F.D.A Grants Full Approval to Pfizer-BioNTech Covid-19 Vaccine

The Food and Drug Administration today granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and older, making it the first to move beyond emergency use status in the United States.

The decision will set off a cascade of vaccine requirements by hospitals, colleges, corporations and other organizations.

Defense Secretary Lloyd Austin today will be sending guidelines to the country’s 1.4 million active duty service members mandating that they be vaccinated, the Pentagon announced on Monday.

The approval comes as the nation’s fight against the pandemic has intensified again, with the highly infectious Delta variant dramatically slowing the progress that the country had made over the first half of the year.

The Biden administration hopes the development will motivate at least some of the roughly 85 million unvaccinated Americans who are eligible for shots to get them.

President Biden is planning to commemorate it in a speech today urging vaccination scheduled for 10:30am Pacific time. “If you’re not vaccinated yet, now is the time,” the president said on Twitter.

“While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the F.D.A. approval of a vaccine may now instill additional confidence to get vaccinated,” Dr. Janet Woodcock, the acting F.D.A. commissioner, said in a statement. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

Pfizer said it presented the F.D.A. with data from 44,000 clinical trial participants in United States, the European Union, Turkey, South Africa and South America. The company said the data showed the vaccine was 91 percent effective in preventing infection — a slight drop from the 95 percent efficacy rate that the data showed when the F.D.A. decided to authorize the vaccine for emergency use in December. Pfizer said the decrease reflected the fact that researchers had more time to catch people who became infected.

A recent poll by the Kaiser Family Foundation, which has been tracking public attitudes during the pandemic, found that three of every 10 unvaccinated people said that they would be more likely to get vaccinated with a shot that had been fully approved.

The Pfizer-BioNTech vaccine will continue to be authorized for emergency use for children ages 12 to 15 while Pfizer collects the necessary data required for full approval. A decision on whether to authorize the vaccine for children younger than 12 could be at least several months away. So far, more than 92 million Americans — 54 percent of those fully inoculated — have gotten Pfizer shots. Most of the rest received Moderna’s vaccine.

Dr. Peter Marks, the F.D.A.’s top vaccine regulator, said that the Pfizer vaccine’s licensure followed a rigorous review of hundreds of thousands of pages of data and included inspections of the factories where the vaccine is produced. “The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.,” he said.

Health experts and state officials welcomed the development. With the Delta variant driving up caseloads across the country, “full approval could not come at a more important time,” said Dr. Richard Besser, president of the Robert Wood Johnson Foundation and former acting director of the Centers for Disease Control and Prevention.

“It is time for schools, businesses, health care facilities, and other indoor places where people congregate to mandate Covid-19 vaccines for admittance for all who are vaccine-eligible,” he added.

Some experts have estimated that full approval might convince just 5% of those who are unvaccinated to get shots. Even if that’s so, “that’s still a huge slice of people,” Dr. Thomas Dobbs, the chief health officer for Mississippi, a state that is particularly hard hit by the Delta variant. He said licensure will help “shake loose this false assertion that the vaccines are an ‘experimental’ thing.”

The F.D.A. is in the midst of a decision-making marathon related to coronavirus vaccines. The next major one looming for regulators is whether or not to authorize booster shots. The Biden administration said last week that pending the agency’s clearance, it will offer third shots to adults who got the Pfizer and Moderna vaccines eight months after their second injection, starting Sept. 20. Third shots are already authorized for some people with immune deficiencies, but the risk-benefit calculus is different for the general population.

Federal health officials said that both Pfizer-BioNTech and Moderna’s vaccines, which rely on similar technology, wane in potency over time. That trend, they said, is converging with the rise of the particularly dangerous Delta variant, making those who completed their vaccinations at the start of the year increasingly vulnerable to infection.

Some health experts have challenged the decision to recommend booster shots as premature, saying the data shows that the vaccines are holding up well against severe disease and hospitalization, including against the Delta variant. Boosters would only be warranted if the vaccines were failing to prevent hospitalizations with Covid-19, some of those experts have said.

Regulators are still reviewing Moderna’s application for full approval of its vaccine. That decision could take several weeks. Johnson & Johnson is expected to apply soon for full approval.

