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Billy Crystal and Tiffany Haddish Speak on New Film Here Today

billy crystal
Left: 2019 MTV Movie and TV Awards - Arrivals – Santa Monica, California, U.S., June 15, 2019. Tiffany Haddish poses. REUTERS/Mike Blake; Right: Cast member Billy Crystal arrives for the 30th anniversary screening of comedy movie "When Harry Met Sally" in Hollywood, California, U.S. April 11, 2019. REUTERS/Mario Anzuoni.

By Alicia Powell

Billy Crystal, a Long Beach native, returns to the director’s chair after 20 years for Here Today, in which he also plays a well-known comedy writer who unexpectedly becomes friends with a street jazz singer.

Tiffany Haddish portrays performer Emma who wins a lunch with the veteran writer Charlie Burnz, despite not knowing who he is. Despite some initial setbacks, a friendship develops and she soon takes on an important role as Burnz deals with the onset of dementia.

In a joint interview with Reuters, Crystal and Haddish spoke about the comedy drama, released in the United States on Friday.

Below are excerpts edited for length and clarity.

Q: You have said you only choose projects that make you feel things, what did this script make you feel?

Haddish: “First of all Billy was telling me about it and I was like, ‘I’m in, it’s you, you ain’t got to sell me on this’. And then I read it and I was all the way in because my grandmother is going through that now.”

Q: How did you find the safe line in making a film about dementia funny?

Crystal: “Having dealt with a relative who was stricken with the same kind of onset that Charlie has in a movie, I just wanted to be respectful of that and respectful about those who come in contact with him. It’s a delicate line and I think to find humour in it and make it entertaining as well as emotional was the journey.”

Q: What was it like to direct again after 20 years?

Crystal: “You come to the set as a director, you have to answer every question that everybody has. So I was super prepared and super ready for anything and relished the chance to tell a story.”

Q: In one scene Emma’s ex-boyfriend meets Charlie after a performance. Did Billy allow you to improvise lots?

Haddish: “To be outside in the Meatpacking District (in New York City) and singing in front of a bunch of people and not being like goofy and silly about it was so exhilarating and fun and a little bit, I don’t want to say nervous, I was excited.

And just like ‘oh, don’t mess it up, but if you mess up, just have fun with it anyway’. And Billy let me loose and that was so great.”

(Reporting by Alicia Powell; Writing by Marie-Louise Gumuchian; Editing by Alexandra Hudson)

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FDA Set to Authorize Pfizer Covid-19 Shot for Ages 12-15 Early Next Week – NYT

pfizer
Vials of Pfizer's coronavirus disease (COVID-19) vaccine are seen at a pop-up community vaccination center at the Gateway World Christian Center in Valley Stream, New York, U.S., February 23, 2021. REUTERS/Brendan McDermid

The U.S. Food and Drug Administration is preparing to authorize Pfizer Inc and German partner BioNTech SE’s COVID-19 vaccine for adolescents aged between 12 and 15 years by early next week, the New York Times reported on Monday, citing federal officials familiar with the agency’s plans.

An approval is highly anticipated after the drugmakers said in March that the vaccine was found to be safe, effective and produced robust antibody responses in 12- to 15-year-olds in a clinical trial.

Responding to a Reuters request for comment, the FDA said its review of expanding the vaccine’s emergency use authorization is ongoing, but did not provide further details.

The vaccine has already been cleared in the United States for people aged 16 and above. (https://reut.rs/3nLH8Fj)

Pfizer declined to comment on the NYT report.

The U.S. Centers for Disease Control (CDC) Director Rochelle Walensky said earlier in April that the vaccine could be approved by mid-May.

If an approval for the 12-15 year olds is granted, the CDC’s vaccine advisory panel will likely meet the following day to review the clinical trial data and make recommendations for the vaccine’s use in adolescents, the report added. (https://nyti.ms/3eclRld)

A potential approval of the vaccine would boost the country’s immunization drive and help allay fears of parents anxious to protect their children from COVID-19.

Moderna Inc and Johnson & Johnson are also testing their vaccines in 12- to 18-year olds, with data from Moderna’s trial expected to come soon.

