Pfizer COVID-19 shot expanded to US children as young as 12


The Associated Press 10 May, 2021 - 05:09pm 34 views

U.S. regulators on Monday expanded the use of Pfizer’s COVID-19 vaccine to children as young as 12, offering a way to protect the nation’s adolescents before they head back to school in the fall and paving the way for them to return to more normal activities.

Shots could begin as soon as a federal vaccine advisory committee issues recommendations for using the two-dose vaccine in 12- to 15-year-olds. An announcement is expected Wednesday.

Most COVID-19 vaccines worldwide have been authorized for adults. Pfizer’s vaccine is being used in multiple countries for teens as young as 16, and Canada recently became the first to expand use to 12 and up. Parents, school administrators and public health officials elsewhere have eagerly awaited approval for the shot to be made available to more kids.

“This is a watershed moment in our ability to fight back the COVID-19 pandemic,” Dr. Bill Gruber, a Pfizer senior vice president who’s also a pediatrician, told The Associated Press.

The Food and Drug Administration declared that the Pfizer vaccine is safe and offers strong protection for younger teens based on testing of more than 2,000 U.S. volunteers ages 12 to 15. The study found no cases of COVID-19 among fully vaccinated adolescents compared to 18 among kids given dummy shots. More intriguing, researchers found the kids developed higher levels of virus-fighting antibodies than earlier studies measured in young adults.

The younger teens received the same vaccine dosage as adults and had the same side effects, mostly sore arms and flu-like fever, chills or aches that signal a revved-up immune system, especially after the second dose.

Pfizer’s testing in adolescents “met our rigorous standards,” FDA vaccine chief Dr. Peter Marks said. “Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic.”

Pfizer and its German partner BioNTech recently requested similar authorization in the European Union, with other countries to follow.

The latest news is welcome for U.S. families struggling to decide what activities are safe to resume when the youngest family members remain unvaccinated.

“I can’t feel totally comfortable because my boys aren’t vaccinated,” said Carrie Vittitoe, a substitute teacher and freelance writer in Louisville, Kentucky, who is fully vaccinated, as are her husband and 17-year-old daughter.

The FDA decision means her 13-year-old son soon could be eligible, leaving only her 11-year-old son unvaccinated. The family has not yet resumed going to church, and summer vacation will be a road trip so they do not have to get on a plane.

“We can’t really go back to normal because two-fifths of our family don’t have protection,” Vittitoe said.

Pfizer is not the only company seeking to lower the age limit for its vaccine. Moderna recently said preliminary results from its study in 12- to 17-year-olds show strong protection and no serious side effects. Another U.S. company, Novavax, has a COVID-19 vaccine in late-stage development and just began a study in 12- to 17-year-olds.

Next up is testing whether the vaccine works for even younger children. Both Pfizer and Moderna have begun U.S. studies in children ages 6 months to 11 years. Those studies explore whether babies, preschoolers and elementary-age kids will need different doses than teens and adults. Gruber said Pfizer expects its first results in the fall.

Outside of the U.S., AstraZeneca is studying its vaccine among 6- to 17-year-olds in Britain. And in China, Sinovac recently announced that it has submitted preliminary data to Chinese regulators showing its vaccine is safe in children as young as 3.

Children are far less likely than adults to get seriously ill from COVID-19, yet they represent nearly 14% of the nation’s coronavirus cases. At least 296 have died from COVID-19 in the U.S. alone, and more than 15,000 have been hospitalized, according to a tally by the American Academy of Pediatrics.

That’s not counting the toll of family members becoming ill or dying -- or the disruption to school, sports and other activities so crucial to children’s overall well-being.

The AAP welcomed the FDA’s decision.

“Our youngest generations have shouldered heavy burdens over the past year, and the vaccine is a hopeful sign that they will be able to begin to experience all the activities that are so important for their health and development,” said AAP President Dr. Lee Savio Beers in a statement.

Experts say children must get the shots if the country is to vaccinate the 70% to 85% of the population necessary to reach what’s called herd immunity.

In the meantime, the Centers for Disease Control and Prevention says unvaccinated people — including children — should continue taking precautions such as wearing masks indoors and keeping their distance from other unvaccinated people outside of their households.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Read full article at The Associated Press

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CNN 10 May, 2021 - 06:12pm

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BioNTech CEO: Patent waivers are not needed

The Hill 10 May, 2021 - 10:45am

BioNTech recorded a net profit of 1.13 billion euros, or $1.37 billion, for the first three months of 2021, compared to a net loss of 53.4 million euros for the first quarter last year.

He said the best, and only, near-term solution is to increase the existing manufacturing network and ensure that the vaccines produced in the United States and Europe can be provided to low- and middle-income countries.

