Pfizer to seek FDA approval after final trial results show COVID-19 vaccine is 95% effective

Coronavirus Vaccine

FILE – In this Nov. 9, 2020, file photo, pedestrians walk past Pfizer world headquarters in New York. Pfizer announced Wednesday, Nov. 18, 2020, more results in its ongoing coronavirus vaccine study that suggest the shots are 95% effective a month after the first dose. (AP Photo/Bebeto Matthews, File)

WASHINGTON (NewsNation Now) — Pfizer Inc. plans to seek emergency use authorization from the U.S. Food and Drug Administration in the coming days after reporting its COVID-19 vaccine is 95% effective, according to final analysis from a late-stage trial.

Pfizer said on Wednesday that they haven’t found any serious safety concerns with the vaccine developed with German partner BioNTech SE, and that there were no major side effects. The shots were also consistent across age, gender, race and ethnicity demographics.

By the end of the company’s Phase 3 study, efficacy in adults over 65 years, who are determined to be in a higher risk group, was over 94%, the company said.

“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” said Pfizer CEO and Chairman Dr. Albert Bourla.

Pfizer first announced over a week ago that early analysis of trial data showed its vaccine had 90% effectiveness against COVID-19.

On Wednesday, Pfizer said there had been 170 cases of the disease in its trial of more 43,000 volunteers, of which 162 were observed in the placebo arm and eight were in the vaccine group.

Ten people developed severe COVID-19, one of whom received the vaccine.

The only severe adverse event that affected more than 2% of those vaccinated was fatigue, which affected 3.7% of recipients after the second dose. Older adults tended to report fewer and milder solicited adverse events following vaccination.

The news comes two days after Moderna announced that early data findings suggested a 94.5% efficacy rate for its vaccine.

Virus cases topped 11 million in the U.S. over the weekend, with 1 million of them recorded in just the past week. State and local officials across the country are tightening restrictions ahead of Thanksgiving.

“With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world,” Bourla said in a statement.

Authorities have stressed it’s unlikely any vaccine will arrive much before the end of the year, and limited initial supplies will be rationed.

The better-than-expected data from the two vaccines, both developed with new technology known as messenger RNA (mRNA), have raised hopes for an end to a resurgent pandemic that has killed more than 1.3 million people globally and wreaked havoc upon economies and daily life.

U.S. officials have said they hope to have about 20 million Moderna doses and another 20 million doses of the vaccine made by Pfizer and its German partner BioNTech to use in late December.

Authorities haven’t yet designated who will get priority, but Health and Human Services Secretary Alex Azar said this week that the aim is to have enough doses available by the end of January to vaccinate adults over 65 and health care workers.

The country’s top infectious disease expert, Dr. Anthony Fauci, said it may take until spring or summer for enough for anyone who is not high risk to get a shot.

Both Pfizer and Moderna’s vaccines require people to get two shots, several weeks apart.

Pfizer and BioNTech also said they plan to submit the data to other regulatory agencies around the world as well as the United States. They also plan to submit data from the study to a peer-reviewed scientific journal.

Pfizer reiterated it expects to make as many as 50 million vaccine doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.

On Monday, the company launched a coronavirus immunization pilot program involving four states to help with planning vaccine delivery and deployment. Rhode Island, Texas, New Mexico and Tennessee were chosen because of their differences in size, population and immunization infrastructure.

Of the dozens of drugmakers and research groups racing to develop vaccines against COVID-19, the next data release will likely be from AstraZeneca Plc with the University of Oxford in November or December. Johnson & Johnson says it is on track to deliver data this year.

The FDA has required that U.S. vaccine candidates be studied in at least 30,000 people. In addition to adequate numbers of older adults, those studies must also include other groups at high risk, including minorities and people with chronic health problems.

The agency told companies they must track half their participants for side effects for at least two months, the time period when problems typically crop up. 

The Associated Press and Reuters contributed to this report.

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