 #54
BumRushDaShow Mar 2021 #59
ForgoTheConsequence Mar 2021 #75
BumRushDaShow Mar 2021 #20
SheltieLover Mar 2021 #25
BumRushDaShow Mar 2021 #33
SheltieLover Mar 2021 #44
BumRushDaShow Mar 2021 #49
SheltieLover Mar 2021 #50
lagomorph777 Mar 2021 #31
Bear Creek Mar 2021 #39
ForgoTheConsequence Mar 2021 #52
Tommymac Mar 2021 #40
BumRushDaShow Mar 2021 #45
lagomorph777 Mar 2021 #27
House of Roberts Mar 2021 #29
lagomorph777 Mar 2021 #32
House of Roberts Mar 2021 #36
lagomorph777 Mar 2021 #38
BumRushDaShow Mar 2021 #53
Tommymac Mar 2021 #41
lagomorph777 Mar 2021 #43
BumRushDaShow Mar 2021 #34
h2ebits Mar 2021 #46
BumRushDaShow Mar 2021 #56
Yo_Mama_Been_Loggin Mar 2021 #58
BumRushDaShow Mar 2021 #60
Steelrolled Mar 2021 #67
BumRushDaShow Mar 2021 #69
Steelrolled Mar 2021 #73
h2ebits Mar 2021 #68
BumRushDaShow Mar 2021 #70
BobTheSubgenius Mar 2021 #51
Jon King Mar 2021 #55
Yo_Mama_Been_Loggin Mar 2021 #57
mwooldri Mar 2021 #61
BumRushDaShow Mar 2021 #66
Bayard Mar 2021 #62
BumRushDaShow Mar 2021 #71
SharonClark Mar 2021 #64
oasis Mar 2021 #72
mpcamb Mar 2021 #74

Response to BumRushDaShow (Original post)

Tue Mar 2, 2021, 09:07 AM

1. Now that's unity!

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Response to Auggie (Reply #1)

Tue Mar 2, 2021, 09:08 AM

2. I'm sure they are gonna get a cut outta that!

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Response to BumRushDaShow (Reply #2)

Tue Mar 2, 2021, 09:16 AM

4. For sure ...

Merck recoups some of the money spent on R&D. Smart business move.

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Response to BumRushDaShow (Original post)

Tue Mar 2, 2021, 09:10 AM

3. Sweet!

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Response to BumRushDaShow (Original post)

Tue Mar 2, 2021, 09:16 AM

5. Fantastic news!

Happy to wake up to this.

I wonder if some of the manufacturing will be done here in nj. We are the nation’s pharmaceutical capitol.

🧪. 💊. 🔬. 💉.

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Response to NJCher (Reply #5)

Tue Mar 2, 2021, 09:27 AM

7. I expect their vaccine production is done at different facitlies

than their pharmaceuticals. They already had plans to expand their large NC campus for other vaccines and therapeutics that they do and and had been looking at other states for vaccine production (article from 2019) - https://www.pharmaceuticalonline.com/doc/merck-new-manufacturing-facility-north-carolina-support-hpv-vaccine-production-0001


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Response to BumRushDaShow (Original post)

Tue Mar 2, 2021, 09:20 AM

6. Great news!

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Response to BumRushDaShow (Original post)

Tue Mar 2, 2021, 09:27 AM

8. This is great news.

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Response to BumRushDaShow (Original post)

Tue Mar 2, 2021, 09:29 AM

9. Grown ups are back

Nice to see this news.

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Response to BumRushDaShow (Original post)

Tue Mar 2, 2021, 09:33 AM

10. This is a BFD

You can have the vaccine formulae, you can have distribution, you can have the money to pay for it, but you must have the manufacturing capacity. Whether its the Defense Production Act or just brokering a deal, this is great news, not just for the US but for the world.

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Response to BumRushDaShow (Original post)


Response to Post removed (Reply #11)

Tue Mar 2, 2021, 10:06 AM

12. Janssen (J&J's company) is going through a trial with a double shot

to determine if there is increased efficacy.

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Response to BumRushDaShow (Reply #12)

Tue Mar 2, 2021, 10:09 AM

13. Until proven

It should not have been approved.