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The Latest: Michigan poised to ease rules on in-office work

Yahoo! Voices 10 May, 2021 - 01:36am

Employers currently must prohibit onsite work if an employee’s job can feasibly be done remotely. With Monday’s announcement, state officials say they anticipate lifting the rule May 24.

Under the state’s pandemic system, when the vaccination rate reaches 60%, sports stadiums, banquet halls, conference centers and funeral homes will be allowed to raise their capacity to 25% of normal — and gyms will go to 50%. Restaurants and bars will no longer have an 11 p.m. curfew.

After 65%, all limits on indoor capacity will be lifted. At 70%, the state will rescind its mask and gatherings rules.

Authorities, however, can delay easing restrictions in any area with a high infection rate.

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JACKSON, Miss. — Mississippi will stop accepting supplemental unemployment benefits for pandemic relief from the federal government next month.

Gov. Tate Reeves said Monday that the weekly supplement of $300 per person was intended to help people “who are unemployed through no fault of their own” because of the coronavirus pandemic. He says that conversations with small business owners and employees indicate the aid is no longer needed.

Reeves says Mississippi will opt out of the additional federal unemployment benefits June 12, the earliest date allowed by federal law. Without the federal supplement, the maximum weekly unemployment benefit in Mississippi is $235.

The governor also says he has told the Department of Employment Security to resume requiring that a person document they are looking for a job in order to receive unemployment benefits.

MONTGOMERY, Ala.—Alabama Gov. Kay Ivey announced Monday that Alabama will be the latest U.S. state to halt pandemic-related unemployment boosts, including the additional $300 benefit from the federal government.

Ivey cites an increase in job postings and complaints from businesses that they are unable to hire workers. She says she believes the increased unemployment assistance intended to bring emergency relief during the pandemic is now contributing to a labor shortage.

That view is echoed by conservative groups but disputed by some advocates for low-income families.

“As Alabama’s economy continues its recovery, we are hearing from more and more business owners and employers that it is increasingly difficult to find workers to fill available jobs, even though job openings are abundant,” Ivey said in a statement.

Ivey says Alabama will end its participation in all federally funded pandemic unemployment compensation programs effective June 19. That includes the additional $300 weekly payment to recipients of unemployment compensation and benefits to gig and part-time workers who would not usually qualify.

LOS ANGELES -- Los Angeles County expects to reach so-called community immunity by mid-to-late July, officials said Monday.

According to Barbara Ferrer, the county’s public health director, the county expects to administer 400,000 shots weekly.

The county has administered nearly 8.5 million doses as of May 7 and needs to put an additional 1.5 million first doses in arms to hit the goal of 80% of county residents vaccinated.

The county reported four deaths on Monday and there is a lag in weekend reporting, Ferrer said. The county has had just over 24,000 pandemic-related deaths in total.

The county also reported 179 new cases on Monday.

LOS ANGELES -- The superintendent of the Los Angeles Unified School District said Monday there are disparities in the return of students to classrooms in the nation’s second-largest district.

Elementary schools have higher in-person enrollment in more affluent communities than in low-income communities while the opposite is true in high schools, Superintendent Austin Beutner said in his weekly video briefing to the school community.

Beutner cited the example of West Los Angeles, where median household incomes exceed $115,000 and nearly 70% of elementary school students have returned to campus for in-person learning. In the city of Bell, however, where incomes are about $44,000, fewer than 20% of students are at schools.

At the high school level, COVID-19 safety protocols keep most instruction on-line, even for those who attend in person.

In the city of Huntington Park, where the median income is about $44,000, 12% of high school students have returned to in-person learning. In the Woodland Hills area of Los Angeles, where the median is nearly $100,000, only 5% have returned.

Beutner stressed the extensive safety measures put in place on campuses, the district’s massive COVID-19 testing program and commitment to make vaccinations available.

IRVINE, Calif. -- Prosecutors say a Southern California man has pleaded not guilty to charges he obtained $5 million in federal coronavirus-relief loans for phony businesses and then used the money for lavish vacations and to buy a Ferrari, a Bentley and a Lamborghini.

Mustafa Qadiri was arrested last week on suspicion of scheming to defraud the Paycheck Protection Program.

The 38-year-old will stand trial in June on multiple charges including bank fraud, wire fraud, aggravated identity theft and money laundering.

Prosecutors say his loan applications included altered bank records, fake tax returns and false information about employees.

He was released on $100,000 bond.

Qadiri’s attorney, Bilal A. Essayli, declined further comment Monday.

SEATTLE -- Washington state’s Department of Health says preliminary data shows more people died of drug overdoses in 2020 than any other year in at least the last decade.

Authorities say the effects of the coronavirus pandemic likely led to a drug use surge.

The Seattle Times reports fatal drug overdoses increased by more than 30% last year compared to 2019. That’s an increase more than twice as large as any other year over the last decade.

