At least 229.7 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of Monday evening, September 20, 2021, including at least 4.71 million deaths. Healthcare officials in the United States have reported more than 43 million positive COVID-19 cases and approximately 693,000 deaths. Source: www.worldometers.info/coronavirus
At least 5.95 billion individual doses of COVID-19 vaccine have been administered worldwide as of Monday evening, including at least 386 million in the United States. Source: GitHub
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Pfizer and BioNTech report positive vaccine results for kids 5-11
Results from a Phase 2/3 clinical trial for the COMIRNATY vaccine show favorable safety results and robust neutralizing antibody responses among children 5-11 years of age, according to officials with Pfizer Inc. and BioNTech.
These are the first results from a pivotal trial of a COVID-19 vaccine in this age group. The trial utilized a two-dose regimen of 10 µg administered 21 days apart, a smaller dose than the 30 µg dose used for people ages 12 and older.
The antibody responses in the participants given 10 µg doses were comparable to those recorded in a previous Pfizer-BioNTech study in people ages 16-25 immunized with 30 µg doses. The 10 µg dose was carefully selected as the preferred dose for safety, tolerability, and immunogenicity in children ages 5-11.
“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine,” said Albert Bourla, chairman and chief executive officer at Pfizer. “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.”
The data summarized from the study, which is now also enrolling children 6 months to 11 years of age, included 2,268 participants. In the trial, the virus-neutralizing antibody geometric mean titer (GMT) was 1,197.6 (95% confidence interval), demonstrating strong immune response in this cohort of children one month after the second dose.
This compares well to the GMT of 1146.5 (95% confidence interval) from participants ages 16-25, used as the control group for this analysis and who were administered a two-dose regimen of 30 µg. Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants ages 16-25.
Pfizer and BioNTech plan to share these data with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulators. For the United States, the companies expect to include the data in a near-term submission for Emergency Use Authorization (EUA) as they continue to accumulate the safety and efficacy data required to file for full FDA approval in this age group. A request to the EMA to update the European Conditional Marketing Authorization is also planned. Topline readouts for the other two age cohorts from the trial — children 2-5 years of age and children 6 months to 2 years of age — are expected as soon as the fourth quarter of this year.
Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-reviewed publication.
Learn more about the process of vaccine development in the newest podcast from Elite with noted virologist Dr. Angela Rasmussen.
WHO offers guidance on “infodemic” management
The World Health Organization (WHO) has released guidance for the management against the current “infodemic,” a concept that refers to a rapid and far-reaching spread of both accurate and inaccurate information about important issues, including the pandemic. As rumors, fears, and misinformation mixes with fact, people have more discerning the truth.
Following a global consultation to produce a framework for managing the COVID-19 infodemic, a need was identified for a competency framework for the emerging workforce of infodemic managers. WHO, in partnership with the United States Centers for Disease Control & Prevention (CDC), conducted qualitative research and consultation to produce a recently released document online.
The guidance aims to strengthen efforts at the country level to manage infodemics by outlining a set of competencies to guide the empowerment, education, and training of employees of health institutions.
Based on the five work streams for infodemic preparedness and response, the framework comprises four domains that group specific competencies, namely:
- Infodemic management: competencies in infodemiology;
- Prepare and monitor: competencies in the use of effective tools to listen to target audiences and how to design and share appropriate information;
- Detect and intervene: competencies to design, implement, and evaluate interventions to promote resilience to mis/disinformation and to empower individuals and communities to exercise their right to access quality health information;
- Strengthen: competencies to empower health systems to ensure healthier populations through better infodemic management in health emergencies and in regular contexts.
The framework can be used as a reference tool when planning infodemic management capacities, training, or teams, and can be adapted to be applied to the local context and needs.
The WHO will use this new framework to develop training curricula and programs through the WHO Academy, which will deliver internationally certified micro-skill certificates to health workers globally. The framework will be evaluated on a rolling basis and was developed through three main steps:
- Preparatory work identified the overall structure for the framework.
- A series of semi-structured interviews were held with identified participants to investigate current processes, models, tools, and key disciplines for competence development.
- The complete framework was presented to experts from health institutions and academia through discussion panels.
Want to learn more about COVID-19? Explore essential learning for nurses.
Moderna vaccine more effective long term, CDC study learns
A report by the U.S. Centers for Disease Control and Prevention (CDC) has found that the Moderna COVID-19 vaccine is more effective at reducing the short-term risk of hospitalization after 120 days than the Pfizer-BioNTech vaccine.
Data collected from 18 states between March and August suggest the former vaccine was 93% effective at reducing the short-term risk of COVID-19 hospitalization and remained 92% effective after 120 days, while the Pfizer-BioNTech vaccine reduced the risk of being hospitalized with COVID-19 by 91% in the first four months after receiving the second dose, but the vaccine efficacy dropped to 77% after 120 days.
Representatives from Pfizer have pointed to clinical trial results involving 306 mostly healthy participants to argue that a booster “restores” the 95% vaccine effectiveness rate seen earlier in the pandemic, according to a recent report by the Los Angeles Times.