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A vaccine developed by Pfizer Inc. and BioNTech SE protects most people from COVID-19, according to a study whose early results sent share prices soar and was hailed by the US’s leading infectious disease specialist as ” extraordinary”.
The stroke prevented more than 90 percent of symptomatic infections in the trial of tens of thousands of volunteers, the most encouraging scientific advance so far in the battle against the coronavirus. Although the findings are preliminary, they could pave the way for companies to apply for an emergency use authorization if further research shows the vaccine is also safe.
Pfizer shares rose up to 15% and traded 11% higher at 12:52 pm in New York, while BioNTech’s American depository receipts rose up to 25%. The news fueled a global rally that added over $ 1.8 trillion to the value of the MSCI All Country World Index.
The findings are based on an interim analysis conducted after 94 participants, split between those who received a placebo and those who were vaccinated, contracted COVID-19. The process will continue until 164 cases have occurred. If the data holds up and even a key security reading Pfizer expects in about a week looks good, it could mean the world has a vital new tool to control a pandemic that has killed more than 1.2 million people worldwide. world.
With an early vaccine efficacy previously predicted to be between 60% and 70%, a rate of over 90% “is simply extraordinary,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, in a call with reporters.
Data has limits. It is unknown how well shooting works in key subgroups, such as the elderly. And it’s not known whether the vaccine prevents serious disease, as none of the participants who received COVID-19 in this round of analysis had similar cases, said William Gruber, Pfizer’s senior vice president for clinical research and vaccine development.
External researchers said they needed much more data, including safety information, to assess how good the vaccine is. Assuming the first encouraging results are confirmed and the vaccine approved, use in the general public would still be a long way off, with those at the highest risk likely to get it first.
“So far, it looks promising,” said Peter Jay Hotez, vaccine researcher and dean of Baylor College of Medicine’s National School of Tropical Medicine. “Helps provide proof of concept that it is possible to make a human COVID-19 vaccine.”
Assuming the vaccine removes the final hurdles, attention will quickly shift to its spread around the world. The challenges will be immense: Companies have agreed to provide deals with the U.S. government and other countries, but it is widely expected that frontline medical personnel, essential workers and risk groups will receive any authorized blows first.
U.S. states have been working on distribution plans, but many can’t finalize deals until it’s clear what chance will be given, as the best candidates have different requirements for storage and transportation. Pfizer’s vaccine, for example, must be stored at ultra low temperatures.
“Vaccine launch requires nearly flawless execution of a chain of interconnected processes,” according to an Oct. 21 report from the Boston Consulting Group. In addition to handling products, officials will need to organize public awareness and education campaigns, monitor whether vaccines have safety or efficacy concerns once they reach a larger population, and
Two-stroke regime
Pfizer vaccine is tested in a two-dose regimen. The trial started in July, and since most participants only received the second dose much more recently, no one knows how long a protection will last.
However, the strong reading from the first large-scale trial to post-efficacy results bodes well for other experimental vaccines, especially one developed by Moderna Inc. that uses similar technology. His large study could generate efficacy and safety results in weeks. If the study is also successful, there may be two vaccines available in the United States by the end of the year.
Pfizer expects to obtain two months of safety follow-up data, a key metric required by US regulators before an emergency clearance is granted, in the third week of November. If these findings don’t raise any issues, Pfizer may be applying for a US license this month. A progressive review is underway in Europe.
So far, the study’s data monitoring committee hasn’t identified any serious safety issues, Pfizer and BioNTech said.
Leading the race
Positive preliminary data indicates that the US pharmaceutical giant and its German partner are on track to be the first with a vaccine, having signed upfront agreements with governments around the world for hundreds of thousands of doses. The companies said they should be able to produce 1.3 billion doses – enough to vaccinate 650 million people – by the end of 2021. About 50 million doses are expected to be available in 2020.
“It proves that Covid-19 can be controlled,” BioNTech CEO Ugur Sahin said in an interview. “At the end of the day, it’s really a science win.”
Pfizer has found itself embroiled in a controversial political debate about how quickly regulators in the United States should allow Americans to administer a vaccine. President Donald Trump has pushed for an attempt to be approved before election day, but regulators have put in place stringent standards that have largely pushed that goal out of reach.
On October 16, Pfizer chief executive Albert Bourla said companies could apply for an emergency use authorization from U.S. regulators by the end of November if the test results prove that the injection is safe and effective.
Donald Trump Jr. and Senator Ted Cruz questioned whether the data was released on Monday after the election. “What time?” the senator asked, with the president’s son calling the times “rather surprising”.
Pfizer and BioNTech have a $ 2 billion deal to supply 100 million doses to the United States, with an option for another 500 million. Among the precursors, theirs is the only vaccine project that has not received funding from the White House-led Operation Warp Speed program to support research, development or manufacturing. However, BioNTech received up to € 375 million ($ 445 million) in development funding from the German government.
The shot is based on messenger RNA technology never used before in an approved medicine. The use of mRNA, which essentially teaches the body’s cells to become vaccine factories, has allowed it to develop much faster than a traditional vaccine.
Pfizer originally planned to conduct an initial analysis of the study data after only 32 cases of the virus occurred in the study, which enrolled 43,538 volunteers across multiple countries. Analyzing the data that initially proved controversial among medical experts. Other vaccine companies have planned to wait longer before reviewing the trial information.
After discussions with US regulators, Pfizer and BioNTech said they recently chose to lower the threshold of 32 cases and conduct the first analysis to a minimum of 62 cases. The evaluation focuses on symptomatic Covid-19 infections, not just those that test positive.
94 cases
While Pfizer was conducting those negotiations, it suspended testing participants’ samples for the virus, Gruber said. By the time Pfizer made the changes to the testing plan and restarted virus testing a few days ago, there had been around 94 cases, far more than the study needed to reach the new threshold.
Pfizer raced to verify the data, which was still blind to almost everyone in the company as well as a few statisticians. On Sunday afternoon, an independent data monitoring committee met in a closed-door video session to review the results for the first time. Afterward, the panel brought Gruber, Sahin, and other company representatives to the call and told them the vaccine had easily achieved its efficacy goal.
“Everyone is quite ecstatic,” Gruber said.
– With the assistance of Celeste Perri, Teaganne Finn, Jeannie Baumann and Blaise Robinson.
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