Er Pfizer meðða?

"In September 2020, Pfizer expanded the enrollment of its Phase 3 pivotal COVID-19 vaccine trial to approximately 44,000 participants. This allowed for the enrollment of new populations, including adolescents as young as 16 years of age and people with chronic, stable HIV (human immunodeficiency viruses), Hepatitis C, or Hepatitis B infection. In October 2020, we received permission from the FDA to enroll adolescents as young as 12. By doing so, we will be able to better understand the potential safety and efficacy of the vaccine in individuals from more ages and backgrounds.

How are you able to move with this speed in the trial?

Even though we are moving with extraordinary speed, preservation of high quality and safety standards is critically important throughout development. We are taking all of the regulatory and operational steps that we would normally take for all of our vaccine trials, maintaining the highest standards in our development process. This required enormous mobilization of Pfizer and BioNTech resources upfront at a never before seen scale. We are also working closely with regulatory agencies, providing near real-time data and receiving review and advice quicker than ever before, to ensure the development of this potential vaccine can proceed as quickly as possible.

Commitment to Safety

How are you monitoring the safety of trial participants?

Participant safety is paramount. As with all of our trials, we are following all of the rules and regulations in place to ensure participant safety. For example, the trial protocols are reviewed by regulatory authorities and approved by Institutional Review Boards, an independent committee that reviews the methods proposed for research. In addition, the trial’s progress is closely monitored by both Pfizer and an outside group of independent experts called a Data and Safety Monitoring Committee. Trial investigators are also responsible for monitoring participants health, and participants in the trial have regular planned follow-up visits as part of the trial.

Commitment to Diversity

COVID-19 has disproportionately affected underrepresented populations. How are you addressing this in the trial?

We are committed to decreasing health disparities in underrepresented populations through our clinical trials.  We have selected investigative sites in diverse communities that have been disproportionately affected by COVID-19 to help ensure that individuals who have been most impacted have the opportunity to participate. We have shared with our investigative sites the importance of recruiting individuals who fully represent the racial and ethnic diversity of their communities, and we are engaging patient advocacy partners and community groups to raise awareness about the importance of participation and representation.

Access to a Vaccine, Once Approved

When is the earliest the vaccine will be available to the public?

If regulatory approval or authorization is obtained, the companies expect to manufacture globally up to 100 million doses by the end of 2020 and potentially 1.3 billion doses by the end of 2021.

Who will get the vaccine first, once approved?

We are working with governments around the world to provide and distribute our vaccine, if approved. Once our vaccine is approved, those governments and local regulatory authorities will decide how the vaccine will be distributed.

How much will the vaccine cost?

We will price our vaccine in a way to help governments ensure there is little to no out-of-pocket costs for the vaccine for their populations. It is also important to note that our COVID-19 vaccine development and manufacturing costs are entirely self-funded, with billions of dollars already invested in an effort to find a solution to this pandemic."

Þetta er af heimasíðu Pfizer. Þeir eru með mRNA einsog Moderna.

Er Pfizer meðða á undan Moderna?

Athugasemdir

[Þorsteinn Siglaugsson, 18.10.2020 kl. 22:51]

Hvet þig til að lesa um svínaflensuna 1976, sem var svo engin svínaflensa, og hversu margir veiktust af Guillain-Barré vegna bóluefnisins. Það var einmitt svona Speedy Gonzales bóluefni, undanþegið öllum kröfum og lyfjafyrirtækin þvinguðu Bandaríkjaþing til að samþykkja að taka ábyrgð á öllu svínaríinu.

Er ekki að reyna að hræða þig Halldór minn, en horfðu raunsætt á þetta.

[Halldór Jónsson, 18.10.2020 kl. 23:49]

Um það bil 348.000 niðurstöður (0,40 sekúndur) 

 

 

 

 

 

Leitarniðurstöður

Vefniðurstöður

GBS (Guillain-Barré Syndrome) and Vaccines | Vaccine Safety ...

www.cdc.gov › vaccinesafety › concerns

 

 

Þýða þessa síðu

In 1976, there was a small increased risk of GBS after swine flu vaccination, which was a special flu vaccine for a potential pandemic strain of flu virus. The ...

Fólk spyr einnig um

What happened in 1976 swine flu outbreak?

In 1976, an outbreak of the swine flu, influenza A virus subtype H1N1 at Fort Dix, New Jersey caused one death, hospitalized 13, and led to a mass immunization program.

1976 swine flu outbreak - Wikipedia

en.wikipedia.org › wiki › 1976_swine_flu_outbreak

 

 

Leita að: What happened in 1976 swine flu outbreak?

How many died in 1976 swine flu?

Only about 200 cases of swine flu and one death were ultimately reported in the U.S., the CDC said. The public viewed the entire episode as political farce, Sencer said. But at the time, he said, the government erred on the side of caution.27. apr. 2009

Swine flu 'debacle' of 1976 is recalled - Los Angeles Times

www.latimes.com › archives › la-xpm-2009-apr-27-sci-s...

 

 

Leita að: How many died in 1976 swine flu?

What causes Guillain Barre Syndrome?

Guillain-Barré syndrome is thought to be caused by a problem with the immune system, the body's natural defence against illness and infection. Normally the immune system attacks any germs that get into the body. But in people with Guillain-Barré syndrome, something goes wrong and it mistakenly attacks the nerves.

Guillain-Barré syndrome - Causes - NHS

www.nhs.uk › conditions › causes

 

 

Leita að: What causes Guillain Barre Syndrome?

Where did the 1976 swine flu originate?

In 1976, I was Director of the Center for Disease Control (CDC, the name of the agency at the time) when a new influenza virus, characterized as an influenza A(H1N1) swine virus, was isolated from military recruits at Fort Dix, New Jersey.

Perspective: Swine-Origin Influenza: 1976 and 2009 - Oxford ...

[Halldór Jónsson, 18.10.2020 kl. 23:50]

Lítil áhætta miðað við hvert heimurinn er að fara í katastrófu þar sem flest er að fara til andskotans

[Þorsteinn Siglaugsson, 19.10.2020 kl. 00:34]

Já, nóg fyrir mig til að láta ekki sprauta mig með einhverju óprófuðu bóluefni. En þú ræður auðvitað hvað þú gerir.

"Svínaflensan" í þetta skiptið ('76) var engin flensa heldur veiktist hópur af fólki út af bakteríum úr stöðnu vatni sem komust inn í loftræstikerfi. Áður en það kom í ljós var búið að víkja til hliðar öllum reglum, láta þingið skrifa upp á óútfyllta tékka og sprauta haug af fólki með stórhættulegu bóluefni.