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U.S. FDA clears Pfizer COVID-19 booster for older and at-risk Americans

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The U.S. Food and Drug Administration on Wednesday authorized a booster dose of the Pfizer Inc and BioNTech COVID-19 vaccine for those 65 and older, all people at high risk of severe disease, and others who are regularly exposed to the virus.

The decision paves the way for a quick rollout of the booster shots as soon as this week for millions of people who had their second dose of the vaccine at least six months ago.

The change to the vaccine’s emergency use authorization will allow boosters for groups such as health-care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, FDA acting Commissioner Janet Woodcock said in a statement.

Pfizer had asked the FDA to expand its vaccine approval to include boosters for all people aged 16 and older and presented data last week to an outside FDA panel of advisers that it said showed waning immunity over time.

The panel voted against the proposition that boosters were needed by everyone but said evidence showed they were helpful to older people and those at high risk. 

Dr. William Schaffner, medical director of the National Foundation for Infectious Diseases (NFID), said the FDA’s statement was more expansive in who it included as eligible for boosters when compared to the panel’s recommendation.

“Very broad indeed, especially that ‘among others.’ That could essentially give the green light for giving boosters to a very substantial proportion of the previously vaccinated adult population,” said Schaffner, who serves as the NFID’s liaison to the Advisory Committee on Immunization Practices (ACIP) at the U.S. Centers for Disease Control and Prevention (CDC).

ACIP could vote Thursday on the use of a third shot of the vaccine, an agency official said at a public meeting of the panel on Wednesday.

“Tomorrow’s ACIP meeting at the CDC will be focused on turning this into an official recommendation for implementation,” said Dr. Amesh Adalja, senior scholar at the Johns Hopkins University Center for Health Security.

The FDA authorization was “generally in line” with the advisory panel vote, said Dr. Jesse Goodman, an infectious disease expert at Georgetown University in Washington and former chief scientist at the FDA.

“These are pretty broad categories that give a fair amount of latitude to the judgment of healthcare providers and people providing immunizations,” he added.

President Joe Biden and eight top health officials including Woodcock announced in August the government’s intention to roll out booster shots for people aged 16 and older this week, pending approval by the FDA and CDC.

But the advisory panel said there was not enough evidence to support booster shots for that population and also sought more safety data. The FDA does not have to follow the advisory panel’s recommendation, but often does.

The agency could revisit the issue for a broader authorization in the future.

“This first FDA authorization of a COVID-19 vaccine booster is a critical milestone in the ongoing fight against this disease,” said Pfizer chief Albert Bourla. The company had argued that boosters are needed for the general population.

Top FDA members have been split on the need for boosters for the general population, with Woodcock backing them while some of the agency’s senior scientists argued that current evidence does not support them.

Some countries, including Israel and Britain, have already rolled out COVID-19 booster campaigns. The United States authorized extra shots for people with compromised immune systems last month and over 2 million people have already received a third shot, CDC data showed.

Source: https://tuoitrenews.vn/news/international/20210923/us-fda-clears-pfizer-covid19-booster-for-older-and-atrisk-americans/63232.html

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Alec Baldwin fires prop gun on movie set, killing cinematographer

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Actor Alec Baldwin fired a prop gun on a movie set in New Mexico on Thursday, killing cinematographer Halyna Hutchins and wounding director Joel Souza, authorities said.

The incident occurred on the set of independent feature film “Rust,” the Santa Fe County Sheriff’s office said in a statement, at the Bonanza Creek Ranch, a production location south of Santa Fe.

“The sheriff’s office confirms that two individuals were shot on the set of Rust. Halyna Hutchins, 42, director of photography, and Joel Souza, 48, director, were shot when a prop firearm was discharged by Alec Baldwin, 68, producer and actor,” the police said in a statement.

According to authorities, Hutchins was transported by helicopter to University of New Mexico Hospital, where she was pronounced dead, while Souza was taken by ambulance to Christus St. Vincent Regional Medical center to undergo treatment for his injuries.

It was not immediately known how serious Souza’s injuries were.

No charges have yet been filed in regard to the incident, said the police, adding they are investigating the shooting and interviewing witnesses.

Deadline cited a source in the Santa Fe Sheriff’s Department as saying that Baldwin was questioned by investigators and later released, which Reuters was unable to immediately verify.

Baldwin’s representatives did not immediately respond to Reuters‘ request for comment.

Baldwin is a co-producer in the Western movie set in 1880s Kansas and plays the eponymous “Rust”, an outlaw grandfather of a 13-year-old boy convicted of an accidental murder.

Most recently famous for his impersonations of former U.S. President Donald Trump on NBC’s comedy sketch show “Saturday Night Live,” Baldwin has a long history in film and television, including roles in “Glengarry Glen Ross” and “30 Rock.”

Originally from Ukraine, Hutchins once worked as an investigative reporter in Europe. She graduated from the American Film Institute in 2015 and was selected as one of American Cinematographer’s Rising Stars of 2019, according to her website biography.

Her last Instagram post, two days ago, was a video of her riding on a horse, wearing a wide-brimmed hat. “One of the perks of shooting a western is you get to ride horses on your day off:)” she said in the post.

April Wright, a writer, director and producer, paid tribute to Hutchins on Facebook.

“I’m in disbelief,” wrote Wright. “So young, vibrant, and talented. Such a wonderful soul. My heart goes out to her son and family.”

Source: https://tuoitrenews.vn/news/international/20211022/alec-baldwin-fires-prop-gun-on-movie-set-killing-cinematographer/63716.html

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Plastics to outpace coal’s greenhouse gas emissions by 2030: report

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The carbon-intensive production of plastics is on pace to emit more greenhouse gases than coal-fired power plants within this decade, undercutting global efforts to tackle climate change, a report released on Thursday said.

