Pfizer ends COVID-19 vaccine trial with 95% success rate

Illustrative Vials with COVID-19 vaccine stickers attached and syringes with the logo of US pharmaceutical company Pfizer and German partner BioNTech

Pfizer says its COVID-19 vaccine is 95% effective in final clinical trial results analysis

The companies said they'll also submit an application for emergency authorization with the U.S. Food and Drug Administration (FDA) and other worldwide regulators in the same time frame.

The first two to show any results - made by Pfizer-BioNTech and Moderna - both use an experimental approach, called mRNA, which involves injecting part of the virus's genetic code into the body to train the immune system.

The ball is in Health Canada's court after companies Pfizer and BioNTech announced Wednesday that they have finished the final round of human trials on their COVID-19 vaccine candidate - testing they say found it to be 95 per cent effective with no serious safety concerns.

Eight occurred in volunteers who got the actual vaccine, as opposed to 162 who received a dummy placebo shot. The Japanese government has an agreement to receive a supply of 120 million vaccine doses, enough for 60 million people or roughly half its population.

On November 16, Moderna said early analysis of its vaccine trial showed that it is 94.5% effective at preventing the virus. Canada signed a deal with the company in August to secure 20 million doses of the vaccine in 2021.

Once the companies submit their request for emergency use authorization to the FDA, the agency will review the data and could make a decision quickly, based on the quality of data and the urgent need for a vaccine to address the pandemic.

An FDA advisory committee tentatively plans to meet on December 8-10 to discuss the vaccine, a source familiar with the situation said, though the dates could change.

Asked about the confusion during his daily COVID-19 briefing at Queen's Park on Thursday, Ford said that he has since spoken with senior officials in the Ministry of Health and has been assured that they were provided the estimates by federal government officials.

Pfizer says its COVID-19 vaccine is 95% effective in final clinical trial results analysis

"We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world", Pfizer chief executive Albert Bourla said in a statement. The vaccine must be stored at minus 94 degrees Fahrenheit, colder than any other vaccine in development. It isn't known how well the shot works in key subgroups, such as the elderly. Pfizer is promising 50 million doses by the end of the year.

The announcement comes just days after similarly encouraging news from Moderna Inc. about its vaccine. It can, however, be kept in a normal fridge for up to five days, or up to 15 days in a thermal shipping box.

USA company Moderna, which is using similar technology to Pfizer, has also announced promising early results for its vaccine candidate, though that testing is ongoing.

"The only Grade 3 (severe) solicited adverse event greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.7% following dose 2", the companies said. Older adults tended to report fewer and milder adverse events.

The company has not yet released detailed data on its study, and results have not been analyzed by independent experts.

Andrew Hill is a researcher at the University of Liverpool's department of pharmacology. Johnson & Johnson says it is on track to deliver data this year.

If the vaccine is authorized, attention will immediately shift to how it will be distributed. Only Pfizer has started vaccinating volunteers under the age of 18 in trials, giving shots to children as young as 12.

Arecibo Observatory’s Iconic Telescope Will be Decomissioned Following Cable Failure