US FDA Gearing Up for Rapid Review of Potential Covid-19 Booster Shots Amid Rise of Virus Variants
3 years, 10 months ago

US FDA Gearing Up for Rapid Review of Potential Covid-19 Booster Shots Amid Rise of Virus Variants

News 18  

The US Food and Drug Administration is planning a rapid review process for quick turnaround of new COVID-19 booster shots if variants of the coronavirus emerge against which the vaccines do not provide protection, the agency’s top official said on Thursday. Dr. Janet Woodcock, acting commissioner of the FDA, said that if new variants of the coronavirus emerge that require booster shots or changes to vaccines, the agency will not require the type of large trials that were required for emergency use authorization or approval. Both Pfizer Inc and German partner BioNTech SE as well as Moderna Inc, whose vaccines have been authorized for emergency use in the United States, have said they are preparing for the possibility that variants will emerge that could require a booster shot. Countries must build surveillance measures to find variants of concerns, and then scientists must agree upon at what point a variant has strayed too far from the unaltered virus and requires a new vaccine.

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History of this topic

As COVID-19 ticks up in some places, US health officials recommend a fall vaccination campaign
5 months, 3 weeks ago

As COVID-19 ticks up in some places, US health officials recommend a fall vaccination campaign

Associated Press  

NEW YORK — With fresh COVID-19 cases bubbling up in some parts of the country, health officials are setting course for a fall vaccination campaign. What’s more, health officials have reported upticks this month in COVID-19-associated emergency room visits and hospitalizations, and a pronounced increase in positive test results in the southwestern U.S. It’s not clear whether that’s a sign …

As COVID-19 ticks up in some places, US advisers recommend a fall vaccination campaign
5 months, 3 weeks ago

As COVID-19 ticks up in some places, US advisers recommend a fall vaccination campaign

The Independent  

For free real time breaking news alerts sent straight to your inbox sign up to our breaking news emails Sign up to our free breaking news emails Please enter a valid email address Please enter a valid email address SIGN UP I would like to be emailed about offers, events and updates from The Independent. Please try again later {{ …

FDA advisers urge targeting JN.1 strain in recipe for fall’s COVID vaccines
6 months, 2 weeks ago

FDA advisers urge targeting JN.1 strain in recipe for fall’s COVID vaccines

Associated Press  

WASHINGTON — Government advisers Wednesday said it’s time to update the recipe for the COVID-19 vaccines Americans will receive in the fall -- targeting a version of the ever-evolving coronavirus called JN.1. But just a few months later, numerous offshoots of JN.1 already are on the rise, prompting Moderna and Pfizer to also test a slightly different vaccine formula targeting …

COVID-19: US CDC recommends updated boosters for Americans, President Joe Biden calls it important milestone
1 year, 3 months ago

COVID-19: US CDC recommends updated boosters for Americans, President Joe Biden calls it important milestone

India TV News  

US COVID updated boosters: The US health agency Centers for Disease Control and Prevention on Tuesday authorised, approved, and recommended everyone six months and older get an updated COVID-19 booster. According to an official White House release, Biden said, "Since entering office, my Administration has made historic progress in our ability to manage COVID-19 so that it no longer meaningfully …

Updated COVID vaccines will be available later this week, recommended for everyone six months and up
1 year, 3 months ago

Updated COVID vaccines will be available later this week, recommended for everyone six months and up

Salon  

A new, fourth round of COVID-19 booster shots was approved Tuesday, following the recommendation of federal health agencies, which will make the vaccines available to Americans later this week. The Centers for Disease Control and Prevention followed suit this afternoon, with CDC director Mandy Cohen recommending updated vaccination for "everyone 6 months and older to better protect you and your …

US FDA authorizes Pfizer-BioNTech, Moderna's updated Covid shots
1 year, 3 months ago

US FDA authorizes Pfizer-BioNTech, Moderna's updated Covid shots

India Today  

The U.S. Food and Drug Administration on Monday authorized updated Covid-19 vaccines from Pfizer/BioNTech and Moderna that target a recently circulating Omicron variant of the coronavirus, paving the way for the launch later this week of a fall vaccination campaign. Pfizer and Moderna said their updated vaccines, which target the XBB.1.5 subvariant of the virus, were expected to be available …