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Response to Bear Creek (Reply #13)

Tue Mar 2, 2021, 10:12 AM

14. None of the vaccines are "approved"

They simply have "Emergency Use Authorization".

The flu vaccines are "approved". The polio vaccines are "approved". The COVID-19 vaccines are not "approved".

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Response to BumRushDaShow (Reply #14)

Tue Mar 2, 2021, 10:17 AM

16. The others offer better protection

This one has proven not be be as good and until it can prove to have the same results needs to be on hold.

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Response to Bear Creek (Reply #16)

Tue Mar 2, 2021, 10:33 AM

19. In general, there is pre-set criteria for efficacy of vaccines

and that is at least 50% effective. COVID-19 vaccine guidance (FDA PDF).

The FDA's cutoff for Covid-19 vaccine effectiveness is 50 percent. What does that mean?
No vaccine is 100 percent effective, but some work better than others.

Nov. 3, 2020, 4:58 AM EST
By Jacqueline Stenson

Over the summer, the Food and Drug Administration announced that in order for an experimental Covid-19 vaccine to get the green light, it would need to be safe and “prevent disease or decrease its severity in at least 50 percent of people who are vaccinated.”

In fact, no vaccine is 100 percent effective, but some work better than others. One of the most successful is the measles vaccine — two doses are 97 percent effective in preventing the disease, according to the Centers for Disease Control and Prevention. Still, 50 percent sounds like a far cry from 97 percent.

“I know that 50 percent does sound low but that is still some protection, and some protection is better than no protection,” said Dr. Jeff Kwong, professor of public health and family medicine and interim director of the Centre for Vaccine Preventable Diseases at the University of Toronto.

Based on the effectiveness threshold the FDA has set for a Covid-19 vaccine to be approved or granted emergency use authorization, it’s possible a vaccine becomes available that helps only half of people receiving it, while offering no benefit to the other half. It’s also possible that a vaccine could have different effects in different people – helping to prevent disease in some people while reducing the severity of Covid-19 in others.

https://www.nbcnews.com/health/health-news/fda-s-cutoff-covid-19-vaccine-effectiveness-50-percent-what-n1245506


Even with the annual flu vaccine(s), you are lucky to get 50 - 60% effectiveness if they can target the right ones that will end up in circulation here in the northern/western hemisphere.

Here is the general process for vaccine development - https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/vaccine-development-101

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Response to Post removed (Reply #11)

Tue Mar 2, 2021, 10:51 AM

23. Please stop spreading fear. The shot highly effective.

The vaccine was tested at a later time under different conditions than the 2 shot vaccines. This was at a point in time where the virus was raging. It was also tested in South Africa, where the variants are spreading.

It has proven to be highly effective against severe cases, hospitalization, and death.

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Response to tinrobot (Reply #23)


Response to Post removed (Reply #35)

Tue Mar 2, 2021, 11:54 AM

42. Again, please stop spreading misinformation. It does not help.

If the J&J vaccine was not effective, it would not have been approved.

Here's a more in-depth analysis of the different ways the vaccines were tested:

https://www.statnews.com/2021/02/02/comparing-the-covid-19-vaccines-developed-by-pfizer-moderna-and-johnson-johnson/

But comparing the efficacy of those vaccines to the efficacy of Johnson & Johnson’s is challenging because of differences in the designs of the Phase 3 clinical tests — essentially the trials were testing for different outcomes. Pfizer’s and Moderna’s trials both tested for any symptomatic Covid infection. Pfizer started counting cases from seven days after receipt of the second dose of vaccine, while Moderna waited until day 14 to start counting cases.

J&J, by contrast, sought to determine whether one dose of its vaccine protected against moderate to severe Covid illness — defined as a combination of a positive test and at least one symptom such as shortness of breath, beginning from 14 or 28 days after the single shot. (The company collected data for both.)

Because of the difference in the trials, making direct comparisons is a bit like comparing apples and oranges. Additionally, Pfizer and Moderna’s vaccines were tested before the emergence of troubling new variants in Britain, South Africa, and Brazil. It’s not entirely clear how well they will work against these mutated viruses.


Different vaccines, tested differently in different places at different times. ALL of them provided excellent protection against severe disease and death. Spreading misinformation does not help get us through this.

