COVID-19 Pandemic (Coronavirus)

[Malcolmxxx_23]

The people who are against mask and at the same time anti vax

 

[winb83]

This vaccination is for one strain of the Virus. This thing is creating new forms. One vac isn’t gonna end this. The flu shot exists yet people still get the flu because there’s multiple variations of it.

Face masks should continue on til at least a year from now.

It's not for a strand last I heard it's for the spike protein from COVID-19. It tricks your body into making a harmless version of it then your body detects that and eliminates it. It then knows how to deal with a virus with that spiked protein. When you get infected with COVID-19 it handles it quickly and without major complications because it's had practice dealing with something like it.

 

[null]

It's not for a strand last I heard it's for the spike protein from COVID-19. It tricks your body into making a harmless version of it then your body detects that and eliminates it. It then knows how to deal with a virus with that spiked protein. When you get infected with COVID-19 it handles it quickly and without major complications because it's had practice dealing with something like it.

That's another reason why we have to keep case numbers down. Each time the virus passes through a living organism it could mutate (transcription error, viral recombination with another pathogen). if the spike protein changes too much the vaccine induced antibodies won't recognise it.

This risk is why certain mutations were sufficient to justify the mink slaughters (denmark, the netherlands, ...) and also the reason why we await Boris' announcement tomorrow about the "new" UK strain.

Exclusive: Alarming new evidence on Coronavirus mutation could bring tougher restrictions

If it mutates a lot it might no longer be able to attach to ACE2/CD147 and therefore become "harmless", but the more strains you have and the more people it is in, the less likely it is that they will all just mutate away into harmlessness.

 

[CreepyMcCreeperson]

 

[King Kai]

Doesn't look a day over 210 either

 

[Benjamin Sisko]

Will the Johnson and Johnson vaccine be better then the ones being implemented now?

 

[null]

I found two docs on the FDA website. I'm not sure if they have been posted on here yet

No "anti-vax" blanket statements in here please

Pfizer-BioNTech COVID-19 Vaccine EUA Fact Sheet for HCP_0
https://www.fda.gov/media/144413/download

Spoiler: important cliffs

Rev is ed : 12/20201 FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS)EMERGENCY USE AUTHORIZATION (EUA) OFTHE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19)The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent C O VID-19 in individuals 16 years of age and older.SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS

Vaccination providers enrolled in the federal COVID-19 Vaccination Program must report all vaccine administration errors, all serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 Vaccine. See “MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION” forreporting requirements.

There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series.

Contraindications
Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine (see Full EUA Prescribing Information).

Warnings
Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine.

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine.Pfizer-BioNTech C O VID-19

Vaccine may not protect all vaccine recipients.

Adverse Reactions

Adverse reactions following the Pfizer-BioNTech COVID-19 Vaccine that have been reported in clinical trials include injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, malaise, and lymphadenopathy (see Full EUA Prescribing Information). Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials.

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.

FDA has authorized the emergency use of the Pfizer-BioNTech C O VID-19 Vaccine, which is not an FDA-approved vaccine.

The significant known and potential risks and benefits of Pfizer-BioNTech COVID-19 Vaccine, and the extent to which such risks and benefits are unknown

Pfizer-BioNTech C O VID-19 Vaccine is authorized for use in individuals 16 years of age and older

Although limited scientific information is available, based on the totality of the scientific evidence available to date, it is reasonable to believe that the Pfizer-BioNTech C O VID-19 Vaccine may be effective for the prevention of C O VID-19 in individuals as specified in the Full EUA Prescribing Information.

Pfizer-BioNTech COVID-19 Vaccine EUA Fact Sheet for Recipients
https://www.fda.gov/media/144414/download

Spoiler: important cliffs

1 Revised: December 2020 FACT SHEET FOR RECIPIENTS AND CAREGIVERSEMERGENCY USE AUTHORIZATION (EUA) OFTHE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (CO VID-19) IN INDIVIDUALS 16 YEARS OF AGE AND OLDER

The Pfizer-BioNTech COVID-19 Vaccine is a vaccine and may prevent you from getting COVID-19. There is no U.S. Food and Drug Administration (FDA) approved vaccine to prevent COVID-19.