U.S. approves updated COVID vaccines to rev up protection this fall
1 year, 3 months ago

U.S. approves updated COVID vaccines to rev up protection this fall

The Hindu  

The U.S. approved updated COVID-19 vaccines Monday, hoping to rev up protection against the latest coronavirus strains and blunt any surge this fall and winter. It’s part of a shift to treat fall updates of the COVID-19 vaccine much like getting a yearly flu shot. “Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including …

US approves updated COVID vaccines to rev up protection this fall
1 year, 3 months ago

US approves updated COVID vaccines to rev up protection this fall

Associated Press  

WASHINGTON — The U.S. approved updated COVID-19 vaccines Monday, hoping to rev up protection against the latest coronavirus strains and blunt any surge this fall and winter. It’s part of a shift to treat fall updates of the COVID-19 vaccine much like getting a yearly flu shot. “Vaccination remains critical to public health and continued protection against serious consequences of …

FDA approves updated COVID vaccines to rev up protection this fall
1 year, 3 months ago

FDA approves updated COVID vaccines to rev up protection this fall

LA Times  

Single-dose vials of Pfizer’s updated COVID vaccine for adults, which was approved by U.S. regulators on Monday. The U.S. approved updated COVID-19 vaccines Monday, hoping to rev up protection against the latest coronavirus strains and blunt any surge this fall and winter. “Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” …

Gov. DeSantis and Florida surgeon general warn against new COVID-19 restrictions and vaccine
1 year, 3 months ago

Gov. DeSantis and Florida surgeon general warn against new COVID-19 restrictions and vaccine

Associated Press  

JACKSONVILLE, Fla. — Florida Gov. Ron DeSantis on Thursday criticized recent efforts across the U.S. to tamp down a recent jump in COVID-19 cases through temporary restrictions or masking, and his state surgeon general warned against getting the latest COVID-19 vaccine, which is expected to be available this month. The criticism from DeSantis at news conference in Jacksonville, Florida, arrived …

New Covid booster shots to be approved in just TWO DAYS, sources suggest - but only 17% of Americans got the last one
1 year, 3 months ago

New Covid booster shots to be approved in just TWO DAYS, sources suggest - but only 17% of Americans got the last one

Daily Mail  

Updated Covid booster shots designed to target new variants could be approved in just two days time, reports suggest — and be available to Americans from next week. A member of the FDA's vaccine advisory committee, Dr Paul Offit, said last year that healthy young people do not need an updated booster vaccine. The head of Moderna, Stephane Bancel, also …

With coronavirus uptick, should I get a COVID shot? When are new vaccines available?
1 year, 4 months ago

With coronavirus uptick, should I get a COVID shot? When are new vaccines available?

LA Times  

The fall vaccination season is just around the corner, and officials are rolling out a new updated version of the COVID-19 vaccine. The fall vaccination season is just around the corner, and officials are set to roll out another updated version of the COVID-19 vaccine, as well as new tools to protect against RSV. Scientists say the 2023 COVID-19 vaccine …

Next round of COVID-19 shots in fall will target latest omicron strain
1 year, 6 months ago

Next round of COVID-19 shots in fall will target latest omicron strain

Associated Press  

NEW YORK — The next round of COVID-19 vaccines will target one of the latest versions of the coronavirus, the Food and Drug Administration said Friday. The agency told vaccine makers to provide protection against just one omicron strain, known as XBB.1.5. The three U.S. companies that make COVID-19 shots said this week they had geared up to make the …

FDA advisers endorse updating COVID vaccines to target latest omicron strain
1 year, 6 months ago

FDA advisers endorse updating COVID vaccines to target latest omicron strain

Associated Press  

The COVID-19 vaccines are on track for a big recipe change this fall. Today’s vaccines still contain the original coronavirus strain, the one that started the pandemic — even though that was long ago supplanted by mutated versions as the virus rapidly evolves. While infections have declined, the virus could be a real concern next winter, FDA’s vaccine chief Dr. …

An FDA panel meets about which COVID strains the U.S. will target with vaccines
1 year, 6 months ago

