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Post by Admin on Nov 10, 2020 2:13:56 GMT
Mike Pence has broken his post-election silence to trumpet the Trump administration’s backing of a new coronavirus vaccine - only for the company to immediately point out that the research and development of their vaccine had nothing to do with the government.
Pfizer announced on Monday morning that their Covid-19 vaccine was 90 per cent effective, in early trials.
"HUGE NEWS: Thanks to the public-private partnership forged by President @realdonaldtrump, @pfizer announced its Coronavirus Vaccine trial is EFFECTIVE, preventing infection in 90% of its volunteers," tweeted Mr Pence.
Nikki Haley, Mr Trump’s former UN ambassador, also claimed that the Pfizer work was down to Mr Trump, saying: “Many thanks”.
Seemingly unaware that Pfizer had very publicly rejected federal funds, she said: "This will be one of the most important action items done by the administration in response to this pandemic."
But the New York-based company was quick with a clarification.
Dr Kathrin Jansen, Pfizer’s head of vaccine development, told the New York Times: “We were never part of the Warp Speed ... We have never taken any money from the US government, or from anyone.”
Pfizer later clarified that they were considered “part” of Warp Speed, because the US government had placed an order for a potential vaccine. But they received no funding for its development, unlike their rivals.
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Post by Admin on Nov 10, 2020 6:38:27 GMT
Both Pfizer’s vaccine and Moderna’s use messenger-RNA, or 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. Other vaccines in the late stages of development use genetically engineered viruses for a similar purpose, or pieces of protein that are directly injected. No mRNA product has ever been approved by regulators.
The story of how the data have been analyzed seems to include no small amount of drama. 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.
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 companies 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.
Scientists can now design genetic material called mRNA to help us build immunity to certain viruses, including SARS-CoV-2, the coronavirus that causes Covid-19. Find out how mRNA vaccines work in this video.
That 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 their announcement of the results, Pfizer and BioNTech revealed 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.
Gruber said that Pfizer and BioNTech 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 in the trial. The DSMB met on Sunday.
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.
Gruber 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.
But Gruber said he 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.
He also emphasized that although there will only be a few months of data from this study, results from earlier studies make him optimistic that immunity from the vaccine will not wane rapidly.
The study has enrolled 43,538 volunteers the companies said, and 38,955 have received their second dose. About 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds.
Bourla, Pfizer’s CEO, said the results mark “a great day for science and humanity,” in a statement, saying they provide “initial evidence of our vaccine’s ability to prevent Covid-19.” He added: “We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”
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Post by Admin on Nov 11, 2020 21:36:05 GMT
Some volunteers who took part in Pfizer’s coronavirus vaccine trials say they were left feeling like they had a “severe hangover,” according to reports.  The more than 43,500 people in six countries who took part in phase three trials by the pharmaceutical giant were never told whether they were injected with the vaccine or a placebo in the double-blind tests. But some said they believe they had the drug because of headaches, fever and muscle aches that were compared to getting the flu shot or recovering from a heavy night out, the Sun said. Texan Glenn Deshields, 44, said his “severe hangover” symptoms soon cleared up, however — and he later took an antibody test that came back positive. He said he was “very excited” by Monday’s news that the tests showed the vaccine was 90 percent effective — and compared it to the end of a war.  “My grandfather, one of his first memories was of the bells ringing when World War I ended,” said the lobbyist from Austin. “It was a horrific war and horrible things happened and people were just happy it was over with. “In my mind, I felt the same way … I kind of felt it was something like that. Thank God, it’s going to be over at some point.” Another volunteer who only gave her first name, Carrie, said she suffered a headache, fever and aches all over her body after her first shot — symptoms that were even more severe after the second one, Metro UK said. The 45-year-old from Missouri said taking part in the trials was her “civic duty.” “There are so many people who have had it and suffered. The thought that we could do something to stop people from suffering from this, from losing family members, that we could get rid of it and get back to some sort of normal in our lives — that’s a driving factor for this for me,” she said. “I don’t want anyone else to be sick.” |
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Post by Admin on Nov 14, 2020 4:12:17 GMT