WHAT I S THE PFIZER-BIONTECH CO VID-19 VACCINE?The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine that may prevent C O VID-19. There is no FDA-approved vaccine to prevent COVID-19.

WHO SHOULD NOT GET THE PFIZER-BIONTECH CO VID-19 VACCINE?

You should not get the Pfizer-BioNTech COVID-19 Vaccine if you:
• had a severe allergic reaction after a previous dose of this vaccine
• had a severe allergic reaction to any ingredient of this vaccine

WHAT ARE THE INGREDIENTS IN THE PFIZER-BIONTECH COVID-19 VACCINE?The Pfizer BioNTech COVID-19 Vaccine includes the following ingredients: mRNA, lipids ((4-hydroxybutyl)azanediyl) bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose

HAS THE PFIZER-BIONTECH COVID-19 VACCINE BEEN USED BEFORE?

The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine. In clinical trials, approximately 20,000 individuals 16 years of age and older have received at least 1 dose of the Pfizer-BioNTech COVID-19 Vaccine.

WHAT ARE THE BENEFITS OF THE PFIZER-B IONTECH CO VID-19 VACCINE?
In an ongoing clinical trial, the Pfizer-BioNTech COVID-19 Vaccine has been shown to prevent COVID-19 following 2 doses given 3 weeks apart. The duration of protection against COVID-19 is currently unknown

There is a remote chance that the Pfizer-BioNTech COVID-19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Pfizer-BioNTech COVID-19 Vaccine. Signs of a severe allergic reaction can include:• Difficulty breathing • Swelling of your face and throat• A fast heartbeat• A bad rash all over your body• Dizziness and weakness

These may not be all the possible side effects of the Pfizer-BioNTech COVID-19 Vaccine.

Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19 Vaccine is still being studied in clinical trials.

CAN I RECEIVE THE PFIZER-BIONTECH CO VID-19 VACCINE WITH OTHER VACCINES?

There is no information on the use of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines

WHERE WILL MY VACCINATION INFORMATION BE RECORDED?

The vaccination provider may include your vaccination information in your state/local jurisdiction’s Immunization Information System (IIS) or other designated system.

WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)?

The United States FDA has made the Pfizer-BioNTech COVID-19 Vaccine available under an emergency access mechanism called an EUA. The EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic.

The Pfizer-BioNTech COVID-19 Vaccine has not undergone the same type of review as an FDA-approved or cleared product. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19

@Rhakim
@CHICAGO
@winb83
@Malcolmxxx_23
@Uptown WaYo87
@gabbo
@xExodus
@Atlrocafella

 

[null]

Talk to these people. I worked in pharma for years before transitioning to medical devices. I know how to break down a clinical trial. I also know the shenanigans involved with configuring the trial and data to get the results that you want.

Folks are conveniently skipping over the fact that the vaccines were approved for emergency use. Everything has been fast-tracked. Not the traditional procedure. New mRNA tech as well. I don’t criticize anyone that exercises caution and wants to do their due diligence with this vaccine. Without longer term studies, there are bound to be some hiccups. Learn as much as you can.

I found these https://www.thecoli.com/threads/covid19-pfizer-biontech-vaccine-the-fdas-official-pdfs.822077/

 

[Dafunkdoc_Unlimited]

I'll just leave this here....​

Frequently Asked Questions​

Will the Countermeasures Injury Compensation Program provide compensation to individuals injured by COVID-19 vaccines?

COVID-19 vaccines are covered countermeasures under the Countermeasures Injury Compensation Program (CICP), not the National Vaccine Injury Compensation Program (VICP).

The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to certain individuals or estates of individuals who sustain a covered serious physical injury as the direct result of the administration or use of covered countermeasures identified in and administered or used under a PREP Act declaration. The CICP also may provide benefits to certain survivors of individuals who die as a direct result of the administration or use of such covered countermeasures. The PREP Act declaration for medical countermeasures against COVID-19 states that the covered countermeasures are:

1. any antiviral, any drug, any biologic, any diagnostic, any other device, any respiratory protective device, or any vaccine manufactured, used, designed, developed, modified, licensed, or procured:
   1. diagnose, mitigate, prevent, treat, or cure COVID–19, or the transmission of SARS–CoV–2 or a virus mutating therefrom; or
   2. to limit the harm that COVID–19, or the transmission of SARS–CoV–2 or a virus mutating therefrom, might otherwise cause;
2. a product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by a product described in paragraph (a) above;
3. a product or technology intended to enhance the use or effect of a product described in paragraph (a) or (b) above; or
4. any device used in the administration of any such product, and all components and constituent materials of any such product.

