Pfizer shares rose 1.6% and BioNTech 6% on news that the vaccine could be available soon, raising hopes of the end of a pandemic that has claimed more than a quarter of a million lives in the United States and more than 1.3 million worldwide.
The petition also includes safety data on about 100 young people between the ages of 12 and 15. The company said 45% of trial participants in the United States were between 56-85 years old.
If the data is strong, “we could literally be weeks away from the approval of a 95% effective vaccine,” US Health Secretary Alex Azar said on CBS’s “This Morning.”
The firms expect the FDA to approve the emergency use authorization by mid-December and said they could begin shipping doses almost immediately. Pfizer said it expects to have 50 million doses of vaccines ready this year, enough to protect 25 million people.
An FDA advisory committee plans to meet tentatively on Dec. 8-10 to discuss the vaccine, a source familiar with the process told ., though the dates could change.
Data from the final trial showed that the vaccine provided a similar level of protection to different ages and ethnic groups, an encouraging result against a disease that disproportionately affects the elderly and minorities.
Of the 170 volunteers who contracted COVID-19 in the Pfizer trial involving 43,000 more people, 162 had received just a placebo, meaning the vaccine is 95% effective, well above what was initially expected. The FDA has a minimum efficacy limit of 50%.
Pfizer said that nearly 42% of the global participants and 30% of the US participants in Phase 3 of the study were racially and ethnically diverse.
“The launch in the United States is a crucial milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine,” said the CEO of Pfizer, Albert Bourla, in a statement.
Moderna Inc is expected to be the next company to seek emergency use approval in the United States for its COVID-19 vaccine. An initial analysis of data from the last stage of his trial showed the vaccine to be 94.5% effective. The final results and the safety data are expected for the next days or weeks.