The company said it plans to apply for emergency approval from the Food and Drug Administration « within days.
Pharmaceutical company Pfizer said on Wednesday that its coronavirus vaccine was 95% effective and had no serious side effects – the first set of full results from a late-stage vaccine trial as Covid-19 cases soared across the country. the world.
The company said the data showed the vaccine prevented the mild and severe forms of Covid-19. It was 94 percent effective in the elderly, who are more likely to contract severe Covid-19 and who do not respond strongly to some types of vaccines.. .
Pfizer, which developed the vaccine with its partner BioNTech, said the companies are planning to apply to the Food and Drug Administration for emergency authorization « within days », raising hopes that an effective vaccine could soon become a reality..
The results of the experiment – less than a year after researchers began working on the vaccine – shattered all records of speed for vaccine development, a process that usually takes years..
« The results of the study represent an important step in this historic eight-month journey to provide a vaccine capable of helping to end this devastating epidemic. ». . Albert Burla, CEO of Pfizer, said in a statement.
If the letter F. . Dr. a. Authorizing the two-dose vaccine, Pfizer said it could have up to 50 million doses available by the end of the year, and up to 1. 3 billion by the end of next year.
However, only about half of its supplies will go to the United States this year, or enough for about 12. 5 million people – a slice of the US population of 330 million. Americans will get the vaccine for free, for less than a dollar. 95 billion deals reached by the federal government with Pfizer for 100 million doses.
The results are consistent with an early analysis published by Pfizer and BioNTech last week, which found the vaccine was more than 90% effective.. Then on Monday, the pharmaceutical company Moderna reported that its vaccine was 94. 5% effective in early analysis.
The Pfizer and BioNTech trial involved nearly 44,000 volunteers, half of whom received the vaccine. The other half received a fake dose of salt water. Then the researchers waited to see how many people in each group developed Covid-19.
The companies said that of the 170 cases of Covid-19, there were 162 cases in the placebo group, and eight in the vaccine group. Of the 10 cases of severe Covid-19, nine have received a placebo.
Pfizer and BioNTech said vaccine efficacy was consistent across age, race and ethnicity.. Fatigue was the most common serious adverse event, with 3. 7 percent of volunteers reported fatigue after taking the second dose. Two percent of the volunteers reported a headache after the second dose. The companies said older adults reported fewer and less severe side effects.
It’s really amazing, said Akiko Iwasaki, an immunologist at Yale University.. She said results in people over the age of 65 were the most promising. “We know from the influenza vaccine that it is very difficult to achieve protection in this age group with vaccines,” she said, so the 94 percent efficacy in this group is really impressive..
Federal health officials said the first doses of vaccines will likely go to groups such as health-care workers who are at high risk of exposure, as well as people most at risk of contracting the disease, such as the elderly.
Dr.. Saad b. Omar, director of the Yale Institute for Global Health, said the results showing that vaccines protect people from severe disease were also good news, because with such limited availability at first, the first goal would not be to stop disease transmission, but to prevent people from becoming sick. Extremely. He said, « This is very reassuring. ».
He called on Pfizer to quickly release a more detailed analysis of the data – other than the initial news release – so that scientists can evaluate the results more comprehensively.. The companies said they plan to present the results for review in a scientific journal, a process that could take weeks or months. « These are not normal times, this is a pandemic, and a major policy is being developed, » said Dr.. Omar said. “It is always better to have a policy on scientific data, not a press release.
In addition to the results of its clinical trial, Pfizer said it is ready to present it to F.. Dr. a. Two months of agency-recommended safety data, plus detailed manufacturing records showing the company can consistently produce high-quality batches of its products.. The F. Dr. a. He will review the data and ask an outside panel of vaccine experts to consider the request, a process that could take weeks.
Both Pfizer and Moderna said the accelerating pace of the pandemic gave a glimmer of hope to speed up their experiments, as volunteers contract the virus quickly..
Pfizer and Moderna have developed vaccines that use a new technology that has not previously been approved for human use. They both use a synthetic copy of the genetic material for the Coronavirus, called mRNA, to program a person’s cells to make multiple copies of part of the virus.. This piece alerts you to the immune system and stimulates it to attack if a person is exposed to the real virus.
If the vaccine is licensed, attention will immediately shift to how it was distributed. The vaccine should be stored below 94 degrees Fahrenheit, which is colder than any other vaccine in development. Pfizer will ship the vaccine in special boxes of 1,000 to 5,000 doses stuffed with dry ice and equipped with GPS sensors.. Pfizer vaccine can be stored in conventional refrigerators for up to five days, or in special coolers for up to 15 days, as long as the dry ice is replenished and the boxes are not opened more than twice a day..
Moderna vaccine should also be stored in the freezer for a long time, but at temperatures below 4 degrees Fahrenheit. The company said Monday that its vaccine can be stored at standard refrigerator temperatures of 36 to 46 degrees Fahrenheit for up to 30 days, not seven as previously thought, which may make it easier to store than the Pfizer vaccine.. .
Vaccine, Moderna, Pfizer, Coronavirus
World News – United States – New Pfizer Results: Corona virus vaccine is 95% safe and effective
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