An FDA panel meets about which COVID strains the U.S. will target with vaccines

NPR  

An FDA panel meets about which COVID strains the U.S. will target with vaccines An advisory committee to the Food and Drug Administration meets to discuss the COVID strains that vaccines in the U.S. will target this fall. ARI SHAPIRO, HOST: Updated COVID vaccines are coming this fall, and they'll likely target a variant that's circulating now. HUANG: Yeah, you …

FDA advisers back updated COVID shots for fall vaccinations
1 year, 6 months ago

FDA advisers back updated COVID shots for fall vaccinations

NPR  

FDA advisers back updated COVID shots for fall vaccinations Enlarge this image toggle caption Esteban Felix/AP Esteban Felix/AP A panel of expert advisers to the Food and Drug Administration voted unanimously Thursday to recommend that the COVID-19 vaccine be updated to target emerging subvariants of omicron. The COVID shot that's currently available is known as a "bivalent" vaccine because it …

CDC signs off on additional Covid-19 booster doses for certain people
1 year, 8 months ago

CDC signs off on additional Covid-19 booster doses for certain people

CNN  

CNN — The US Centers for Disease Control and Prevention updated its recommendations on the Covid-19 vaccines on Wednesday to allow another dose of the bivalent booster for people who are 65 and older or who have weakened immune systems and who “want the option of added protection” against the coronavirus. The move aligns with Tuesday’s US Food and Drug …

No need for booster vaccine against coronavirus this spring, experts decide
1 year, 9 months ago

No need for booster vaccine against coronavirus this spring, experts decide

Dutch News  

Coronavirus experts have advised against another round of vaccinations this spring because there is enough immunity in the population from previous vaccines or infections. The advisers will decide later in the year whether there should be another booster round in the autumn, when the peak season for coronavirus infections begins. Doctors should still be able to prescribe a vaccine for …

No need for booster vaccine against coronavirus this spring, experts decide
1 year, 9 months ago

No need for booster vaccine against coronavirus this spring, experts decide

Dutch News  

Coronavirus experts have advised against another round of vaccinations this spring because there is enough immunity in the population from previous vaccines or infections. The advisers will decide later in the year whether there should be another booster round in the autumn, when the peak season for coronavirus infections begins. Doctors should still be able to prescribe a vaccine for …

FDA advisers set to consider one-and-done annual covid booster plan
1 year, 10 months ago

FDA advisers set to consider one-and-done annual covid booster plan

Live Mint  

The message has come through loud and clear that Americans have already had enough of frequent Covid shots. The new strategy would require health officials to meet each year to review which strains of the virus should be included in the shots, just as they do with flu, for use in September. “I don’t think that we can chase after …

FDA’s advisors back plan to simplify COVID-19 vaccinations
1 year, 10 months ago

FDA’s advisors back plan to simplify COVID-19 vaccinations

LA Times  

Syringes with COVDI-19 vaccines are prepared at a free public clinic in Lynwood last year. “We’re still protected against severe disease, thank goodness,” even after the latest Omicron strains cropped up, said FDA advisor Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia. The first step: The FDA advisory panel voted unanimously that people should get the same …

FDA proposes once-a-year COVID-19 shots for most Americans
1 year, 11 months ago

FDA proposes once-a-year COVID-19 shots for most Americans

LA Times  

U.S. health officials are proposing a simplified approach to COVID-19 vaccinations for most adults and children. That baseline of protection should be enough to move to an annual booster against the latest strains in circulation and make COVID-19 vaccinations more like the yearly flu shot, according to the agency. FDA scientists and vaccine companies would study vaccination, infection rates and …

FDA wants to simplify the use and updating of Covid-19 vaccines
1 year, 11 months ago

FDA wants to simplify the use and updating of Covid-19 vaccines

CNN  

CNN — The US Food and Drug Administration wants to simplify the Covid-19 vaccine process to look more like what happens with the flu vaccine, according to documents posted online on Monday. “This simplification of vaccine composition should reduce complexity, decrease vaccine administration errors due to the complexity of the number of different vial presentations, and potentially increase vaccine compliance …

FDA vaccine advisers ‘disappointed’ and ‘angry’ that early data about new Covid-19 booster shot wasn’t presented for review last year
1 year, 11 months ago

FDA vaccine advisers ‘disappointed’ and ‘angry’ that early data about new Covid-19 booster shot wasn’t presented for review last year

