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Source: COVID-19 Vaccine  Nov 10, 2020  2 years, 10 months, 3 weeks, 12 hours, 34 minutes ago

COVID-19 Vaccine: More American Scams? Pfizer Announces Preliminary Results That Suggested Their Vaccine Was More Than 90 Percent Effective!

COVID-19 Vaccine: More American Scams? Pfizer Announces Preliminary Results That Suggested Their Vaccine Was More Than 90 Percent Effective!
Source: COVID-19 Vaccine  Nov 10, 2020  2 years, 10 months, 3 weeks, 12 hours, 34 minutes ago
COVID-19 Vaccine: American headquartered pharmaceutical giant Pfizer spend a fortune on a PR conference and paying off numerous unethical media writers and media to do an elaborate piece about its vaccine which it claims is more than 90 percent effective. In the last few hours its stocks were rallying and God knows who is going to make millions but the key issue is that there were no published studies or data to back any of its claims! It was simply just another typical American scam which stupid and gullible Americans fall for to raise the value of a company's stocks.

Numerous stupid media that have no credibility published the story without questioning for facts or supporting studies or preliminary published  data. (Never read mainstream media for medical news or stories)
The claims and so called results have not been peer-reviewed by outside scientists or published in a medical journal, and even Pfizer and BioNTech (Pfizer’s’ partner for the vaccine)  have been given no other  details about how the vaccine performed by the independent monitors overseeing the study.
America has lowered the standards for vaccine approvals and efficacy and even for drugs and therapeutics as long as certain politicians and entities can make a buck.
Many real vaccine experts and professionals were shocked by the announcement as many felt that it was still too early to make any claims.
The COVID-19 vaccine is the first to be tested in the United States to generate late-stage data. The companies said an early analysis of the results showed that individuals who received two injections of the vaccine three weeks apart experienced more than 90% fewer cases of symptomatic Covid-19 than those who received a placebo. For months, researchers have cautioned that a vaccine that might only be 60% or 70% effective. (Thailand Medical News even feels that it should be lower than 20 percent! Based on past data about coronavirus, studies showing the waning levels and effectiveness of antibodies and also the issue of numerous emerging variants and mutated strains)
Importantly the Phase 3 study is ongoing and additional data could affect results.
Pfizer will not file for an emergency use authorization to distribute the vaccine until they reach another milestone: when half of the patients in their study have been observed for any safety issues for at least two months following their second dose. Pfizer expects to cross that threshold in the third week of November.
While it is a bright spot in the battle against the pandemic and a triumph for Pfizer and BioNTech, a German company, key information about the vaccine is not yet available. There is no information yet on whether the vaccine prevents severe cases, the type that can cause hospitalization and death.
Furthermore there is no information yet on whether it prevents peo ple from carrying the virus that causes Covid-19, SARS-CoV-2, without symptoms. 
In reality without more information, it’s too early to start predicting how much of an impact the vaccine could make.
For a vaccine to really have maximal impact, it’s going to have to also reduce severe illness and death. And we just don’t know yet.
Furthermore as the vaccine has been studied for only a matter of months, it is impossible to say how long it will protect against infection with the virus. The vaccine does cause side effects, including aches and fevers, according to previously published data.
Pfizer said that they believed the side effect profile was comparable to standard adult vaccines, but probably worse than Pfizer’s pneumonia vaccine, Prevnar, or a flu shot.
It was reported that initial supplies of the vaccine, if authorized, will be limited. Pfizer says up to 50 million doses could be available globally by the end of the year, with 1.3 billion available in 2021. There are also expected to be distribution challenges. The vaccine must be stored at super-cold temperatures, which could make it extremely difficult to deliver to many places. Pfizer however has said it is confident those issues can be managed.
“If that headline number really holds up, that is huge. That is much better than I was expecting and it will make a huge difference,” said Dr Ashish Jha, the dean of the School of Public Health at Brown University. He cautioned, however, that it is always difficult to evaluate science via press release and that researchers will need to see the full results. He noted that side effects are something to watch, because even if there are no serious long-term complications, people feeling sick for a day or two could lead some to be hesitant to take a vaccine.