Pfizer and Moderna have also launched trials in even younger children, aged six months to 11 years old. Both companies have said they hope to be able to vaccinate children under 11 as soon as early 2022.

(Reporting by Trisha Roy in Bengaluru; Editing by Devika Syamnath)

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Most Pandemic-era Capacity Restrictions to End in Tri-state Area May 19, Cuomo Says

capacity
New York Governor Andrew Cuomo speaks at an event to announce five new walk-in pop-up vaccination sites for New York City Bodega, grocery store and supermarket workers amid the coronavirus disease (COVID-19) pandemic, in the Harlem section of Manhattan in New York City, New York, U.S., April 23, 2021. REUTERS/Mike Segar/Pool

Most coronavirus capacity restrictions on activities including retail stores, food services, and gyms will end on May 19 in the tri-state area of New York, New Jersey, and Connecticut, Gov. Andrew Cuomo said on Monday.

Cuomo said mitigation measures such as keeping six feet apart will remain in place, as per guidance from the U.S. Center for Disease Control and Prevention, except in situations where there is proof of vaccination or a negative COVID-19 test.

“This is a major reopening of economic and social activity,” Cuomo said. The governor also announced that the New York City subway will resume its 24-hour service beginning on May 17.

Previously, Cuomo had said that offices could increase to 75 percent capacity, and casinos, gyms, and fitness centers to 50 percent on May 15. Large stadiums will still only move from 25 to 33 percent capacity on May 19. Indoor arenas, such as Nassau Coliseum, will move from 10 to 25 percent capacity on May 19.

The reopening announcement is the latest of many recently, including that New York is lifting its midnight food and beverage service curfew on May 17 for outdoor dining and May 31 for indoor dining.

The lifting of capacity restrictions comes as the number of people receiving the Covid-19 vaccine is increasing, while the Covid-19 infection rate is decreasing across the state. Long Island’s Covid-19 positivity rate is 1.79 percent, the governor said.

(Reporting by Maria Caspani, Editing by Franklin Paul and Chizu Nomiyama)

-With Briana Bonfiglio

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U.S. Labor Secretary Supports Classifying Gig Workers As Employees

gig workers
Secretary of Labor Marty Walsh speaks during a news conference at the White House in Washington, U.S. April 2, 2021. REUTERS/Erin Scott

By Nandita Bose

A lot of gig workers in the United States should be classified as “employees” who deserve work benefits, President Joe Biden’s labor secretary said on April 29, suggesting a shift in policy that is likely to raise costs for companies that depend on contractors such as Uber and Lyft.

Labor Secretary Marty Walsh, a son of Irish immigrants and a former union member, has been expected to boost the Biden Administration’s efforts to expand workers’ protections and deliver a win for the country’s organized labor movement.

“We are looking at it but in a lot of cases gig workers should be classified as employees… in some cases they are treated respectfully and in some cases they are not and I think it has to be consistent across the board,” Walsh told Reuters in an interview, expressing his view on the topic for the first time.

“These companies are making profits and revenue and I’m not (going to) begrudge anyone for that because that’s what we are about in America. But we also want to make sure that success trickles down to the worker,” he said.

Shares of Uber fell as much as 8 percent while Lyft dived as much as 12 percent. Doordash fell nearly 9 percent and Grubhub was down 3.3 percent.

Walsh’s work at the Department of Labor is expected to have a major impact on U.S. workplace laws and regulations, including vigorous enforcement of occupational safety and health rules, overtime payments, and proper administration of employee benefit plans.

As many as 55 million people in the United States were gig workers or 34 percent of the workforce in 2017, according to the International Labor Organization, and the total was projected to rise to 43 percent in 2020.

Walsh’s views on the issue could usher in new rulings from the department, which sets legal guidelines for how employers treat workers. Before his appointment, the Labor Department’s Wage and Hour Division proposed rescinding a rule adopted in January that would have made it easier to classify workers as independent contractors.

Walsh said the Department will have conversations with companies that employ gig labor in the coming months to make sure workers have access to consistent wages, sick time, healthcare, and “all the things that an average employee in America can access.”