CNN  

CNN — Some vaccine advisers to the federal government say they’re “disappointed” and “angry” that government scientists and the pharmaceutical company Moderna didn’t present a set of infection data on the company’s new Covid-19 booster during meetings last year when the advisers discussed whether the shot should be authorized and made available to the public. Video Ad Feedback 'Outrageous': Bernie …

COVID-19: no need for scaremongering, precautions needed, say health experts
2 years ago

COVID-19: no need for scaremongering, precautions needed, say health experts

The Hindu  

Even as the Central and State governments have called for a general alert over a possible rise in COVID-19 cases, public health experts have warned against scaremongering over COVID-19. Public health experts point out that as the new virus variants coming into circulation are the sub variants of Omicron, which in itself was less lethal than Delta, there was no …

Health Minister Mandaviya to review COVID situation on Dec. 21 amid spurt in cases in U.S., China
2 years ago

Health Minister Mandaviya to review COVID situation on Dec. 21 amid spurt in cases in U.S., China

The Hindu  

Amid a fresh spurt in COVID-19 cases in Japan, South Korea, Brazil, China and the U.S., Union Health Minister Mansukh Mandaviya will review the pandemic situation on December 21, 2022, official sources said. Earlier on Tuesday, the Health Ministry urged all states and Union territories to ramp up the whole genome sequencing of positive samples to keep track of newer …

As COVID-19 spikes in California, booster shots could make all the difference
2 years ago

As COVID-19 spikes in California, booster shots could make all the difference

LA Times  

With coronavirus cases and hospitalizations rising in Los Angeles County, officials are voicing new confidence in the effectiveness of the updated COVID-19 booster shot. New data has found that the updated COVID-19 vaccines offer “significant additional protection” against symptomatic infection in people who were previously vaccinated or boosted with the older formula. “We have seen very low uptake of the …

Panel votes to add COVID shots to recommended vaccinations
2 years, 2 months ago

Panel votes to add COVID shots to recommended vaccinations

Associated Press  

NEW YORK — COVID-19 shots should be added to the lists of recommended vaccinations for kids and adults, a panel of U.S. vaccine experts said Thursday. The panel’s unanimous decision has no immediate effect — COVID-19 shots already are recommended for virtually all Americans. Because the shots have already been recommended under emergency authorization for Americans older than 6 months, …

Panel votes to add COVID shots to recommended vaccinations
2 years, 2 months ago

Panel votes to add COVID shots to recommended vaccinations

LA Times  

A nurse prepares a syringe of a COVID-19 vaccine at an inoculation station in Jackson, Miss. A panel of U.S. vaccine experts said COVID-19 shots should be added to the lists of recommended vaccinations for kids and adults. COVID-19 shots should be added to the lists of recommended vaccinations for kids and adults, a panel of U.S. vaccine experts said …

Pfizer says bivalent booster increases antibodies for Omicron variants
2 years, 2 months ago

Pfizer says bivalent booster increases antibodies for Omicron variants

LA Times  

Pfizer Inc. and its German vaccine partner BioNTech said their new COVID-19 booster designed to target the dominant Omicron subvariant produced more antibodies against the intended strains than did the original version of the shot. Pfizer and BioNTech plan to release additional data on the COVID-19 shots in the coming weeks to measure immune responses one month after administration of …

Covid-19 vaccination campaign held back by poor planning, safety board finds
2 years, 2 months ago

Covid-19 vaccination campaign held back by poor planning, safety board finds

Dutch News  

The Dutch vaccination programme against Covid-19 was held back because the government’s initial plan was too reliant on family doctors, a report by the safety council has concluded. In the second of three reports into the government’s response to the coronavirus crisis, the OVV said preparations to set up vaccination centres through the local health board network only started in …

Covid-19 vaccination campaign held back by poor planning, safety board finds
2 years, 2 months ago

Covid-19 vaccination campaign held back by poor planning, safety board finds

Dutch News  

The Dutch vaccination programme against Covid-19 was held back because the government’s initial plan was too reliant on family doctors, a report by the safety council has concluded. In the second of three reports into the government’s response to the coronavirus crisis, the OVV said preparations to set up vaccination centres through the local health board network only started in …

New vaccines approved, booster campaign to start in September
2 years, 3 months ago

