Full FDA Approval of a COVID-19 Vaccine: What You Should Know
The three COVID-19 vaccines authorized for use in the U.S. are safe and effective in helping prevent serious disease or death due to the coronavirus. These vaccines were granted an emergency use authorization, or EUA, by the Food and Drug Administration (FDA). The Pfizer/BioNTech COVID-19 vaccine received full approval by the FDA on Aug. 23, 2021.
Lisa Maragakis, M.D., M.P.H., senior director of infection prevention, and Gabor Kelen, M.D., director of the Johns Hopkins Office of Critical Event Preparedness and Response, explain what that means.
What does full FDA approval of a COVID-19 vaccine mean? Review for full FDA approval is a normal step in the process of making a vaccine available for the public. One of the COVID-19 vaccines (Pfizer) has full approval, and the FDA may grant full approval for others in the future.
Full FDA approval takes place when enough data demonstrate that the vaccines are safe and effective for most people who receive them, and when the FDA has had an opportunity to review and approve the whole vaccine manufacturing process and facilities. After many months of studies and more than 165 million people having received a COVID-19 vaccine, the FDA has a lot of information on how safe and effective the COVID-19 vaccines are in protecting people, how well they work to prevent severe coronavirus disease, and how the vaccines are safely and consistently manufactured.
COVID Vaccines: Emergency Use Authorization vs. Approval Not every vaccine is granted an emergency use authorization before full approval. The FDA authorized three COVID-19 vaccines to answer an urgent need to protect people from the coronavirus pandemic, which was (and continues to be) a public health emergency.
When it was clear in 2020 that COVID-19 was a rapidly spreading, dangerous disease, the FDA worked with vaccine manufacturers, independent laboratories, academic research centers and nonprofit organizations to quickly gather and interpret large amounts of data on the vaccines.
The data showed that the vaccines were very effective in preventing severe COVID-19 and the risks of serious side effects was extremely low. Based on these findings, the FDA granted the EUA so people could be vaccinated earlier in the approval process and be protected from serious effects of COVID-19.
Full approval is granted when, over time, the FDA has amassed even more scientific evidence to support use of the COVID-19 vaccines, showing that the benefits of the vaccine are greater than its risks, and that the vaccines can be manufactured reliably, safely and with consistent quality.
COVID-19 Vaccines Authorized for Emergency Use or FDA-Approved Comirnaty and Pfizer-BioNTech COVID-19 Vaccine Moderna COVID-19 Vaccine Janssen COVID-19 Vaccine Fact sheets for health care providers and patients included Report vaccine side effects toll-free at 1-800-822-7967 or online
Thought it might help if I tried to explain the rationale behind "emergency use authorisation" in this instance.
New drugs have to jump through large numbers of obstacles before being "fully" authorised. There are a variety of reasons for this, but the most obvious can be shown by Thalidomide. One thing a lot of people are unaware of is that that drug is still widely used today in relation to certain cancers and other illnesses. But it must never be taken by someone who is pregnant.
There is an important legal distinction between "emergency" and "full" authorisation. In short, a maker of "emergency" medication cannot be sued, whereas ones with full authorisation can.
Place yourself in the shoes of say Pfizer and the US Government (Trump or Biden, here it is the same outcome). Pfizer have carried out lots of work on the vaccine, but have not yet completed everything. There is a pandemic. They are perfectly willing to supply a vaccine under emergency use, but are not willing to risk their entire Company's future.
Similarly, Governments have a judgment call. Either
1. To allow a small risk to be run via vaccines; or 2. To watch large numbers of people die from a clear, known risk
Every Government chooses option 1. Everybody but a conspiracy theorist chooses option 1. Because the possible risk involved in Option 1 is almost certainly less than 1% of the inevitable risk of Option 2.
There is a discussion to be had in relation to whether "emergency" providers should be allowed to make large profits. About what steps are being undertaken to ensure "full" authorisation is achieved.