The Department’s decision could have far-reaching implications on ride-hailing services such as Uber, Lyft, and food delivery apps such as Grubhub, Doordash and Postmates.

An Uber spokesman said the United States should be advancing policies to improve independent work and not eliminating it. The company said an overwhelming majority of app-based workers want to stay independent, because it allows them to work when, where and how they want with flexibility no traditional job can match.

A Doordash spokeswoman said “Dashers have overwhelmingly told us that they value the flexibility to earn when and how they choose. We’re committed to protecting their independence while providing greater security and benefits.”

Gig workers are independent contractors who perform on-demand services, including as drivers, delivering groceries, or providing childcare and are one-third more likely to be Black or Latino, according to an Edison Research poll.

Walsh also spoke about the risks that result from not having gig companies paying unemployment insurance for such workers – a scenario that has played out during the pandemic, leaving the U.S. government to foot the bill.

“If the federal government didn’t cover the gig economy workers, those workers would not only have lost their job, but they wouldn’t have had any unemployment benefits to keep their family moving forward. We’d have a lot more difficult situation all across the country,” he said.

The last decade has seen a surge in the number of gig workers, indicating broad economic and demographic shifts and raising concerns around long-term financial security for a growing share of the workforce, according to some experts.

WORKPLACE SAFETY

Walsh said the labor department’s workplace safety arm, the Occupational Safety and Health Administration (OSHA), is also planning to hire 160 federal inspectors to step up checks and enforcement around the country.

“OSHA over the last four years has been decimated,” he said.

There are currently 760 federal inspectors and the latest hiring plan represents a sizable jump at a time when the department has been losing inspectors every year.

OSHA and the Department of Labor have been heavily criticized for applying scant oversight and negligible penalties despite outbreaks of the coronavirus at workplaces such as factories and warehouses around the country.

Walsh is also part of a White House task force that was recently set up by President Biden to help promote unions and labor organizing around the country. He said the first task force meeting will be in a couple of weeks.

Walsh spoke at length about the work organized labor must do to reintroduce itself to America’s younger generation. He also said the recent push to unionize an Amazon.com Inc. facility in Alabama, which the union did not win, is not a loss for the labor movement.

“The labor movement is like a political campaign. I think the younger generation in America seems to have a new interest in the labor movement,” he said, adding that the Amazon campaign is an opportunity for unions and labor groups to discuss what organized labor is all about.

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Twisted Sister Wins Copyright Battle for ‘We’re Not Gonna Take It’

twisted sister
Members of the reunited metal band Twisted Sister, A.J. Pero (L), J.J. French (2nd L), Dee Snider (C), Mark Mendoza (2nd R), and Eddie Ojeda (R) pose for photos before a press conference in New York, U.S. April 29, 2003. REUTERS/Peter Morgan

By Colin Packham

An Australian court ordered mining magnate Clive Palmer to pay A$1.5 million ($1.2 million) in damages to Universal Music on Friday for breaching the copyright of the once-Long Island-based band Twisted Sister‘s 1984 hit song “We’re Not Gonna Take It” in political advertising.

The Federal Court heard that Palmer had refused to pay Universal to license the song but had used it anyway, with modified lyrics, in advertising for his political outfit, United Australia Party (UAP), ahead of a 2019 general election.

Palmer argued the tune in the advertisements was based on the Christian hymn “Oh Come All Ye Faithful” and that his lyrics – “Australia ain’t gonna cop it, no Australia’s not gonna cop it, Aussies not gonna cop it anymore” – had nothing to do with the U.S. glam rockers’ hit song.

Federal Court Justice Anna Katzmann said Palmer’s defense was “fanciful”.

“In the face of the evidence it is, with respect, ludicrous to suggest that the UAP recording was created independently of (We’re Not Gonna Take It),” she wrote in a ruling published.

Palmer had been “high-handed and contemptuous” and “gave false evidence, including concocting a story to exculpate himself,” she added.

As well as the damages, Palmer was ordered to pay costs and to remove all copies of his song.

Twisted Sister lead singer Dee Snider, who grew up in Baldwin, responded to the ruling on Twitter: “It’s over baby! WE WON BIG!!”