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Response to Post removed (Reply #35)

Tue Mar 2, 2021, 02:23 PM

63. "It is not effective"

This is a patently false statement.

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Response to Post removed (Reply #11)

Tue Mar 2, 2021, 11:01 AM

26. Sorry - That's a badly misguided analysis

We do not actually know that it "does not provide the protection" that the other vaccines provide. You see a moderately lower percentage and assume that you know what it means and can compare the two... but it isn't "apples to apples".

There are many reasons to believe that this option could be better overall than the existing two vaccines approved for emergency use.

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Response to FBaggins (Reply #26)

Tue Mar 2, 2021, 11:46 AM

37. Actually it has

Been shown. The 2 companies involved have dubious business practices. J & J with the opiate emergency and Merck with pushing drug for not approved use.

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Response to Bear Creek (Reply #37)

Tue Mar 2, 2021, 12:16 PM

48. No... it most certainly has not

Your concerns re: their business practices or other drugs that they manufacture have exactly nothing to do with how effective their vaccine is relative to the other two currently on the list and/or whether it makes sense for the new offering to be included beside them.



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Response to Bear Creek (Reply #37)

Tue Mar 2, 2021, 02:32 PM

65. That has nothing to do with the efficacy of the vaccine.

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Response to Post removed (Reply #11)

Tue Mar 2, 2021, 11:06 AM

30. Only J&J has even been tested against variants. Your comparison is unfounded.

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Response to Post removed (Reply #11)

Tue Mar 2, 2021, 12:15 PM

47. Also tested in a different environment than Moderna/Pfizer

whose trials took place before the many mutations began to appear.

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Response to BumRushDaShow (Original post)

Tue Mar 2, 2021, 10:16 AM

15. Great, but too bad they aren't producing more of the more effective vaccines

Not sure why anyone would want more of the less effdctive vaccine?

Maybe manufacturing issues. Dunno.

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Response to SheltieLover (Reply #15)

Tue Mar 2, 2021, 10:21 AM

17. Exactly

This makes me wonder who they are going to target as the customer for this vaccine.

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Response to Bear Creek (Reply #17)

Tue Mar 2, 2021, 10:28 AM

18. Exactly!

1st article I saw on this approval said great for rural areas & sailors - people who might not present for 2nd dose for various reasons.

There might well be issues I am not aware of, but upping production of vaccines with much higher efficacy would seem to be a smarter choice.

It sounds like dumming down the vax process from where I'm sitting.

All that said, I do trust Joe's judgment.

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Response to SheltieLover (Reply #18)

Tue Mar 2, 2021, 10:45 AM

21. You're not a scientist are you?

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Response to BumRushDaShow (Reply #21)

Tue Mar 2, 2021, 10:49 AM

22. No I'm not

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Response to BumRushDaShow (Reply #21)

Tue Mar 2, 2021, 11:06 AM

28. Hopefully this explains a little why this is going the way it is

https://www.democraticunderground.com/?com=view_post&forum=1014&pid=2704887

Remember that there is NO COVID-19 vaccine "approved for normal use". All of them ONLY have "Emergency Use Authorization" due to the severity of this terrible pandemic.

So you are seeing something a bit unprecedented because of the fast-track nature to allow the mass vaccinations in order to try to get a handle on this virus since lockdowns and other measures like mask-wearing, are obviously not working well.

Over time, there will be MUCH "tweaking" of all of them and the trials are continuing. In fact as I understand, they are all also working on alterations and/or boosters to deal with the variants. That is what happens yearly with the flu vaccine.

Each year they look at which variants of Influenza are circulating in Asia/Australia and then try to estimate/guess which ones may end up being prevalent here and will select those to come up with a vaccine to use in the annual flu shot. In many cases, the guesses "fail".

For example as reported at the beginning of 2020, CDC released their report on the 2019 flu vaccine effectiveness as reported here -

CDC Releases Interim Flu Vaccine Effectiveness Report

February 26, 2020 10:01 am Chris Crawford -- According to a Feb. 21 CDC Morbidity and Mortality Weekly Report, the current influenza vaccine has been 45% effective overall against 2019-2020 seasonal influenza A and B viruses.