 

 

14 Comments

  1. “The decision will set off a cascade of vaccine requirements by hospitals, colleges, corporations and other organizations.”

    Convenient

  2. With NOT HIM’s comment, this article’s comment total matched last week’s COVID death toll for this county.

    Obviously, NOT HIM must be stopped.

  3. WOW!!!

    WE WILL NOT HAVE CONTROL OVER COVID UNTIL SPRING 2022?

    TO MANY PEOPLE TRYING TO SAY THEY HAVE COVID UNDER CONTROL WHEN THEY DON’T?

    AT LEAST FAUCI DOESN’T MAKE ANY FALSE PROMISES

  4. Just like the common flu, we will never have “control” of Covid.

    In the US, flu kills between 30,000 and 60,000 people per year. We don’t lock down the country for that.

    Just like the flu, Covid will be a management problem that we will have to deal with in perpetuity.

  5. HB You wrote:

    “Just like the common flu, we will never have “control” of Covid.”

    ACTUALLY WE DO HAVE CONTROL OVER FLUS, IT CALLED A FLU VACCINE WHICH A NEW ONE IS MADE EVERY YEAR, I GET MY SHOT ALL THE TIME, AND I DO NOT GET THE FLU. BUT MORE IMPORTANTLY, COVID’S R(NOT) IS AROUND 7-8 WHEREAS THE FLUS R(NOT) IS ONLY ABOUT AT MOST 3 WHICH MAKES THE FOLLOWING SENTENCE TOTALLY IRRELEVANT You wrote:

    “in the US, flu kills between 30,000 and 60,000 people per year. We don’t lock down the country for that.”

    SINCE COVID IS FAR MORE “INFECTIOUS” THAN THE FLU AS PROVEN BY THE R(NOT) THERE IS REASON FO THE SHUTDOWNS, YOU DO REALIZE THAT WE HAD 1,700 DEATHS YESTERDAY, AND 630,000 DEATHS TO DATE, WHICH IS ABOUT 10 TIMES THE DEATHS YOU PROPOSED. SO YES, UNTIL WE CAN ACHIEVE YOUR LEVELS OF DEATHS YOU PROPOSE WE WILL HAVE LOCKDOWNS, IN ORDER TO ACHIEVE YOUR STANDARD, WE NEED TO ONLY HAVE AT MOST 170 DEATHS A DAY FOR A YEAR. WE MAY HAVE SEEN NUMBERS THAT LOW ONLY SAY 4-5 WEEKS OF THIS PANDEMIC

  6. Flip-Flopping Fauci is doing more damage to fighting Covid every time he opens his mouth.
    Is Fauci being “used” by the Biden Admin to distract from the Worst Debacle in US history?
    Fauci’s Moving Goal Posts.
    “..Fauci apologizes for latest GAFFE in COVID analysis”
    “..Monday (Fauci said) that if enough people get vaccinated, the US could
    “really get some good control over this” by the Fall or Winter of next year.”

    Later the same day, Fauci – who has been under fire repeatedly for flip-flopping on his public advice from the early days of the pandemic –
    said he actually thinks that control will come even sooner.
    “…I have to apologize. …I meant to say the spring of 2022,”

    “I didn’t mean the fall – I misspoke. MY BAD” Fauci said.

    Of course, you would have Whip-Lash following his advice on Masking..
    – “Masks don’t work.”
    – “Masks DO work.
    – “Masks don’t work unless you get an N95 mask.
    – “You don’t need an N95 mask – just a cloth mask.
    – “One mask is okay, but 2 masks are better to prevent ‘leakage.’”
    – “Kids don’t need to wear masks.
    – “Kids should wear masks.
    – “Did I remember to unplug the toaster?
    – “Vaccinated people don’t need to wear a mask.
    – “Vaccinated people should definitely wear a mask.
    Yes… Must listen to the Flip-Flopping Media Clown..

  7. CA PATRIOT You wrote:

    “Flip-Flopping Fauci is doing more damage to fighting Covid every time he opens his mouth.”