On Monday, Pfizer announced in a press release that its coronavirus vaccine candidate was more than 90 percent effective in preventing COVID-19 in study participants. The news from the largest pharmaceutical company in the U.S., which has been working in partnership with German firm BioNTech, came just as the U.S. has been experiencing a record number of cases of the deadly virus, and set off a wave of celebrations — stocks surged, the Trump camp touted it as a victory and top infectious disease expert Dr. Anthony Fauci described the results as “extraordinary.” Previously, Fauci and the Food and Drug Administration had said a coronavirus vaccine that protected 50 to 60 percent of the population would have been acceptable, so a 90 percent efficacy represents “light at the end of the tunnel,” as Pfizer CEO Dr. Albert Bourla told MSNBC. But there are still some significant unknowns. The press release from Pfizer does not include the two months of safety data required by the FDA before companies can apply for emergency use authorization; Pfizer says it should have this by next week. The company’s Phase III clinical trial began in July and has enrolled 43,538 participants, with about 30 percent of U.S. participants from “racially and ethnically diverse backgrounds.” But beyond that, nothing has been made public yet about how participants from different demographics have reacted to the vaccine.  “We still don’t know very much about the participants of the trial as far as how they responded to the vaccine, any side effects, any other complications, any comorbidities,” said Yahoo News medical contributor Dr. Dara Kass. “We will have more information when this data is published, so it’s not time to overanalyze this press release. It’s just time to wait and be optimistic about the idea that a vaccine for this coronavirus is likely coming.” Information on how participants from different demographics — particularly those who are most vulnerable not only to infection but also to complications from infection — will be important. Black, Hispanic and Native American communities have been hit especially hard by the coronavirus pandemic, so insight into how the vaccine affected trial participants from those groups will be key. Information on trial participants from the vulnerable elderly population will also be crucial. |
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Post by Admin on Nov 25, 2020 22:33:28 GMT
When the Department of Health and Human Services released Pfizer's $1.95 billion coronavirus vaccine contract with Operation Warp Speed last Wednesday, the agreement revealed that the Trump administration didn't include government rights to intellectual property typically found in federal contracts. The drugmaker has downplayed its involvement in Operation Warp Speed, the Trump administration's more than $10 billion program to make a coronavirus vaccine available in record time. Although Pfizer didn't receive government funding this spring toward research and development of the vaccine, it nevertheless received one of the largest Operation Warp Speed supply contracts to date on July 21. Pfizer is working on the vaccine with BioNTech, a German company. They announced results of final efficacy analysis last Wednesday, revealing that the vaccine is 95% effective. The company announced that it submitted its request for emergency use authorization on Friday. That nearly $2 billion contract will pay for 100 million doses of the Pfizer vaccine at a price of $19.50 per dose if the vaccine is OK'd by the Food and Drug Administration. The government also has the option to buy up to 500 million more doses. The other Operation Warp Speed agreements pay for vaccines regardless of FDA approval or authorization.  "The potential for a vaccine like this is nothing short of miraculous," Robin Feldman, a professor at the University of California Hastings College of the Law, who focuses on the pharmaceutical industry and drug policy, wrote in an email to NPR. "The government, however, is giving away the store — meeting critical short-term goals but ignoring long-term serious costs." Natalie Baldassarre, a spokesperson for the Department of Health and Human Services, disputes the notion that the Pfizer contract is worse for taxpayers than the others. "When the U.S. government does not fund creation of any of the intellectual property, as is the case in our agreement with Pfizer, the government is not entitled to any rights to a company's intellectual property." Baldassarre elaborated in an email to NPR: "This production contract was aggressively negotiated on behalf of the American public and is a fair deal. This contract is not for research and development (R&D), but for Pfizer to produce and distribute 100 million doses of an FDA approved or authorized vaccine. The U.S. government did not fund and is not funding any of Pfizer's or BioNTech's R&D used to create the intellectual property for their mRNA vaccine. If Pfizer's vaccine does not receive FDA approval or authorization, the USG [United States Government] does not pay." Although Pfizer's Operation Warp Speed participation is different from that of the other companies in the vaccine race in that respect, treating its deal as a simple government purchase doesn't make sense, says James Love, director of Knowledge Ecology International, a nonprofit public interest group focused on intellectual property. |
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