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The Latest: Pfizer gives vaccine data from kids 5-11 to FDA

Pfizer has submitted research to the U.S. Food and Drug Administration on the effectiveness of its COVID-19 vaccine in children as it moves closer to seeking approval for expanded use of the shots

Via AP news wire
Tuesday 28 September 2021 11:41 EDT

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NEW YORK — Pfizer has submitted research to the U.S. Food and Drug Administration on the effectiveness of its COVID-19 vaccine in children as it moves closer to seeking approval for expanded use of the shots.

The drugmaker and its partner, Germany’s BioNTech say they expect to request emergency use authorization of their vaccine in children ages 5 to 11 “in the coming weeks.” The companies also plan to submit data to the European Medicines Agency and other regulators.

The two-shot Pfizer vaccine is currently available for those 12 and older. An estimated 100 million people in the U.S. have been fully vaccinated with it, according to the Centers for Disease Control and Prevention.

Pfizer tested a lower dose of the shots in children. The drugmaker said last week that researchers found the vaccine developed coronavirus-fighting antibody levels in children that were just as strong as those found in teenagers and young adults getting regular-strength doses.

Earlier this month, FDA chief Dr. Peter Marks told the AP that once Pfizer turns over its study results, his agency would evaluate the data “hopefully in a matter of weeks” to decide if the shots are safe and effective enough for younger kids.

Another U.S. vaccine maker, Moderna, also is studying its shots in elementary school-aged children. Results are expected later in the year.

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MORE ON THE PANDEMIC:

— Japan to lift all coronavirus emergency steps nationwide

— Vaccination situation in Europe a story of two regions

— World Bank cuts Asia growth outlook, calls for virus action

— Coronavirus deaths in Russia hit another record

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See all of AP's pandemic coverage at https://apnews.com/hub/coronavirus-pandemic

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HERE’S WHAT ELSE IS HAPPENING:

PARIS — French drugmaker Sanofi says it is shelving plans for a COVID-19 vaccine based on messenger RNA but will develop a new flu vaccine.

The Paris-based company says it will continue to develop another vaccine candidate already undergoing late-stage human trials. That vaccine, developed with Britain’s GlaxoSmithKline, is being tested as a COVID-19 booster.

Sanofi recently expanded trials of that recombinant protein vaccine as a booster dose to extend immunity for people inoculated with a variety of other vaccines. Results from that study are expected later this year.

Messenger RNA vaccines are currently made by Pfizer and Moderna. Sanofi officials say they decided it wasn’t worth pursuing that technology for COVID-19 vaccines, given how those vaccines are widely available.

They plan to use the mRNA technology to develop a new flu vaccine, with clinical studies expected to start next year, according to Jean-Francois Toussaint, global head of research and development at Sanofi’s vaccine unit.

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TOKYO — Japan’s government says the coronavirus state of emergency will end Thursday to help rejuvenate the economy as infections slow.

Prime Minister Yoshihide Suga announced virus restrictions will be eased gradually. Government officials are instituting other plans, such as vaccine passports and virus tests, Suga says.

With the lifting, Japan will be free of emergency requirements for the first time in more than six months. The current state of emergency, declared in April, was repeatedly extended and expanded, especially during the Tokyo Olympics and Paralympics.

Infections started to worsen in July and peaked in mid-August after the Olympics, surging above 5,000 daily cases in Tokyo alone and topping 25,000 nationwide. Thousands of patients unable to find hospital beds had to recover from the illness at home.

Daily reported cases have fallen to around 2,000 nationwide. Health experts attributed the declining numbers to the progress of vaccinations — 58% of the population is fully vaccinated — increased social distancing efforts after alarm from full hospitals.

There have been 1.69 million confirmed cases and 17,500 confirmed deaths from COVID-19 in Japan.

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PHOENIX — A judge has struck down Republican-passed Arizona laws that block schools from requiring masks and restrict the power of local governments to impose COVID-19 requirements.

The ruling Monday could clear the way for cities and counties to enact mask requirements if it withstands a promised appeal. It comes as the fight over school masks and other COVID-19 restrictions has moved into courtrooms across the U.S. Lawsuits have been filed in at least 14 states either for or against masks in schools.

The federal Centers for Disease Control and Prevention recommends mask-wearing in schools, and children 12 and under are not yet eligible for vaccines.

The sweeping Arizona ruling also struck down several non-virus provisions slipped into the state budget and an entire measure that served as a vehicle for a conservative policy wish list. It included a required investigation of social media companies and stripping the Democratic secretary of state of her duty to defend election laws.

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MOSCOW — Coronavirus confirmed deaths in Russia hit another record at 852 on Tuesday.

Russia’s state coronavirus task force reported the increase from the previous record of 828 on Friday.