Thought it might help if I tried to explain the rationale behind "emergency use authorisation" in this instance.
New drugs have to jump through large numbers of obstacles before being "fully" authorised. There are a variety of reasons for this, but the most obvious can be shown by Thalidomide. One thing a lot of people are unaware of is that that drug is still widely used today in relation to certain cancers and other illnesses. But it must never be taken by someone who is pregnant.
There is an important legal distinction between "emergency" and "full" authorisation. In short, a maker of "emergency" medication cannot be sued, whereas ones with full authorisation can.
Place yourself in the shoes of say Pfizer and the US Government (Trump or Biden, here it is the same outcome). Pfizer have carried out lots of work on the vaccine, but have not yet completed everything. There is a pandemic. They are perfectly willing to supply a vaccine under emergency use, but are not willing to risk their entire Company's future.
Similarly, Governments have a judgment call. Either
1. To allow a small risk to be run via vaccines; or 2. To watch large numbers of people die from a clear, known risk
Every Government chooses option 1. Everybody but a conspiracy theorist chooses option 1. Because the possible risk involved in Option 1 is almost certainly less than 1% of the inevitable risk of Option 2.
There is a discussion to be had in relation to whether "emergency" providers should be allowed to make large profits. About what steps are being undertaken to ensure "full" authorisation is achieved.
But scaremongering does not help.
Conspiracy theorists seem unmoved by logic, common sense, and facts. I dont know much about this, but I do know that the approval of new drugs/vaccines can take years. Would the conspiracy theorists have been happy for us to have remained in a lockdown for 5 or 10 years, while millions more people died, and economies were shot to pieces? The original post was at best misleading, yet they want to share it at every possible opportunity. How many anti-vaxxers have to die from covid before they finally see the light? Do they have no conscience over the people they infect and kill?
I have no wish to become involved in a debate on conspiracy theories, so I am now going.
Twitter permanently suspends US politician's personal account over COVID-19 misinformation
Twitter has permanently suspended the personal account of US politician Marjorie Taylor Greene for repeated violations of its COVID-19 misinformation policy.
Ms Greene has been kicked off of Twitter after being issued a "fourth strike" in August when she was suspended for a week for saying that vaccines were failing.
She claimed in July that COVID-19 was "not dangerous for non-obese people and those under 65" - despite US government figures saying people under 65 accounted for nearly 250,000 of roughly 825,000 deaths.
Ms Greene has been an ardent supporter of former president Donald Trump, whose personal account has also been permanently suspended from Twitter despite his pleas.
Her official Twitter account as a member of the House of Representatives remains on the platform.
Following the permanent suspension Ms Taylor Greene said: "Twitter is an enemy to America and can't handle the truth."
She also accused the social media platform of attempting to "complete a Communist revolution" by preventing people telling "the truth".
The Republican, who sits in the House of Representatives for Georgia, was thrown off of two committees last February after being accused of spreading hateful and violent conspiracy theories.
At the time, Republican Senate leader Mitch McConnell labelled Ms Greene's embrace of conspiracy theories as "loony lies" and a "cancer" for their party.
She has courted controversy by questioning whether a plane really struck the Pentagon during the 9/11 terrorist attacks in 2001, unapologetically alleging that school shootings were staged, and claiming a space laser was to blame for a California fire.
Twitter permanently suspends US politician's personal account over COVID-19 misinformation
Twitter has permanently suspended the personal account of US politician Marjorie Taylor Greene for repeated violations of its COVID-19 misinformation policy.
Ms Greene has been kicked off of Twitter after being issued a "fourth strike" in August when she was suspended for a week for saying that vaccines were failing.
She claimed in July that COVID-19 was "not dangerous for non-obese people and those under 65" - despite US government figures saying people under 65 accounted for nearly 250,000 of roughly 825,000 deaths.
Ms Greene has been an ardent supporter of former president Donald Trump, whose personal account has also been permanently suspended from Twitter despite his pleas.
