FDA vaccine panel approves Pfizer booster shots for people over 65 after rejecting it for younger adults

The panel that advises the Food and Drug Administration on vaccines rejected the use of a booster dose of the Pfizer COVID-19 vaccine in people younger than 65 on Friday.

Pfizer had petitioned the FDA to approve a third dose of the two-shot vaccine for use in those ages 16 to 65 in the United States about six months after receiving the second dose of the vaccine, but the FDA’s Vaccines and Related Biological Products Advisory Committee voted 16-2 to deny the petition, citing a lack of evidence to show the clear benefit of administering the booster shots to patients with fully functional immune systems. The committee did end up approving third doses of the Pfizer vaccine for people ages 65 and older, the group deemed most susceptible to serious complications and even death due to the disease.

There were two key controversies that informed the decision. The first was whether the effectiveness of the COVID-19 vaccine waned over time against cases of severe COVID-19 and hospitalizations.

There was ample evidence that the vaccine’s efficacy at preventing severe illness dropped over time. Data from the Centers for Disease Control and Prevention show that prior to the delta surge, the vaccine provided between 72% and 97% protection against infection. That fell to 39% to 84% during the surge. Pfizer reported that protection against infection was about 88% shortly after the second dose of the two-shot vaccine was administered. But that fell to 47% after five months.

But neither the CDC nor Pfizer found that protection against hospitalization dropped following about six months after the second dose.

Dr. Michael Kurilla, director of the Division of Clinical Innovation at the National Institutes of Health, seemed to speak for many on the panel in saying that most of the focus had been on the waning of antibodies, which prevent infection, and not enough on B and T cells, which prevent hospitalization and severe disease.

“So, it’s unclear that everyone needs to be boosted other than a subset of the population that's clearly at high risk for severe disease,” Kurilla said.

Another controversy concerned the safety of the third dose. Pfizer data showed that in the trials of the third dose of its vaccine, the side effects were no worse than those after a second dose, but that was based on only 300 patients.

“That’s a small number of people,” said Dr. Paul Offit, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at the Children's Hospital of Philadelphia.

Dr. Doran Fink, deputy director of the Division of Vaccines and Related Products Applications at the FDA, worried that the data was insufficient to determine whether younger people would suffer higher rates of heart inflammation known as myocarditis and pericarditis. The CDC had previously found a link between the Pfizer and Moderna vaccines and heart inflammation in people under age 30.

The FDA has only authorized extra doses for people with weakened immune systems due to underlying medical conditions such as end-stage renal disease and those being treated for cancer. Over 76% of U.S. adults have received at least one dose of a vaccine, totaling more than 211 million people. However, roughly 80 million people have declined to get the shots, putting them at increased risk of becoming seriously ill due to COVID-19.

Washington Examiner Videos

Tags: Healthcare, News, Coronavirus, Vaccination, Pfizer, FDA, CDC

Original Author: David Hogberg, Cassidy Morrison

Original Location: FDA vaccine panel approves Pfizer booster shots for people over 65 after rejecting it for younger adults

Internet Explorer Channel Network
News Related


New World server transfers paused after some players encounter ‘invalid' character state

© Provided by Dot Esports Server transfers went live in New World yesterday after players waited eagerly for weeks for the option to roll out so they could move to ... Read more »

Deshaun Watson's girlfriend enjoys ‘sexy date night' amid QB's trade rumors

Deshaun Watson’s relationship with girlfriend Jilly Anais is apparently going strong amid rumors the Texans quarterback is close to getting traded to the Dolphins. Watson — who has not played ... Read more »

Farmacéuticas y ricos dan séptima parte de dosis prometidas a más pobres: informe

© SinEmbargo vacunas-COVID-19 A pesar del tiempo, aún se notan las diferencias en la repartición de las vacunas contra la COVID-19 entre países ricos y pobres. Madrid, 21 de octubre ... Read more »

Scheifele, Carter, Jarry added to NHL COVID-19 protocol

Earlier this week Winnipeg Jets captain Blake Wheeler entered the NHL’s COVID-19 protocol, prompting concerns that the Jets could have a breakout and more positive tests ahead. So far, that ... Read more »

Jason Kelce calls out Ben Simmons over 76ers beef

Philadelphia Eagles offensive lineman Jason Kelce didn’t hold back when discussing Ben Simmons and the drama with the 76ers.  © Provided by Fansided Countless folks all over Philadelphia have had ... Read more »

