Pfizer: COVID-19 shot 95% effective, seeking clearance soon

By LINDA A. JOHNSON and FRANK JORDAN

Pfizer said Wednesday that new test results show its coronavirus vaccine is 95% effective, is safe and also protects older people most at risk of dying — last data needed to seek emergency use of limited shot supplies even as the catastrophic outbreak worsens across the globe.

The announcement from Pfizer and its German partner BioNTech, just a week after they revealed the first promising preliminary results, comes as the team is preparing within days to formally ask U.S. regulators to allow emergency use of the vaccine.

They also have begun “rolling submissions” for the vaccine with regulators in Europe, the U.K. and Canada and soon will add this new data.

Pfizer and BioNTech had initially estimated the vaccine was more than 90% effective after 94 infections had been counted in a study that included 44,000 people. With the new 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.

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

The companies have not yet released detailed data on its study, and results have not been analyzed by independent experts. Also still to be determined are important questions such as how long protection lasts and whether people might need boosters.

But all eyes are on the progress of potential vaccines as the grim infection rate jumps in the U.S. and abroad as winter weather forces people indoors, in the close quarters that fuels viral spread.

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

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

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.

Similar results from two vaccines both made with a brand-new technology — using a snippet of the genetic code of the coronavirus to train the body to recognize if the real virus comes along — likely will add to experts’ reassurance about the novel approach.

While initial supplies will be scarce and rationed, as the supply grows Sahin said the companies have a responsibility to help ensure access for lower income countries as well.

Pfizer and BioNTech also say now have the required data on the vaccine’s safety needed to seek emergency authorization from the Food and Drug Administration.

The companies 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.

The study has enrolled nearly 44,000 people in the U.S. and five other countries. The trial will continue to collect safety and effectiveness 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.

U.S. 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 are expected to be offered to vulnerable groups like medical and nursing home workers, and people with serious health conditions.

___

AP medical writer Lauran Neergaard contributed to this report.

___

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

 

Panorama Hispano is the regional news and information newspaper for Hispanic and other diverse communities.

US Hispanics are now the largest ethnic minority in the United States numbering 54.2 million as of July 2014. Serving: Buffalo, Rochester, Fredonia, Niagara Falls, NY and Erie, PA. Outside our Market area: Visit our affiliate at: http://www.impremedia.com/

Contact us: Contact@PanoramaHispanoNews.com

Featured News

Apr 9, 2021
Muere el príncipe Felipe, esposo de la reina Isabel II - Prince Philip, husband of Queen Elizabeth II, dies at 99

LONDON (AP) El duque de Edimburgo, el príncipe Felipe, marido de la reina Isabel II, ha muerto a los 99 años, según anunció la Casa Real británica en un comunicado. “Es con gran pesar que Su Majestad la Reina anuncia la muerte de su amado marido, Su Alteza Real el príncipe Felipe, duque de Edimburgo”, […]

Read More
Apr 9, 2021
Expert: Lack of oxygen killed George Floyd, not drugs

MINNEAPOLIS (AP) — George Floyd died of a lack of oxygen from being pinned to the pavement with a knee on his neck, medical experts testified at former Officer Derek Chauvin’s murder trial, emphatically rejecting the defense theory that Floyd’s drug use and underlying health problems killed him. “A healthy person subjected to what Mr. […]

Read More
Apr 8, 2021
Buffalo Employment and Training Center - Hiring during COVID 19 - Job postings

Buffalo Employment and Training Center 77 Goodell St., Buffalo, NY 14203 716-856-5627 / 716-856-5670 Fax www.workforcebuffalo.org Orientation Times: Monday-Thursday, 10 am or 2 pm. Mayor: Byron W. Brown * County Executive: Mark C. Poloncarz  Exec. Director, BETC Demone Smith BETC HOURS MONDAY THROUGH FRIDAY: 9:00 AM to 5:00 BETC: MEET THE EMPLOYERS: APRIL 2021 Attached is […]

Read More

popular categories

Copyright © 2021 Panorama Hispano News. All Rights Reserved.
crossmenuchevron-downmenu-circlecross-circle
linkedin facebook pinterest youtube rss twitter instagram facebook-blank rss-blank linkedin-blank pinterest youtube twitter instagram