“We’re not gonna take copyright infringement any more!!” he wrote after the verdict.

A spokesman for Palmer said the businessman would examine the ruling and consider an appeal.

Palmer made a fortune from real estate and mining before entering federal politics in 2013 on a populist platform.

His party won a handful of seats before imploding in acrimony and in-fighting, and failed to win a single seat in 2019 despite spending A$83 million on advertising.

($1 = 1.2855 Australian dollars)

(Reporting by Colin Packham; Editing by Stephen Coates)

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NY AG Opens Probe into Toxic Metals in Baby Food

baby food
New York State Attorney General, Letitia James speaks during a news conference in New York, U.S., August 6, 2020. REUTERS/Brendan McDermid

By Jonathan Stempel

New York‘s attorney general said on Thursday she has opened a probe into whether baby food contains arsenic and other toxic metals, and asked four manufacturers to provide information on whether their infant rice cereal products are safe.

In letters to Nestle’s Gerber, Beech-Nut Nutrition, Earth’s Best Organic maker Hain Celestial Group and Happy Family Organics maker Nurture, Attorney General Letitia James also said she wants to ensure the companies’ advertising complied with state consumer protection laws.

The letters follow a Feb. 4 report by a U.S. House of Representatives subcommittee that said “dangerous levels of toxic heavy metals” in some popular baby foods could cause brain and other neurological damage.

“No child should be exposed to toxic substances in their food,” and parents are entitled to “peace-of-mind” from knowing their children’s food is safe to eat, James said in a statement.

A Gerber spokeswoman said that company’s baby food is safe, and that babies’ health and nutrition is “our priority.”

Beech-Nut, Hain and Nurture did not immediately respond to requests for comment.

James wants the companies to inform consumers about the risk of arsenic contamination and to disclose information about how the companies test infant rice cereal products by May 28.

The House report said internal company standards permitted excessive levels of toxic metals in baby food, which was “often” sold with even higher levels.

It noted that the U.S. Food and Drug Administration has declared that inorganic arsenic, lead, cadmium and mercury are dangerous, particularly to infants and children.

Manufacturers have said they were working to reduce levels of metals in baby food.

Many proposed class-action consumer lawsuits have been filed, and on April 21 the attorney general in Washington, D.C. sued Beech-Nut over its labeling.

In March, a group of House Democrats proposed legislation, the Baby Food Safety Act, to cap within one year the presence of inorganic arsenic, lead, cadmium and mercury in baby food and cereal.

(Reporting by Jonathan Stempel in New York; Additional reporting by David Shepardson in Washington, D.C.; Editing by Aurora Ellis)

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Fully Vaccinated People Can Unmask Outdoors in Some Cases: U.S. CDC

fully vaccinated
A group of people walk wearing protective masks head to a restaurant as coronavirus disease (COVID-19) restrictions are eased in Ann Arbor, Michigan, U.S., April 4, 2021. REUTERS/Emily Elconin/File Photo

Fully vaccinated people can safely engage in outdoor activities like walking and hiking without wearing masks but should continue to use face-coverings in public spaces where they are required, U.S. health regulators said on Tuesday.

The updated health advice comes as more than half of all adults in the United States have now received at least one dose of COVID-19 vaccine, according to the U.S. Centers for Disease Control and Prevention (CDC).

“The release of these new guidelines is a first step at helping fully vaccinated Americans resume activities they had stopped doing because of the pandemic, while being mindful of the potential risk of transmitting the virus to others,” the CDC said.

Wearing face masks has been considered by experts as one of the most effective ways of controlling virus transmission. With most COVID-19 transmission occurring indoors, and vaccinations on the rise, the use of masks outdoors has been under public debate for weeks in the United States as Americans look to enjoy the benefits of being fully vaccinated.

New COVID-19 cases have dropped 16% in the last week as the U.S. surpassed 140 million people having received at least one shot of authorized vaccines from Pfizer/BioNTech, Moderna or Johnson & Johnson’s one-dose vaccine.

This was the biggest percentage drop in weekly new cases since February, according to a Reuters analysis of state and county data.