Covered Countermeasures must be ''qualified pandemic or epidemic products,'' or ''security countermeasures,'' or drugs, biological products, or devices authorized for investigational or emergency use, as those terms are defined in the PREP Act, the Federal Food, Drug, and Cosmetic Act, and the Public Health Service Act, or a respiratory protective device approved by National Institute for Occupational Safety and Health (NIOSH) under 42 CFR part 84, or any successor regulations, that the Secretary of the Department of Health and Human Services determines to be a priority for use during a public health emergency declared under section 319 of the Public Health Service Act.

For a category of vaccines to be covered by the VICP, the category of vaccines must be recommended for routine administration to children or pregnant women by the Centers for Disease Control and Prevention, subject to an excise tax by federal law, and added to the VICP by the Secretary of Health and Human Services. This has not been done for any COVID-19 vaccines to date.

Occasionally, a pandemic, epidemic, or security danger threatens our country. To combat these threats, the government supports the development of countermeasures.

Just found out one of my cousins tested positive. Her only symptoms were slight fatigue. She's self-quarantining.
​

 

[Professor Emeritus]

I found two docs on the FDA website. I'm not sure if they have been posted on here yet

No "anti-vax" blanket statements in here please

Pfizer-BioNTech COVID-19 Vaccine EUA Fact Sheet for HCP_0
https://www.fda.gov/media/144413/download

Spoiler: important cliffs

Rev is ed : 12/20201 FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS)EMERGENCY USE AUTHORIZATION (EUA) OFTHE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19)The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent C O VID-19 in individuals 16 years of age and older.SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS

Vaccination providers enrolled in the federal COVID-19 Vaccination Program must report all vaccine administration errors, all serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 Vaccine. See “MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION” forreporting requirements.

There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series.

Contraindications
Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine (see Full EUA Prescribing Information).

Warnings
Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine.

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine.Pfizer-BioNTech C O VID-19

Vaccine may not protect all vaccine recipients.

Adverse Reactions

Adverse reactions following the Pfizer-BioNTech COVID-19 Vaccine that have been reported in clinical trials include injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, malaise, and lymphadenopathy (see Full EUA Prescribing Information). Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials.

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.

FDA has authorized the emergency use of the Pfizer-BioNTech C O VID-19 Vaccine, which is not an FDA-approved vaccine.

The significant known and potential risks and benefits of Pfizer-BioNTech COVID-19 Vaccine, and the extent to which such risks and benefits are unknown

Pfizer-BioNTech C O VID-19 Vaccine is authorized for use in individuals 16 years of age and older

Although limited scientific information is available, based on the totality of the scientific evidence available to date, it is reasonable to believe that the Pfizer-BioNTech C O VID-19 Vaccine may be effective for the prevention of C O VID-19 in individuals as specified in the Full EUA Prescribing Information.

Pfizer-BioNTech COVID-19 Vaccine EUA Fact Sheet for Recipients
https://www.fda.gov/media/144414/download

Spoiler: important cliffs

1 Revised: December 2020 FACT SHEET FOR RECIPIENTS AND CAREGIVERSEMERGENCY USE AUTHORIZATION (EUA) OFTHE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (CO VID-19) IN INDIVIDUALS 16 YEARS OF AGE AND OLDER

The Pfizer-BioNTech COVID-19 Vaccine is a vaccine and may prevent you from getting COVID-19. There is no U.S. Food and Drug Administration (FDA) approved vaccine to prevent COVID-19.

WHAT I S THE PFIZER-BIONTECH CO VID-19 VACCINE?The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine that may prevent C O VID-19. There is no FDA-approved vaccine to prevent COVID-19.

WHO SHOULD NOT GET THE PFIZER-BIONTECH CO VID-19 VACCINE?

