Do Americans need boosters yet? Here are the questions the FDA will be asking

Vaccine advisers to the US Food and Drug Administration start meeting early Friday to discuss whether Americans need booster shots yet.

© Hannah Beier/Bloomberg/Getty Images Pfizer-BioNTech Covid-19 vaccines at a senior living facility in Worcester, Pennsylvania, U.S., on Wednesday, Aug. 25, 2021. Pfizer Inc. and BioNTech SE are seeking full U.S. approval for a Covid-19 booster shot for people 16 and older, asking regulators to sign off on a third dose to quell a rise in infections among vaccinated people. Photographer: Hannah Beier/Bloomberg via Getty Images

It’s a simple question but one that has become bogged down in politics and turf battles. It’s sometimes seemed to put the FDA’s independence at odds with a White House team eager to appear to be out ahead of an unpredictable pandemic.

On the surface, it’s a routine consideration of one company’s request for permission to start giving people a third, booster shot of its vaccine to help improve protection.

Underneath, it’s a decision that will affect all three vaccines authorized for the US market, and more that are in the pipeline. It could affect how people view vaccines, and for many, it taps into fears about disease and unknown risks.

But the questions the FDA’s Vaccine and Related Biological Products Advisory Committee will be considering are straightforward: Is immunity waning, and will boosters restore it?

Researchers have been busy answering the second question first. Multiple studies now show that a third dose of Pfizer’s or Moderna’s vaccines, or a second dose of Johnson & Johnson’s vaccine, turbo-charge the production of antibodies.

Levels of these immune system proteins — the first line of defense against infection — spike after people get a booster dose. As with other vaccines that require boosters, a longer interval of time between initial immunization and the booster seems to amplify this response.

Some initial data from Israel also indicates this boost in antibodies does translate into fewer infections among vaccinated people. It’s this data that has helped drive the enthusiasm of White House advisers, including National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci.

The second question is a little harder to answer. Is immunity waning? Are fully vaccinated people becoming, with each day, more likely to become infected?

Again, data from Israel indicated that the longer out people were from their first round of immunizations, the more likely they were to suffer breakthrough infections.

But there is much less data about this from the United States. That’s in no small part because the US Centers for Disease Control and Prevention has not been tracking all breakthrough cases — only those serious enough to put people into the hospital or to kill them. One question VRBPAC will be asking is how much data there is indicating that immunity is starting to drop off among Americans who were among the first to be vaccinated.

There are two ways to answer that question. Most of the studies Pfizer and other groups have done to support the argument for boosters look at people’s blood — their levels of antibody protection. There’s not a lot of data yet that shows more people who were vaccinated early on are becoming infected in the US.

And the FDA has been clear that it wants US data. “Some studies may be more reliable than others. Furthermore, US-based studies of post-authorization effectiveness of BNT162b2 may most accurately represent vaccine effectiveness in the US population,” it said pointedly in briefing documents released ahead of Friday’s meeting.

Then there is a question about what vaccines are actually intended to do. Are they meant to prevent all infection, in essence creating a force field around people? Or is it, as FDA, CDC and the White House have all argued, that what vaccines are really meant to do is prevent severe disease and death?

There are very strong indications that vaccines are still doing that. As of September 7, according to the CDC’s limited tracking, 14,115 fully vaccinated people have been hospitalized with Covid-19 or died of it. That’s out of 176 million fully vaccinated people.

One reason they’re protecting against severe disease and death is the complex nature of the human immune system. Antibodies are not the only defense against infection. They may stop the virus from getting into some cells in the body, but there’s another line of defense: cell-based immunity. Cells called B cells and T cells can take longer to generate than antibodies, but they provide a longer-lived, broader defense against infection and are responsible for decreases in severe infections.

Plus, FDA has already okayed the use of third shots in the most vulnerable people — those with immune systems that have been compromised by disease or drug treatment who may not have mounted a proper response to the first doses.

So VRBPAC members will be asking questions about all of this science.

There’s a third factor. It has little to do with hard science and more to do with global public health.

The World Health Organization has been arguing long and hard against the use of booster doses in wealthier nations until most of the rest of the world is vaccinated. WHO’s concern is equity — the organization says there’s not enough evidence yet to show boosters are even needed, but it also wants to make sure that rich nations don’t get bogged down in arguing about boosters and distributing them while other countries go without a single dose of vaccine.

There’s a pragmatic angle to this argument, also. If coronavirus is circulating anywhere in the world, it can spread anywhere. And vaccination may not always protect people who argue that what happens in, say, Africa is not their problem. Because if a virus is spreading, it is mutating — and coronavirus could easily evolve into a form that resists current vaccines.

Internet Explorer Channel Network
News Related


49ers' Jimmy Garoppolo to be '100 percent' for Colts game?

