facebook linkedin twitter

Pfizer Plans Filing as Its COVID-19 Vaccine Proves 95% Effective

November 19, 2020by Robert Langreth, Bloomberg News (TNS)
An illustration picture shows vials with Covid-19 Vaccine stickers attached and syringes with the logo of US pharmaceutical company Pfizer and German partner BioNTech, on November 17, 2020. (Justin Tallis/AFP/Getty Images/TNS)

Pfizer Inc. said a final analysis of clinical trial data showed its COVID-19 vaccine was 95% effective, paving the way for the company to apply this week for the first U.S. regulatory authorization for a coronavirus shot.

The U.S. drugmaker and partner BioNTech SE said their vaccine protected people of all ages and ethnicities, with no significant safety problems so far in a trial that includes almost 44,000 participants.

The update is the latest in a string of promising developments on the vaccine front in recent days. Moderna Inc.’s rival shot appears equally effective, judging from data published earlier this week, and a third contender, from AstraZeneca Plc and the University of Oxford, is expected to release trial results soon.

Pfizer and its German partner now plan a filing with the U.S. Food and Drug Administration by Friday at the latest, BioNTech Chief Executive Officer Ugur Sahin said in a Bloomberg Television interview. Documents have already been filed with the European Medicines Agency, which is conducting a rolling review, he said.

“There are almost daily phone calls and document exchange” with the European regulator, Sahin said. “I am confident that based on the positive data we have generated today, all authorities — the FDA, the EMA and other regulatory authorities — will really push to get this done as quickly as possible.”

The Pfizer-BioNTech data shows 170 trial participants contracted COVID-19 overall. Eight participants who got the vaccine fell ill, while 162 cases were seen among those who got the placebo. The shot helped to prevent severe disease, according to the analysis, with nine of 10 severe cases in the trial occurring in the placebo group.

The vaccine’s efficacy in people older than 65 was more than 94%, the companies said.

Most people who received the shot tolerated it well. Severe fatigue was seen in 3.8% of volunteers after the second dose in the two-shot regimen, and 2% of people had a severe headache after the second dose. But those were the only severe side effects that occurred in at least 2% of people, according to the data.

The results “appear to confirm a highly impressive efficacy profile for the vaccine and a side-effect profile that appears very reasonable given the vaccine’s benefits,” Mizuho analyst Vamil Divan wrote in a research note.

Pfizer and BioNTech said last week that an initial readout showed the vaccine was more than 90% effective. The news helped spark a broad stock-market rally on hopes that the shot could help control a pandemic that has killed more than 1.3 million people worldwide.

On Monday, Moderna released its own promising results and said it expects to be able to apply for emergency authorization in the U.S. within weeks.

On Tuesday, Pfizer Chief Executive Officer Albert Bourla said at a conference that the companies had gathered the two-month safety follow-up data required by the FDA.

Both the Moderna and the Pfizer-BioNTech vaccines are based on messenger RNA, a new type of vaccine technology that is able to be deployed very quickly. It essentially transforms the body’s cells into tiny vaccine-making machines. The vaccines instruct cells to make copies of the coronavirus spike protein, stimulating the production of protective antibodies.

___

Blaise Robinson, Guy Johnson, Alix Steel and Naomi Kresge contributed to this story.

___

(c)2020 Bloomberg News

Distributed by Tribune Content Agency, LLC

Health

October 27, 2021
by Alexa Hornbeck
How Horror Films Help Individuals Cope With Scary Situations

WASHINGTON — A study funded by the Research Program for Media, Communication, and Society at the School of Communication and... Read More

WASHINGTON — A study funded by the Research Program for Media, Communication, and Society at the School of Communication and Culture at Aarhus University in Denmark reveals how watching horror films may have helped individuals cope and prepare for the psychological distress of the COVID-19 pandemic.... Read More

October 27, 2021
by Alexa Hornbeck
Can Psychedelic Treatments Help People Quit Smoking?

WASHINGTON — The National Institutes of Health recently awarded a $4 million grant to Johns Hopkins Medicine for a three-year... Read More

WASHINGTON — The National Institutes of Health recently awarded a $4 million grant to Johns Hopkins Medicine for a three-year clinical trial to examine if psilocybin-assisted psychotherapies can help people quit smoking. “Psychedelic treatments ... when properly applied can help people get to the roots of... Read More

October 27, 2021
by Alexa Hornbeck
Letter Urges Passage of National Paid Leave to Combat Drug Addiction

WASHINGTON — When Khrista Messinger, a 46-year-old who works for the City of Charleston, W.Va., requested time off from work... Read More

WASHINGTON — When Khrista Messinger, a 46-year-old who works for the City of Charleston, W.Va., requested time off from work to seek treatment for her substance abuse addiction she was told by her employer that she needed to use her sick leave and vacation time. “I’ve... Read More

COVID Cases Falling, But Trouble Signs Arise as Winter Looms

Tumbling COVID-19 case counts have some schools around the U.S. considering relaxing their mask rules, but deaths nationally have been... Read More

Tumbling COVID-19 case counts have some schools around the U.S. considering relaxing their mask rules, but deaths nationally have been ticking up over the past few weeks, some rural hospitals are showing signs of strain, and cold weather is setting in. The number of new cases... Read More

October 20, 2021
by Dan McCue
FDA Signs Off on Moderna, J&J Boosters, Mixing Vaccines

WASHINGTON - The Food and Drug Administration on Wednesday said Americans who got either the Moderna or Johnson & Johnson... Read More

WASHINGTON - The Food and Drug Administration on Wednesday said Americans who got either the Moderna or Johnson & Johnson vaccine can now get a COVID-19 booster, and also say that those eligible for a booster don’t have to get the same brand as their initial... Read More

October 20, 2021
by Alexa Hornbeck
EPA Accelerates Efforts to Clean Up PFAS Pollution

This week, the Environmental Protection Agency released a new roadmap to accelerate efforts to protect Americans from per- and polyfluoroalkyl... Read More

This week, the Environmental Protection Agency released a new roadmap to accelerate efforts to protect Americans from per- and polyfluoroalkyl substances, a class of toxic chemicals found in food packaging and other common commercial products that can cause severe health problems. "We are exploring ways for... Read More

News From The Well
scroll top