Pfizer delays emergency use authorization request for COVID-19 vaccine for kids under 5

WTVD logo
Friday, February 11, 2022

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

3:35 p.m.

U.S. Rep. Richard Hudson, R-NC, is urging the Cumberland County Health Department to revise an order and allow optional masks for county schools.

On Tuesday, the Cumberland County Board of Education voted to make masks optional for students. But the decision is being blocked by an abatement order issued by the Cumberland County Health Department in Aug. 2021 mandating masks indoors, Hudson said.

In a letter to the Cumberland County Health Director, Hudson urged the Department to revise the order.

"In addition to following the well-established science, I would further urge you to follow the parents," Hudson wrote in part. "Our local Cumberland County Board of Education made the decision to make masks optional based on both the existing science and their current roles as parents, educators, and local leaders. I respectfully urge you to follow their lead, and revise the August 2021 abatement order, in light of both the recent evidence and respected parental input."

On Tuesday, Hudson spoke on the U.S. House Floor and urged support for the Unmask Our Kids Act.

2:52 p.m.

The FDA has just authorized a new monoclonal antibody treatment from Eli Lilly which has shown to hold up against the Omicron and the BA.2 subvariant.

This one is called bebtelovimab, and Lilly has been working on it for months.

As with the other monoclonal therapies, this one is for Covid patients early on in their infection to help keep them from getting even sicker and keep them out of the hospital, who are at high risk of getting severely ill.

The Biden administration has announced they have purchased 600,000 doses in anticipation of its EUA, for roughly $720 million. The plan is to get about 300,000 doses this month, and another 300,000 in March. The contract also includes a future option for 500,000 more doses as necessary.

2 p.m.

The US Food and Drug Administration announced Friday that it is postponing the meeting of its Vaccines and Related Biological Products Advisory Committee, originally scheduled for February 15, as "new data have recently emerged" regarding Pfizer and BioNTech's emergency use authorization request for their Covid-19 vaccine for children younger than 5.

"This will give the agency time to consider the additional data, allowing for a transparent public discussion as part of our usual scientific and regulatory processes for COVID-19 vaccines. We will provide an update on timing for the advisory committee meeting once we receive additional data on a third dose in this age group from the company's ongoing clinical trial and have an opportunity to complete an updated evaluation," acting FDA Commissioner Dr. Janet Woodcock and Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement.

12:56 p.m.

House Speaker Tim Moore, R-Cleveland, said that the House will propose legislation that gives parent's the option of opting out of mask requirements for schoolchildren.

The Speaker's office said Tim Moore sent a letter to Gov. Roy Cooper on Thursday asking him to end the policies that effectively mandate masks in schools.

Though NCDHHS said it would be updating COVID guidelines for students, the only major updates in the toolkit were to eliminate contact tracing for K-12 and end the recommendation that students who were asymptomatic quarantine.

"This failure by Governor Cooper and DHHS to roll back obsolete mask mandates will mean that many schools will leave those mandates in place," Moore said. "Yesterday's updates were simply not strong enough. We must do more to protect our children from further learning setbacks and the other consequences of keeping these mandates in place."

He added: "As soon as redistricting is completed, we will be advancing legislation in the House to give parents the ability to opt-out of mask requirement. Virginia is already advancing a bipartisan bill just like this. It is parents, not politicians, who should decide whether or not to mask their children."

12:21 p.m.

NCDHHS reported 7,539 new cases for a total of 2,525,734 since the start of the pandemic.

There are three times fewer cases than two Fridays ago, more indication that the Omicron variant is running its course here in North Carolina.

The daily percent positive is the lowest since Christmas.

The latest figure is 15.4%. Just two weeks ago, it was 30.4%.

Hospitalizations also fell, with 130 fewer patients than the previous day. The total number is 3,556. A week ago, there were 4,492 in the hospital.

That's a 21% drop since last Friday and the lowest number of patients since Jan. 6.

There were 85 new deaths reported for a total of 21,665.

7:05 a.m.

The first vaccine shipments for children younger than 5 could arrive at pediatricians' doors as soon as Feb. 21, according to a planning guide sent to states from federal health officials and obtained by ABC News.

Doses can ship once the FDA signs off.

The FDA's independent advisory committee will meet on Tuesday and after that, the FDA can issue an emergency use authorization.

The CDC's independent advisory panel is expected to meet within days of the FDA's authorization. Once the CDC signs off on its panel's recommendations, vaccinations for kids under 5 can start.


Durham and Orange counties are giving away free N95 masks Friday.

In Durham County, each household can get a bag of 10 masks at any county library location.

In Orange County, free masks are available at the library on Margaret Lane in Hillsborough or at the Inter Faith Council for Social Service in Carrboro.

State health leaders updated COVID-19 guidance for schools. Masks are still strongly recommended for all students 5 and older, but big changes were announced to contact tracing and quarantining guidelines.

Contact tracing has been completely eliminated. State health leaders said the omicron variant and an increase in at-home testing made contact

tracing much less effective than it had been in the past.

In addition, students and staff members exposed to COVID-19 no longer have to stay home and isolate--unless they begin to present symptoms or test positive for the virus.

Those guidelines will be discussed by the Wake County School Board when it meets Tuesday.


4:47 p.m.

The Chatham County Public Health Department and Chatham County Public Libraries distributed more than 100,000 N95 respirators to residents last week and have received another shipment of 100,000 masks.

Moncure Fire Department has been added as a distribution site, expanding the availability of these free resources to another section of the county. The CCPHD will continue to distribute N95s to churches and other community partners as well.