SMALL OUTDOOR GATHERINGS

The agency said fully-vaccinated Americans can safely dine outdoors with friends from multiple households at restaurants and attend small outdoor gatherings with a mixture of fully vaccinated and unvaccinated people.

CDC continues to recommend masking for crowded outdoor events such as parades and sporting events and indoor visits to the hair salon, shopping malls, movie theaters and houses of worship.

The agency classified activities as “red,” “yellow” and “green” based on level of safety for unvaccinated people.

It said unvaccinated people can also walk and run unmasked with household members outdoors safely and attend small outdoor gatherings with fully vaccinated family and friends.

Data on whether vaccinated people can spread infection to those who did not receive their shots is limited and the CDC warned that people should evaluate risk to friends and family before going out without masks.

This is an update to the CDC‘s guidance, which in March said people who have been fully vaccinated against COVID-19 can meet without masks indoors in small groups with others who also have been inoculated.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Caroline Humer and Bill Berkrot)

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NY Losing One Congressional Seat Due to 2020 Census Count

census
Sample U.S. 2020 Census Form for population count. (Getty Images)

By Joseph Ax, Reuters, and Robert Pozarycki

The Empire State is losing just one seat in the House of Representatives in 2022 after the U.S. Census Bureau released new population data Monday based on the 2020 Census.

The Bureau delivered the results of the Census to the president on Monday, keeping up with its 10-year Constitutional obligation for a population count. New York state’s population topped 20 million for the first time in the 2020 Census, with approximately 20,201,249 residents; that’s a 4.2% growth from the 19,378,102 people counted as New York state residents in the 2010 census.

But that wasn’t enough to keep New York from losing a House seat, dropping its delegation from 27 to 26 members. It also reduces by one the state’s presidential/vice presidential electoral vote count, from 29 to 28. Still, New York has the fourth most electoral votes and members of Congress of any state in the Union.

The state legislature will be tasked with redrawing the state Congressional map, dividing New York into 26 Congressional districts in time for the 2022 elections. The Census data for New York state will also be used by the state and local governments to redistrict other legislative seats in the Empire State.

Every 10 years, the population data gained in the Census is used to reapportion House of Representative members, with states gaining or losing seats based on their population growth or loss.

Under the U.S. Constitution, the 435 seats in the House and the votes in the Electoral College that select the U.S. president every four years are divided among the 50 states based on population, with every state receiving at least one congressional seat.

Texas will receive two congressional seats, and five states – Florida, North Carolina, Colorado, Montana and Oregon – will gain one congressional seat each, the census bureau said.

California, Illinois, Michigan, Ohio, Pennsylvania and West Virginia are also each losing one seat.

The shift in seats to states such as Texas and Florida, where Republicans control the statehouses, could be enough to erase Democrats’ razor-thin majority in the House. Republicans in both of those states have in the past engaged in aggressive gerrymandering, the process by which maps are deliberately redrawn to benefit one party over another.

Every state uses the census data to redraw lines both for districts and thousands of state legislative seats, a process known as redistricting.

That work cannot be completed until the census releases more precise block-by-block data, which is slated for September. The delay has raised concerns about whether states will have time to complete redistricting ahead of next year’s midterm elections.

The U.S. Supreme Court ruled in 2019 that federal courts have no power to restrict political gerrymandering, although racial gerrymandering – which aims to curb the political power of specific racial or ethnic groups – remains unlawful.

The four most populous U.S. states – California, Texas, Florida and New York – have more than 110 million residents combined and will hold about one-third of the House seats.

The shift of seven seats among 13 states was the smallest number of seats moving among states in any decade since the current method of calculating them was adopted in 1941, officials said.

Overall, the U.S. population stood at 331,449,281 as of April 2020, a 7.4% increase over the previous decade, according to the agency. That rise is the second-slowest in history, behind only the 1930s, census officials said.

Utah’s population grew faster than any other state’s, increasing by more than 18% since 2010. Only three states lost population, led by West Virginia, which saw its population decrease by 3.2%.

Washington, D.C., the nation’s capital, grew by 14.6% to a population of 689,545. Congressional Democrats have passed legislation to admit the district as the 51st state, but Republicans oppose the measure.