You should not get the Pfizer-BioNTech COVID-19 Vaccine if you:
• had a severe allergic reaction after a previous dose of this vaccine
• had a severe allergic reaction to any ingredient of this vaccine

WHAT ARE THE INGREDIENTS IN THE PFIZER-BIONTECH COVID-19 VACCINE?The Pfizer BioNTech COVID-19 Vaccine includes the following ingredients: mRNA, lipids ((4-hydroxybutyl)azanediyl) bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose

HAS THE PFIZER-BIONTECH COVID-19 VACCINE BEEN USED BEFORE?

The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine. In clinical trials, approximately 20,000 individuals 16 years of age and older have received at least 1 dose of the Pfizer-BioNTech COVID-19 Vaccine.

WHAT ARE THE BENEFITS OF THE PFIZER-B IONTECH CO VID-19 VACCINE?
In an ongoing clinical trial, the Pfizer-BioNTech COVID-19 Vaccine has been shown to prevent COVID-19 following 2 doses given 3 weeks apart. The duration of protection against COVID-19 is currently unknown

There is a remote chance that the Pfizer-BioNTech COVID-19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Pfizer-BioNTech COVID-19 Vaccine. Signs of a severe allergic reaction can include:• Difficulty breathing • Swelling of your face and throat• A fast heartbeat• A bad rash all over your body• Dizziness and weakness

These may not be all the possible side effects of the Pfizer-BioNTech COVID-19 Vaccine.

Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19 Vaccine is still being studied in clinical trials.

CAN I RECEIVE THE PFIZER-BIONTECH CO VID-19 VACCINE WITH OTHER VACCINES?

There is no information on the use of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines

WHERE WILL MY VACCINATION INFORMATION BE RECORDED?

The vaccination provider may include your vaccination information in your state/local jurisdiction’s Immunization Information System (IIS) or other designated system.

WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)?

The United States FDA has made the Pfizer-BioNTech COVID-19 Vaccine available under an emergency access mechanism called an EUA. The EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic.

The Pfizer-BioNTech COVID-19 Vaccine has not undergone the same type of review as an FDA-approved or cleared product. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19

@Rhakim
@CHICAGO
@winb83
@Malcolmxxx_23
@Uptown WaYo87
@gabbo
@xExodus
@Atlrocafella

Yeah, the application process for regular approval takes months, so they did an Emergency Use Approval instead that didn't have as much red tape. But from what I understand the amount of testing, # of test subjects, and standards for efficacy weren't any less than in a normal approval.

The FDA didn’t ‘approve’ Pfizer’s COVID-19 vaccine. Here’s why

Clinical trial data indicate that:

• It was 95% effective at preventing cases of COVID-19 in both Latinos and non-Latinos.

• It was 100% effective in Black people.

• It was 94% effective in people who were at least 56 years old. (The older you get, the greater the risk of a serious case of COVID-19.)

• It was 95% effective in those who had at least one medical condition that made them more likely to develop a serious case of COVID-19.

• It was 96% effective for people who were obese, another condition that makes people more vulnerable to COVID-19.

FDA Head Defends Covid-19 Vaccine-Approval Process

In an interview with The Wall Street Journal, Dr. Hahn said his agency has had 150 people working days, nights and weekends in parallel teams to review the test data submitted by Pfizer and German partner BioNTech SE.

The FDA has also scheduled a meeting of an outside advisory committee for Dec. 10 to review the test data, which Dr. Hahn said was another step taken to assure the public amid concerns that the FDA might rush approval....

Dr. Hahn’s comments came on the day that British regulators cleared the Pfizer vaccine for general distribution. A day before, Dr. Hahn had been summoned to the White House by President Trump’s chief of staff, Mark Meadows, to explain why the FDA wasn’t acting as quickly as the British.

Both men declined to discuss their conversation, but in the interview Dr. Hahn said the FDA was working as fast as it could to confirm that Pfizer’s vaccine is as safe and effective as the company has claimed.

Since Pfizer submitted its application for FDA vaccine authorization on Nov. 20, agency vaccine analysts have been looking at questions such as whether there are differences in how different ethnic and age groups respond. The agency has been looking at the results of about 44,000 study patients.

 

[null]

Yeah, the application process for regular approval takes months, so they did an Emergency Use Approval instead that didn't have as much red tape. But from what I understand the amount of testing, # of test subjects, and standards for efficacy weren't any less than in a normal approval.