"We're grateful to the staff at Chatham County Public Libraries for continuing to support this effort. They have been our primary points of distribution for the N95s and we could not do this without them," said Chatham County Public Health Director Mike Zelek. "We're also excited to partner with the Moncure Fire Department. They are a central part of the Moncure community, and I'm thankful to Fire Chief Robert Shi and his staff for their willingness to partner with us and serve as a distribution hub for southeast Chatham."

Residents can pick up one free box of 20 N95 respirators per household at any of the following locations during their operating hours while supplies last:

Pittsboro: Chatham Community Library, 197 NC Highway 87 N, Monday to Thursday, 9 a.m. to 8 p.m.. Friday, 9 a.m. to 6 p.m., Saturday, 9 a.m. to 5 p.m.

Siler City: Wren Memorial Library, 500 N. Second Ave., Monday, noon to 8 p.m., Tuesday to Friday, 10 a.m. to 6 p.m., Saturday, 9 a.m. to 5 p.m.

Goldston: Goldston Library, 9235 Pittsboro-Goldston Road, Monday and Wednesday, 10 a.m. to 1 p.m. and 2 p.m. to 6 p.m., Thursday: 10 a.m. to 1 p.m. and 2 p.m. to 8 p.m., Friday: 10 a.m. 1 p.m. and 2 p.m. to 5 p.m., Saturday, 9 a.m. to 1 p.m.

Moncure: Moncure Fire Department, 2389 Old US Highway 1, Moncure, 8 a.m. to 8 p.m. daily.

2:43 p.m.

On Friday, free KN95 masks will be available for pickup at Durham County Libraries. All masks are available for free, and no identification is needed for pickup.

Masks will be available at all Durham County libraries except the Stanford L. Warren Library (currently closed for repairs). At these library sites, each household may pick up one bag of 10 KN95 masks.

Masks are currently required while in public indoor spaces in Durham County.

2:39 p.m.

RALEIGH - The North Carolina Department of Health and Human Services announced updates to the StrongSchoolsNC Public Health Toolkit.

NCDHHS is no longer recommending individual contact tracing in K-12 schools. Additionally, NCDHHS recommended students and staff no longer be required to stay home from school following a COVID-19 exposure, unless they have symptoms or test positive.

"We are committed to ensuring North Carolinians have the guidance and information necessary to balance their risk during each stage of the pandemic and learn to live with COVID-19," said NCDHHS Secretary Kody H. Kinsley. "Keeping kids in the classroom remains a top priority. As we have done throughout the pandemic, we evaluate which tools are most effective to protect students and staff. This is the right approach for this point in the pandemic and includes flexibility for local schools and health departments to use data to make informed decisions and respond to local conditions."

NCDHHS continues to emphasize measures such as getting vaccinated and boosted, wearing a mask while transmission rates are high, getting tested and staying home if sick.

"Our COVID-19 response is built on teamwork and trust between local officials, school nursing staff, child care staff and parents as we follow the science and use the best public health tools available to protect our children," said State Health Director and NCDHHS Chief Medical Officer Elizabeth Cuervo Tilson, M.D. "When conditions change, we adapt our tools, prioritize what works and stay focused on our shared goal -- keeping our children healthy and learning."

Although exclusion from school is no longer recommended following an exposure, notification of potential exposure is recommended.

2:19 p.m.

The mass COVID-19 testing event at the Roanoke Rapids Theatre, 500 Carolina Crossroads Parkway in Roanoke Rapids is ongoing. This event runs weekly, Monday-Friday through Feb. 18 from 9 a.m. - 6 p.m. daily.

As of Feb. 10, the Halifax County Health Department reports 13,578 total positive COVID-19 cases since March 2020. That includes 226 new cases reported since Feb. 3.

Six additional deaths have been added for a total of 168 countywide.

1:30 p.m.

NCDHHS reports 8,725 new cases for a total of 2,518,195 since the start of the pandemic.

The case total is down 42% from last week and represents a 70% decrease from two weeks ago on the same day.

The daily percent positive is 16.6%. Two weeks ago it was 29.5%.

There were 126 fewer patients in hospitals than the previous day. There are 3,686 people hospitalized for COVID-19 related-issues.

A total of 98 new deaths were recorded for a total of21,580 since the start of the pandemic.

1 p.m.

National Guard troops are responding to strained North Carolina hospitals.

Twenty-five guardsmen will arrive at Alamance Regional Hospital on Thursday to provide assistance as the hospital continues to battle staffing shortages and increased workload caused by the COVID-19 omicron variant.

Hospitalizations are trending downward statewide, but the surge from omicron is still putting a major strain on all hospitals.

The guardsmen will check vital signs, conduct COVID-19 testing, enter data, deliver meals and help with transportation. This will allow Alamance doctors and nurses to spend more time focused on patient care.

"The emotional and the spiritual lift of the guard being here just to provide the frontline support for doing some tasks and some skills--that really relieves our frontlines of the things that they don't necessarily need to do, but they can focus directly on their patient care and licensed care is a huge support and need," Alamance Regional Medical Center Senior Vice President Mark Gordon said.

They will be working at the hospital for several weeks. Right now they're scheduled to assist Alamance Regional Hospital until Friday, March 4.

12 p.m.

COVID-19 cases continue to drop in North Carolina.

With 8,725 new cases today, the state's daily cases are down 70 percent from two weeks ago and 42 percent from last week.

The percentage of all tests coming back positive also dropped from 29.5 percent two weeks ago to 16.6 percent today.

Hospitalizations have also seen a decrease. A total of 3,686 people are hospitalized today, that's down 20 percent since last week. However, the percentage of patients in the ICU and on ventilators has increased slightly.