HIGHLIGHTS FROM PRESIDENT BIDEN’S BRIEFING ON THE COVID-19 RESPONSE AND VACCINATION PROGRAM

Watch President Biden’s full remarks here.

• FDA Full Approval to Pfizer’s COVID-19 Vaccine: President Biden highlighted the FDA’s full and final approval of Pfizer’s COVID-19 vaccine. President Biden stated, “The FDA approval is the gold standard… Those who have been waiting for full approval should go get your shot now.”
• Delta Variant: President Biden emphasized that the Delta variant is dangerous and spreading, causing a pandemic of the unvaccinated. While we are starting to see initial signs that cases may be declining in a few places, nationwide cases are still rising, especially among the unvaccinated. While there are cases where vaccinated people do get COVID-19, they are far less common than unvaccinated people getting COVID-19 and their conditions are far less severe. President Biden stated, “Across the country, virtually all the COVID-19 hospitalizations and deaths continue to be among the unvaccinated.”
• COVID-19 Cases Among Children: President Biden stated that COVID-19 cases among children are still rare and severe cases among children are very rare. However, he urged parents to use the tools at their disposal to keep their child safer: “One, make sure that everyone around your child who can be vaccinated is vaccinated… [and] two, make sure your child is masked when they leave home. That’s how we can best keep our kids safe.”
• Vaccine Requirements and Incentives: While we have made tremendous progress on where we were last winter in our fight against COVID, President Biden commented that we still need governors, mayors, and private sector leaders to encourage new incentives and set new requirements in order for more people to get vaccinated. President Biden stated, “If you’re a business leader, a nonprofit leader, a state or local labor who has been waiting for full FDA approval to require vaccinations, I call on you now to do that.”

CASE UPDATE

New Cases (based on 7-day rolling average)
• 37,583,545 US cases
• 11.7% increase in new cases (7-day average), as of August 20th; (was 15.6% increase last week)
Testing
• 511,822,768 tests completed (8/23)
• 9.4% positive test rate as of the week of 8/13 – 8/19 (was 10.3% last week)
Hospitalizations
• 2,623,897 total COVID hospital admissions
• The 7-day average (8/14 – 8/20) number of new confirmed COVID-19 admissions increased from 10,569 to 11,615 admissions per day
Deaths
• 625,375 total US deaths
• The 7-day average (8/14 – 8/20) number of reported deaths increased from 545 to 735 deaths per day
Vaccines
• 362,657,711 vaccine doses administered (8/22)
• 60.7% of the population (201.4 million people) has received at least one dose and 51.1% of the population (170.8 million people) is fully vaccinated
• 73% of adults 18 years and older have received at least 1 dose and 62.4% are fully vaccinated

VACCINE UPDATES

FDA Approves First COVID-19 Vaccine: Today, the FDA approved the first COVID-19 vaccine . The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

Booster Shot: CDC released a page on booster shots for COVID-19. This page includes information on when you can get the booster, who will get the booster first, and more.

Possibility of COVID-19 Illness After Vaccination: CDC updated the page on the possibility of COVID-19 illness after vaccination . COVID-19 vaccines protect people against severe illness, including disease caused by Delta and other variants circulating in the U.S. COVID-19 vaccines protect people from getting infected and severely ill, and significantly reduce the likelihood of hospitalization and death.

Myocarditis Outcomes Investigation: CDC is actively investigating reports of people developing myocarditis (inflammation of the heart muscle) after receiving a mRNA COVID-19 vaccine (Pfizer-BioNTech or Moderna). Most of these people fully recover, but information is not yet available about potential long-term effects. Therefore, CDC is conducting surveys of patients (or their parents or guardians) and healthcare providers to gather information about myocarditis after mRNA COVID-19 vaccination.

TESTING AND TREATMENT

FDA Testing Update: As of Friday, 402 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs) . These include 282 molecular tests and sample collection devices, 87 antibody and other immune response tests and 33 antigen tests. There are 56 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, three antigen prescription at-home tests, six antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests. The FDA has authorized 13 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 610 revisions to EUA authorizations.

INFORMATION FOR SPECIFIC POPULATIONS

Health Tips for Back to School: CDC offers heath tips for returning to school during COVID-19 . As schools plan for a safe return to campus this year, it is critically important to consider the health and well-being of students and staff, and address issues with COVID-19, mental and physical health, and managing other chronic health conditions. Learn what parents and teachers can do to help children have a successful school year.

Lab Workplace Safety: CDC updated the guidance for lab workplace safety. These updates include added mask guidance for staff who are fully vaccinated and in areas of substantial or high transmission and added public health laboratories to guidance audience.

When Not to Travel: CDC recommends delaying travel until you are fully vaccinated, because travel increases your chance of getting and spreading COVID-19. If you are not fully vaccinated and must travel, follow CDC’s recommendations for people who are not fully vaccinated traveling internationally or domestically. View information on what to do after international travel, travel tips, and information on domestic travel.

FDA Warning Letter: As part of the FDA’s effort to protect consumers, on August 19, the agency issued a warning letter jointly with the Federal Trade Commission to Mahita, LLC dba PushMyCart for selling unapproved products with unproven COVID-19 claims. Consumers concerned about COVID-19 should consult with their health care provider.

Competition to Help Children at Risk for Severe COVID-19: BARDA and its HHS partners launched a data challenge competition today to develop algorithms that could help healthcare providers predict which of their pediatric patients with COVID-19 are likely to develop severe COVID-19 complications, including conditions such as multisystem inflammatory syndrome in children (MIS-C). MIS-C is a rare but serious condition associated with COVID-19 in which different body parts become inflamed, including the heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal organs. More than 4,100 cases of MIS-C had been reported to the CDC, and 37 children in the U.S. have died from the condition.

RESEARCH

How Can Kids Go Back to School Safely: The NIH Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) managed many projects as part of the Safe Return to School Diagnostic Testing Initiative. This initiative includes studies in a variety of schools and communities, with a variety of testing approaches. These projects will build evidence that school administrators can use to make sure all children are able to return to school safely and stay there.

COVID Data Tracker Weekly Review: On Friday, CDC released their weekly review from the COVID Data Tracker. As of August 19, 2021, nearly 200 million people in the United States have received at least one dose of a COVID-19 vaccine. However, vaccination among pregnant people remains low. Data show that only about 1 in every 4 pregnant people report vaccination, and certain groups have much lower uptake. This low uptake persists despite recent increases in COVID-19 cases in pregnant people. CDC recommends all people 12 years and older – including people who are pregnant, breastfeeding, trying to get pregnant now, or who might become pregnant in the future – get vaccinated against COVID-19.

Science Update: On Friday, CDC released their weekly COVID-19 science update. This update includes research on evaluation of Moderna vaccine in adolescents, Pfizer-BioNTech and Moderna vaccine effectiveness against the Delta variant in Qatar, and more.

Marvin B. Figueroa, Director

Intergovernmental and External Affairs
U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201