The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices has scheduled an emergency meeting for Wednesday. It’s expected to vote to recommend use of the vaccine. After that, CDC Director Dr. Rochelle Walensky is expected to give her final approval, after which states can give the go-ahead to administer the vaccine to the new age group.
States regulate medical practice but things should move quickly, said Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, the arm of the FDA that regulates vaccines.
“We would assume they could be as soon as Thursday,” Marks told reporters in a briefing Monday evening.
“Thursday, right,” added FDA Acting Commissioner Dr. Janet Woodcock.
7:52 p.m. ET, May 10, 2021
FDA decision on extending coronavirus authorization to younger teens was "straightforward"
From CNN's Maggie Fox
The US Food and Drug Administration’s decision to extend emergency use authorization of Pfizer’s coronavirus vaccine to kids ages 12 to 15 was “straightforward,” an FDA official said Monday.
“It was a relatively straightforward decision,” Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, the arm of the FDA that regulates vaccines, told reporters Monday evening.
The FDA looked at safety data from more than 2,000 adolescents, half who got the vaccine and half who got a saline placebo injection, before making its decision. Field efficacy data on 1,000 children showed none of the vaccinated youth became infected with the virus.
They also looked at the immune responses of some of the children who were vaccinated, and compared them to the immune responses of older teens and adults who got the shot.
“The response to the vaccine was excellent and in fact it was even better, really, in the younger age group than it was in the 16-25 age group,” Marks said.
“The safety profile was very similar in 12-15-year-olds as in 16-25-year-olds.”
What's next: The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices has scheduled an emergency meeting for Wednesday. It’s expected to vote to recommend use of the vaccine. After that, CDC Director Dr. Rochelle Walensky is expected to give her final approval, after which states can give the go-ahead to medical professionals to administer the vaccine.
7:48 p.m. ET, May 10, 2021
Only 7% of L.A. high school students return to campus for in-person learning
From CNN’s Sarah Moon
Only 7% of high school students enrolled in the Los Angeles Unified School District (LAUSD) have returned to campuses for in-person learning, according to new data from the nation’s second largest school district.
While the LAUSD reopened all of its schools with extensive safety measures, including upgraded air filtration systems and a school-based Covid-19 testing and contact tracing program, data released Monday shows that most high school students are taking classes online at home rather than returning to school.
LAUSD Superintendent Austin Beutner noted that more high school students from lower income communities are returning to school for in-person learning compared to those in higher income communities.
“In Huntington Park, where the median income is about $44,000, 12% of high school students have returned to in-person learning, while in Woodland Hills, with incomes of nearly $100,000, only 5% have returned,” Beutner said in a briefing Monday.
“We must do all we can do bring them back including providing access to vaccinations to help facilitate their safe return,” Beutner added.
The district, which has an enrollment of over 600,000 K-12 students across 1,000 schools, has launched 15 school-based vaccination clinics in neighborhoods hardest hit by the pandemic. These clinics provide access to those who may lack transportation to get to other sites or don’t have the time or technology to make an appointment on a computer, according to Beutner.
“Our aim is to bring access to the vaccine to every middle and high school in Los Angeles Unified as soon as we can,” said Beutner. “Our schools serve almost 650,000 students and there is no better place to provide vaccinations to school children than at a local neighborhood school.”
While data shows that only 7% of LAUSD’s high school students returned to campus, the rate of in-person attendance for elementary school students is about 30%. Elementary schools have also had higher in-person enrollment in more affluent communities, Beutner noted.
“Students are allowed to use playground equipment at schools for the first time since the pandemic hit last March,” the superintendent said. “If you happened by a school at recess last week, there were smiles all around.”
7:09 p.m. ET, May 10, 2021
Pediatricians prepare to vaccinate 12-to-15-year-olds against Covid-19
From CNN’s Lauren Mascarenhas
The US Food and Drug Administration authorized Pfizer/BioNTech’s coronavirus vaccine for children and teens ages 12 to 15 Monday. Now pediatricians are preparing to vaccinate the youngest cohort of Covid-19 vaccine recipients yet.
