More than 517.3 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of Monday evening, including more than 6.2 million deaths.
Healthcare officials in the United States have reported more than 83.5 million positive COVID-19 cases and more than 1.02 million deaths. Source: www.worldometers.info/coronavirus
More than 11.7 billion individual doses of COVID-19 vaccine have been administered worldwide as of Monday evening, including at least 579 million in the United States. Source: GitHub
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Johnson & Johnson’s COVID vaccine is restricted by FDA
Officials with the U.S. Food and Drug Administration (FDA) are restricting the use of the Johnson & Johnson (J&J) Janssen COVID-19 vaccine due to the risk of thrombosis with thrombocytopenia syndrome (TTS), a potentially fatal syndrome of blood clots.
Research has shown the condition develops approximately 1-2 weeks after the administration of the vaccine. The onset of symptoms was accompanied by low blood platelet levels.
According to a statement released by the FDA on May 5, officials have determined that the risk of TTS warrants limiting the authorized use of the vaccine following a recent analysis, evaluation, and investigation of reported cases.
Due to the findings, the FDA has limited authorized use of the vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the vaccine because they would otherwise not be able to receive another COVID-19 vaccine.
The FDA has also determined that the known and potential benefits of the vaccine for the prevention of COVID-19 outweigh the known and potential risks for individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate and for individuals 18 years of age and older who elect to receive the vaccine because they would otherwise not receive a vaccine.
The FDA has released a Fact Sheet for Healthcare Providers Administering Vaccine that reflects the revision of the vaccine’s authorized use and includes a warning statement that summarizes information on the risk for TTS.
Additionally, information on the revision to the authorized use of the vaccine and updated information on the risk of blood clots with low levels of blood platelets have been added to the Fact Sheet for Recipients and Caregivers.
The vaccine was given an emergency use authorization (EUA) on Feb. 27, 2021. On April 13, 2021, the FDA and the Centers for Disease Control and Prevention (CDC), announced a recommended pause in the administration of the vaccine to investigate six reported cases of TTS.
This pause was also to help ensure healthcare providers were made aware of the potential for TTS, giving them a chance to plan for proper recognition and management.
On April 23, 2021, following a thorough safety evaluation, including two meetings of the CDC’s Advisory Committee on Immunization Practices (ACIP), the FDA and CDC lifted the recommended pause and confirmed a total of 15 cases of TTS had been reported to the Vaccine Adverse Event Reporting System (VAERS). This included the original six reported cases out of approximately 8 million doses administered.
“We recognize that the Janssen COVID-19 vaccine still has a role in the current pandemic response in the United States and across the global community,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a prepared statement. “Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals. We’ve been closely monitoring the Janssen COVID-19 vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA. The agency will continue to monitor the safety of the Janssen COVID-19 vaccine, and all other vaccines, and, as has been the case throughout the pandemic, will thoroughly evaluate new safety information.”
In making the determination to limit the authorized use of the vaccine, the agency considered that reporting rates of TTS and TTS deaths following administration of the vaccine are not appreciably lower than previously reported.
Furthermore, the factors that put an individual at risk for TTS following administration of the vaccine remain unknown. The FDA also considered that individuals with TTS may rapidly deteriorate, despite prompt diagnosis and treatment, that TTS can lead to long-term and debilitating health consequences, and that TTS has a high death rate.
The agency also considered the availability of alternative authorized and approved COVID-19 vaccines that provide protection from COVID-19 and have not been shown to present a risk for TTS.
Examples of individuals who may still receive the vaccine include:
- Those who experienced an anaphylactic reaction after receipt of another COVID-19 vaccine
- Individuals who have personal concerns with receiving other vaccines and would otherwise not receive a COVID-19 vaccine
- Individuals who would remain unvaccinated for COVID-19 due to limited access to other COVID-19 vaccines.
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Omicron is thought to lead to increased upper airway infections in children
Young children are reportedly more vulnerable to upper airway infections (UAIs) due to their small and relatively collapsible airways when they become infected with the Omicron strain.
A study recently published by the Journals of the American Medical Association (JAMA) network has also found that Omicron has proven more likely than other variants to cause UAIs in children and can lead to an increased risk of heart attack and other complications despite children’s overall not typically expected to experience the serious disease when they are infected with COVID.
According to the study, more than one-fifth of children hospitalized with the virus and any UAI developed severe disease. Children diagnosed with UAIs during the Omicron period were also more likely to be younger, Hispanic or Latino, and less likely to receive dexamethasone or develop severe disease compared with those in the pre-Omicron period.
However, the proportion of children with a pediatric complex chronic condition was not significantly different in the pre-Omicron period compared with the Omicron period.
CDC claims most U.S. residents have been infected with COVID
More than half the population of the United States has been infected with the coronavirus at least once since the start of the pandemic, according to data recently released by the Centers for Disease Control & Prevention (CDC).
Many of the cases are presumed to have been asymptomatic or with few symptoms. The data were drawn from blood samples.
Given this data, Dr. Anthony Fauci, President Biden’s chief medical adviser, has said that the country has emerged “out of the full-blown explosive pandemic phase” and has entered a transitional phase that could be more controllable.
The findings are subject to at least four limitations, according to the CDC:
- Convenience sampling might limit generalizability.
- Lack of race and ethnicity data precluded weighting for these variables.
- All samples were obtained for clinical testing and might over-represent persons with greater healthcare access or who more frequently seek care.
- Findings might underestimate the cumulative number of infections because infections after vaccination might result in lower anti-nucleocapsid titers, and anti-nucleocapsid seroprevalence cannot account for reinfections.
FDA announces plans to meet on children’s vaccines
The potential for vaccinating the world’s youngest patients against COVID-19 will reportedly be discussed by the U.S. Food & Drug Administration (FDA) in June.
According to a recent press release, FDA officials have scheduled meetings on June 8, 21, and 22 for its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss updates to potential emergency use authorizations (EUAs) for the vaccines produced by Moderna and Pfizer-BioNTech.
“As we continue to address the ongoing COVID-19 pandemic, there are a number of anticipated submissions and scientific questions that will benefit from discussion with our advisory committee members,” said Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research, in a prepared statement. “The agency is committed to a thorough and transparent process that considers the input of our independent advisors and provides insight into our review of the COVID-19 vaccines. We intend to move quickly with any authorizations that are appropriate once our work is completed.”
Once the meeting dates are finalized, the FDA intends to release background materials to the public, including the meeting agenda and committee roster.