    ACTUALLY YOU CAN THANK THE SO CALLED “ANTI-VAXERS” AND THE “ANTI-MASKERS” BECAUSE THEY ARE THE ONES THE PROMOTE UNSAFE AND IRRESPONSIBLE LIVING. SINCE THE REST OF THE WORLD CANNOT GET VACCINATED AS FAST AS WE CAN THERE ARE GOING TO BE NEW MUTATIONS. AS FAR AS THE U.S. IS CONCERNED THE “ANTIVAXERS” AND THE “ANTI-MASKERS” ARE THE ONES THAT ARE SABOTAGING THE EFFORTS WORLDWIDE AGAINST THE VIRUS. THUS, THE VIRUS NUTATES AND GETS WORSE. THE FACTS ARE AS MUCH AS 30%+ OF AMERICANS REFUSE TO BE VACCINATED NOR WEAR MASKS. YOU CANNOT PUT THAT SITUATION ON FAUCI.

  8. Yes, thank DEM Elitists like Gavin Newsom (RECALL) yucking it up with his rich donors, mask-less indoors, during the height of the scare. AND..
    “You Don’t Need A Mask If You’re A Rich DEM” As Hypocrite Nancy Pelosi Hosts A Huge 30K Per Ticket, Rich White Napa Fundraiser over the weekend.

    The CDC says Napa County is a coronavirus hotspot, garnering the designation of “HIGH” for its current level of transmission.
    The CDC further says..“In areas with high numbers of COVID-19 cases, consider wearing a mask in crowded outdoor settings and for activities with close contact with others who are not fully vaccinated,”

    But 81yr old Nancy Pelosi and dozens of her elitist friends, some looking clearly Obese and Elderly – deep in the risk range for the virus.
    Are NOT social distancing, wearing face shields or even a mask – hopefully they washed their hands.

    “They’re breathing all the fresh air they want like it’s 2019.
    The only people there in masks are their servants – faceless brown serfs, scurrying back and forth to bring them things.
    Nothing worse than having the help breathe on you.”

  9. CA PATRIOT,

    AT LEAST I CANNOT ARGUE AGAINST YOU ON THAT. THEY WERE ALL BEING IRRESPONSIBLE. BUT YOU DO NOT KNOW IF ALL THE PARTICANTS IN NAPA WERE VACCINATED, DO YOU?

    COMPARE THIS TO THE WHITE HOUSE EVENT THAT BECAME A SPREADER EVENT THAT EVEN TRUMP GOT THE COVID, ATLEAST THAT WAS TOLD TO US. I SUSPECT THAT WAS A FALSE STORY, TRYING TO GET HIS BASE STRONGER.

    BUT YES, I AM CALLING OUT ALL IRRESPONSIBLE PEOPLE, BUT YOU ARE ALSO TRYING TO BE RACIST AGAIN. THE BOTTOM LINE IS THAT THE SO CALLED RED STATES ARE IN THE WORST COVID SURGES THEY HAVE SEEN. BUT COVID IS EQUALLY ATTACKING EVERYONE.

  10. BY THE WAY YOU ALL HAVEN’T ADDRESSED THE PROBLEM THAT COVID KILLS AT LEAST 10 TIMES THE PEOPLE AS THE FLU, AND IS MORE INFECTIOUS

    NOW IF I WERE REALLY COLD BLOODED, THIS WOULD BE MY APPROACH TO THE PROBLEM.

    LET ANYONE NOT VACINATED NOT GET ANY HEALTH CARE SERVICES. LET THEM TAKE THE RESPONSIBILITY FOR THEIR ACTIONS.

    THUS IF ALL OF THEM ARE TRUMP SUPPORTERS, THEY WILL EITHER DIE OR BECOME TOO DISABLED TO VOTE. THUS MAKING A MAJOR SHIFT IN THE LONG TERM ELECTIONS.

    I AM JUST JOKING, I AM NOT THAT HEARTLESS.

  11. StevenG, making Dumb & Racist comments.. you yell a lot but know little.. and regularly spread mis-information and blather.
    “Young people, minorities less likely to get vaxxed”

    LATimes: Los Angeles County health dept reports that for residents ages of 16 and 29 yrs:
    “Only 18% of Black men & 20% of Black women have received at least one dose of the vaccine,
    In the Latino community, the numbers are also low, with 24% of men and 31% of women receiving at least one dose.
    By comparison, 43% of white men and 51% of white women within the same age group have received a dose, as have
    57% of Asian American men and 65% of Asian American women, and
    43% of Native American men and 53% of Native American women.

