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Pfizer plans filing as its COVID-19 vaccine proves 95% effective

by By Robert Langreth/TNS
| November 19, 2020 1:00 AM

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.