FDA advisers consider Moderna’s COVID shots for older kids

FDA advisers consider Moderna’s COVID shots for older kids

WKMG News 6 & ClickOrlando

A government advisory panel met Tuesday to decide whether to recommend a second brand of COVID-19 vaccine for school-age children and teens.

The Food and Drug Administration’s outside experts will vote on whether Moderna’s vaccine is safe and effective enough to give kids ages 6 to 17. If the panel endorses the shot and the FDA agrees, it would become the second option for those children, joining Pfizer’s vaccine.

The same expert panel will meet Wednesday to consider tot-sized shots from Moderna and Pfizer for the littlest kids, those under 5.

Moderna’s COVID-19 vaccine has long been available for adults in the U.S. and elsewhere and dozens of countries offer it to children, too. In the U.S., children ages 12 to 17 would get two full-strength doses; ages 6 to 11 would get half-sized doses.

The FDA held up Moderna’s teen vaccine for months while it investigated a rare side effect, heart inflammation. That’s mostly a risk for teen boys and young men, and also can occur with the Pfizer vaccine. Moderna got extra scrutiny because its shots are a far higher dose..

In their review, FDA scientists said there were no confirmed cases of the heart inflammation in Moderna’s kid studies. But experts say the studies may have had too few participants for a rare side effect like that to appear.

“It’s just not enough people in the clinical trials to detect” the problem if it’s occurring, said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief, in a call with reporters earlier this week.

The FDA analysis concluded that two doses of Moderna are effective in preventing symptomatic COVID-19 illness in teens and younger kids, with the levels of virus-fighting antibodies comparable to those developed in young adults.

Vaccine effectiveness was estimated at 93% for the 12-17 group, and 77% for the younger group. However, the research was done when earlier versions of the coronavirus were causing most U.S. infections, and it’s not clear how well they work against more recent variants.

The FDA review said it was likely a booster shot would be needed, as is now recommended for children vaccinated with Pfizer’s shots, as well as for all adults.

How much demand there will be for Moderna’s shots isn’t clear. Teens became eligible a year ago for Pfizer’s vaccine, which uses the same technology, and only 60% have gotten two doses. Shots for younger kids started in November; about 29% have been vaccinated, according to the Centers for Disease Control and Prevention.

If the FDA authorizes Moderna shots for teens and schoolchildren, the matter moves next to the CDC, which makes recommendations about vaccinations to doctors and the public. A CDC spokesperson said the agency is not expected to take up the question until later this month.

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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.

Congress examines fraud in pandemic aid for small businesses

Congress examines fraud in pandemic aid for small businesses

WKMG News 6 & ClickOrlando

A congressional panel Tuesday will examine payouts under a federal coronavirus pandemic aid program intended to help small businesses weather the COVID-19 outbreak amid revelations that as much as 20% of the money may have been awarded to fraudsters.

The problems in the COVID-19 Economic Injury Disaster Loan program, overseen by the U.S. Small Business Administration, included a finding by congressional investigators that some 1.6 million applications for the loans may have been approved without being evaluated.

Separately, the SBA’s Office of the Inspector General estimated that at least $80 billion distributed from the $400 billion program could have been potentially fraudulent, much of it in scams using stolen identities.

The program is expected to be at the center of a congressional subcommittee hearing that also will tackle broader fraud concerns with the flood of pandemic aid from multiple federal government programs for states, local governments, businesses and the unemployed.

The $5 trillion in total aid, delivered in a series of bills signed by Presidents Donald Trump and Joe Biden, have come with numerous complications.

Fraud overwhelmed enhanced unemployment insurance programs funded by the federal government and administered by the states. There was so much aid to governments that many struggled to find a way to spend it all under the original regulations. And there have been questions about whether the Paycheck Protection Program to keep employees working was worth it.

The House Select Subcommittee on the Coronavirus Crisis says more than $10 billion allocated under two massive business loan programs has been returned because of investigations and bank actions. Federal prosecutors have charged nearly 1,500 people with crimes related to fraud against the government over the business loans and enhanced unemployment insurance programs.

The government’s Pandemic Response Accountability Committee says inspectors general for various federal agencies have at least 1,150 ongoing investigations into fraud from the different aid funds. Officials say it could take years to untangle all the problems.

One focus for the subcommittee is a report released Tuesday by its own staff that found up to 1.6 million applications for loans intended to keep small businesses open and making payroll were approved by a batch method. That could mean they were not even opened by officials before being greenlighted for funding.

The report blames the SBA for creating the batch approval function early in the pandemic, during the Trump administration.

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McDermott reported from Providence, Rhode Island, and Mulvihill reported from Cherry Hill, New Jersey.

HHS secretary Becerra tests positive for COVID-19 again

HHS secretary Becerra tests positive for COVID-19 again

WKMG News 6 & ClickOrlando

President Joe Biden’s top health official has again tested positive for COVID-19, less than a month after he came down with virus symptoms while on a trip to Germany.

U.S. Health Secretary Xavier Becerra woke up with symptoms again Monday morning and tested positive afterward, spokeswoman Sarah Lovenheim said.

His symptoms are mild and he is isolating in Sacramento, California. Lovenheim said Becerra had been in California for a “personal commitment.”

A statement from HHS said the secretary was not believed to be a close contact of Biden or Vice President Kamala Harris, who also tested positive earlier this spring.

Becerra is continuing to work from isolation.

Becerra had joined Biden at the Summit of the Americas last week in Los Angeles. Canadian Prime Minister Justin Trudeau announced Monday that he had tested positive after attending the event, which gathered diginitaries, diplomats and business leaders from across the hemisphere.

Becerra is fully vaccinated and has received a booster shot guarding against the virus.

In May, Becerra tested positive while in Berlin for a meeting of health ministers from the Group of Seven wealthy nations to discuss the ongoing pandemic. His office said then that he had mild symptoms and continued his work from isolation.

No satisfaction: Jagger has COVID, Rolling Stones gig off

No satisfaction: Jagger has COVID, Rolling Stones gig off

WKMG News 6 & ClickOrlando

The Rolling Stones canceled their concert in Amsterdam on Monday, just hours before it was due to start after lead singer Mick Jagger tested positive for COVID-19.

The band announced the cancelation in a statement, saying the 78-year-old Jagger tested positive “after experiencing symptoms of COVID upon arrival at the stadium” on the outskirts of Amsterdam. There were no further details about his condition.

“The Rolling Stones are deeply sorry for tonight’s postponement, but the safety of the audience, fellow musicians and the touring crew has to take priority,” the statement said, adding that the show would be rescheduled and tickets for the concert at Amsterdam’s Johan Cruyff Arena would be honored for the new date.

Some fans were already in the stadium when it was announced that the show had been scrapped.

The veteran rockers are touring Europe with a show called SIXTY to mark six decades together. Their last show was at Liverpool’s Anfield Stadium on June 9. The next scheduled concert is in Bern, Switzerland, on June 17.

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Follow AP’s pandemic coverage at https://apnews.com/hub/coronavirus-pandemic