Specifically, the flu vaccine has been 50% effective against influenza B/Victoria viruses and 37% effective against influenza A(H1N1)pdm09.

According to former AAFP Vaccine Science Fellow John Epling, M.D., M.S.Ed., of Roanoke, Va., that means the vaccine is about as effective as it typically is in a season when it offers a decent match to circulating influenza antigens.

"The meaning of the effectiveness number gets misinterpreted frequently," he told AAFP News. "While we would all want an even more effective vaccine, it remains the best way we have to prevent flu and its complications."

https://www.aafp.org/news/health-of-the-public/20200226interimfluve.html


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Response to SheltieLover (Reply #18)


Response to Post removed (Reply #24)

Tue Mar 2, 2021, 12:51 PM

54. You're implying that this is the result of campaign contributions to Biden's campaign?

Good Lord.

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Response to ForgoTheConsequence (Reply #54)

Tue Mar 2, 2021, 01:27 PM

59. Glad that got removed

(meaning that's it for any more posting in this thread)

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Response to BumRushDaShow (Reply #59)

Tue Mar 2, 2021, 07:29 PM

75. Same here.

Pretty vulgar to assume that our President is allowing a lesser vaccination because of campaign contributions. You can have conversations about things without wading into conspiracy theories or outside of your area of understanding.

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Response to SheltieLover (Reply #15)

Tue Mar 2, 2021, 10:45 AM

20. Remember that NORMAL vaccine devopment is a *multi-year* process

It hasn't even been a year since they started working on this. Most of the initial trial phases didn't even start until around May or so.

But consider two other things -

1.) This vaccine is a more "traditional" type that utilizes some type of viral material to trigger the body's antibody reaction versus the novel way (using messenger RNA a/k/a "mRNA" ) to do the same as attempted by Pfizer & Moderna (i.e., which don't use any viral material at all). What Janssen/J&J has done is pretty much how EVERY other vaccine is developed. They seemed to have a better outcome than GSK/Sanofi's attempt or even Merck's attempt using the "traditional" method.

2.) Vaccines like the flu vaccines don't have the type of effectiveness as being demanded for these. You are lucky to get 60% out of an annual flu vaccine.

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Response to BumRushDaShow (Reply #20)

Tue Mar 2, 2021, 10:55 AM

25. Ty for sharing insights!

I'm sure they are going for herd immunity but, as an individual, I would be furious if someone tried go get me to take the less effective one. Or if that were the only vax available...

Just trying to understand.

Again, this must be a good decision or else Joe wouldn't have brokered the deal.

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Response to SheltieLover (Reply #25)

Tue Mar 2, 2021, 11:16 AM

33. Also see this (I think I stuck it in the wrong place)



https://www.democraticunderground.com/?com=view_post&forum=1014&pid=2704908

I know they keep using that damn term "herd immunity" but we have never had "herd immunity" with stuff like "the common cold" or "the flu" (which is what this is closer to) vs polio or measles or chicken pox, and it really gets my goat for them to keep repeating that term. Respiratory viruses are hard to deal with vs other viruses like the ones mentioned or tetanus, Hepatitis, or HPV, etc.

This virus may have to be taken care of like we do with the flu shot (a yearly booster thing).

As I understand it after watching FDA/CBER's Vaccine Advisory Committee meeting last Friday, they are trialing what happens with a 2nd dose of this vaccine.

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Response to BumRushDaShow (Reply #33)

Tue Mar 2, 2021, 12:02 PM

44. Ty again!

You are very kind to share!

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Response to SheltieLover (Reply #44)

Tue Mar 2, 2021, 12:19 PM

49. YW

We are gonna be stuck with this for awhile, just like how the "bird flu" (H5N1) and the "swine flu" (H1N1 - a variant of which caused the 1918 Flu pandemic) pop up every once in awhile... although neither of those were as virulent as this, and this isn't even as bad as something like Ebola, which is fortunately not as widespread or prevalent because it's not a "respiratory" virus like COVID-19).

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Response to BumRushDaShow (Reply #49)

Tue Mar 2, 2021, 12:20 PM

50. No doubt!

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Response to SheltieLover (Reply #15)

Tue Mar 2, 2021, 11:07 AM

31. Unfair comparison. J&J's lower number includes variants. The others were tested pre-variant.

So don't go assuming that J&J is, in reality, less effective.