Officials are still analyzing the preliminary data and causes of death in specific cases and expect the number of overdose deaths to grow even higher.

SACRAMENTO, Calif. -- Millions of Californians would get tax rebates of up to $1,100 under a proposal unveiled by Democratic Gov. Gavin Newsom as part of a broader pandemic recovery plan made possible by an eye-popping $75 billion budget surplus.

Individuals and households making between $30,000 and $75,000 annually would get a $600 payment under Newsom’s plan announced Monday. All households making up to $75,000 with at least one child, including immigrants who file taxes, would get an extra $500 payment.

The payments are part of what Newsom is calling a $100 billion plan to drive the state’s economic recovery. It also comes as Newsom faces a recall election.

The massive budget surplus is largely due to taxes paid by rich Californians who generally did well during the pandemic, and marks a major turnaround after officials last year said they feared a deficit of more than $50 billion.

The payments will total an estimated $8.1 billion, said H.D. Palmer, a spokesman for the state Department of Finance. The proposal also includes $5.2 billion to pay back rent and $2 billion for overdue utility bills for people who fell behind during the pandemic.

PORTLAND, Ore. — Portland’s mass vaccination site will close on June 19 after giving hundreds of thousands of COVID-19 inoculations.

The All4Oregon site has been running since Jan. 20 at the Oregon Convention Center. The site began offering walk-in appointments last week but organizers say a drop in volume makes it clear that demand for a mass vaccination site is waning as shots become more widely available elsewhere.

All4Oregon will offer stop offering first doses of the two-dose Pfizer vaccine on May 27 and will offer second doses only in June. As of Friday, the site had administered 465,000 shots.

NEW ORLEANS -- Organizers of a New Orleans vaccination event on Thursday will offer a free jab in the arm — and a free pound of boiled crawfish.

The Times-Picayune/The New Orleans Advocate reports that the vaccine promotion is being arranged by local business incubator Propeller, City Councilman Jay Banks, the city health department and longtime local seafood dealer Cajun Seafood.

It’s one of numerous vaccination events held day to day in New Orleans, where as of late April roughly 43% of city residents had received at least one vaccine dose.

MADRID — Spain’s top coronavirus expert has delivered a stern warning to people who are acting as if the pandemic had ended just because the government has relaxed measures amid an accelerating rollout of vaccines.

Fernando Simón said Monday that he was unable to predict how the contagion rate in Spain will evolve in coming days following scenes of revelers partying in mass over the past weekend, in many cases without social distancing or masks.

The street celebrations followed the end of a state of emergency, a blanket national rule that allowed authorities take strict measures such as travel bans, curfews and curbs on social gatherings, which collide with fundamental freedoms.

Spain’s rate of contagion fell to 188 new cases in two weeks per 100,000 residents from 198 on Friday and, way down from a peak of nearly 900 at the end of January. The country accumulates over 3.5 million confirmed cases since the beginning of the pandemic and over 78,000 deaths.

Simón said that he expected that new infections would hit harder people under 60 years ago, an age group that barring those in essential jobs is not being vaccinated yet. The expert said that the impact in older people could be lower among the elderly.

Nearly one third of Spain’s 47 million residents has received at least one coronavirus vaccine shot and 6 million people, most of them above 70, are fully vaccinated.

LONDON -- British Prime Minister Boris Johnson has confirmed that he has given the go-ahead for people in England to hug someone outside of their household bubble from next week as part of the latest easing of lockdown restrictions.

Johnson told a news briefing that he was able to sanction that much-needed contact from May 17 because new coronavirus infections have fallen sharply. However, he stressed that people should exercise common sense given that social contact is the main way the virus is transmitted.

The U.K. is now recording around 2,000 new coronavirus cases a day, compared with a daily peak of nearly 70,000 in January. Daily deaths have also plummeted with only four recorded on Monday.

Other easing measures included the reopening of pubs and restaurants indoors as well as cinemas and hotels, and allowing two households to meet up inside a home.

Johnson said this “unlocking amounts to a very considerable step on the road back to normality” and that he is confident of further easing on June 21.

PRAGUE — The Czech Republic is further easing coronavirus restrictions, opening bars and restaurants for outdoor dining amid falling numbers of coronavirus infections.

Industry and Trade Minister Karel Havlicek says the establishments will reopen on May 17 for people who have a negative coronavirus test, have been vaccinated or recovered from COVID-19. Only up to four people who are not relatives will be allowed to sit at one table.

Also next week on Monday, the elementary schools in the seven of the country’s 14 regions, including Prague will be able to abandon a rotating principle, with in-school attendance one week and distance learning the next.

At the same time, up to 700 people will be allowed to attend outdoor concerts and other outdoor cultural events. People will have to present a negative coronavirus test, be vaccinated or recovered from COVID-19. All will have to wear a respirator.