New vaccines approved, booster campaign to start in September

Dutch News  

The new Pfizer and Moderna booster vaccines have been given approval by the European Medicines Agency for over-12s, and another booster campaign is planned for the second half of September. Although the current vaccines protect against serious sickness, they have become less good at protecting against a coronavirus infection due to mutations in the virus, reports NOS. The EMA expects …

New vaccines approved, booster campaign to start in September
2 years, 3 months ago

New vaccines approved, booster campaign to start in September

Dutch News  

The new Pfizer and Moderna booster vaccines have been given approval by the European Medicines Agency for over-12s, and another booster campaign is planned for the second half of September. Although the current vaccines protect against serious sickness, they have become less good at protecting against a coronavirus infection due to mutations in the virus, reports NOS. The EMA expects …

US CDC endorses updated Covid boosters, shots to begin soon
2 years, 3 months ago

US CDC endorses updated Covid boosters, shots to begin soon

India Today  

The US Centers for Disease Control and Prevention on Thursday endorsed updated Covid-19 boosters, opening the way for a fall vaccination campaign that could blunt a winter surge if enough Americans roll up their sleeves. The CDC’s advisers struggled with who should get the new boosters and when because only a similarly tweaked vaccine, not the exact recipe, has been …

CDC endorses updated COVID boosters, shots to begin soon
2 years, 3 months ago

CDC endorses updated COVID boosters, shots to begin soon

Associated Press  

The Centers for Disease Control and Prevention on Thursday endorsed updated COIVD-19 boosters, opening the way for a fall vaccination campaign that could blunt a winter surge if enough Americans roll up their sleeves. “I think they’re going to be an effective tool for disease prevention this fall and into the winter,” said CDC adviser Dr. Matthew Daley of Kaiser …

CDC Advisers Weigh Who Needs Updated COVID Booster And When
2 years, 3 months ago

CDC Advisers Weigh Who Needs Updated COVID Booster And When

Huff Post  

LOADING ERROR LOADING COVID-19 boosters updated to match the newest omicron strains are about to roll out, and government advisers met Thursday to decide who should roll up their sleeves ― and when. The original COVID-19 vaccines still offer strong protection against severe illness and death, especially among younger and healthier people who’ve gotten at least one booster. The new …

U.S. authorizes updated COVID-19 boosters targeting newest variants
2 years, 3 months ago

U.S. authorizes updated COVID-19 boosters targeting newest variants

LA Times  

The U.S. on Wednesday authorized its first update to COVID-19 vaccines, booster doses that target today’s most common Omicron strains. “Give a clear, forward-looking set of expectations.” Here’s the rub: The original vaccines still offer strong protection against severe disease and death from COVID-19 for most generally healthy people, especially if they got that important first booster dose. First, FDA …

US approves updated COVID boosters targeting Omicron variants
2 years, 3 months ago

US approves updated COVID boosters targeting Omicron variants

Al Jazeera  

Drugmaker Pfizer said it has doses ready to ship and can deliver up to 15 million shots by the end of next week. The United States has authorised booster doses of the COVID-19 vaccines that target the most common Omicron strain, and shots could be available within days. “You’ll see me at the front of the line,” FDA vaccine chief …

Tweaked COVID boosters close but how much will they help?
2 years, 3 months ago

Tweaked COVID boosters close but how much will they help?

Associated Press  

COVID-19 vaccines tweaked to better match today’s omicron threat are expected to roll out in a few weeks but still up in the air is how much benefit the booster shots will offer, who should get one -- and how soon. Dr. Peter Marks, the FDA’s vaccine chief, said Thursday that once authorized, the tweaked boosters could help right away …

Tweaked COVID boosters are close, but how much will they help?
2 years, 4 months ago

Tweaked COVID boosters are close, but how much will they help?

