Pfizer to seek FDA okay within days as trial results show vaccine 95% effective

Pfizer said Wednesday that more interim results from its ongoing coronavirus vaccine study suggest the shots are 95% effective and that the vaccine protects older people most at risk of dying from COVID-19.

The announcement, just a week after Pfizer first revealed promising preliminary results, comes as the company is preparing within days to formally ask US regulators to allow emergency use of the vaccine.

Pfizer initially had estimated its vaccine, developed with German partner BioNTech, was more than 90% effective after 94 infections had been counted. With Wednesday’s announcement, the company now has accumulated 170 infections in the study — and said only eight of them occurred in volunteers who got the actual vaccine rather than a dummy shot. One of those eight developed severe disease, the company said.

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

A bus stop ad for COVID-19 testing is shown outside Pfizer world headquarters in New York on Monday Nov. 9, 2020. Pfizer says an early peek at its vaccine data suggests the shots may be 90% effective at preventing COVID-19, but it doesn’t mean a vaccine is imminent. (AP Photo/Bebeto Matthews)

Pfizer said its vaccine was more than 94% effective in adults over age 65, though it is not clear how the company determined effectiveness in older adults, with only eight infections in the vaccinated group to analyze and no breakdown provided of those people’s ages.

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

Pfizer says it now has the data on the vaccine’s safety needed to seek emergency authorization from the Food and Drug Administration.

The company didn’t disclose safety details but said no serious vaccine side effects have been reported, with the most common problem being fatigue after the second vaccine dose, affecting about 4% of participants.

A Pfizer production line for the COVID-19 vaccine (Screencapture/YouTube)

The study has enrolled nearly 44,000 people in the US and five other countries. The trial will continue to collect safety and efficacy data on volunteers for two more years.

Pfizer and BioNTech said they expect to produce up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses in 2021.

US officials have said they hope to have about 20 million vaccine doses each from Moderna and Pfizer available for distribution in late December. The first shots will be offered to vulnerable groups like medical and nursing home workers, and people with serious health conditions.

After Pfizer announced its initial results last week, Prime Minister Benjamin Netanyahu began a crusade to secure the product for Israel, making at least two phone calls to Pfizer CEO Albert Bourla. By Friday Netanyahu announced that Israel had closed a deal.

As part of the agreement with Pfizer, Netanyahu said Israel would receive 8 million shots, enough to inoculate 4 million Israelis. Netanyahu expressed hope that Pfizer would begin supplying the vaccine in January, pending authorization from health officials in the United States and Israel.

Israel also has an agreement with Moderna, though the number of vaccines has not been disclosed. Netanyahu on Tuesday said he was negotiating with the company for additional shots.

Source Link: https://www.timesofisrael.com/pfizer-to-seek-fda-okay-within-days-as-trial-results-show-vaccine-95-effective/

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