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Pifzer and BioNTech announced that, based on the first results of subsequent clinical trials of the new corona pneumonia vaccine, the candidate vaccine has an effective rate of 90%, which has stimulated the rise of the global stock market. The tagline alone opened the door to more questions, but now the data is limited and many questions have not been answered.
Pfizer plans to launch its first vaccine in December, and is expected to produce 50 million doses by the end of the year, enough for 25 million people to receive two injections and reach 1.3 billion doses in 2021. Now this goal seems to be coming true. According to a press release from Pfizer, the phase 3 clinical trial of the candidate vaccine has been partially completed. Among the 43,538 participants, 38,955 received two candidate vaccines or placebo injections. So far, 94 of the participants have been infected with the new coronavirus and fewer than 9 have received two doses of the vaccine, which is strong evidence and the source of 90% effectiveness.
This result far exceeded expectations. Originally, experts warned that the effectiveness of the first batch of vaccines could be as low as 60% or 70%, and the FDA stated that it would be willing to approve as long as the 50% threshold is reached. Paul A. Offit, director of the Center for Vaccine Education at Children’s Hospital of Philadelphia, said the data looks encouraging. He said “the 94 cases in the trial are progressing faster than expected. This is the benefit of the virus getting out of control.”
But QUARTZ reported that for public health organizations like the Centers for Disease Control and Prevention, efficacy and effectiveness representTwo things. Randomized vaccine trials can demonstrate different degrees of efficacy. Once the vaccine is implemented in the real world, the effectiveness of the vaccine itself must be based on observational studies.
Since all candidate vaccines are new products, experimental scientists will take precautions, try to select the healthiest participants to avoid dangerous reactions, and carefully organize testing to ensure that everyone can get the plan right. Correct result.
But in the real world, some vaccinators have health problems and are older than the average trial participant. Real-world vaccinators can also be more diverse than study participants, which is one reason Pfizer is trying to recruit people from many population groups for trials. The report states that 42% of global participants and 30% of American participants come from diverse backgrounds.
Pfizer stated that the main efficacy indicator (end point) for evaluating the efficacy of the vaccine is the study of new cases of coronavirus that occurred one week after the second dose. If allowed by the US Food and Drug Administration (FDA), Pfizer will study cases in the second week after the second vaccination to see if there are differences in immune response over time.
Pfizer will also monitor participants for two years, collect more safety data, and see how long immunity lasts.Report “New York Times”During this period, Pfizer also plans to look at how the vaccine reduces the severity of Wuhan pneumonia and whether the vaccine responds differently to people who are already sick. All other elements of the efficacy of the vaccine are currently unclear.
Pfizer said it will continue to recruit new participants until 164 people have developed antibodies. It is believed that the trial could come to an end before the end of the month. Pfizer and BioNTech stated that they plan to submit an emergency authorization request to the US Food and Drug Administration after the third week of November. By then, more than half of the subjects will have two-month safety monitoring data and some information about the manufacturing process. In addition, Pfizer plans to submit Phase 3 data to journals for peer review and publication after the trial is complete.
“The Washington Post” interviewed outside experts and noted that this experiment is very encouraging, but the two most important questions are how long the effect can last and how effective the vaccine is in preventing severe cases of new coronary pneumonia. Both will still need more data can be used to get a clear answer, but for now this is very good news.
Pfizer was the first company to mass produce penicillin during World War II and now it will be possible to obtain the reputation and financial resources of the first batch of new vaccines against coronary pneumonia. The US government agreed to pay US $ 1.95 billion for 100 million doses of vaccine. The forecast for future sales varies greatly, but SVB Leerink predicts that in 2021 sales will exceed US $ 3 billion, and JP Morgan will increase them to US $ 5.5 billion.
(Source of the first image: Flickr / Andres Rueda CC BY 2.0)
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