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Pharmaceutical company Pfizer says new test results show its coronavirus vaccine is 95 percent effective, safe, and also protects older people at higher risk of dying – the latest data needed to find use of limited vaccine supplies as the catastrophic outbreak worsens around the world. .
The announcement by Pfizer and its German partner BioNTech, just a week after they revealed the first promising preliminary results, comes as the team prepares within days to formally petition US regulators to allow emergency use of the vaccine.
They have also started “rolling submissions” for the vaccine with regulators in Europe, the UK and Canada and will add this new data soon.
The New Zealand government has already agreed to buy 1.5 million doses, enough for 750,000 people, from Pfizer and BioNTech.
Pfizer and BioNTech had initially estimated the vaccine to be more than 90 percent effective after 94 infections were counted in a study that included 44,000 people. With the new announcement, the company has racked up 170 infections in the study and said only eight of them occurred in volunteers who received the actual vaccine rather than a sham injection. One of those eight developed a serious illness, the company said.
“This is extraordinarily strong protection,” said Dr. Ugur Sahin, CEO and co-founder of BioNTech. The Associated Press.
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The companies have yet to release detailed data on their study and the results have not been analyzed by independent experts. Important questions such as how long protection lasts and whether people might need backups also remain to be determined.
But all eyes are on the progress of potential vaccines as the infection rate rises in the US and abroad as winter weather forces people to stay indoors, in enclosed spaces that fuels viral spread.
Pfizer and BioNTech said the vaccine was more than 94 percent effective in adults 65 and older, although it is unclear exactly how it was determined with only eight infections in the vaccinated group to test and no breakdown of the ages of those was provided. people.
Bebeto Matthews / AP
Pfizer says its vaccine is very effective in people 65 and older.
Sahin said there were enough older adults enrolled in the study and among the placebo recipients who became infected, he is confident that “this vaccine appears to work in the highest risk population.
Earlier this week, Moderna announced that its experimental vaccine appears to be 94.5 percent effective after an interim analysis of its late-stage study.
Similar results from two vaccines made with an entirely new technology, using a snippet of the coronavirus genetic code to train the body to recognize if the real virus appears, will likely add to the experts’ reassurance about the new approach.
While initial supplies will be scarce and rationed, as supply increases, Sahin said companies have a responsibility to help ensure access to lower-income countries as well.
Pfizer and BioNTech also say they now have the required vaccine safety data needed to apply for emergency clearance from the US Food and Drug Administration.
The companies did not disclose safety details, but said that no serious side effects from the vaccine have been reported, and that the most common problem is fatigue after the second dose of the vaccine, affecting about 4 percent of participants .
Bebeto Matthews / AP
The latest data is promising for Pfizer’s Covid-19 vaccine.
The study has enrolled nearly 44,000 people in the United States and five other countries. The trial will continue to collect safety and efficacy data on volunteers for a further two years.
Pfizer and BioNTech said they expect to produce up to 50 million doses of vaccines globally in 2020 and up to 1.3 billion doses in 2021.
US officials have said they expect to have about 20 million doses of Moderna and Pfizer vaccines available for distribution by the end of December. The first vaccines are expected to be offered to vulnerable groups such as nursing home and medical workers, and people with serious health problems.