A delivery of 1,000 Pfizer/BioNTech Covid-19 vaccine doses arrived at Sandhills Pediatrics in Southern Pines, North Carolina, early this morning. Dr. Christoph Diasio, a pediatrician at the office, is preparing to start vaccinating his patients as soon as possible.
“We've been playing defense for 15 months,” said Diasio. “It's time to go on offense and end this thing.”
For years now, Diasio’s office has been offering routine vaccinations to family members who come in with pediatric patients – which he says is a pretty common practice among pediatricians nationwide. With the Covid-19 vaccine, Diasio hopes it will also be a way to overcome some hesitancy.
“We feel that primary care is going to have a real role with the folks who are a little bit hesitant or just need some questions answered,” he said. “Maybe the community, for whatever reason, trusts their family doctor or their pediatrician more than they trust, for example, a corporate pharmacy.”
Diasio said his office has not yet offered Covid-19 vaccines to patients 16 and older, partially because his community has been able to cover the need with existing vaccine sites.
“I think we’re moving to a phase of the campaign where now we need to be giving the Covid vaccine like we do the flu vaccine, where it’s just a regular part of what we do every day,” Diasio said.
Diasio said quite a few family members have recently called the office to inquire about when their 12-to-15-year-olds can make an appointment to get vaccinated.
One of those family members is Betsy Saye, who is eager to get her 14-year-old daughter Hannah vaccinated. Hannah is the youngest member of the family and the only person in the household yet to be vaccinated against coronavirus.
She was born with a heart defect that places her at high risk for Covid-19. Her family decided that the benefits of Hannah being protected against the virus outweigh any potential risks associated with the vaccine.
Vaccine advisers to the US Centers for Disease Control and Prevention will meet Wednesday to discuss if and how the vaccine should be recommended for use in this age group, and CDC Director Dr. Rochelle Walensky will make the final recommendation.
6:15 p.m. ET, May 10, 2021
L.A. County will reach herd immunity by July with current rate of Covid-19 vaccinations
From CNN's Sarah Moon
At the current rate of Covid-19 vaccinations, Los Angeles County is expected to reach herd immunity to coronavirus by mid to late July, county health officials said in a briefing Monday.
Dr. Barbara Ferrer, L.A. County's public health director, explained that at least 400,000 residents need to be vaccinated each week before the county reaches this level of community immunity.
The county still has about 1.5 million first doses to administer before 80% of all residents are vaccinated, according to Ferrer.
“The more and more people that get vaccinated, the less and less there’s community transmission,” Ferrer said.
While over eight million doses of the Covid-19 vaccine have been administered in the county, there are over three million eligible residents who have not yet been vaccinated, Supervisor Hilda L. Solis said.
The county is encouraging people to get vaccinated and is now offering mobile vaccination units to go directly to the workplace for those who may have limited availability or time.
According to Ferrer, the rate of vaccinations continues to rise, but at a slightly slower pace now than earlier in the year.
With over 10 million residents, Los Angeles County is the most populous county in the nation. The county has reported a total of 24,003 Covid-19 deaths and at least 1,235,797 cases.
5:54 p.m. ET, May 10, 2021
FDA schedules advisory meeting to discuss Covid-19 vaccines for children under 12
From CNN's Maggie Fox
The US Food and Drug Administration, which extended emergency use authorization for Pfizer’s coronavirus vaccine to 12-15-year-olds on Monday, also scheduled a meeting of its vaccine advisers for next month to discuss authorizing Covid-19 vaccines for younger children.
The FDA had said it would not need input from advisers for the EUA for younger teens, but plans input from its outside advisers before deciding on use in children under 12.
“The U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) will convene a virtual meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 10, 2021, via webcast,” the FDA said in a statement.
“During the meeting the agency will provide a status update on our approach to emergency use authorization (EUA) for COVID-19 vaccines intended for use in individuals 12 through 17 years of age. The committee will also discuss the data needed to support an EUA and a biologics license application (BLA) for a COVID-19 vaccine intended for use in children less than 12 years of age. The committee will not discuss any specific products.”