The territory of Puerto Rico, which was devastated by Hurricane Maria in 2017, has seen its population decrease by 11.8% since 2010.

Wyoming remains the least populated state, with 576,851 residents.

This story first appeared on amNY.com.

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U.S. Ends J&J Covid-19 Vaccine Pause; Shots to Resume Immediately

vaccine
A vial and sryinge are seen in front of a displayed Johnson&Johnson logo in this illustration taken January 11, 2021. REUTERS/Dado Ruvic/Illustration/File Photo

By Julie Steenhuysen and Manas Mishra

The United States can immediately resume use of Johnson & Johnson’s Covid-19 vaccine, top health regulators said on Friday, ending a 10-day pause to investigate its link to extremely rare but potentially deadly blood clots.

The Centers for Disease Control and Prevention (CDC) and Food and Drug Administration said the risks of experiencing the syndrome involving severe blood clots and low platelets as a result of the vaccine was very low. They found 15 cases in the 8 million shots given.

“We are no longer recommending a pause in the use of this vaccine,” CDC Director Rochelle Walensky told a news briefing. “Based on the in-depth analysis, there is likely an association but the risk is very low.”

Top U.S. FDA officials said the decision was effective immediately, clearing the way for shots in arms as early as Saturday. The agency said it would warn of the risk in an updated fact sheet given to vaccine recipients and providers.

The agencies made the decision following a meeting of outside advisers to the CDC who recommended that the vaccine pause be ended.

In an analysis presented at the meeting, CDC staff said that the cases of the syndrome that they had found occurred at a rate of seven per one million doses in women under age 50, with the highest risk occurring among women ages 30 to 39.

For women over age 50 and for all men, the clots appeared at a rate of one per one million doses, the analysis showed. In all, there were three deaths, officials said.

After a day-long meeting, the CDC panel voted 10-4 that the J&J vaccine be used as recommended in people 18 years of age and older, the parameters of its current FDA authorization.

Dr. Jesse Goodman, an infectious disease expert at Georgetown University in Washington and a former chief scientist at the FDA, said the risk was not trivial, but still small.

“But we should keep it in perspective. I mean the risk of dying from a car accident in your life is something like one in 100, the risk of being struck by lightning is something like one in 15,000,” Goodman said.

Unlike the highly effective vaccines by Pfizer Inc and Moderna Inc, which require two doses and must be kept frozen at ultra-cold temperatures, J&J’s vaccine can be given in a single dose and stored at regular refrigeration temperatures, making it a better option for hard-to-reach areas.

Johnson & Johnson shares closed up 0.2% at $165.52.

EARLY IDENTIFICATION

“We will collaborate with health authorities around the world to educate healthcare professionals and the public to ensure this very rare event can be identified early and treated effectively,” J&J’s Chief Scientific Officer Paul Stoffels said in a statement after the agencies made their announcement.

When the agencies first announced the pause, they urged doctors to avoid using the blood thinner heparin, commonly given to patients to break up blood clots, in people who had received the J&J vaccine and were experiencing blood clots and low blood platelets.

In the cases of the vaccine-induced blood clots, however, heparin appears to make the condition worse. Walensky said doctors heeded that warning, noting that the drug had not been used in any of the cases identified after the pause began.

The U.S. decision follows a similar one by the European Medicines Agency, which on Tuesday said the benefits of the J&J shot outweighed its risks and recommended adding a warning about unusual blood clots with low blood platelet counts to the vaccine’s product label. J&J resumed its rollout there.

The J&J probe followed an investigation in Europe of the AstraZeneca PLC vaccine, with which similar cases of blood clots were first identified. Dr. Peter Marks of the FDA said the cases appear so similar that a doctor would not be able to tell which vaccine caused them.

Both the J&J and AstraZeneca vaccine use different versions of a cold virus to deliver instructions for making coronavirus proteins into cells to produce an immune response. Marks said studies are underway to determine whether the adenovirus or something else is behind the rare blood clots.

Dr. William Moss, executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health, said the J&J vaccine will help advance the vaccination effort.