    “In total, 61% of Black residents and 63% of Latino residents 65 and older
    have received one dose, compared to
    70% of Native American residents,
    76% of Asian American residents and
    78% of white residents.”

    “..in California, 30% of vaccinations have gone to Hispanic people, while they account for 63% of cases, 48% of deaths, and 40% of the total population in the state.”

    “..in the District of Columbia, Black people have received 43% of vaccinations, while they make up 56% of cases, 71% of deaths, and 46% of the total population.”

  12. CA PATRIOT,

    THE REAL PROBLEM IS THAT COVID IS NOT A REGIONAL PROBLEM, IT IS AN AIR-BORNE VURUS AND IS TRANSPORTED BY PEOPLE. THUS EVEN THE MEDICAL COMMUNITY IS GIVING WARNINGS THAT THE VACCINES ALONE WILL NOT DO THE JOB.

    IN FACT AS WE ARE AWARE EVERY TIME IT MUTATES, IT SEEMS TO GET MORE INFECTIOUS AND LESS RESPONSIVE TO THE VACCINES.

    AT CRRENT COUNT WE HAVE 66 ICU BEDS FREE IN SANTA CLARA COUNTY AND THE 7 DAY RUNNING AVE OF DEATHS IS OVER 1,000, WHICH MEANS IF THAT REMAINS STEADY WE WILL SEE 360,000 PEOPLE DIE OF COVI IN A YEAR.

    THE REALITY IS BY TRYING TO REGIONALIZE COVID IS A FAILURE UNLESS YOU PREVENT PEOPLE FROM TRAVELING OUTSIDE THE REGIONS ENTIRELY, OTHERWISE IT IS JUST ANOTHER GAME OF WHACK A MOLE.

  13. Efficacy of flu vaccines:

    https://www.webmd.com/lung/news/20200902/how-effective-is-the-flu-vaccine

    The flu shots are only about 50% effective!

    We will be dealing with “spikes” and “outbreaks “ of COVID in perpetuity. And, yes it is worse than influenza, but just like flu, auto accident deaths, overdose death, etc, we will have to live with it. And, just like the flu, we can’t fully stop it. We can’t shut down our entire society and take people’s civil rights from them in a futile effort to reach the unattainable goal of zero COVID deaths. Just like flu, a COVID zero rate of infection and transmission is unattainable.

    The virus is circulating among the entire world’s population (7 billion people). We represent just about five percent of the entire population. Even if we reach a 100 percent vaccination rate, the rest of the world will not, because a couple billion of them are poor and illiterate and will never get vaccinated or “socially distant, wear masks, or practice hospital level personal hygiene,” The virus will continue to mutate in this huge reservoir of vectors—new variants will continue to arise.

    It occurs to me that with modern air travel (and open borders) new strains of COVID will reach the US even if we reach the unicorn number of 100% of the US population vaccinated Oh, yeah, since we have our own poor and illiterate groups, we will never reach 100%. We currently have a couple hundred thousand people coming into our country monthly over the southern border who are processed and released into the US and we don’t require them to get vaccinated before they are released. And, many more come into the country that aren’t apprehended.

    Are we really serious about stopping the spread?

  14. HB,

    YES WE ARE! BUT THE REAL PROBLEM IS THAT RECXENT RESEARCH IS STARTING TO SHOW THAT THE VARIANTS ARE GETTING RESISTANT TO THE VACCINES, AND ALSO BEATING OLDER INFECTION AQUIRED IMMUNITY. READ THE MERCURY NEWS ARTICLE “New UCSF study: Vaccine-resistant viruses are driving ‘breakthrough’ COVID infections ‘As long as the virus continues to circulate, it will continue to mutate’. THAT MEANS THE VACCINES ARE LOSING THE WAR, AND WE HAVE NO OTHERS YET, WHAT HAPPENED TO THE CONTINUING RESAERCH? WE STILL HAVE LESS THAN 60 ICU BEDS AVAILIBLE.

    WE ARE GOING BACKWARDS BADLY AND IT MAY DEFINTELY REQUIRE SHUTDOWNS AGAIN.

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