The Real Reason Dune Doesn't Have Post-Credit Scenes

Jeff Spicer/Getty There’s a familiar scene people witness almost every time they go to the movies, and it’s not one they see on the big screen. Instead, it’s the moment ... Read more »

Look: Dwyane Wade Got Special Lesson Wednesday Night

Now that he’s retired from the NBA, Dwyane Wade has time to pursue other passions, like golf. © Provided by The Spun A closeup of Dwyane Wade attending an NFL ... Read more »

GOP senators call on Biden to back down from vaccine mandates

A group of Republican senators on Thursday sent a letter to the White House calling on President Biden to back down from his COVID-19 vaccine mandate policies. © GETTY IMAGES ... Read more »

Chicago Fire's Jesse Spencer And David Haas Reveal Their Conversations About Spencer's Fate

Frazer Harrison/Getty Images Television actors with recurring roles leave their shows all the time, for all sorts of reasons. It’s relatively rare for those reasons to become public knowledge. But ... Read more »

African lives matter: Covid-19 didn't miss the continent, as some would conveniently have it — and the numbers back this up

African countries are still struggling to get Covid-19 vaccines. One reason for this is the misconception that the continent wasn’t hard-hit by the pandemic. But the numbers tell a different ... Read more »

Shaq Names His 5 Most-Accomplished Current NBA Players

In honor of the NBA’s 75th anniversary, the league is releasing its list of the 75 greatest players of all time. The final 25 players on the list will be ... Read more »

Financial watchdog to investigate British Steel Pension Scheme scandal

© Getty Tata Steel Nearly 8,000 people transferred out of the BSPS ahead of a restructuring of the scheme in 2018, after receiving advice from financial advisers. Together, they accounted ... Read more »

Report: 76ers believe Ben Simmons is faking injury, mental health issue

Ben Simmons appears unlikely to play in the Philadelphia 76ers’ game against the Brooklyn Nets on Friday night, but it sounds like the team feels strongly that he is fit ... Read more »

Martin Lewis explains three things homeowners must do now as mortgage rates could soar

Martin Lewis has explained three things homeowners must do now over fears mortgage rates could be about to soar. The MoneySavingExpert used his ITV show this evening to explain how ... Read more »

Jamaica arrests Colombian national in connection with Haitian president's murder

© Reuters/RICARDO ARDUENGO FILE PHOTO: Haiti holds funeral for assassinated President Jovenel Moise in Cap-Haitien By Gessika Thomas and Kate Chappell PORT-AU-PRINCE (Reuters) – Haitian authorities said on Thursday that ... Read more »

100% capacity for nightclubs from Friday under new guidelines

© Brian Lawless Industry representatives were briefed by officials on the new guidelines on Thursday evening (Brian Lawless/PA) Nightclubs will return with 100% capacity while customers will once again be ... Read more »

Consumer watchdog to probe Big Tech payment systems

© Provided by The Canadian Press NEW YORK (AP) — In its first significant action under a new director, the Consumer Financial Protection Bureau is ordering Apple, Amazon, PayPal and ... Read more »

3 talking points as Rangers light a fire under their Europa League campaign with dominant Brondby win

Rangers lit a fire under their Europa League campaign with a dominant victory over Brondby. Steven Gerrard sent his players out at Ibrox with a message that it was now ... Read more »

House holds Trump ally Steve Bannon in criminal contempt of Congress

The House voted on Thursday to hold Donald Trump’s former chief strategist Steve Bannon in criminal contempt of Congress, over his refusal to comply with a subpoena issued by the ... Read more »

Video shows cops tasing severely autistic man who can't speak

© Eustis Police Department/WESH Eustis Police Department released body camera footage of Louis Grahai being tased – Eustis Police Department/WESH A man who cannot speak and has autism was tased ... Read more »

Cheers as Melbourne emerges from lockdown

Melbourne has awakened from its COVID-19 lockdown slumber, with cheers erupting in the city when the clock struck midnight. © James Ross/AAP PHOTOS Melburnians will flock to restaurants, cafes and ... Read more »

Gutsy Murray falls to slick Schwartzman in Antwerp

Andy Murray suffered a hard-fought straight-sets defeat to second seed Diego Schwartzman at the European Open in Antwerp on Thursday. Wild card Murray came through an epic first-round contest against ... Read more »

History 'rewritten' as Vikings beat Christopher Columbus to the Americas by 471 years