“Giving people the choice to receive a single-dose vaccine will help get more people vaccinated faster and will better protect some populations, such as those who are homeless or incarcerated,” Moss said by email.

J&J has faced several setbacks since its vaccine gained U.S. emergency authorization in February, including drawing scrutiny over production shortfalls.

In the United States, 35% of adults are fully vaccinated and 53% have received at least one shot, according to CDC data. The United States leads the world with roughly 570,000 COVID-19 deaths.

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U.S. Officials Hopeful As Advisers Meet Again on J&J Covid-19 Vaccine

J&J covid-19 Vaccine
Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Johnson & Johnson logo in this illustration taken October 31, 2020. REUTERS/Dado Ruvic

By Manas Mishra

Advisers to the U.S. Centers for Disease Control and Prevention will meet again on Friday to consider whether it is safe to resume injections of Johnson & Johnson’s Covid19 vaccine, as senior U.S. health officials prepare for a green light.

The panel last week called for more data about a possible link to rare blood clots in the brain before deciding how and whether to end a “pause” in administration of J&J vaccines called for by the CDC and the Food and Drug Administration.

The decision by CDC’s advisory panel has global implications since J&J’s immunization is seen as an important tool for poorer countries and less accessible populations, given that it only requires one dose and can be stored at normal refrigerator temperatures, making it relatively easy to transport.

Some panel members argued an extension of the pause could signal to the world that the vaccine had major safety issues. There have been six reported cases of rare brain blood clots accompanied by low platelets in the blood out of nearly 8 million doses administered in the United States. U.S. officials last week said a handful more possible cases were under review.

State health officials on Thursday said the CDC was investigating two more possible cases, probing the death of an Oregon woman in her 50s and the hospitalization a Texas woman with symptoms similar to those found in the clot cases – both of whom had received J&J’s shot. Officials have not linked the cases to the vaccine.

The United States has ordered enough doses of vaccines from Pfizer Inc/BioNTech and Moderna Inc to cover all U.S. adults, but many senior regulators, including U.S. infectious disease chief Anthony Fauci, have signaled they hope to resume use of the J&J vaccine.

CDC Director Dr. Rochelle Walensky said she was hopeful for a quick decision on J&J’s vaccine, especially as EU regulators backed the shot this week, and added U.S. advisers on Friday would review data as well as the agency’s risk/benefit analysis.

“I will look toward their guidance. I believe its really important to make a swift decision,” she told NBC News’ “Today” program on Thursday, adding that she expected U.S. guidance to be issued soon after Friday’s meeting.

The European Medicines Agency on Tuesday recommended adding a warning about unusual blood clots with low blood platelet counts to the vaccine‘s product label, saying that benefits of the shot outweighed the risks. The drugmaker has said it would resume rolling in the region.

U.S. National Institutes of Health Director Dr. Francis Collins told ABC News’ “Good Morning America” program on Friday the Europeans’ decision to move ahead while adding a warning was “encouraging.”

He added possible clots are “one in a million kind of risk” while “this vaccine can save lives” in the fight against a pandemic, which has already claimed more than 3.2 million lives globally, including at least 570,674 in the United States.

J&J has faced several setbacks since its shot gained U.S. emergency authorization in February, first drawing scrutiny over its halting process to scale up production of the vaccine, and then over rare cases of clots in a handful of vaccine recipients. FDA inspectors this week cited serious cleanliness and medical safety issues at an Emergent BioSolutions plant making the J&J vaccine.

The company’s shares were near flat in early morning pre-trade on Friday ahead of the meeting.

European regulators said the blood clots in patients who received the J&J vaccine bear close resemblance to 169 cases in Europe reported with the AstraZeneca Plc vaccine.

U.S. officials said a key reason for their pause was to communicate the risk to doctors on how to recognize the side effects and treat them, saying patients with clot-related symptoms following the J&J vaccine should not be given heparin, a blood thinner widely used to treat clotting disorders.

“This is a treatable condition if you recognize it right away,” Collins told ABC.

(Reporting by Manas Mishra in Bengaluru; additional reporting by Susan Heavey in Washington; editing by Peter Henderson, William Maclean and Steve Orlofsky)

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