It also has some massive advantages:
Single Dose.
Simple Storage and shipment.

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Response to lagomorph777 (Reply #31)

Tue Mar 2, 2021, 11:47 AM

39. Sorry

What that is what has been shown.

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Response to Bear Creek (Reply #39)

Tue Mar 2, 2021, 12:39 PM

52. You're intentionally spreading misinformation.

Misinformation that could be harmful and confusing. You're not an immunologist or epidemiologist, stay in your lane and stop spreading Facebook like misinformation.

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Response to SheltieLover (Reply #15)

Tue Mar 2, 2021, 11:49 AM

40. Profits. We live in a Global Corporate Oligarchy, never forget that simple fact.

If there is money to be made, the actual benefit to the common person is secondary.

I am a staunch Democrat, but I do recognize that Our party has it's corporate side too. Fortunately, We the People can still have a say, unlike the Authoritarian QOP Party.

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Response to Tommymac (Reply #40)

Tue Mar 2, 2021, 12:11 PM

45. I mentioned upthread that for big pharma

vaccines are NOT a money-maker and that is why they rarely get into the manufacturing of them, usually only when countries beg them to make them (and probably offer subsidies and other incentives to do so).

What happened with COVID-19 seems to have changed the whole equation and business model due to the severity of the diseases it causes, the fatality rate that is higher than other very prevalent viruses (like Influenza), and how widespread it has been. So now you will see more and more jumping on the bandwagon - which because of the virulence of this virus, is good. But it is also unfortunate because just plain common sense measures like wearing a damn mask, have failed.

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Response to BumRushDaShow (Original post)

Tue Mar 2, 2021, 11:04 AM

27. See!! I knew they could do this! It's a win-win-win!

Merck has idle capacity to exploit, after their failed project. J&J will surely collect royalties. And the public gets more shots.

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Response to BumRushDaShow (Original post)

Tue Mar 2, 2021, 11:06 AM

29. February 11th, Biden announced a contract extension with Pfizer and Moderna.

https://www.washingtonpost.com/health/2021/02/11/vaccine-supply-biden/

President Biden said Thursday that his administration had finalized deals for another 200 million doses of the two coronavirus vaccines authorized in the United States, giving the country enough vaccine by the end of July to cover every American adult.


Every American adult. Why are all the administration officials working so hard to sell the public on this Johnson and Johnson vaccine? I always become skeptical when I get the high pressure pitch on anything. On Sunday, Fauci and every other medical expert went overboard to convince people the J&J vaccine was just as good as Pfizer and Moderna. It's not. I worry we're having our expectations lowered to accept less as good enough.

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Response to House of Roberts (Reply #29)

Tue Mar 2, 2021, 11:08 AM

32. Pfizer and Moderna's tests were before the variants. J&J's number includes South African and others

Totally unfair comparison.

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Response to lagomorph777 (Reply #32)

Tue Mar 2, 2021, 11:46 AM

36. Can you show results of the J&J vaccine against the new variants

COMPARED to the earlier strain?

Moderna has tested their vaccine against the new variants, as soon as they were discovered, and are prepared to produce booster shots as needed. As of a month ago, they weren't needed.
The RNA based vaccine can be re-engineered much more quickly to counter new strains than the DNA based.

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Response to House of Roberts (Reply #36)

Tue Mar 2, 2021, 11:47 AM

38. No. The testing coincided with variant emergence.

Also, I don't run the tests.

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Response to House of Roberts (Reply #36)

Tue Mar 2, 2021, 12:47 PM

53. Here is a link to the FDA/CBER's Vaccine Advisory Committee's meeting with them last Friday

https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-february-26-2021-meeting-announcement

If you scroll down, there are links to all of the presentation slides (including their trial data and reported adverse effects, etc).

This slide (PDF) has info on this vaccine in general including the variants - https://www.fda.gov/media/146218/download

This one (PDF) also discusses the types and prevalence of the variants - https://www.fda.gov/media/146264/download

There is also recording of the entire session (I watched the whole thing from 9am ET until almost 5:30 pm ET on 2/26/21) -



One of the Vaccine Advisory Board members is located here in Philly (Dr. Dr. Paul Offit who is currently Director of Philadelphia's Children's Hospital Vaccine Education Center and also a co-inventor of a rotavirus vaccine).

