COVID-19 shot 95% effective, authorization request soon

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Pfizer said on Wednesday that new test results show its coronavirus vaccine is 95% effective, safe, and also protects older people most at risk of dying – the latest data needed to research emergency use of vaccine stocks limited as catastrophic epidemic worsens around the world.

The announcement from Pfizer and its German partner BioNTech, just a week after unveiling the first promising preliminary results, comes as the team prepares in the days to formally ask US regulators to allow the use of vaccine emergency.

They have also started “continuous submissions” for the vaccine to regulators in Europe, the UK and Canada and will add this new data soon.

Pfizer and BioNTech initially estimated the vaccine to be over 90% effective after 94 infections were found in a study involving 44,000 people. With the new announcement, the company has now racked up 170 infections in the study – and said only eight of them occurred in volunteers who received the vaccine itself rather than a dummy injection. One of those eight developed a serious illness, the company said.

“It’s extraordinarily strong protection,” Dr. Ugur Sahin, CEO and co-founder of BioNTech, told The Associated Press.

The companies have yet to release detailed data on his study, and the results have not been analyzed by independent experts. Important questions such as how long the protection lasts and whether people might need boosters also remain to be determined.

But all eyes are on the progress of potential vaccines as grim infection rates rise in the United States and abroad as wintry weather forces people indoors, in the close quarters that fuel the viral spread.

Pfizer and BioNTech said the vaccine was over 94% effective in adults over 65, although it is not known exactly how this was determined with only eight infections in the vaccine group to be analyzed and none. age breakdown for these individuals is not provided.

Sahin said there were enough older adults enrolled in the study and among those placebo recipients who got infected, he is confident that “this vaccine appears to work in the higher risk population.”

Earlier this week, Moderna, Inc. announced that its investigational vaccine appeared to be 94.5% effective after an interim analysis of its late stage study.

Similar results from two vaccines both made with brand new technology – using a snippet of the coronavirus’ genetic code to train the body to recognize if the real virus is coming – will likely add experts to the reassurance of the new approach.

While initial supplies will be scarce and rationed, as the supply increases, Sahin said companies also have a responsibility to help ensure access to low-income countries.

Pfizer and BioNTech also say they now have the required vaccine safety data needed to seek emergency clearance from the Food and Drug Administration.

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The companies did not disclose safety details, but said no serious side effects from the vaccine have been reported, with the most common problem being fatigue after the second dose of the vaccine, affecting around 4% of people. participants.

The study recruited nearly 44,000 people in the United States and five other countries. The trial will continue to collect safety and efficacy data from volunteers for another two years.

Pfizer and BioNTech plan to produce up to 50 million doses of vaccine globally in 2020 and up to 1.3 billion doses in 2021.

U.S. officials said they expected to have around 20 million doses of the vaccine each from Moderna and Pfizer available for distribution by the end of December. The first vaccines are expected to be offered to vulnerable groups like medical workers and nursing home workers, as well as people with serious health problems.

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AP medical editor Lauran Neergaard contributed to this report.

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The Associated Press’s Department of Health and Science receives support from the Department of Science Education at the Howard Hughes Medical Institute. The AP is solely responsible for all content.

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