This news has been received from: CNBC

All trademarks, copyrights, videos, photos and logos are owned by respective news sources. News stories, videos and live streams are from trusted sources.

mail: [NewsMag]

A nurse holds a phial of the Pfizer/BioNTech COVID-19 vaccine at University Hospital, on the first day of the largest immunisation programme in the British history, in Coventry, Britain December 8, 2020.Jacob King | Reuters

A key Food and Drug Administration advisory panel on Thursday recommended the approval of Pfizer and BioNTech's coronavirus vaccine for emergency use in people over 16 years old, the last step before the FDA gives the final OK to broadly distribute the first doses throughout the United States.

If the FDA accepts the nonbinding recommendation from the Vaccines and Related Biological Products Advisory Committee — which is expected — it would mark a pivotal moment in the Covid-19 pandemic, which has infected more than 15.4 million people and killed roughly 290,000 in the U.S. in less than a year.

The committee plays a key role in approving flu and other vaccines in the U.S., verifying the shots are safe for public use. While the FDA doesn't have to follow the advisory committee's recommendation, it often does.

The FDA could grant emergency use authorization of Pfizer's vaccine as early as Friday, James Hildreth, a member of the committee, told NBC's "Weekend Today" on Saturday. An emergency use authorization, or EUA, generally allows a drug or vaccine to be administered to a limited population or setting, such as to hospitalized patients, as the agency continues to evaluate safety data.

It's unclear whether the FDA will authorize Pfizer and BioNTech's vaccine for use in certain groups. Some people, including pregnant women and young children, will likely have to wait to get the vaccine in the U.S. until Pfizer can finish trials on those specific groups. The FDA said Tuesday that there is currently insufficient data to make conclusions about the safety of the vaccine in children under age 16, pregnant women and people with compromised immune systems. Regulators in Canada, the U.K. and Bahrain have all cleared the vaccine for use by most adults.

An EUA isn't the same as a full approval, which can typically take months. Pfizer has submitted only two months of follow-up safety data, but the agency usually requires six months for full approval.

U.S. officials say they are prepared to distribute the vaccine within 24 hours of authorization. Initial doses will be limited as manufacturing ramps up, with officials predicting it will take months to immunize everyone in the U.S. who wants to be vaccinated. Pfizer has said it plans to ship 50 million vaccine doses this year, enough to inoculate 25 million people. The vaccine is expected to be distributed in phases, with the most critical U.S. workers and vulnerable people getting it first. The Centers for Disease Control and Prevention has provided states with an outline that recommends prioritizing health-care workers and nursing homes first, but states can distribute the vaccine as they see fit.

U.S. officials plan to continue watching for any adverse reactions to Pfizer's vaccine in the health-care workers and nursing home residents who receive it, Dr. Nancy Messonnier, director of the CDC's National Center for Immunization and Respiratory Disease, said during the agency's meeting Thursday. Officials will use a text-messaging system, called v-safe, which is intended to provide early indications about possible adverse reactions from the vaccines.

The U.K., which authorized Pfizer's vaccine for emergency use last week, began mass inoculations on Tuesday. The vaccine there is being given to front-line health workers, nursing home workers and those over age 80 before being given more widely among the U.K. population.

Pfizer's vaccine uses messenger RNA, or mRNA, technology. It's a new approach to vaccines that uses genetic material to provoke an immune response. Late-stage clinical trial data shows the vaccine is 95% effective in preventing Covid, is safe and appears to fend off severe disease. To achieve maximum effectiveness, the vaccine requires two doses taken about three weeks apart.

The FDA has indicated it would authorize a Covid-19 vaccine that's safe and at least 50% effective. The flu vaccine, by comparison, generally reduces people's risk of getting influenza by 40% to 60% compared with people who aren't inoculated, according to the CDC.

Two days before the meeting, the FDA published documents on its website that said trial data submitted by Pfizer was consistent with recommendations put forth by the agency for emergency use. It also confirmed that the vaccine was highly effective and did not raise any major safety concerns, adding that more safety data is still needed on the vaccine in children, pregnant women and people with compromised immune systems.

During the meeting, FDA vaccine reviewer Dr. Susan Wollersheim noted the trial data showed a "numerical imbalance" in cases of Bell's palsy, a condition that causes a temporary weakness or paralysis of the muscles in the face. She said there were four cases in the vaccine group and none in the placebo group. While the frequency of cases was not above that of the general population, the FDA recommended further surveillance if the vaccine is authorized for more broad use. 

