CORONAVIRUS

US Panel Endorses Widespread Use Of Pfizer COVID-19 Vaccine

Dec 10, 2020, 3:11 PM | Updated: 4:05 pm
TRURO, ENGLAND - DECEMBER 09: Kimberley Olds, NHS Pharmacy Technician, prepares the Covid-19 vaccin...
TRURO, ENGLAND - DECEMBER 09: Kimberley Olds, NHS Pharmacy Technician, prepares the Covid-19 vaccine for use by the vaccinations team at the Royal Cornwall Hospital as they commenced their vaccination programme on December 9, 2020 in Truro, United Kingdom. More than 50 hospitals across England were designated as covid-19 vaccine hubs, the first stage of what will be a lengthy vaccination campaign. NHS staff, over-80s, and care home residents will be among the first to receive the Pfizer/BioNTech vaccine, which recently received emergency approval from the country's health authorities. (Photo by Hugh Hastings/Getty Images)
(Photo by Hugh Hastings/Getty Images)

WASHINGTON (AP) — A U.S. government advisory panel endorsed widespread use of Pfizer’s coronavirus vaccine Thursday, putting the country just one step away from launching an epic vaccination campaign against the outbreak that has killed close to 300,000 Americans.

Shots could begin within days, depending on how quickly the Food and Drug Administration signs off, as expected, on the expert committee’s recommendation.

In a 17-4 vote with one abstention, the government advisers concluded that the vaccine from Pfizer and its German partner BioNTech appears safe and effective for emergency use in adults and teenagers 16 and older.

That endorsement came despite questions about allergic reactions in two people who received the vaccine earlier this week when Britain became the first country to begin dispensing the Pfizer-BioNTech shot.

Despite all the remaining unknowns, in an emergency, “the question is whether you know enough,” said panel member Dr. Paul Offit of Children’s Hospital of Philadelphia, who concluded that the shot’s potential benefits outweigh its risks.

The independent review by non-government experts in vaccine development, infectious diseases and medical statistics was considered critical to boosting Americans’ confidence in the safety of the shot, which was developed at breakneck speed less than a year after the virus was identified.

The decision came as COVID-19 cases surge to ever-higher levels across the U.S., with deaths hitting an all-time, one-day high of more than 3,100 on Wednesday.

Pfizer has said it will have about 25 million doses of the two-shot vaccine for the U.S. by the end of December. But initial supplies will be limited and reserved primarily for health care workers and nursing home residents, with other vulnerable groups next in line until the shots become widely available on demand, something that will probably not happen until the spring.

Experts estimate at least 70% of the U.S. population will have to be vaccinated to achieve herd immunity, the point at which the virus can be held in check. That means it could be several months before things start get back to normal and Americans can put away their masks.

The FDA next week will review a second vaccine, from Moderna and the National Institutes of Health, that appears about as protective as Pfizer-BioNTech’s shot. A third candidate, from Johnson & Johnson, which would require just one dose, is working its way through the pipeline. Behind that is a candidate from AstraZeneca and Oxford University

All eyes now turn to the FDA staff scientists who will make the final decision on whether to greenlight use of the Pfizer-BioNTech vaccine. Regulators not only in Britain but in Canada have already approved it for use in their countries, and President Donald Trump and White House officials have complained for weeks about the pace of FDA’s careful review.

FDA’s vaccine director Dr. Peter Marks said ahead of the expert meeting that a decision would come within “days to a week.”

“Americans want us to do a scientific review, but I think they also want us to make sure we’re not wasting time on paperwork as opposed to going forward with the decision,” FDA Commissioner Stephen Hahn said before the meeting.

A positive vote for the vaccine was virtually assured after FDA scientists issued a glowing review of the vaccine earlier in the week. Agency staffers said data from Pfizer’s ongoing study of 44,000 people showed strong protection across different age groups, races and health conditions with no major, unexpected safety problems.

The Pfizer-BioNTech shot remains experimental because that final-stage study isn’t complete. As a result, the expert panel wrestled with a list of questions that have yet to be answered.

For example, while the vaccine is more than 90% effective in blocking the symptoms of COVID-19, the FDA’s advisers stressed it is not yet clear if it can stop the silent, symptomless spread that accounts for up to half of cases.

“Even though the individual efficacy of this vaccine is very, very, very high, you really as of right now do not have any evidence” that it will lower transmission, said Dr. Patrick Moore of the University of Pittsburgh. He urged Pfizer to take additional steps to answer that question.

And the advisers are worried that Pfizer will lose its opportunity to answer critical questions as it begins offering the real vaccine to study participants who had been getting dummy shots.