Daily coronavirus infections in Russia have fallen from more than 20,000 in late August to about 18,000 in mid-September. However, the numbers have started creeping up again. Since last Thursday, the state coronavirus task force has been reporting more than 21,000 new cases a day. On Tuesday, 21,559 new infections were registered.

Despite the increase, there are few restrictions in place in Russia, which had one, six-week lockdown last spring. Vaccination rates have remained low, too, with only 32% of the country’s 146 million population having received at least one shot of a vaccine and only 28% fully vaccinated.

Russian authorities have reported a total of about 7.4 million confirmed infections and more than 205,000 confirmed deaths. However, reports by the government’s statistical service Rosstat indicates the tally of coronavirus-linked deaths retroactively reveal much higher mortality numbers.

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LISBON, Portugal — Portugal is winding down its military-led vaccine task force after almost reaching its target of fully inoculating 85% of the population against COVID-19.

The task force, led for the past eight months by a senior naval officer from a NATO building near Lisbon, will be replaced by three teams reporting to the Health Ministry.

Portugal’s vaccination drive e rollout is the most advanced in the world, with 84.88% of the country’s 10.3 million people having received shots, according to Our World in Data.

Portugal is scrapping most of its pandemic restrictions starting Friday. Prime Minister Antonio Costa said many people deserved credit for the country’s expeditious vaccine rollout, but he singled out Portugal’s acceptance of vaccinations as the prime reason for success.

Portugal has no significant anti-vaccination movement and is one of the European Union’s leading countries in terms of vaccine uptake for illnesses such as measles and influenza.

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ISLAMABAD — Pakistan’s planning minister says the government will begin a drive to vaccinate children ages 12 and above to protect them from the coronavirus.

The announcement by Planning Minister Asad Umar came Tuesday amid a steady decline in COVID-19 deaths across the country.

Umar said in a tweet that the government would soon launch a campaign soon to vaccinate children at schools. He didn't give a precise date.

Pakistan is currently offering free vaccine shots to teenagers and adults.

The country on Tuesday reported 41 more COVID-19 deaths and 1,400 new cases in the past 24 hours. It was the first time since July that Pakistan confirmed fewer than 1,500 daily cases..

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SYDNEY — Australia’s Victoria state has recorded more coronavirus infections than New South Wales for the first time since an outbreak of the delta variant began in Sydney in June.

Victoria is Australia’s second-most populous state and on Tuesday the state capital of Melbourne reported 867 new virus cases and four deaths from COVID-19 in the latest 24-hour period.

It was the highest daily numbers of infections and deaths in Victoria for the latest outbreak. Victoria’s previous high infection count was 847 reported Saturday.

New South Wales is the most populous state and home to Sydney, which reported 863 new infections Tuesday and seven deaths. The state has seen daily infections plateau as vaccinations have risen.

Sydney has been in lockdown since June 26 and Melbourne since Aug. 5.

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WELLINGTON, New Zealand — New Zealand is relaxing travel restrictions in Auckland six weeks after the nation’s most populous city was locked down due to the coronavirus.

People can cross the city boundary beginning Monday night if they are permanently relocating, have shared caring-giving arrangements or are returning home. Those leaving Auckland on care-giving trips will have to be tested for the virus within a week of their departure.

Prime Minister Jacinda Ardern says more flexibility is being given because the system of pandemic restrictions is “currently doing its job.”

The city reported eight new infections Tuesday in the latest 24-hour period. Auckland was locked down Aug. 17 after the delta variant leaked from hotel quarantine from a New Zealander who had returned from Sydney.

Pandemic restrictions elsewhere in New Zealand amount to little more than mandatory mask-wearing.

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NEW YORK — A federal appeals panel says New York City may require teachers to be vaccinated against the coronavirus.

The three-judge panel of the 2nd U.S. Circuit Court of Appeals acted late Monday to lift a temporary order issued Friday that blocked the mandate from taking effect so a challenge could be heard from a group of teachers.

The mandate had been set to go into effect Monday for teachers and other employees of the city’s schools. The appeals panel’s ruling put the mandate back in force.

Lawyers for the teachers said they will now ask the U.S. Supreme Court to intervene. One attorney said: “With thousands of teachers not vaccinated the city may regret what it wished for. Our children will be left with no teachers and no security in schools.”

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SACRAMENTO, Calif. — A federal judge has ordered all employees entering California prisons be vaccinated or have a religious or medical exemption.

The order is aimed at heading off another coronavirus outbreak like the one that killed 28 inmates and a correctional officer at San Quentin State Prison last year.

The order also requires that inmates who want in-person visits or who work outside prisons, including inmate firefighters, must be fully vaccinated or have a religious or medical exemption. The prison guard’s union says it may appeal.

More than 50,000 California inmates have been infected with the coronavirus and at least 240 have died of COVID-19.

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