LA Times  

Pre-loaded syringes are ready for use at a school in New Orleans. Dr. Peter Marks, the FDA’s vaccine chief, said Thursday that once authorized, the tweaked boosters could help right away — while BA.5 infections still are too high — and hopefully blunt yet another winter surge. To evaluate the combo shots, the FDA is using data from human testing …

Pfizer seeks OK of COVID booster that targets Omicron
2 years, 4 months ago

Pfizer seeks OK of COVID booster that targets Omicron

LA Times  

A health worker administers a dose of Pfizer’s Comirnaty COVID-19 vaccine in Reading, Pa. Pfizer has asked U.S. regulators to authorize its combination COVID-19 shot that adds protection against Omicron subvariants. Pfizer asked U.S. regulators Monday to authorize its combination COVID-19 vaccine that adds protection against Omicron subvariants, a key step toward opening a fall booster campaign. The U.S. has …

New Covid vaccination round with improved vaccines set for the autumn
2 years, 4 months ago

New Covid vaccination round with improved vaccines set for the autumn

Dutch News  

Everyone over the age of 12 will soon be invited to make an appointment for another booster coronavirus vaccination, health minister Ernst Kuipers announced on Friday. The first invitations, focusing on people who would be more at risk if they caught coronavirus and medical staff who have direct contact with patients, will be sent out in mid September, Kuipers said. …

New Covid vaccination round with improved vaccines set for the autumn
2 years, 4 months ago

New Covid vaccination round with improved vaccines set for the autumn

Dutch News  

Everyone over the age of 12 will soon be invited to make an appointment for another booster coronavirus vaccination, health minister Ernst Kuipers announced on Friday. The first invitations, focusing on people who would be more at risk if they caught coronavirus and medical staff who have direct contact with patients, will be sent out in mid September, Kuipers said. …

White House urges caution on COVID variants, pushes boosters
2 years, 5 months ago

White House urges caution on COVID variants, pushes boosters

Associated Press  

WASHINGTON — The Biden administration is calling on people to exercise renewed caution about COVID-19, emphasizing the importance of getting booster shots for those who are eligible and wearing masks indoors as two new highly transmissible variants are spreading rapidly across the country. “If you’re over 50 and you haven’t gotten the shot this year, you should go get a …

US health officials urge booster shots as COVID variants spread
2 years, 5 months ago

US health officials urge booster shots as COVID variants spread

Al Jazeera  

The administration of US President Joe Biden pushes vaccines as the best way to avoid potential disruptions from new BA.4 and BA.5 variants. “Staying up to date on your COVID-19 vaccines provides the best protection against severe outcomes.” Walensky said the US has seen a doubling in the number of hospitalisations due to COVID-19 since April, reflecting the spread of …

FDA advisers recommend updating COVID booster shots for fall
2 years, 5 months ago

FDA advisers recommend updating COVID booster shots for fall

Associated Press  

At least some U.S. adults may get updated COVID-19 shots this fall, as government advisers voted Tuesday that it’s time to tweak booster doses to better match the most recent virus variants. Their combination shots, what scientists call “bivalent” vaccines, substantially boosted levels of antibodies capable of fighting that variant, more than simply giving another dose of today’s vaccine. Marks …

FDA advisors recommend updating COVID booster shot formula for fall
2 years, 5 months ago

FDA advisors recommend updating COVID booster shot formula for fall

LA Times  

Advisors to the Food and Drug Administration are recommending that some U.S. adults get a modified COVID-19 booster shot this fall that better matches the recent variants. Some U.S. adults are a step closer to getting updated COVID-19 boosters this fall, as government advisors voted Tuesday that it’s time to tweak the shots to better match the most recent virus …

FDA grapples with whether to modify COVID vaccine for fall
2 years, 5 months ago

FDA grapples with whether to modify COVID vaccine for fall

LA Times  

The Food and Drug Administration will debate Tuesday whether it’s time to update COVID vaccine formulas. “This is science at its toughest,” said FDA vaccine chief Dr. Peter Marks, adding that a final decision is expected within days of the advisory panel’s recommendation. In an analysis prepared for Tuesday’s meeting, FDA officials acknowledged targeting last winter’s version of Omicron is …

US opens COVID vaccine to little kids; shots begin this week
2 years, 6 months ago

US opens COVID vaccine to little kids; shots begin this week

Associated Press  

NEW YORK — The U.S. on Saturday opened COVID-19 vaccines to infants, toddlers and preschoolers. “We know millions of parents and caregivers are eager to get their young children vaccinated, and with today’s decision, they can,” Walensky said in a statement. The shots offer young children protection from hospitalization, death and possible long-term complications that are still not clearly understood, …

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