Pfizer's vaccine requires a storage temperature of minus 94 degrees Fahrenheit, presenting potential logistical challenges for rural areas and inner cities that may not have good health-care infrastructure. By comparison, Moderna has said its vaccine can be stored for up to six months at minus 4 degrees Fahrenheit.

President Donald Trump's coronavirus vaccine czar, Dr. Moncef Slaoui, has said the U.S. should be able to distribute enough coronavirus vaccine doses to immunize 100 million Americans, nearly a third of the U.S. population, by the end of February. He has said the entire U.S. population could be vaccinated against Covid-19 by June.

Pfizer said last week its full-scale production lines in the U.S. and Europe are now complete and it is "confident" it will be able to supply the targeted doses.

— CNBC's Noah Higgins-Dunn and Will Feuer contributed to this report.

This is a developing story. Please check back for updates.

Related Tags
  • Coronavirus: Prevention
  • Breaking News: Business
  • Coronavirus
  • Disease outbreaks
  • Epidemics

News Source: CNBC

Tags:

US congressional delegation visits Taiwan

Next News:

7 million people are under flood watches while 7 million face extreme heat alerts

(CNN)A flood watch is in place from Arizona to Wyoming, covering more than 7 million people, with afternoon and evening rain and thunderstorms expected in much of the Southwest on Sunday.

The flood watch includes Las Vegas, where two people died last week in flooding in what has become the wettest monsoon season in a decade. The flood threat is forecast to remain from Monday into Tuesday but will include a smaller area surrounding the Four Corners region, where Colorado, Utah, Arizona and New Mexico meet.

    Thunderstorms with heavy rain may produce mainly localized areas of flash flooding in parts of the Central Rockies, Great Basin, and Southwest and southern Texas. Summer heat with above normal temperatures are likely in the central Plains. pic.twitter.com/r6ePS1ND6L

    — National Weather Service (@NWS) August 14, 2022 In Texas, the National Hurricane Center is monitoring a disturbance that will bring heavy rain and thunderstorms to South Texas as it pushes onshore Sunday morning. As much as 6 inches of rain is expected across that region over the next few days and may lead to flash flooding.

      8 am EDT Aug 14: A low pressure area located near the coast of Texas just SSE of Corpus Christi is expected to move inland over southern Texas this morning. Although significant development is not anticipated, heavy rainfall could cause localized flash flooding through Monday. pic.twitter.com/hKKmmRPQRd

      — National Hurricane Center (@NHC_Atlantic) August 14, 2022 Meanwhile, temperatures are expected to be above normal in the Central Plains, the National Weather Service said Sunday. Read MoreThat's as excessive heat watches are in place for 7 million people in California's Central Valley, including Redding, Sacramento, Fresno and Bakersfield, where the thermometer will reach triple digits from Tuesday through at least Thursday.

      Other News

      • Arizona Grassroots Groups Rally at Redfest to Push Conservative Legislators for Leadership Positions in 2023
      • Kids forced to lock down and cower in fear at Six Flags in Illinois after shooter opens fire from a car in the parking lot - leaving three with gunshot wounds
      • Six Flags Great America ‘active shooter’ updates – ‘At least two shot’ at Gurnee, Illinois park as visitors take cover
      • Cramer: The big market rally out of nowhere since mid-June is why I tell people to stay invested
      • Little People fans praise Amy Roloff’s husband Chris Marek & slam her ‘toxic’ ex Matt after sweet 60th birthday tribute
      • We are in the midst of a national emergency. Labour would stop energy prices rising this winter
      • World News | Fire at Cairo Coptic church kills 41, including 15 children
      • You’ve got eagle eyes if you can spot all 10 differences in these pictures in less than 60 seconds
      • Who is Prey star Dakota Beavers?
      • Kandi Burruss on why she hates RHOA reunions: makes my stomach turn
      • We Didnt Deserve Freya the Walrus
      • Beloved walrus Freya put down after getting ‘too close to people’ – as crowds swam with ‘stressed’ animal & took selfies
      • Fire at Cairo Coptic church kills 41, including 10 children
      • Skin care charity SLAMS Man City for telling fans sun cream is BANNED from stadium despite 32 degree heatwave
      • Business | Who owns your credit score? Not you
      • Who owns your credit score? Not you
      • I’m a master catfish…. my make-up skills are so good, I can turn myself into a Bratz doll in minutes
      • Italian greyhound belonging to gay couple in Paris catches monkeypox after sharing bed with its infected owners, scientists reveal
      • Republican who had phone seized suggests he would have destroyed it if there was Jan. 6 evidence