5:49 p.m. ET, May 10, 2021
Novavax has about 30 to 40 million doses of Covid-19 vaccine right now
From CNN's Jacqueline Howard
Novavax has about 30 or 40 million doses of coronavirus vaccine stockpiled on the shelf currently, the American biotechnology firm's president and CEO Stanley Erck said during an investors call on Monday.
"In the third quarter, we had expected to produce roughly 70 to 80 million doses per month at the Novavax sites, excluding Serum," Erck said, referring to the company's manufacturing partner Serum Institute of India.
"I would guess that we’re probably in half that right now," Erck said. "We’ve made 30 or 40 million doses on the shelf and it’s getting larger every week.”
Novavax noted in a news release on Monday that the company's anticipated manufacturing capacity has been revised to 100 million doses per month by the end of the third quarter of this year, with the remainder of capacity expected to come online in the fourth quarter to support 150 million doses per month.
Erck said earlier Monday the company plans to apply for emergency use authorization of its Covid-19 vaccine in the US in the third quarter of this year.
5:43 p.m. ET, May 10, 2021
FDA authorizes Pfizer's Covid-19 vaccine for use in kids ages 12 to 15
From CNN's Jamie Gumbrecht
The US Food and Drug Administration has expanded the emergency use authorization for Pfizer’s Covid-19 vaccine to include kids ages 12 to 15.
This is the first Covid-19 vaccine in the United States authorized for use in younger teens and adolescents; the vaccine had previously been authorized for people age 16 and older. Covid-19 vaccines from Moderna and Johnson & Johnson are authorized for use in people age 18 and older.
To support the extended use, the FDA reviewed data submitted by Pfizer. The company said at the end of March that a clinical trial involving 2,260 12-to-15-year-olds showed the vaccine’s efficacy is 100% and it is well tolerated.
The FDA’s independent Vaccines and Related Biological Products Advisory Committee did not meet to vote on whether to recommend the expansion of the EUA to 12-to-15-year-olds. But the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is scheduled to meet Wednesday to advise CDC on whether to recommend use of the vaccine in this age group. CDC Director Dr. Rochelle Walensky will then decide whether the agency will recommend the vaccine’s use in the new group.
Vaccinations for 12-to-15-year-olds are not expected to begin until after that recommendation. The Biden administration has said it will quickly mobilize to ready vaccinations for 12-to-15-year-olds through the federal pharmacy program, pediatricians and family doctors.
Expanding authorization to people 12 to 15 opens Covid-19 vaccination to another 5% of the US population, nearly 17 million more people. The expanded authorization means 85% of the US population is eligible to receive a Covid-19 vaccine.
“Today’s expansion of our EUA represents a significant step forward in helping the U.S. government broaden its vaccination program and help protect adolescents ages 12-15 before the start of the next school year. We are grateful to all of our clinical trial volunteers and their families, whose courage helped make this milestone possible. Together, we hope to help bring a sense of normalcy back to young people across the country and eventually around the world,” Albert Bourla, Pfizer's chairman and chief executive officer, said in a statement.
Pfizer said last week it expects to submit for emergency use authorization for its Covid-19 vaccine for children ages 2 to 11 years old in September. Its vaccine safety and efficacy study in children ages 6 months to 11 years old is ongoing.
4:17 p.m. ET, May 10, 2021
Novavax's Covid-19 vaccine could be a "booster for everyone," CEO says
From CNN's Jacqueline Howard
Novavax's coronavirus vaccine could be used as a booster shot later this year for people in the United States who have already been vaccinated against Covid-19, the biotech firm's CEO Stanley Erck told CNN Monday.
"In the US, I think it will be the booster for everyone, particularly if we get it out late in the third quarter," Erck said in a phone interview. "It's going to be time to start boosting — whether it's six months or at a year point."
The US Centers for Disease Control and Prevention says vaccine types and brands are not interchangeable for the initial immunization, and there has been no decision either in the US or globally on the need for booster doses, let alone which vaccine might be appropriate for any booster.