The FDA didn’t ‘approve’ Pfizer’s COVID-19 vaccine. Here’s why

FDA Head Defends Covid-19 Vaccine-Approval Process

Not trying to be too critical of that but the MIT study showed that they didn't test it on enough of a spread black people. 100% of a limited set is NOT proof of 100% of the population right? Or even 100% of a sufficiently representative sample set for phase 3 trials.

MIT study: Covid-19 vaccines may be less effective for Asian Americans | MIT CSAIL

I'll just leave that on the back-burner for now but from the FDA the bottom line from the 2nd PDF is

"The Pfizer-BioNTech COVID-19 Vaccine has not undergone the same type of review as an FDA-approved or cleared product. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19"

Your "here's why" link doesn't justify, if just explains what emergency authorization is - essentially just "emergency authoriztion". It does not detail what has and hasn't been done.

Interestingly the article also suggests that Covid19 will become endemic and further links to COVID-19 will probably become endemic – here's what that means. That's a big statement to make.

 

[Professor Emeritus]

Not trying to be too critical of that but the MIT study showed that they didn't test it on enough of a spread black people. 100% of a limited set is NOT proof of 100% of the population right? Or even 100% of a sufficiently representative sample set for phase 3 trials.

MIT study: Covid-19 vaccines may be less effective for Asian Americans | MIT CSAIL

I'll just leave that on the back-burner for now but from the FDA the bottom line from the 2nd PDF is

"The Pfizer-BioNTech COVID-19 Vaccine has not undergone the same type of review as an FDA-approved or cleared product. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19"

Your "here's why" link doesn't justify, if just explains what emergency authorization is - essentially just "emergency authoriztion". It does not detail what has and hasn't been done.

Interestingly the article also suggests that Covid19 will become endemic and further links to COVID-19 will probably become endemic – here's what that means. That's a big statement to make.

Yes, of course 100% of a limited set is not a confident 100%, and it would be better if more Black folk signed up for trials and/or vaccine testers made a greater effort to get Black folk in the trial. That being said, there were nearly 4,000 Black folk in the trial. I haven't seen the breakdown data (I don't know that it's publicly available), but reading between the lines it looks like 0 of ~2000 who were vaccinated got Covid and ~20 of ~2000 of those who were not vaccinated got Covid. That's enough data to show that the vaccine is a net positive for Black folk beyond any reasonable doubt, but not nearly enough data to get a clear % on exactly how effective it is.

In terms of what hasn't been done to receive full authorization, I think they want additional studies and longer-term follow-through in order to more rigorously prove long-term safety. In an EUA you merely have to show strong evidence that the vaccine is safe compared to the current threat - thus the pandemic itself becomes a measuring line. But in order to get full authorization, you'll need enough data for long enough that it shows the vaccine is objectively safe by the standards that all vaccines are held to - and in order to do that, you need to get more data and follow-through for longer. You also need to show that the vaccine is more effective than reasonable alternatives - a moot point now considering there are no approved alternatives, but will become relevant later when we're deciding which vaccines to go with in the long run after there are potentially dozens of candidates in the running, which may be true by 2022. There's also additional steps like factory inspections and labeling approval, and I am sure the red tape itself is more extensive.

I'm surprised that you seem surprised that Covid-19 is likely to become endemic. Of course it's impossible to predict for certain, but when you consider the fact that it's transmitted person-to-person, is well-suited to our climate, is highly infectious, doesn't mutate rapidly, and the large majority of victims survive, why wouldn't it become endemic? Diseases usually fail to be endemic if you destroy the host, the climate doesn't suit it, infectivity is low and contract-tracing is rigorous and successful, or it burns itself out due to high mortality. Absent those factors, pretty much the only way to keep it from becoming endemic is to have such a rigorous vaccine program (like we did for smallpox, or measles) that we approach 100% vaccination. That appears unlikely now considering how many people are going to refuse vaccination, especially if vaccination protection fades at some point after the initial doses.

 

[King Kai]

Will the Johnson and Johnson vaccine be better then the ones being implemented now?

What we know is that it will be a one-shot vaccine and they're already mass producing it in the hundreds of millions. They said they will have at least 100m ready by March/April pending approval.