Her official Twitter account as a member of the House of Representatives remains on the platform.
Following the permanent suspension Ms Taylor Greene said: "Twitter is an enemy to America and can't handle the truth."
She also accused the social media platform of attempting to "complete a Communist revolution" by preventing people telling "the truth".
The Republican, who sits in the House of Representatives for Georgia, was thrown off of two committees last February after being accused of spreading hateful and violent conspiracy theories.
At the time, Republican Senate leader Mitch McConnell labelled Ms Greene's embrace of conspiracy theories as "loony lies" and a "cancer" for their party.
She has courted controversy by questioning whether a plane really struck the Pentagon during the 9/11 terrorist attacks in 2001, unapologetically alleging that school shootings were staged, and claiming a space laser was to blame for a California fire.
Comments
Being added to "Covid cases"
https://en.wikipedia.org/wiki/Human_coronavirus_229E
Watch:
"I looked this up and WTF is going on"
Coronaviruses are a large family of viruses and the common cold is included.
No need to have kittens.
The three COVID-19 vaccines authorized for use in the U.S. are safe and effective in helping prevent serious disease or death due to the coronavirus. These vaccines were granted an emergency use authorization, or EUA, by the Food and Drug Administration (FDA). The Pfizer/BioNTech COVID-19 vaccine received full approval by the FDA on Aug. 23, 2021.
Lisa Maragakis, M.D., M.P.H., senior director of infection prevention, and Gabor Kelen, M.D., director of the Johns Hopkins Office of Critical Event Preparedness and Response, explain what that means.
What does full FDA approval of a COVID-19 vaccine mean?
Review for full FDA approval is a normal step in the process of making a vaccine available for the public. One of the COVID-19 vaccines (Pfizer) has full approval, and the FDA may grant full approval for others in the future.
Full FDA approval takes place when enough data demonstrate that the vaccines are safe and effective for most people who receive them, and when the FDA has had an opportunity to review and approve the whole vaccine manufacturing process and facilities. After many months of studies and more than 165 million people having received a COVID-19 vaccine, the FDA has a lot of information on how safe and effective the COVID-19 vaccines are in protecting people, how well they work to prevent severe coronavirus disease, and how the vaccines are safely and consistently manufactured.
COVID Vaccines: Emergency Use Authorization vs. Approval
Not every vaccine is granted an emergency use authorization before full approval. The FDA authorized three COVID-19 vaccines to answer an urgent need to protect people from the coronavirus pandemic, which was (and continues to be) a public health emergency.
When it was clear in 2020 that COVID-19 was a rapidly spreading, dangerous disease, the FDA worked with vaccine manufacturers, independent laboratories, academic research centers and nonprofit organizations to quickly gather and interpret large amounts of data on the vaccines.
The data showed that the vaccines were very effective in preventing severe COVID-19 and the risks of serious side effects was extremely low. Based on these findings, the FDA granted the EUA so people could be vaccinated earlier in the approval process and be protected from serious effects of COVID-19.
Full approval is granted when, over time, the FDA has amassed even more scientific evidence to support use of the COVID-19 vaccines, showing that the benefits of the vaccine are greater than its risks, and that the vaccines can be manufactured reliably, safely and with consistent quality.
https://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/full-fda-approval-of-a-covid-19-vaccine-what-you-should-know
Comirnaty and Pfizer-BioNTech COVID-19 Vaccine
Moderna COVID-19 Vaccine
Janssen COVID-19 Vaccine
Fact sheets for health care providers and patients included
Report vaccine side effects toll-free at 1-800-822-7967 or online
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines
New drugs have to jump through large numbers of obstacles before being "fully" authorised. There are a variety of reasons for this, but the most obvious can be shown by Thalidomide. One thing a lot of people are unaware of is that that drug is still widely used today in relation to certain cancers and other illnesses. But it must never be taken by someone who is pregnant.