San Francisco 49ers head coach Kyle Shanahan suggested Wednesday that veteran quarterback Jimmy Garoppolo was recovering from the calf contusion he first suffered on Oct. 3 and would start this ... Read more »

Matt Hasselbeck enters Seahawks Ring of Honor on Monday night

© Provided by NBC Sports Eight years before the Seahawks won a Super Bowl, quarterback Matt Hasselbeck got them to a game that, but for repeated blunders by the officials, ... Read more »

Black, female DC police officers say they were given ultimatum: Have an abortion or be fired

D.C.’s assistant police chief this week claimed that as an 18-year-old cadet she was told to get an abortion or she would be fired, according to reports from NBC News. ... Read more »

Biden takes questions on ambitious agenda during CNN town hall in Baltimore

President Joe Biden is taking part in a CNN town hall from Baltimore Thursday evening and taking questions as Democrats are finalizing negotiations over key aspects of his legislative agenda. ... Read more »

Melanie C Talks Shocking 'Dancing With the Stars' Elimination and Spice Girls Reunion Plans (Exclusive)

© ET Melanie C is opening up about life after Dancing With the Stars. The 47-year-old singer co-hosts Thursday’s episode of Entertainment Tonight, and admits that “it’s so, so strange” to no ... Read more »

Duran Duran drop new album 40 years after debut

By Hanna Rantala LONDON, Oct 22 (Reuters) – When British pop band Duran Duran made their debut, they did not know how long they would last. But 40 years on, ... Read more »

Dems pushing amnesty for millions of illegal immigrants through reconciliation package: GOP

Republican Leader Kevin McCarthy held a roundtable discussion Thursday as a means to “expose” one of the underreported provisions in the Democrats’ multitrillion-dollar reconciliation package: An attempt to grant amnesty ... Read more »

Major sticking points remain as Democrats struggle to close deal

The prospects for reaching a tentative agreement on President Joe Biden’s sweeping social safety net package by the end of the week are increasingly dire with Democrats still haggling over ... Read more »

EUROPA LEAGUE ROUND-UP: Insigne's ROCKET inspires Napoli win

© Provided by Daily Mail MailOnline logo Napoli kept alive their hopes of advancing from Group C after Lorenzo Insigne, Victor Osimhen and Matteo Politano secured a 3-0 home win ... Read more »

Texas and Missouri attorneys general sue to force Biden to restart border wall construction

Attorneys General Ken Paxton of Texas and Eric Schmitt of Missouri filed a joint lawsuit Thursday seeking to force President Joe Biden’s administration restart building the wall along the U.S.-Mexico ... Read more »

Joel Deleón Drops First Solo Song After CNCO ‘La Culpa': Stream It Here

Joel Deleón Joel Deleón — formerly known as Joel Pimentel (of CNCO) — has released his debut solo single “La Culpa,” an acoustic, guitar-led melancholic song that marks the beginning of ... Read more »

'Black in Sac' 10/21/21: Here's your weekly list of events created by Black Sacramentans

Oct. 21—It’s week seven and counting for the ‘Black in Sac’ event list. We are always looking forward to featuring the events and happening around Sacramento each week. This will ... Read more »

Kelly Clarkson & Jimmy Fallon Join Forces (And Hands) for This Sonny & Cher Cover

Kelly Clarkson Kelly Clarkson and Jimmy Fallon transformed into Sonny & Cher for Thursday’s (Oct. 21) special Kellyoke duet of “I Got You Babe.” In their own words, they “totally nailed” their ... Read more »

Carmelo Anthony explains what led to funny in-game gaffe

Carmelo Anthony punched a one-way ticket to “Shaqtin’ A Fool” with a complete brain fart during Tuesday’s season opener against Golden State. Now he is explaining what led to the ... Read more »

Lakers' defense is a work in progress that will take time

© (Allen J. Schaben/Los Angeles Times) Lakers forward Anthony Davis blocks a layup by Warriors guard Stephen Curry during the season opener Tuesday at Staples Center. (Allen J. Schaben/Los Angeles ... Read more »

Whitney Mercilus: Coming to Packers “pumps new life” into me

© Provided by NBC Sports Whitney Mercilus spent his entire NFL career with one team before the Texans released him this week and he’s enjoying his first chance to spend ... Read more »

Watch 'Fantasy Football Live' for last-minute Week 7 news and sit-start advice

It’s Week 7 in the NFL and with SIX teams on bye, there’s no better place to prepare for your fantasy matchup than with the Yahoo “Fantasy Football Live” crew. ... Read more »

How Belarus is helping ‘tourists' break into the EU

Belarus has been accused of taking revenge for EU sanctions by offering migrants tourist visas, and helping them across its border. The BBC has tracked one group trying to reach ... Read more »

Congress requests NFL documents on Washington Football Team investigation

The NFL is under fire from Congress over the league’s investigation into the Washington Football Team. Congress requested documents from the league, and questioned whether the NFL was impartial in ... Read more »

California sets new rules for mystery donations made on behalf of lawmakers

California regulators approved new transparency requirements Thursday for charitable contributions made on behalf of politicians with whom the donors may be trying to curry favor, an attempt to reveal wealthy ... Read more »

Schumer endorses socialist for Buffalo mayor

Senate Majority Leader Chuck Schumer has endorsed India Walton, a self described socialist, for mayor of Buffalo. “Today, I endorse @indiawaltonbflo, the Democratic nominee for Mayor of Buffalo,” the New ... Read more »