Monday’s announcement comes on the day when all stores and shopping malls are reopening and most services return to business.

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The Pfizer vaccine has been authorized for children ages 12 and up, widening the U.S. population that will be protected against the virus and bolstering chances for a safe return to full time school in the fall, the Food and Drug Administration announced Monday. "Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations," said acting FDA Commissioner Janet Woodcock. Pfizer announced in late March that its clinical trials showed the vaccine was safe and 100% effective in children ages 12-15, similar to the 95% efficacy among adult clinical trial participants.

Britain’s economy will rebound more slowly this year than the Bank of England expects, according to the National Institute of Economic and Social Research (NIESR), because of the huge wave of Covid sweeping through India and much of the globe. Weaker worldwide growth will hold back the UK's open and trade-dependent economy, the analysts predict, with sustained travel restrictions proving particularly painful. At the same time families will be more cautious about spending their lockdown savings or returning to their old financial habits, the economists warn, and will hold back more cash than they used to, also limiting the economic rebound. As a result NIESR expects the economy to grow by 5.7pc this year and 4.5pc next year - an upgrade on its previous predictions, but firmly below the Bank of England’s much stronger forecasts of 7.25pc in 2021 and 5.75pc in 2022. NIESR’s forecast indicates the economy will only get back to its pre-Covid size next year, when the Bank of England thinks it should happen by the end of this year.

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The Pfizer coronavirus vaccine has been approved for use in children aged 12 to 15 by regulators in the US in what was described as a “watershed moment” in the effort to bring the pandemic under control. Until now, only those aged 16 and older have been permitted to receive the two-dose vaccine. The Federal Drug Administration’s (FDA) approval after a weeks-long safety review must be ratified by an advisory committee of the government’s Centres for Disease Control and Prevention (CDC). If it gives its go ahead at a scheduled meeting on Wednesday, vaccinations of children can begin immediately. The authorisation comes after a successful wide-scale trial of the vaccine in which 2,260 volunteers aged 12 to 15 received two doses of either the vaccine or a placebo three weeks apart. There were no cases of Covid-19 among those who received the vaccine, and 18 in those who received the dummy shot. Side effects were comparable to those seen in a similar trial of 16- to 25-year-olds, the FDA found. “This is a watershed moment in our ability to fight back the Covid-19 pandemic,” said Dr Bill Gruber, a senior vice-president of Pfizer and a paediatric doctor. “We have safety, we got the immune response we wanted, it was actually better than what we saw in the 16 to 25 population, we had outright demonstration of efficacy.” Dr Richard Besser, a former acting director of the CDC, said the authorisation brought him “hope and joy”. “There are now millions more who can be protected from Covid and a lot of hope that this fall school is going to feel a lot more like school should feel like,” he told CNN. Trials continue in children for the Moderna vaccine, the only other two-dose vaccine already approved for adults in the US. Results are expected later in the summer. The FDA said that its regulatory panel would meet again on June 10 to discuss a roadmap for authorising Pfizer vaccines for those under 12.

Months after his rehab stint, comedian John Mulaney is divorcing artist Anna Marie Tendler, his wife of nearly seven years.

The German Green Party has been hit by a new scandal involving one of its best known and most controversial politicians. Boris Palmer, the maverick mayor of Tübingen, who only months ago was widely hailed for his successful coronavirus policy, faces expulsion from the party over an alleged racist tweet. The scandal comes at a pivotal moment for the Greens, who are currently leading in the polls ahead of September’s elections. Annalena Baerbock, the party leader, has promised decisive action against Mr Palmer after he used the n-word in a tweet defending a former German footballer against accusations of racism. “Aogo is a poor racist,” Mr Palmer wrote of Dennis Aogo, the former international. “He offered his n----r d--k to women.” Mr Palmer was defending Mr Aogo, who is of mixed German and Nigerian heritagem,after he was fired from his role as a television pundit over remarks in which he spoke of “training to the point of gassing”. He also spoke out in support of Jens Lehmann, another former footballer who described Mr Aogo as the television network’s “token black”. Mr Palmer has denied the charge of racism and says it should be clear his tweet was “obvious irony taken to the extreme”. He is refusing to resign quietly from the Green Party and insisting on a full hearing.

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Shoppers and staff at a New Zealand supermarket were being praised for their bravery Monday after authorities said they managed to stop a frenzied man from hurting others after he stabbed four people in a random attack, severely wounding three of them. New Zealand Police Superintendent Paul Basham said he'd watched CCTV footage of the attack at a Countdown supermarket in the city of Dunedin and the actions of the bystanders in detaining the man until police arrived was “nothing short of heroic.” Two of those wounded were supermarket staff members.

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