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Response to lagomorph777 (Reply #32)

Tue Mar 2, 2021, 11:51 AM

41. Please post a link to the studies otherwise this is just opinion.

Thanks.

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Response to House of Roberts (Reply #29)

Tue Mar 2, 2021, 11:40 AM

34. Here is the irony of this situation

In general, "vaccines" are loss-leaders for big pharma so they usually have to be begged to "please please make some" because they make little or no money on them.

So many of the "big boys" sat this out and smaller companies like Moderna (or some of the subsidiaries of the bigger companies and/or partnerships like Pfizer did) were working on some after the ugly predecessor virus SARS-CoV-1 (commonly called "SARS" in 2003) - possibly so they could exploit the Asian market with a vaccine. But their doing that actually helped to get them in on the ground floor of development early on and thus in position to be ready to go with some vaccine candidates so they could set up trials very quickly.

Meanwhile the "big boys" like Merck and J&J and GSK sortof sat back or tried some halting efforts until they facepalmed with an "Oh shit!" and realized they were now missing out on not just one or two continents' cha-chings, but the WHOLE world's CHA-CHING - $$$$$$$$$!

So here we are.

I expect some of the push (although this vaccine is actually being made by a J&J subsidiary Janssen Pharmaceuticals which is HQ'd in Belgium) is that J&J is an "American company".

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Response to BumRushDaShow (Original post)

Tue Mar 2, 2021, 12:14 PM

46. This is such good news for the entire world. THANK YOU for sharing

This is a pandemic that we are dealing with and we have worldwide shortages of vaccines to fight it off. A number of countries have not received any--or minimal--amounts of vaccine.

Biden boosted production by invoking the National "whatever it is called" Act and now the big production numbers will help boost worldwide coverage of the vaccines.

Science, ingenuity, pharma companies stepping up to share production facilities around the world, logistical distribution--helping each other globally to fix a GLOBAL problem.

It makes me so happy to read the news that you shared. THANK YOU!

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Response to h2ebits (Reply #46)

Tue Mar 2, 2021, 01:05 PM

56. "Biden boosted production by invoking the National 'whatever it is called' Act"



Defense Production Act (codified in 50 USC Ch. 55)

Biden to use Defense Production Act for gloves, COVID-19 vaccines

60 million more at-home tests will be available by end of summer, administration says


By Ariel Cohen
Posted February 5, 2021 at 3:24pm

The White House COVID-19 task force announced Friday that the Biden administration plans to use the Defense Production Act to ramp up manufacturing of COVID-19 vaccines, surgical gloves and at-home testing kits as part of an effort to increase supplies and reduce long-term dependence on foreign suppliers. The administration said it will use the DPA to contract with six more COVID-19 at-home test suppliers, which should result in more than 60 million at-home tests becoming available by the end of the summer.

This news comes just days after the administration announced a $231.8 million deal with at-home COVID-19 test-maker Ellume to produce 100,000 test kits per month for the United States from February to July, with a goal of ramping that number up to 19 million tests per month by the end of the year. The COVID-19 task force did not yet disclose who makes the tests or how much the tests will cost, as the contracts aren't final. COVID-19 Response Team Supply Coordinator Tim Manning said the U.S. would work with these companies to construct new domestic plants and production lines.

The administration also plans to help Pfizer ramp up its COVID-19 vaccine production by expanding the priority rating on Pfizer's vaccine production contract to ensure the drugmaker gets first dibs on specific products and materials it needs to produce vaccines. This will now include filling pumps and tangential flow filtration skid units, two critical components of vaccine manufacturing. This action should have an immediate impact, officials said. This move could help Pfizer reach its production goals of delivering 200 million doses of its COVID-19 vaccine to the U.S. by May. Since Jan. 20, the new administration has increased vaccine supplies to states by more than 20 percent. Right now, one of the factors restraining manufacturing is limited equipment and ingredients, Manning said.