Researchers believe they have the evidence to prove the theory Vikings discovered North America nearly 1000 years ago. Tests of wooden artefacts are cited as evidence of a Viking warriors’ ... Read more »

Report: 76ers think Ben Simmons 'is faking injury and mental illness'

Those wondering if a day would pass by without there being any new drama regarding Philadelphia 76ers All-Star guard Ben Simmons will have to keep waiting, perhaps indefinitely.  © Tommy ... Read more »

Foreign portfolio investors turn net sellers of debt so far in October

© Provided by The Financial Express Additionally, foreign investors are looking at the yields in the US, which have consistently been moving upwards. This has led to sell-off by these ... Read more »

'Disgustingly good', 'Magnificent' - Many WHU fans blown away by 'beast' after 'massive' display

As West Ham United breezed past Genk at the London Stadium this evening, taking yet more control of Group H, many Irons supporters were blown away by the performance and ... Read more »

Remote due diligence is the new normal, given wings by technology

© Provided by Business Today Remote due diligence is the new normal, given wings by technology The word crisis is comprised of two characters when written in Chinese, representing danger ... Read more »

Dinners beat world titles in Hamilton's Austin memories

Despite securing two world titles in Austin, Lewis Hamilton says the social side provides his most vivid memories of the United States Grand Prix. © PA Images Lewis Hamilton holding ... Read more »

Santo happy to give fringe Spurs players a ‘chance' in the ‘tough' ECL

Nuno Espirito Santo is happy to give Tottenham Hotspur’s fringe players a “chance” to play in the Europa Conference League as it provides “tough moments”. © PA Images Tottenham-boss-Nuno-Espirito-Santo-1 Spurs ... Read more »

Centre raises DA by 3%, 4.7mn govt employees set to benefit

The central government on Thursday decided to raise the dearness allowance (DA) to employees and the dearness relief (DR) to pensioners by 3% to 31% from July to cushion them ... Read more »

How to write and edit Amazon reviews, and find or delete your reviews

© Alistair Berg/Getty Images How to write and edit Amazon reviews, and find or delete your reviews You can write Amazon reviews on the product page of the item you ... Read more »

Riddle hilariously rides down to the ring on a camel before big title match at WWE Crown Jewel

With WWE in Saudi Arabia, Riddle rode down to the ring on a camel before he and Randy Orton defended their Raw Tag Team Championship. © GiveMeSport Riddle rode a ... Read more »

UK Athletics crisis continues as CEO Joanna Coates and performance director Sara Symington resign

© Getty Images gettyimages-1163172066.jpg UK Athletics chief executive Joanna Coates has stepped down from her role, while the organisation’s performance director, Sara Symington, has left to join British Cycling. Coates, ... Read more »

Gwyneth Paltrow on overcoming body insecurities: 'I'm always on a journey toward self-improvement'

Gwyneth Paltrow is opening up about the insecurities she has about her physical appearance and how she combats them. The entrepreneur behind the goop beauty and wellness brand gets candid ... Read more »

The Hairy Bikers' Dave Myers and Si King's health scares led to 6st weight loss – see photos, plus how they did it

The Hairy Bikers stars Dave Myers and Si King both got massive wake-up calls after Dave reached 18 stone, and Si 19.5 stone. SEE: Gordon Ramsay's 4st weight loss story ... Read more »

Soccer-Horror night for Mourinho as Roma hit for six in Norway

(Reuters) – Jose Mourinho suffered one of biggest defeats of his coaching career as AS Roma stumbled to a shock 6-1 loss at Norwegian champions Bodo/Glimt in the Europa Conference ... Read more »

CDC advisory panel clears the way for J&J, Moderna and mix-and-match COVID boosters

Mix and match COVID-19 booster shots could be available by the weekend after a critical federal committee voted to allow them Thursday. Letting Americans choose among the Pfizer-BioNTech, Moderna and ... Read more »

53 more dengue cases surface in Ludhiana

© Provided by Hindustan Times With the fresh cases, the total number of confirmed dengue cases in Ludhiana has reached 580 this year, while 2,075 others are also suspected to ... Read more »

VHP activists stopped from taking out procession clash with police in Tripura

© Provided by Hindustan Times VHP activists were taking out a Bangladesh protest rally in Tripura’s Gomati district when the police told them not to proceed further. (Representative image) (Samir ... Read more »
On free-english-test.com you will find lots of free English exam practice materials to help you improve your English skills: grammar, listening, reading, writing, ielts, toeic