There is an important legal distinction between "emergency" and "full" authorisation. In short, a maker of "emergency" medication cannot be sued, whereas ones with full authorisation can.
Place yourself in the shoes of say Pfizer and the US Government (Trump or Biden, here it is the same outcome). Pfizer have carried out lots of work on the vaccine, but have not yet completed everything. There is a pandemic. They are perfectly willing to supply a vaccine under emergency use, but are not willing to risk their entire Company's future.
Similarly, Governments have a judgment call. Either
1. To allow a small risk to be run via vaccines; or
2. To watch large numbers of people die from a clear, known risk
Every Government chooses option 1. Everybody but a conspiracy theorist chooses option 1. Because the possible risk involved in Option 1 is almost certainly less than 1% of the inevitable risk of Option 2.
There is a discussion to be had in relation to whether "emergency" providers should be allowed to make large profits. About what steps are being undertaken to ensure "full" authorisation is achieved.
But scaremongering does not help.
I was not aware of much of that, but in hindsight, it all makes perfect sense.
PS - Don't think you'd be very popular on QAnon, the source of so much nonsense, somehow.
Don't eat the Yellow Snow.
I dont know much about this, but I do know that the approval of new drugs/vaccines can take years.
Would the conspiracy theorists have been happy for us to have remained in a lockdown for 5 or 10 years, while millions more people died, and economies were shot to pieces?
The original post was at best misleading, yet they want to share it at every possible opportunity.
How many anti-vaxxers have to die from covid before they finally see the light?
Do they have no conscience over the people they infect and kill?
I have no wish to become involved in a debate on conspiracy theories, so I am now going.
https://www.ibtimes.co.uk/brain-damaged-uk-victims-swine-flu-vaccine-get-60-million-compensation-1438572
https://www.independent.co.uk/news/health/coronavirus-vaccine-pandemic-swine-flu-covid-a9693721.html
https://www.msn.com/en-gb/news/world/mother-29-who-refused-to-get-vaccine-as-she-wasn-t-afraid-of-covid-dies-of-virus/ar-AASjoI8?ocid=msedgntp
Twitter has permanently suspended the personal account of US politician Marjorie Taylor Greene for repeated violations of its COVID-19 misinformation policy.
Ms Greene has been kicked off of Twitter after being issued a "fourth strike" in August when she was suspended for a week for saying that vaccines were failing.
She claimed in July that COVID-19 was "not dangerous for non-obese people and those under 65" - despite US government figures saying people under 65 accounted for nearly 250,000 of roughly 825,000 deaths.
Ms Greene has been an ardent supporter of former president Donald Trump, whose personal account has also been permanently suspended from Twitter despite his pleas.
Her official Twitter account as a member of the House of Representatives remains on the platform.
Following the permanent suspension Ms Taylor Greene said: "Twitter is an enemy to America and can't handle the truth."
She also accused the social media platform of attempting to "complete a Communist revolution" by preventing people telling "the truth".
The Republican, who sits in the House of Representatives for Georgia, was thrown off of two committees last February after being accused of spreading hateful and violent conspiracy theories.
At the time, Republican Senate leader Mitch McConnell labelled Ms Greene's embrace of conspiracy theories as "loony lies" and a "cancer" for their party.
She has courted controversy by questioning whether a plane really struck the Pentagon during the 9/11 terrorist attacks in 2001, unapologetically alleging that school shootings were staged, and claiming a space laser was to blame for a
California fire.
https://www.msn.com/en-gb/news/world/twitter-permanently-suspends-us-politician-s-personal-account-over-covid-19-misinformation/ar-AASmy8I?ocid=msedgntp
https://www.msn.com/en-gb/health/familyhealth/mother-of-three-gives-up-being-anti-vaxxer-after-she-caught-covid/ar-AASm9D4?ocid=msedgntp
Ms Greene appears to need psychiatric help, & that's even before her bizarre COVID & anti-vaccine rantings.
God bless Twitter.