Finally, the administration said it will leverage the DPA to increase the production of surgical gloves, something the country needs more of now. Currently, the U.S. is nearly completely reliant on overseas manufacturers of surgical gloves, Manning said. So, the United States will build plants to produce the raw materials for surgical gloves so they can be produced in the U.S. By the end of the year, the administration hopes to make 1 billion nitrile gloves per month in the U.S, although this will satisfy only half of the country's demand for surgical gloves. Due to procurement law restrictions, the task force cannot say who it is contracting with until the contracts are finalized. Manning said the contracts usually take about four to five weeks to finalize and officials are roughly halfway through the process, so more details are expected to be released in the coming weeks.

https://www.rollcall.com/2021/02/05/biden-to-use-defense-production-act-for-gloves-covid-19-vaccines/

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Response to BumRushDaShow (Reply #56)

Tue Mar 2, 2021, 01:21 PM

58. Yes and the orange dumbass was advised to do the same

Instead he put boy blunder Jared in charge of everything.

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Response to Yo_Mama_Been_Loggin (Reply #58)

Tue Mar 2, 2021, 01:34 PM

60. They had Ford and GM make lots of ventilators

that now sit unused. The NEED was for masks and gloves and other PPE (which is still a need)... but...Jared.

The U.S. forced major manufacturers to build ventilators. Now they’re piling up unused in a strategic reserve.

By Faiz Siddiqui
August 18, 2020 at 7:00 a.m. EDT

SAN FRANCISCO — Months into a $3 billion U.S. effort to manufacture tens of thousands of ventilators to stave off coronavirus deaths, the government stockpile is facing a glut. General Motors and Ford by early May began delivering the first ventilators they scrambled to manufacture, in part compelled by President Trump’s invocation of the federal Defense Production Act. General Electric, Philips and other manufacturers’ efforts have delivered more than 94,000 of them to the stockpile, and General Motors plans to soon hand over its business to a counterpart.

During the first weeks of the covid-19 crisis in March, health officials panicked over an anticipated shortage of ventilators, breathing machines that were essential to help keep patients alive. But during the months it took for companies to develop their supply chains, test prototypes and train workers to build them, the approach to treating covid-19 changed. Now, unexpectedly, the vast majority of ventilators are going unused. The Department of Health and Human Services said it had handed out 15,057 ventilators by Friday, and there were 95,713 ventilators in the federal stockpile. Of those, 94,352 came from contracts signed since the beginning of the pandemic.

“In the fog of war against the virus, we were trying to do our best to protect the health and safety of the American people,” said Peter Navarro, White House trade adviser and Defense Production Act policy coordinator. “In this particular chess game, the best move was to make sure we had too many ventilators rather than too few.” Navarro said that excess ventilators will be used to help other countries fighting the novel coronavirus, either as revenue-generating exports or as donations.

The misalignment between the availability and need for ventilators shows that the medical understanding of and response to the coronavirus has moved faster than companies can adapt. And for Ford, which got the order to supply the largest quantity of ventilators to the federal stockpile, production and delivery were delayed, further throwing it out of sync with the pandemic needs.

https://www.washingtonpost.com/business/2020/08/18/ventilators-coronavirus-stockpile/

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Response to BumRushDaShow (Reply #60)

Tue Mar 2, 2021, 02:48 PM

67. I think they had to do the ventilator push

There were daily stories from NYC and Italy about ventilator numbers, and how doctors were going to have to decide who gets a ventilator and who dies.

The "fog of war" is an apt metaphor - the medical establishment didn't really know the best treatments and were learning as they went.

I have learned a little about what I should and shouldn't expect from the medical establishment. Everyone is working more-or-less towards the goal, but human nature causes detours.

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Response to Steelrolled (Reply #67)

Tue Mar 2, 2021, 03:15 PM

69. When this was going on

my concern was them using the car companies vs using vacuum companies like Dyson (which had started making them in the UK), as they could be ready to roll much faster. So time was wasted trying to come up with designs and training, etc., to force-fit this type of product within companies that really didn't have that type of expertise as part of their base product lines.

And yes I recall when NY was going through their peak nightmare number of cases early on and the shortage of ventilators issue, so there was a real need. But had they made a better decision on WHO would make them, then what eventually turned out to have been a short-term need, could have been filled faster.

