The Slatest

Pfizer Says Coronavirus Vaccine Is 95 Percent Effective, Will Apply for FDA Approval “Within Days”

A syringe sits next to a vial labeled "Vaccine COVID-19."
A coronavirus vaccine could be on the way soon. Joel Saget/Getty Images

More good news on the vaccine front Wednesday: Pfizer reported its complete late-stage vaccine trial results showed the drug to be 95 percent effective in preventing coronavirus infections with no serious side effects. The American drugmaker’s updated results saw its efficacy rise slightly from the company’s initial report earlier this month that its vaccine was 90 percent effective. The company and its German partner BioNTech also said the vaccine’s effectiveness held up across demographic groups, including adults over 65, a key demographic given older individuals’ heightened vulnerability to the virus. The independent data monitoring committee for the study has not reported “any serious safety concerns related to the vaccine,” the company said.

Based on this latest data, Pfizer said it will be applying for emergency use authorization from the Food and Drug Administration “within days.” The company said it will publish the results of the trial in a peer-reviewed scientific journal and begin seeking regulatory approval from different agencies around the world. Pfizer entered the third phase of its clinical trial in July with more than 40,000 volunteers receiving the two-dose treatment or a placebo. The FDA has said it would require at least two months of monitoring after the trial vaccine was administered to volunteers to ensure it was safe.

If the FDA approves the vaccine, Pfizer says it could produce as many as 50 million doses by the end of the year and up to 1.3 billion doses next year. The vaccine is a two-dose treatment, so production at that rate would cover roughly 500 million people by the end of 2021. Half of the doses slated to be produced this year will go to the U.S., covering some 12.5 million people.