COVID Vaccine For Kids Ages 5 To 11 Is Safe And Effective, Pfizer Says

Matt Rourke/AP

The first results from the highly anticipated trial studying the effectiveness and safety of the Pfizer and BioNTech COVID-19 vaccine for children ages 5 to 11 showed promising results.

The pharmaceutical companies said early results of their trial indicate the vaccine is safe for children and establishes a strong antibody response against the virus.

Giving a two-dose regimen of 10 μg (micrograms) administered 21 days apart for children between 5 and 11 years old was well tolerated, according to Pfizer and BioNTech. Side effects were also generally comparable to those of people between the ages of 16 and 25 years old who received the vaccine.

This trial used a smaller vaccine dosage, 10 micrograms, rather than the 30 microgram dose used for people 12 and older. The dosage was selected as the preferred dose for safety and effectiveness in young children.

News of the results come as pediatric cases of COVID-19 are increasing amid a nationwide surge of infections.

"Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. — underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency," said Albert Bourla, the chairman and CEO for Pfizer.

"Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children," Bourla said in a statement.

Despite the strong results, it will be some time before the general public can see an official rollout of vaccines for children ages 5 to 11. Once analysis of the trial is completed, Pfizer and BioNTech will submit the results "in the near term" to the Food and Drug Administration for review and possible emergency use authorization.

A Vaccine For Children Is Not Likely To Be Approved Until The End Of Year

And even if the FDA grants that authorization, Dr. Francis Collins, director of the National Institutes of Health, recently told NPR that parents and caregivers will likely have to wait until the end of 2021 before a COVID-19 vaccine is fully approved for young children ages 5 to 11.

Trial results for children under 5 years of age could come later this year, the pharmaceutical companies said.

"Already in March 2021, we have started the study to evaluate the immunization of younger children. Our objective was to generate and submit the data for schoolkids to regulatory authorities around the world before the winter season begins," BioNTech CEO and co-founder Ugur Sahin said.

An FDA Panel Says Only High-Risk Americans And Those 65+ Should Get COVID Boosters

Hannah Beier/Bloomberg

In a surprising vote, a panel of advisers to the Food and Drug Administration on Friday recommended against approval of a booster dose of the Pfizer-BioNTech COVID-19 vaccine for people 16 years and older.

The 16-2 vote against broad use of the booster, which would be given about six months after completion of the two-dose immunization regimen, dealt a setback to Pfizer and complicates the FDA's approach to boosters.

After a brief intermission following the rejection, FDA officials returned to the meeting with a revised booster question. The panel then voted 18-0 in support of the agency authorizing a booster shot of the vaccine for people 65 and older or at high risk of severe COVID-19.

The FDA then polled the panel members for advice on other groups of people who might be considered for a booster. Though not an official vote, the panel members unanimously supported authorization of a Pfizer booster dose for health care workers or others at high risk of occupational coronavirus exposure.

The agency typically follows the advice of its advisory committees, though it isn't required to. The Biden administration said in August that it planned to make booster shots available during the week of Sept. 20. That announcement was controversial because it came before the FDA had weighed Pfizer's application and before the Centers for Disease Control and Prevention's own panel of experts on immunization practices could consider the need for boosters.

The rise of the highly infectious delta variant of the SARS-CoV-2 coronavirus and some evidence that the Pfizer vaccine's protection against infections wanes with time are two of the factors that were cited in support of a booster.

But presentations Friday generally showed that the vaccine is still effective in protecting immunized people against severe illness, hospitalization and death in the United States.

Separately, however, an analysis published Friday in the CDC's "Morbidity and Mortality Weekly Report" found that the Pfizer vaccine's protection against COVID-19 hospitalization dropped from 91% during the first 120 days after vaccination to 77% in the days after that.

Over the course of the meeting, speakers from the FDA, Pfizer, the CDC, Israel and the U.K. presented data on the state of the coronavirus pandemic, experience with the Pfizer vaccine and lab tests.

The most direct support for the Pfizer booster came from laboratory work and a clinical study done by Pfizer that involved a little over 300 people.

"The difficulty for the committee is that you're making incredibly important policy decisions very rapidly in a situation of uncertainty," said Jonathan Sterne, a statistician from the University of Bristol who made a presentation to the panel.

Meet Our Keynote Speaker for the 2021 HHAC Conference!

Meg Johnson

Meg Johnson has motivated people of all abilities with her motto: When life gets too hard to stand, just keep on rollin’! Meg fell off a cliff and broke her neck in 2004, at the age of 22. She spent four months in the hospital recovering from multiple injuries and returned home without the use of her legs, back, stomach, or hands – a quadriplegic. Wheelchair bound and determined, Meg refuses to sit still. Since she was paralyzed, Meg has competed at the national Ms. Wheelchair America pageant in New York, winning the Spirit Award; founded and directs Ms. Wheelchair Utah; instituted a service outreach program; and authored several books. She received the Athena Award, which recognizes inspiring women in business. Meg’s influence is felt around the world as she reaches people through her YouTube channel, newsletter, and presentations. Her story is highlighted in many news outlets including newspapers, magazines, television, and documentaries. Meg has been married to her husband, Whit Johnson, since 2008 and they have two daughters and many tea parties.

$25.5 Billion in New COVID-19 Provider Funding Available

The U.S. Department of Health and Human Services (HHS), through the (HRSA) is making $25.5 billion in new funding available for health care providers affected by the COVID-19 pandemic.

Providers, defined as any provider or supplier of health care, services, and support in a medical setting, at home, or in the community, will apply for both programs in a single application. HRSA will use existing Medicaid, CHIP and Medicare claims data in calculating payments. The application portal will open on September 29, 2021.

PRF Phase 4

75% of the Phase 4 payments will be based on lost revenues and expenditures between July 1, 2020, and March 31, 2021. The remaining 25% of payments will be utilized for bonus payments for providers who serve Medicaid, CHIP, and/or Medicare patients.

Medium and small providers will receive a base payment plus a supplement, with smaller providers receiving the highest supplement. Large providers will receive a minimum payment amount based on a percentage of lost revenues and COVID-related expenses. HHS will determine the exact amount of the base payments and supplements after analyzing data from all the applications received to ensure available funds are distributed equitably.

Rural

HRSA will make $8.5B in rural payments to providers who serve patients who receive Medicaid, CHIP, and/or Medicare services in a rural area as defined by the HHS Federal Office of Rural Health Policy. Search the Rural Health Grants Eligibility Analyzer  to see what areas qualify as "rural" for the rural payments. 

Phase 3 Reconsiderations
Providers who believe their Phase 3 payment was not calculated correctly according to this methodology will now have an opportunity to request a reconsideration. Further details on this Phase 3 reconsideration process are forthcoming.

Grace Period for Reporting Period 1

In order to help providers come into compliance with PRF Reporting requirements if they miss the September 30, 2021 deadline for the first PRF Reporting Time Period, HHS announced a final 60-day grace period for those who received a PRF payment between April 10, 2020 and June 30, 2020.

It’s important to note that the deadlines to use funds and the Reporting Time Period are not changing. However, HHS will not enforce actions for noncompliant providers during the grace period. More information on reporting is available on the HRSA website. 

Additional Information:

Visit the HRSA website for more information about eligibility requirements, documents, and information providers will need to complete their application.