Watch a Marine end a convenience store robbery in a big hurry

A former Marine put a quick end to a 4:30 a.m. robbery attempt in southern Arizona Wednesday. © KNXV Marine stops robbery. Video obtained by ABC News shows an unidentified ... Read more »

DC rolls out old metro cars as derailment inspection and delays continue

Washington, D.C., is bringing old metro cars out of the mothballs as an investigation into a Blue Line derailment last week keeps most of the newer models off the tracks. ... Read more »

Six reasons why the Newcastle United takeover is controversial

The English Premier League football club Newcastle United has been bought by a group led by Saudi Arabia’s sovereign wealth fund. © Getty Images Many Newcastle fans have welcomed the ... Read more »

Orangeburg native writes a song to lift spirits over pandemic fatigue

Orangeburg native Tonya Ceasar hopes to lift people’s spirits with her new song called ‘So Worthy.’  The gospel singer-songwriter says she wrote the song during the pandemic last year. Ceasar says ... Read more »

Toby Keith Pays Tribute to John Prine on New Album

Legendary country folk singer-songwriter John Prine had a lot of fans. Bill Murray, Eric Church, Sturgill Simpson, and everyone who wrote him the postcards that were used in his final ... Read more »

Westerville ArtsLine: November brings eclectic mix of options

From autumn painting, teen mosaics and macramé knots to blues, jazz and percussion, the month of November is filled with a variety of art sessions and musical entertainment. Additionally, theatre ... Read more »

Review: Netflix's starry Black western 'The Harder They Fall' is both a dazzler and a muddle

The Times is committed to reviewing theatrical film releases during the COVID-19 pandemic. Because moviegoing carries risks during this time, we remind readers to follow health and safety guidelines as outlined by the ... Read more »

Harris stumps for McAuliffe in Virginia

© AP Photo/Steve Helber Harris stumps for McAuliffe in Virginia DUMFRIES, Va. – Vice President Harris campaigned with Democratic Virginia gubernatorial candidate Terry McAuliffe on Thursday, urging voters to head ... Read more »

Vaccine rejection drives Russia's Covid nightmare

Near the darkened entrance of Hospital Number One in the city of Vologda in Russia’s north-west, an ambulance crew delivers yet another Covid patient, an elderly man struggling to breathe ... Read more »

Genshin Impact: Labyrinth Warriors “A Tricky Situation” Quest Guide

The Labyrinth Warriors event has started in Genshin Impact, which brings a unique roguelike element to the game. The event begins with a quest to introduce the event’s story, even ... Read more »

New Zealand sets 90% vaccine target to end lockdown

New Zealand set a 90-percent vaccination target Friday for scrapping lockdowns as Prime Minister Jacinda Ardern unveiled a plan to open up despite the stubborn grip of the Delta variant. ... Read more »

Allen Robinson returns to limited practice, but Khalil Mack, Akiem Hicks remain out

© Provided by NBC Sports The Bears got receiver Allen Robinson (ankle) back to practice Thursday. He was limited after sitting out Wednesday. Robinson injured his ankle in Week 5 ... Read more »

Pandemic lessons learned must include prioritizing safe and equitable access to cancer screenings

© (Motortion/iStock) Pandemic lessons learned must include prioritizing safe and equitable access to cancer screenings When President Richard M. Nixon signed the National Cancer Act into law 50 years ago, ... Read more »

Novavax (NVAX) Outpaces Stock Market Gains: What You Should Know

Novavax (NVAX) closed at $138.79 in the latest trading session, marking a +1.41% move from the prior day. This move outpaced the S&P 500’s daily gain of 0.3%. Coming into ... Read more »

Notes: Lions defense offers peek into plan of attack against Matthew Stafford

This week, The Detroit Lions defense is tasked with thwarting a Matthew Stafford-led offense firing on all cylinders as Detroit heads to Los Angeles to take on the Rams. © ... Read more »

Murray out of European Open after straight sets loss to Schwartzmann

© Provided by Daily Mail MailOnline logo Andy Murray ran out of gas at the European Open on Thursday night, going down in straight sets to Diego Schwartzman in the ... Read more »

The 7 Most Common Uterine Cancer Symptoms, According to Doctors

© Provided by Health Adobe Stock – Design: Alex Sandoval An estimated 66,570 new cases of uterine cancer will be diagnosed in 2021 alone, according to the National Cancer Institute ... Read more »

Boyfriend of US roadtripper Gabby Petito found dead

Human remains found in a Florida nature reserve belong to the boyfriend of murdered road tripper Gabby Petito, US authorities said Thursday. © Handout In bodycam images from August 2021, ... Read more »

Kate Walsh Reflects on the 'Fever Dream' of Reuniting on 'Grey's Anatomy' With Ellen Pompeo

© Richard Cartwright/Disney General Entertainment Content via Getty Images Kate Walsh‘s return to Grey’s Anatomy marked a blast to the past, reuniting her with Ellen Pompeo and reintroducing her beloved character, Addison ... Read more »
On you will find lots of free English exam practice materials to help you improve your English skills: grammar, listening, reading, writing, ielts, toeic