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

Biden Releases National Strategy for COVID-19 Response, Pandemic Preparedness
Health
Biden Releases National Strategy for COVID-19 Response, Pandemic Preparedness
January 21, 2021
by Reece Nations

WASHINGTON — On the first full day of his term, President Joe Biden announced his plan to combat the novel coronavirus pandemic, entitled “National Strategy for the COVID-19 Response and Pandemic Preparedness.”  Biden’s strategy includes issuing 10 executive orders to mitigate the virus. In addition to... Read More

Indoor Dining to Resume in the District of Columbia at 25% Capacity
District of Columbia
Indoor Dining to Resume in the District of Columbia at 25% Capacity
January 21, 2021
by Dan McCue

WASHINGTON - Restaurants in the District of Columbia will be able to resume indoor dining at 25% capacity beginning early Friday morning, the chief of staff for Mayor Muriel Bowser said. In a post to his Twitter account, John Falcicchio, who serves as both chief of... Read More

EXPLAINER: What's Next for WHO After US Takes Steps to Stay
Health
EXPLAINER: What's Next for WHO After US Takes Steps to Stay

GENEVA (AP) — The Biden administration has taken quick steps to keep the United States in the World Health Organization and reinforce financial and staffing support for it — part of his ambition to launch a full-throttle effort to fight the COVID-19 pandemic in partnership with... Read More

Biden's US Revives Support for WHO, Reversing Trump Retreat
Health
Biden's US Revives Support for WHO, Reversing Trump Retreat

GENEVA (AP) — The United States will resume funding for the World Health Organization and join its consortium aimed at sharing coronavirus vaccines fairly around the globe, President Joe Biden’s top adviser on the pandemic said Thursday, renewing support for an agency that the Trump administration... Read More

New CDC Director Takes Over Beleaguered Agency Amid Crisis
Health
New CDC Director Takes Over Beleaguered Agency Amid Crisis

NEW YORK (AP) — As the coronavirus swept across the globe last year, the Centers for Disease Control and Prevention sank into the shadows, undermined by some of its own mistakes and stifled by an administration bent on downplaying the nation's suffering. Now a new CDC... Read More

Phase 1B: Interest Groups Appeal to States for Access to Coronavirus Vaccine
State News
Phase 1B: Interest Groups Appeal to States for Access to Coronavirus Vaccine
January 19, 2021
by Reece Nations

Interest groups are pleading their cases to state officials in a bid to expedite their constituents’ access to the novel coronavirus vaccine.  Individuals over the age of 70, frontline health care workers, nursing home residents and staff are the first groups of people to receive the... Read More

News From The Well
scroll top