FDA expected to authorize mix-and-match COVID-19 booster shots

RALEIGH, N.C. -- Here's the latest news and information on COVID-19 and the COVID-19 vaccines.

5:30 p.m.
U.S. regulators on Wednesday signed off on extending COVID-19 boosters to Americans who got the Moderna or Johnson & Johnson vaccine and said anyone eligible for an extra dose can get a brand different from the one they received initially.

2:20 p.m.
North Carolina health officials have released data on COVID-19 clusters in childcare and K-12 settings.

Throughout North Carolina K-12 settings, there are 193 clusters. This is down from last week's 223. There are six in Wake County, eight in Durham and three in Cumberland County.

There are 13 childcare setting clusters, down from last week's 19.

1:10 p.m.
NCDHHS on Wednesday reported 2,610 new daily COVID-19 cases.

The daily percent of positive cases is 6.5%.

1,811 are currently hospitalized with COVID-19 in the state.

1 p.m.
At a White House press briefing, CDC director Rochelle Walensky talked about a new variant - a descendent of the Delta variant - recently identified in the UK.

She confirmed that there have been a few cases of the variant - called AY.4.2 - in the United States, but the variant does not appear to be spreading, nor is there any evidence it will impact vaccines.

The Delta variant is still 99.9% of cases in the United States.

8:40 a.m.
Cape Fear Valley Health is making modifications to the current visitation policy due to declining COVID-19 cases. The changes will go into effect at noon on Wednesday, Oct. 20.

Most Cape Fear Valley Medical Center inpatients, Cape Fear Valley Rehabilitation Center patients, Bladen County Hospital and Hoke Hospital patients may have no more than two visitors from noon and 8 p.m. Visitors must be at least 12 years old.

Visitors and patients in all Cape Fear Valley Health facilities and clinics are required to properly wear a mask at all times. Masks must remain on at all times, even in patients' rooms, or the visitor will be asked to leave. Neck gaiters are not permitted. This mask policy will be strictly enforced.

7:30 a.m.
The Biden administration is looking to plan ahead on their vaccine roll out for kids ages 5-11, announcing today their plan to distribute vaccines if they are authorized by the FDA for the group.

The administration says they have enough of the vaccine to cover the 28 million American children in this age group.

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As part of their plan, the administration is announcing that pending FDA authorization, "the packaging configuration will be 10-dose vials in cartons of 10 vials each (100 doses total), delivered in a newly updated product shipper, and the vaccine can be stored for up to 10 weeks at standard refrigeration temperatures and 6 months at ultracold temperatures."

The plan also includes ensuring the vaccination is available across the country at different vaccination sites, and setting up an education campaign along with HHS to "reach parents and guardians with accurate and culturally-responsive information about the vaccine and the risks that COVID-19 poses to children."

Wednesday's top headlines

Federal regulators are expected to authorize the mixing and matching of COVID-19 booster shots this week.

The upcoming announcement by the Food and Drug Administration follows the OK last month of a third dose for the Pfizer vaccine for many Americans.

The FDA was also expected to say that using the same brand for a booster was still preferable. The move was previewed Tuesday by a U.S. health official familiar with the matter who was not authorized to speak publicly ahead of the announcement.

The CDC will also meet to discuss recommendations for the Moderna and Johnson & Johnson COVID-19 vaccine boosters.

The meetings comes after after an FDA advisory panel made its recommendations last week.

While the recommendations for Moderna are similar to the ones already authorized for Pfizer, the panel made a different choice regarding the Johnson & Johnson shot.

Experts say anyone over 18 who got the single shot vaccine should get a booster at least two months after the first dose.

The Biden administration is threatening to revoke the authority for three Republican-controlled states to handle their own workplace safety regulations because they have refused to adopt rules to protect health care workers from COVID-19.

The threats were sent to Arizona, South Carolina and Utah as the U.S. Occupational Safety and Health Administration prepares to adopt much more far-reaching vaccination and testing rules affecting 80 million Americans.

OSHA officials say Arizona, South Carolina and Utah are not complying with their promises to enforce labor standards that are at least as good as those adopted by the federal government.

TUESDAY



10:30 p.m.
Pediatric COVID-19 vaccines are being rolled out in staggered amounts by the federal government in three waves.

In Wave 1, North Carolina will receive 124,500 doses of the pediatric Pfizer vaccine.

Although the state is placing orders now, the vaccine will not ship until the FDA's Emergency Use Authorization has been granted.

Dr. Christoph Diasio of Sandhills Pediatrics is president of the North Carolina Pediatric Society and told ABC11's Josh Chapin he's excited that the state's assets have been prepositioned.

"We are planning to get a lot of vaccine in the state and there will be many opportunities for people to get vaccinated quickly," said Dr. Diasio. "It's huge. It's the Super Bowl right this is super exciting that we finally get to go on offense and get the rest of the school children vaccinated."

4:45 p.m.
North Carolina is getting ready to roll out vaccinations for kids ages 5 to 11 years old.

The NC Department of Health and Human Services this week sent out a letter to state providers, saying that pediatric vaccination could start as early as Nov. 3.