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Response to BumRushDaShow (Reply #69)

Tue Mar 2, 2021, 05:31 PM

73. I was skeptical of the whole plan, having lots of experience with big companies,

but in my career there have been cases where the "answer is known" whether you believe in it or not, and you just do it.

I imagine there were voices in the wilderness saying we aren't going to need all those ventilators, but of course they were in the wilderness.

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Response to BumRushDaShow (Reply #56)

Tue Mar 2, 2021, 03:01 PM

68. LOL--Whatever it takes to get my thoughts out

Thanks for updating it for me.

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Response to h2ebits (Reply #68)

Tue Mar 2, 2021, 03:16 PM

70. I know the feeling!



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Response to BumRushDaShow (Original post)

Tue Mar 2, 2021, 12:32 PM

51. The "wartime effort" was one of the things I was going to mention.

This does have more than a slight tinge of the WW2 manufacturing efforts. WW1, for that matter. Did you know that a campaign to conserve steel for the war effort was a major factor in the switch from corsets to bras? Also, the constriction of corsets made them totally unsuitable for the new phenomenon of women in large numbers working in factories.

But I digress.

It unnerved me a little to read that phrase "Merck...tried and failed." It seems unlikely that they just could not manage it, but more that they decided they'd missed the window. Could be dead wrong, of course.

Something for which we really need more information to make a better judgment is the months it's going to take Merck to get up to speed. If you listen to politicians and public health authorities, it sounds to me that the massive vaccination effort will be well on its back end by the time Merck ships a single box. The time frame indicated in this article is at least 5 months, which is pretty concurrent with the level of vaccinations considered to be needed to have curbed this menace.

Is there something I've missed in that timeline? The start of the New Eras in both governance and pandemic eradication have got off to spectacular starts. Is this pace going to outstrip supply in the near future?

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Response to BumRushDaShow (Original post)

Tue Mar 2, 2021, 01:03 PM

55. Excellent work Biden-Harris administration...

Another day of a federal government working for the people, all the people.

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Response to BumRushDaShow (Original post)

Tue Mar 2, 2021, 01:18 PM

57. This is what a real president does Donny boy

Seriously, Trump was advised to invoke the Defense Production act to speed up PPE production and vaccine research. Instead he put boy blunder Jared in charge of everything.

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Response to BumRushDaShow (Original post)

Tue Mar 2, 2021, 01:50 PM

61. Good move. Similar to Sanofi and Pfizer.

Sanofi tried to make their own, didn't do so well. Their plants in Europe will be helping make and distribute the Pfizer / BioNTech vaccine.

https://www.sanofi.com/en/media-room/press-releases/2021/2021-01-27-07-30-00

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Response to mwooldri (Reply #61)

Tue Mar 2, 2021, 02:37 PM

66. I had seen where GSK/Sanofi were also going to try some of their other vaccine candidates

and hoped to have something by the end of this year...

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Response to BumRushDaShow (Original post)

Tue Mar 2, 2021, 02:17 PM

62. This is HUGE!

Two of the biggest pharma companies in the industry--and major competitors--joining forces for the greater good. I'm sure they'll get paid handsomely for their cooperation, but the effort to bring these two together deserves major accolades.

Wonder if Merck will continue manufacturing their own products in other areas of the plants. Brand security is a major concern.

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Response to Bayard (Reply #62)

Tue Mar 2, 2021, 03:33 PM

71. Of course Merck will do their own regular pharmaceutical stuff

Vaccines are usually a tiny part of what the big companies do and when the have gone through their buying sprees, they will often buy up smaller companies to do targeted products (under their name) like vaccines or orphan drugs, etc.

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Response to BumRushDaShow (Original post)

Tue Mar 2, 2021, 02:32 PM

64. Thank you for fighting back against the lazy misinformation of some of the posters.

And, yes, this is a good thing. Every person vaccinated is a victory.

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Response to BumRushDaShow (Original post)

Tue Mar 2, 2021, 05:27 PM

72. K and R

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Response to BumRushDaShow (Original post)

Tue Mar 2, 2021, 06:06 PM

74. There are a lot of untrained and unlicensed amateur epidemiologists around these days.

We need a lot of grains of salt.

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