New Pfizer Results: Coronavirus Vaccine Is Safe and 95% Effective
The company said it planned to apply for emergency approval from the Food and Drug Administration “within days.”

“This publication is an exact copy of author’s original, it is intended to spread out information regarding COVID-19 and not necessarily reflects the PREMIERE SCIENTIFIC or its employees opinion”

The company said it planned to apply for emergency approval from the Food and Drug

Administration “within days.”

By Katie Thomas, Nov 18,2020 in The New York Times

Pfizer and BioNTech’s trial has shattered all speed records for vaccine development.

The drug maker Pfizer said on Wednesday that its coronavirus vaccine was 95 percent effective

and had no serious side effects — the first set of complete results from a late-stage vaccine trial

as Covid-19 cases skyrocket around the globe.

The data showed that the vaccine prevented mild and severe forms of Covid-19, the company

said. And it was 94 percent effective in older adults, who are more vulnerable to developing

severe Covid-19 and who do not respond strongly to some types of vaccines.

Pfizer, which developed the vaccine with its partner BioNTech, said the companies planned to

apply to the Food and Drug Administration for emergency authorization “within days,” raising

hopes that a working vaccine could soon become a reality.

The trial results — less than a year after researchers began working on the vaccine — shattered

all speed records for vaccine development, a process that usually takes years.

“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,” Dr. Albert Bourla, Pfizer’s chief

executive, said in a statement.

If the F.D.A. authorizes the two-dose vaccine, Pfizer has said that it could have up to 50 million

doses available by the end of the year, and up to 1.3 billion by the end of next year.

However, only about half of its supply will go to the United States this year, or enough for about

12.5 million people — a sliver of the American population of 330 million. Americans will receive

the vaccine for free, under a $1.95 billion deal the federal government reached with Pfizer for

100 million doses.

The results align with an early analysis that Pfizer and BioNTech reported last week, which

found that the vaccine was more than 90 percent effective. Then on Monday, the drug maker

Moderna reported that its vaccine was 94.5 percent effective in an early analysis.

Pfizer and BioNTech’s trial included nearly 44,000 volunteers, half of whom received the

vaccine. The other half received a placebo shot of salt water. Then the researchers waited to

see how many in each group developed Covid-19.

The companies said that out of 170 cases of Covid-19, 162 were in the placebo group, and

eight were in the vaccine group. Out of 10 cases of severe Covid-19, nine had received a

placebo.

Pfizer and BioNTech said that the vaccine’s efficacy was consistent across age, race and

ethnicity. The most common serious adverse event was fatigue, with 3.7 percent of volunteers

reporting tiredness after they took the second dose. Two percent of volunteers reported a

headache after the second dose. Older adults reported fewer and milder side effects, the

companies said.

“It’s pretty amazing,” said Akiko Iwasaki, an immunologist at Yale University. She said the

results in people over 65 were the most promising. “We know from the influenza vaccine that it’s

very difficult to achieve protection in this age group with vaccines,” she said, so 94 percent

efficacy in that group “is really remarkable.”

Federal health officials have said the first doses of the vaccines will most likely go to groups like

health care workers who are at high risk for exposure, as well as to people who are most

vulnerable to the disease, such as older people.

Dr. Saad B. Omer, the director of the Yale Institute for Global Health, said the results showing

the vaccines protected people from severe disease was also good news, because with such

limited availability initially, the first goal will be not to stop transmission of the disease, but to

prevent people from becoming extremely ill. “So that is very reassuring,” he said.

He called on Pfizer to quickly release a more detailed analysis of the data — beyond the initial

news release — so that scientists could more thoroughly evaluate the results. The companies

have said they plan to submit the results for review in a scientific journal, a process that can

take weeks or months. “These are not normal times, this is a pandemic, and major policy is

being made,” Dr. Omer said. “It’s always better to make policy on scientific data, not a press

release.”

In addition to the results of its clinical trial, Pfizer said it was ready to submit to the F.D.A. two

months of safety data that the agency had recommended, as well as detailed manufacturing

records showing the company can consistently produce high-quality batches of its product. The

F.D.A. will review the data and ask an outside panel of vaccine experts to weigh in on the

application, a process that could take weeks.