The letter said that the department anticipates demand to be particularly high for the first two weeks of the program.

Pfizer asked the U.S. government last week to allow use of its COVID-19 vaccine in children ages 5 to 11.

Now the FDA will have to decide if there's enough evidence that the shots are safe and will work for younger children like they do for teens and adults. An independent expert panel will publicly debate the evidence on Oct. 26.

If the FDA authorizes emergency use of the kid-sized doses, there's another hurdle before vaccinations in this age group can begin. Advisers to the Centers for Disease Control and Prevention will decide whether to recommend the shots for youngsters, and the CDC will make a final decision.

1:50 p.m.
A new CDC study finds that the Pfizer vaccine was 93% effective against hospitalizations for adolescents 12-18 during the Delta surge, from July to September. The researchers also found that nearly all (97%) of adolescents 12-18 who were hospitalized with COVID-19 were unvaccinated.

The study was a real-world analysis of 19 U.S. pediatric hospitals.

1:10 p.m.
1,374 new COVID-19 cases were reported in North Carolina on Tuesday,

The daily percent of positive tests in the state is at 7.6 percent.

1,896 are currently hospitalized with COVID-19.

There are currently 529 adult ICU COVID-19 patients.

10:20 a.m.
The American Academy of Pediatrics (AAP), the American Academy of Child and Adolescent Psychiatry and the Children's Hospital Association declared a national state of emergency in child and adolescent mental health, exacerbated by the COVID-19 pandemic.

"Children's mental health is suffering. Young people have endured so much throughout this pandemic and while much of the attention is often placed on its physical health consequences, we cannot overlook the escalating mental health crisis facing our patients," AAP President Lee Savio Beers, MD, FAAP said in a statement. "Today's declaration is an urgent call to policymakers at all levels of government - we must treat this mental health crisis like the emergency it is."

9:30 a.m.
Starting Thursday, drive-thru COVID-19 testing will be available at Cape Fear Valley Health Pavilion North on Ramsey Street. Patients will remain in their car for testing and results will be available on the same or next day.

The drive-thru testing site will be open Tuesdays through Fridays, from 7 a.m. to 4 p.m., for people who are ages 5 and over. The testing will be done in front of the main entrance, which faces Andrews Road. Vaccinations will continue to be offered in the ExpressCare, located at the east end of the facility.

6:20 a.m.
Wake County Public School System leaders are set to talk about plans to begin COVID-19 testing inside schools.

A proposal calls for a three phased rollout for student and staff testing.

The first phase is voluntary testing for schools with active or potential clusters. Phase two expands that voluntary testing to more schools. Phase three is mandatory testing for all staff members.

Phase one could start in November. Phase two could start by the end of November and last into early January. Phase three's target start date is January.

Phase three would also include mandatory weekly testing for any unvaccinated staff members.

All of these phases and implementation times are subject to change, but school leaders will be discussing all of it during Tuesday afternoon meetings.

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TUESDAY MORNING HEADLINES
Outdoor dining boomed in popularity during the COVID-19 pandemic. Now it looks like it may be here to stay.

Durham city leaders voted to extend and expand the rules regulating outdoor dining--permanently.

The Durham City Council vote applies to outdoor seating on city-owned streets and parking spaces. Before Monday night's vote, restaurants would've been required to move their outdoor seating areas back inside by the end of October.

Meanwhile, the COVID-19 metrics in North Carolina continue to improve. The state reported another decrease in cases and hospitalizations Monday--with the number of people in the hospital dropping below 2,000 for the first time since the beginning of August.

MONDAY
12:30 p.m.
North Carolina's COVID-19 metrics continue to move in the right direction.

3,169 new COVID-19 cases were reported in the state on Saturday.

2,165 were reported on Sunday and 1,599 on Monday.

The number of people who are hospitalized with COVID-19 continues to fall and is now at 1,852.

There are currently 522 adult ICU COVID-19 patients.

59 percent of the population of North Carolina is vaccinated with at least one dose.

MONDAY MORNING HEADLINES

Durham city leaders are expected to vote on a plan to expand outdoor dining and allow it permanently.

The latest proposal would apply to all of Durham--not just downtown.

It would also expand outdoor seating capacity to 50% of the restaurants' indoor capacity, instead of 25%.

The Durham lawmakers are scheduled to meet and debate the proposal Monday evening.

Across the country, anyone who got the Johnson & Johnson COVID-19 vaccine should not be concerned about the shot's lower efficacy now that boosters have been recommended, White House chief medical adviser Dr. Anthony Fauci told ABC "This Week" co-anchor Martha Raddatz.

"I think that they should feel good about it because what the advisers to the FDA felt is that given the data that they saw, very likely this should have been a two-dose vaccine to begin with," he said Sunday.

The FDA vaccine advisory panel unanimously recommended booster shots for the Johnson & Johnson vaccine Friday. The panel recommended all J&J recipients 18 years and older to get an additional jab as early as two months after the first dose -- key differences from their recommendations for the Moderna and Pfizer boosters which were only for Americans 65 and older or in higher risk groups.

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Copyright © 2021 ABC11-WTVD-TV/DT. All Rights Reserved - The Associated Press contributed to this report.