The company proposed gradually moving those patients to the vaccine group, with priority based on age, health conditions and other factors. Under that plan, 70-year-old participants would cross over before healthy 30-year-olds.

Pfizer must still show whether the vaccine works in children younger than 16 and in pregnant women.

On the safety front, as widespread vaccinations begin, the first recipients will be closely tracked by government health authorities since studies in tens of thousands of people can’t detect rare risks that strike 1 in a million. Hanging over the meeting were the British allergic reactions and a warning from authorities there that people with a history of serious reactions shouldn’t get the vaccine for now.

Pfizer representatives said they have seen no signs of allergic reactions in their trial. But some of the FDA advisers fear the British warning will deter millions of Americans with allergies who might benefit from the COVID-19 vaccine from giving it a try, and urged additional studies to try to settle the issue.

“This issue is not going to die until we have better data,” Offit said.

KSL 5 TV Live

Top Stories

Coronavirus

...
Ashley Moser

Flu, COVID and RSV all trending down for the first time in months, says CDC

Major respiratory illnesses are all trending down for the first time since September, according to the CDC.
11 days ago
FILE PHOTO (Photo by Matthew Hatcher/Getty Images)...
Josh Ellis

Utah doctor, others charged with running COVID vaccine scheme, issuing fake records and giving fake shots

A Utah plastic surgeon, his medical corporation and three others have been charged after prosecutors say they issued fake COVID-19 vaccination record cards and injected minors with saline shots.
17 days ago
Dr. Angela Dunn, executive director of Salt Lake County Health Department, left, discusses schoolch...
Michael Houck

Salt Lake County ends its COVID-19 emergency status

After nearly three years, the Salt Lake County Health Department ended its COVID emergency status Tuesday. 
25 days ago
FILE: People line up in their cars as members of the Utah National Guard give COVID-19 swab tests a...
Eliza Pace

Gov. Cox, along with 24 other governors, call on President Biden to end Federal Public Health Emergency

Gov. Spencer Cox signed a letter with 24 other governors calling on President Joe Biden to end the federal public health emergency over the COVID-19 pandemic.
2 months ago
U.S. President Joe Biden welcomes guests to the East Room of the White House on December 14, 2022 i...
ZEKE MILLER, AP White House Correspondent

White House reveals winter COVID-19 plans, more free tests

The Biden administration is again making some free COVID-19 tests available to all U.S. households as it unveils its contingency plans for potential coronavirus surges this winter.
2 months ago
FILE - Florida Gov. Ron DeSantis speaks during a news conference, Feb. 1, 2022, in Miami. Gov. DeSa...
FREIDA FRISARO, Associated Press

DeSantis seeks grand jury investigation of COVID-19 vaccines

Florida Gov. Ron DeSantis is asking the state’s Supreme Court to convene a grand jury to investigate “any and all wrongdoing” with respect to the COVID-19 vaccines.
2 months ago

Sponsored Articles

vintage photo of lighting showroom featuring chandeliers, lamps, wall lights and mirrors...
Lighting Design

History of Lighting Design | Over 25 Years of Providing Utah With the Latest Trends and Styles

Read about the history of Lighting Design, a family-owned and operated business that paved the way for the lighting industry in Utah.
Fiber Optical cables connected to an optic ports and Network cables connected to ethernet ports...
Brian Huston, CE and Anthony Perkins, BICSI

Why Every Business Needs a Structured Cabling System

A structured cabling system benefits businesses by giving you faster processing speeds and making your network more efficient and reliable.
notebook with password notes highlighted...
PC Laptops

How to Create Strong Passwords You Can Actually Remember

Learn how you can create strong passwords that are actually easy to remember! In a short time you can create new ones in seconds.
house with for rent sign posted...
Chase Harrington, president and COO of Entrata

Top 5 Reasons You May Want to Consider Apartment Life Over Owning a Home

There are many benefits of renting that can be overshadowed by the allure of buying a home. Here are five reasons why renting might be right for you.
Festive kitchen in Christmas decorations. Christmas dining room....
Lighting Design

6 Holiday Decor Trends to Try in 2022

We've rounded out the top 6 holiday decor trends for 2022 so you can be ahead of the game before you start shopping. 
Happy diverse college or university students are having fun on their graduation day...
BYU MBA at the Marriott School of Business

How to Choose What MBA Program is Right for You: Take this Quiz Before You Apply!

Wondering what MBA program is right for you? Take this quiz before you apply to see if it will help you meet your goals.
US Panel Endorses Widespread Use Of Pfizer COVID-19 Vaccine