They have no clue about efficacy rate yet which will be the big question.

 

[null]

I'm surprised that you seem surprised that Covid-19 is likely to become endemic. Of course it's impossible to predict for certain, but when you consider the fact that it's transmitted person-to-person, is well-suited to our climate, is highly infectious, doesn't mutate rapidly, and the large majority of victims survive, why wouldn't it become endemic? Diseases usually fail to be endemic if you destroy the host, the climate doesn't suit it, infectivity is low and contract-tracing is rigorous and successful, or it burns itself out due to high mortality. Absent those factors, pretty much the only way to keep it from becoming endemic is to have such a rigorous vaccine program (like we did for smallpox, or measles) that we approach 100% vaccination. That appears unlikely now considering how many people are going to refuse vaccination, especially if vaccination protection fades at some point after the initial doses.

1. Surprised?

I mean it is a big statement for THEM to make. I didn't say that I was surprised. It's the LA times. I am skeptical about their 100% and I am skeptical about them making he call so early. It's a brave step because I cannot recall any of our leaders admitting to such a possibility yet. If widespread human T-cell protection against SARS II lasts for more than a decade as it did for SARS I, and if this response prevents transmission and IF we get lucky on the animal front it might be possible to eradicate it.

"In a Singapore study, for example, SARS-CoV-1 reactive T cells were found in SARS patients 17 years after infection"

I am pretty undecided about it but have pointed out on here multiple times since Feb 2020 that it is a possibility.

https://www.thecoli.com/search/2388...o=relevance&c[user][0]=21083&c[thread]=757032

Mar 13 2020

That is when it becomes endemic, like the flu already is. But we haven't reached the point yet and it may not happen.

Mar 21 2020

1. reinfection / immunity storm topics.
2. long term damage - esp. for asymptomatic carriers
3. airborne or not
4. other organ damage + transmission vectors (blood?)
5. endemic - becomes a permanent facet of life
6. mutation risk - variants L + S + ?.
7. incubation period - various reports

If Trump came out and said "White Supremacy is a crime against humanity" that would be a BIG statement for HIM to make BUT I would not be surprised at the conclusion itself. Likewise thus far the press have not pushed back against the government narrative of "getting back to normal" hence it's a big statement for THEM to make, especially when it is NOT at all even near certain yet.

I have said that a more certain (and safer?) route to normalcy will involve effective treatments.

2. NOT 100%

Herd immunity levels are on a per disease (and population) basis. For covid19 estimates are around 70% immunity would be enough.

e.g. examples

95% for measles

80% for polio

"The exact herd immunity threshold (HIT) varies depending on the disease. An example of a disease with a low threshold is influenza, with HIT of 33–44%. An example of a disease with a high threshold is the measles, with a HIT of 92–95%."
Herd immunity - Wikipedia

Herd immunity is not eradication and it is dependent on your local population. So China and North Korea might achieve HI while the USA does not.

Herd immunity in human populations everywhere MIGHT lead to eradication at levels far below 100% but animal reservoirs are a risk to that.

"Eradication of diseases[edit]
If herd immunity has been established and maintained in a population for a sufficient time, the disease is inevitably eliminated – no more endemic transmissions occur.[5] If elimination is achieved worldwide and the number of cases is permanently reduced to zero, then a disease can be declared eradicated.[6] Eradication can thus be considered the final effect or end-result of public health initiatives to control the spread of infectious disease.[6][7]"
Herd immunity - Wikipedia

3. "it's transmitted person-to-person, is well-suited to our climate, is highly infectious, doesn't mutate rapidly, and the large majority of victims survive"

I would add as a main and decisive factor is asymptomatic spread. If people felt sick or showed signs of sickness BEFORE becoming transmissive it would be far easier to control exposure - such as with SARS. Yes more people %-wise died but if they were infectious before they felt symptoms or showed signs then that's more spread.