Pfizer’s vaccine and uses messenger-RNA (mRNA) technology, which uses genetic material to cause the body to create a protein from the virus; the immune system then recognizes the virus and learns to attack. To date there is no vaccine in use utilizing that technology and no mRNA vaccines has ever been approved by regulators.
Interestingly the story of how the data have been analyzed seems to include no small amount of games. Pfizer, seeing an opportunity to both help battle a pandemic and demonstrate its research prowess, made decisions that were always likely to make its study the first of a Covid-19 vaccine to produce data including its decision to have an independent group of researchers, known as a data safety and monitoring board, take an early look at the data in the 44,000-volunteer study before its completion. 
It was said that the first analysis was to occur after 32 volunteers both those who received the vaccine and those on placebo had contracted Covid-19. If fewer than six volunteers in the group who received the vaccine had developed COVID-19, the company would make an announcement that the vaccine appeared to be effective. The study would continue until at least 164 cases of COVID-19 individuals with at least one symptom and a positive test result had been reported.
Such a study design, as well as those of other drug makers, came under fire from experts who worried that, even if it was statistically valid, these interim analyses would not provide enough data when a vaccine could be given to billions of people. 
In the PR and media announcement of the results, Pfizer and BioNTech made a surprise. The companies said they had decided not to conduct the 32-case analysis “after a discussion with the FDA.” Instead, they planned to conduct the analysis after 62 cases. But by the time the plan had been formalized, there had been 94 cases of Covid-19 in the study. It’s not known how many were in the vaccine arm, but it would have to be nine or fewer.
Pfizer had decided in late October that they wanted to drop the 32-case interim analysis. At that time, the companies decided to stop having their lab confirm cases of COVID-19 in the study, instead leaving samples in storage. The FDA was aware of this decision. Discussions between the agency and the companies concluded, and testing began this past Wednesday. When the samples were tested, there were 94 cases of COVID-19 in the trial. The DSMB met on Sunday.
Importantly this means that the statistical strength of the result is likely far stronger than was initially expected. It also means that if Pfizer had held to the original plan, the data would likely have been available in October, as its CEO, Albert Bourla, had initially predicted!
Pzifer said that there will not be another interim analysis conducted in the study. He also said that Pfizer’s estimate that it could file for authorization of the vaccine by the third week of November was based on the assumption that the FDA would be willing to accept two-month safety data on half the volunteers in the study as initially planned, when it was to include 30,000 volunteers, not more than 44,000, as is now the case. Those discussions are ongoing.
Pzifer said they now expects that by the time of the planned meeting of the FDA’s vaccine advisory committee in December, the study’s efficacy portion could be completed, having reached 164 cases of COVID-19.
The phase 3 trial has enrolled 43,538 volunteers the companies said, and 38,955 have received their second dose.
Recently even Dr Anthony Fauci made statements that contradicted the whole purpose of vaccines.,-not-the-virus
It should be noted that there are so many ways that studies like this can be manipulated.
We already had the hydrocholoroquine , remdesivir, tocilizumab and certain antibody based therapeutic scams from the United States.
The world has to be careful of anything that originates from China or the United States, as both are no different in terms of credibility as they are basically greedy scammers!
Americans expecting any difference coming from the soon Biden administration are going to be in for a rude shock as both the Trump and Biden factions are laden with corrupted politicians and businessmen wanting to  exploit the COVID-19  situation and make fast bucks at the expense of American tax payers monies and American lives.
Instead of putting too much emphasis and hopes on a COVID-19 vaccine, the world should focus on drugs and therapeutics to help treat COVID-19.
For more on COVID-19 Vaccines, keep on logging to Thailand Medical News.


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