The report by Bennington College and Beyond Plastics projected that the plastic industry releases at least 232 million tons of greenhouse gases each year throughout its lifecycle from the drilling for oil and gas to fuel its facilities to incineration of plastic waste. That is the equivalent of 116 coal-fired power plants.

“The scale of the plastics industry’s greenhouse gas emissions is staggering, but it’s equally concerning that few people in government or in the business community are even talking about it,” said Judith Enck, a former Environmental Protection Agency regional administrator and president of Beyond Plastics.

Also, the report found that petrochemical facilities tend to be clustered in just 18 largely low-income and minority communities, where 90% of the pollution occurs.

With at least a dozen more plastic production plants under construction and 15 more planned, resulting emissions would undercut any gains made by phasing out coal power and shifting toward more renewable energy, Enck said.

The report also said authorities probably have undercounted emissions and air pollution related to different stages of the production of plastics and export of plastic waste. That is because U.S. regulations do not require the plastic industry to report them and no federal agency tracks them, said report author Jim Vallette of research group Material Research.

Plastics Industry Association spokesman George O’Connor said in a statement that the report “cherry picks data” and pointed to other studies that found that plastic actually results in lower carbon emissions due to its lighter weight and durability compared to alternatives like glass and paper.

Enck said the report is based on data from federal agencies including the Environmental Protection Agency and Commerce Department, which are based on plastic industry reporting. She conceded that plastic was lightweight and durable but added that the industry’s calculations neglect other factors that increase emissions.

Source: https://tuoitrenews.vn/news/international/20211022/plastics-to-outpace-coal-s-greenhouse-gas-emissions-by-2030-report/63713.html

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India celebrates 1 billion COVID-19 vaccine doses with song and dance

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NEW DELHI — India celebrated the milestone of administering 1 billion COVID-19 vaccine doses on Thursday, with the government promoting the achievement in song and video even as a recent drop in inoculations worries healthcare providers.

After a slow beginning in the middle of January, India’s immunisation campaign has covered three-quarters of its 944 million adults with at least one dose but only 31% with two. The government wants all adults to get vaccinated this year.

“India scripts history,” Prime Minister Narendra Modi said on Twitter. “We are witnessing the triumph of Indian science, enterprise and collective spirit of (1.3 billion) Indians.”

Modi marked the occasion by interacting with healthcare workers and a security guard at a government hospital in New Delhi. The health ministry announced musical and other programmes across the country, and special illuminations of national monuments including a colonial-era jail.

Nearly 90% of the vaccines administered in India have come from the Serum Institute of India (SII), which produces a licensed version of the AstraZeneca drug. SII has more than tripled its capacity since April and can now produce 220 million vaccine doses a month.

A healthcare worker gives a dose of the COVISHIELD vaccine against the coronavirus disease (COVID-19), manufactured by Serum Institute of India, to a man as others decorate the vaccination centre to celebrate the milestone of administering one billion COVID-19 vaccine doses, in Ahmedabad, India, October 21, 2021. Photo: Reuters

A healthcare worker gives a dose of the COVISHIELD vaccine against the coronavirus disease (COVID-19), manufactured by Serum Institute of India, to a man as others decorate the vaccination centre to celebrate the milestone of administering one billion COVID-19 vaccine doses, in Ahmedabad, India, October 21, 2021. Photo: Reuters

SII has also slowly resumed exports for the first time since April, when the government stopped all overseas sales to meet domestic demand as infections rose dramatically.

The World Health Organization (WHO), which relies heavily on India for supplies to its global vaccine-sharing platform COVAX, congratulated the country for reaching the landmark.

“India’s progress must be viewed in the context of the country’s commendable commitment and efforts to ensure that these life-saving vaccines are accessible globally,” said Poonam Khetrapal Singh, regional director WHO South-East Asia.

COVAX partner UNICEF also congratulated India and said it looked forward to “hearing details about the expected timeline and volumes of supplies to be made” to the global facility.

Reuters has reported that India has delayed supplies of the AstraZeneca vaccine to COVAX. New Delhi has been annoyed by the WHO’s repeated delay in adding India’s own Covaxin shot to the world body’s emergency-use listing, something both parties discussed this week as well as exports. 

A woman reacts as she receives a dose of the COVISHIELD vaccine against the coronavirus disease (COVID-19), manufactured by Serum Institute of India, at a vaccination centre in Ahmedabad, India, October 21, 2021. Photo: Reuters

A woman reacts as she receives a dose of the COVISHIELD vaccine against the coronavirus disease (COVID-19), manufactured by Serum Institute of India, at a vaccination centre in Ahmedabad, India, October 21, 2021. Photo: Reuters

India has so far reported 34.1 million COVID-19 cases and more than 452,000 deaths, most during a second wave of infections of the Delta variant between April and May.

A “sizeable number” of people in India have not taken their second dose by the due date despite adequate supplies, the health ministry said on Tuesday, as new infections fell to their lowest since early March. 

Daily shots have averaged 5 million this month, a fifth of September’s peak, though states are sitting on record stocks of more than 100 million as domestic output of the AstraZeneca vaccine soars.

Despite the current low number of infections, ministry officials have been urging people to get vaccinated fast, especially as the ongoing festival season means family gatherings and mass shopping, raising the risk of a new wave of infections.

Source: https://tuoitrenews.vn/news/international/20211022/india-celebrates-1-billion-covid19-vaccine-doses-with-song-and-dance/63712.html

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