"How long is a person with SARS infectious to others?
Available information suggests that persons with SARS are most likely to be contagious only when they have symptoms, such as fever or cough. Patients are most contagious during the second week of illness.
Is a person with SARS contagious before symptoms appear?
To date, no cases of SARS have been reported among persons who were exposed to a SARS patient before the onset of the patient’s symptoms."
SARS | Frequently Asked Questions | CDC

5. "they want additional studies and longer-term follow-through"
DUH !! of course BUT they are the ones making an argument based on "those missing steps don't matter" and EUA was done to save time in the "marking of tests" only (rather than it being about missing testing).
I and other people on here are the ones talking about missing tests (in terms of duration and spread).

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NB. numbers fudged

While I think of it I think they might be playing with numbers somewhat in the headline results. In the PDFs they state that 22000 participants were given at least one dose. Working through that logically, without me having to write it all down, it looks like they ran 1 and 2 dose test protocols and used the 2 dose test only for the efficacy results. As 1 dose also tests for safety they included those results.That suggests that the "22000 people have been tested" headline is a sleight of hand in that not all of those underwent the 2 dose protocol that has been rolled out to the general public. I should look it up but reading between the lines that is how it appears to me.

Tut tut ...

 

[Professor Emeritus]

Likewise thus far the press have not pushed back against the government narrative of "getting back to normal" hence it's a big statement for THEM to make, especially when it is NOT at all even near certain yet.

"Endemic" and "Getting back to normal" are not mutually exclusive. The flu, even several serious flus, are endemic and yet things are normal. Especially since it is relatively easy to predict who is most at risk to COVID death, I imagine a future reality where many people are vaccinated and the vast majority of the most vulnerable are vaccinated, such that COVID transmission is lowered but not ended and deaths are significantly lower than flu deaths. That would be considered "back to normal".

I have said that a more certain (and safer?) route to normalcy will involve effective treatments.

More effective treatments will certainly develop over time.

Herd immunity levels are on a per disease (and population) basis. For covid19 estimates are around 70% immunity would be enough.

As you note later, herd immunity does not equal eradication. Assuming the 70% number is right, you don't have to reach 70% nationally to eradicate, you have to reach 70% in every subpopulation of significant size that transmits. That is much more difficult in a country like the USA unless we actually embark on an eradication program....

Also, the 70% number may not be correct. It is the approximate math from what we currently understand about the average # of transmissions per person. But COVID transmissions have a strange distribution - the large majority of carriers only infect 1 or 0 persons, while a small % of carriers affect a huge number of other persons. It's not like measles which is highly infectious across the board. I don't know how that effects herd immunity calculations.

I doubt animal reservoirs will be a significant factor but it remains to be seen.

5. "they want additional studies and longer-term follow-through"
DUH !! of course BUT they are the ones making an argument based on "those missing steps don't matter" and EUA was done to save time in the "marking of tests" only (rather than it being about missing testing).
I and other people on here are the ones talking about missing tests (in terms of duration and spread).

I don't think anyone is arguing that the missing steps "don't matter". It's just that there's a difference between "sufficient" and "ideal".

For example, I think speed limits are important. I think if we drive too fast, more people will die. But when my baby was having breathing problems I sped like a demon to the doctor. Was it safe? I was safe enough. I did not make any single driving maneuver that I thought was dangerous, I didn't want to risk my baby's life of course. But due to the present danger I accepted slightly more risk than I would tolerate on a constant, every-day basis.

Similarly here, enough has been shown that we can safely consider the risks much lower than the ongoing danger of the current crisis. They've done more than well enough. But that doesn't mean we would want to go forever without doing better - on a long-term basis we can and will do better.

NB. numbers fudged

While I think of it I think they might be playing with numbers somewhat in the headline results. In the PDFs they state that 22000 participants were given at least one dose. Working through that logically, without me having to write it all down, it looks like they ran 1 and 2 dose test protocols and used the 2 dose test only for the efficacy results. As 1 dose also tests for safety they included those results.That suggests that the "22000 people have been tested" headline is a sleight of hand in that not all of those underwent the 2 dose protocol that has been rolled out to the general public. I should look it up but reading between the lines that is how it appears to me.

Tut tut ...

21,720 of the participants received 2 doses. The # of people who did not complete protocol and receive the 2nd dose was very small. The data they have on potential single-dose efficacy comes from the small window between when the 1st dose response became effective and the 2nd dose was given. But they didn't run true single-dose trials, at least not in Stage 3 testing.

Moderna, not Pfizer, ran true single-dose trials.