At least 219 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of Monday evening, September 6, 2021, including at least 4.55 million deaths. Healthcare officials in the United States have reported at least 40 million positive COVID-19 cases and approximately 648,000 deaths. Source: Johns Hopkins University & Medicine
At least 5.49 billion individual doses of COVID-19 vaccine have been administered worldwide as of Monday evening, including at least 374 million in the United States. Source: GitHub
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Pfizer booster rollout still expected for September
Dr. Anthony Fauci has said that he believes that the United States will be able to begin administering a Pfizer vaccine booster beginning the week of Sept. 20. According to numerous reports, Pfizer’s data on the booster has been submitted and shows that an additional shot would improve immunity for all patients ages 16 and older.
The Pfizer vaccine is the vaccine administered most often in the U.S., with more than 95 million people having already received the two-shot regimen, according to the Centers for Disease Control and Prevention.
Results on the potential for boosters of the Moderna and Johnson & Johnson (J&J) vaccines are pending. The expectation is that these shots will not be approved when the Pfizer vaccine is approved.
Although the different vaccines will not have boosters available simultaneously, as would be the ideal scenario, Fauci has also said that. “… the entire plan looks good.”
A booster after full vaccination would increase immunity and help stem breakthrough and Delta variant COVID-19 cases, according to Fauci, who also says the durability of the protection of a full vaccination “tends to wane, particularly in the context of the Delta variant,” and that data from Israeli studies show booster doses offer “profound protection against infection and hospitalization.”
Data also reportedly show that boosters reconstitute, to an even higher level, protection against infection and hospitalization.
It is advised that those patients who have previously received the Moderna or J&J vaccine do not mix with a Pfizer booster at this time. But the U.S. plans to release data in the coming weeks on mixing vaccines, Fauci noted.
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CDC releases COVID-19 materials for people with intellectual and developmental disabilities
In response to the unique challenges that COVID-19 has created for people living with intellectual and developmental disabilities (IDD), the Centers for Disease Control and Prevention (CDC) has created a toolkit with communication resources that explain how people with IDD and caregivers can protect themselves.
“People with intellectual and developmental disabilities can experience communication barriers that make it harder for them to understand and act on crucial health guidance,” said Karen Remley, MD, director of the CDC’s National Center on Birth Defects and Developmental Disabilities. “The aim of these materials is to help people with IDD, their parents, and other caregivers share critical information with their loved ones about COVID-19 and what to expect when getting a COVID-19 test or vaccine and explain how to stay safe if they are not vaccinated.”
The toolkit contains social stories, videos, posters, and interactive activities that focus on five topics:
- Getting a COVID-19 vaccine
- Wearing a mask
- Hand washing
- Getting a COVID-19 test
To develop the toolkit, the CDC reportedly hosted multiple discussions with adults with IDD and their caregivers, who were most often family members, and asked them to share their individual experiences and what they found helpful in talking about COVID-19 with their loved ones.
There is also a tip sheet for caregivers that offers suggestions for things they can do to ease their loved one’s worries about the virus.
“Parents and caregivers work hard to help the person they support stay healthy and safe,” said Remley. “These materials can help parents or other caregivers of people with IDD navigate important conversations about COVID-19.”
In addition to the toolkit, the CDC has developed videos and web resources in American Sign Language (ASL). To date, more than 40 ASL videos and 25 easy-to-read documents have been produced and viewed by more than 1 million people.
The CDC’s full suite of COVID-19 materials for people with IDD and their caregivers can be found online.
Antibody tests don’t validate future COVID-19 protection
Experts are warning that taking one of the various available COVID-19 antibody tests is not an effective approach when trying to determine whether a previous COVID-19 infection offers enough natural protection against the virus.
According to the CDC, antibody tests are useful in determining whether an individual had been infected in the past, but are limited in their ability to predict immunity from future infections. Both the CDC and the Food and Drug Administration recommend against using antibody tests to assess immunity after COVID-19 vaccination.
Only antibodies that prevent the virus from entering a cell provide protection from infection, research has found.
Learn more about the process of vaccine development in the newest podcast from Elite with noted virologist Dr. Angela Rasmussen.
Moderna provides booster data to FDA
Officials with Moderna Inc. have announced the company has submitted initial data to the U.S. Food and Drug Administration (FDA) for evaluation of the vaccine booster. The company is also submitting data to other global regulatory authorities, according to a recent press release.
“We are pleased to initiate the submission process for our booster candidate at the 50-µg dose with the FDA,” said Stéphane Bancel, chief executive officer. “Our submission is supported by data generated with the 50-µg dose of our COVID-19 vaccine, which shows robust antibody responses against the Delta variant.
“We remain committed to staying ahead of the virus and following the evolving epidemiology of SARS-CoV-2. We will continue to generate data and transparently share to support governments and regulators as they make evidence-based decisions regarding future vaccination strategies.”
A Phase 2 study of the vaccine was amended to offer a booster dose at the 50-µg dose level to interested participants six months following their second dose (n=344). Neutralizing antibody titers had waned significantly prior to boosting at approximately six months. A booster dose of the 50-µg dose level boosted neutralizing titers significantly above the Phase 3 benchmark, according to company officials.
After a third dose, a similar level of neutralizing titers was achieved across age groups, notably in older adults (ages 65 and older). The safety profile following dose three was similar to that observed previously for dose two.
An additional analysis showed that a booster dose of the vaccine at the 50-µg dose level induced robust antibody responses and significantly increased geometric mean titers for all variants of concern, including Beta, Gamma, and Delta.