Diagnosis tracker
More than 354.7 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of Monday evening, January 24, 2022, including more than 5.6 million deaths.
Healthcare officials in the United States have reported more than 72.9 million positive COVID-19 cases and more than 891,000 deaths. Source: www.worldometers.info/coronavirus
Vaccine tracker
More than 9.89 billion individual doses of COVID-19 vaccine have been administered worldwide as of Monday afternoon, including at least 535 million in the United States. Source: GitHub
Pfizer booster offers some Omicron protection
Two recent laboratory studies reportedly demonstrate that three doses of the Pfizer-BioNTech vaccine elicit antibodies that neutralize the Omicron variant.
According to a press release by company officials, the data include results from 51 vaccinated individuals who received two or three doses of the vaccine (30-µg doses) as well as a study evaluating the neutralization potential of serum antibodies from a subset of vaccinated individuals against the live virus.
Both data sets confirm previously announced initial study results showing that serum antibodies induced by the vaccine neutralize the Omicron variant after immunization with three doses, officials said.
In comparison, sera from individuals who received two doses of the vaccine revealed limited neutralization titers against the variant in both data sets, indicating that two doses might not be sufficient to protect against infection with the new variant. However, based on observations that approximately 85% of epitopes in the spike protein recognized by T cells are not affected by the mutations in the Omicron variant, the companies also believe that two doses could still induce protection against severe disease.
Officials at both Pfizer and BioNTech have also initiated a booster research program to help ensure the vaccine continues to offer a high degree of protection. Moving forward, the companies will reportedly evaluate the immunogenicity and efficacy of an additional dose of both the current formulation and an Omicron-based vaccine in the clinical setting.
The companies previously announced that they expect to produce four billion doses of their vaccine in 2022, and this capacity is not expected to change if an adapted vaccine is required, according to company officials.
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Omicron clings to skin and surfaces for longer durations
One of the many reasons that the Omicron variant is proving to be more contagious than other COVID-19 variants is due to its ability to remain on surfaces longer, particularly plastic materials and human skin.
According to a recent report by Reuters, researchers based in Japan have found that Omicron can linger on plastic for nearly 200 hours, a duration that exceeds the ability of any previous variant, such as Alpha, Beta, Gamma, and Delta. As a comparison, Delta is said to survive on plastic for up to 114 hours, whereas Omicron can last for 193.5 hours.
When it comes to human skin, samples from cadavers showed an average virus survival time of 21.1 hours for Omicron compared to 16.8 hours for Delta. The researchers also reportedly found that all variants are completely inactivated by 15 seconds of exposure to alcohol-based hand sanitizers.
Related CE Course: Infection Control: Front and Center
FDA limits use of monoclonal antibodies that are ineffective against Omicron
Authorizations for two monoclonal antibody treatments have been revised by the U.S. Food & Drug Administration (FDA) after new proof that they are not effective enough in treating the Omicron variant.
The monoclonal treatments – the combination treatment of bamlanivimab and etesevimab and the treatment REGEN-COV (casirivimab and imdevimab) – are now limited to be used only among patients who are likely to have been infected with or exposed to a variant that is not Omicron.
According to a recent FDA press release, data show that these treatments are highly unlikely to be active against the Omicron variant, which is circulating at a very high frequency throughout the United States, and therefore these treatments are not authorized for use in the United States, its territories, and its jurisdictions at this time.
Use of these treatments may be authorized in these regions for future use if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to the monoclonal treatments, the FDA has stated.
Based on data from the U.S. Centers for Disease Control and Prevention (CDC), the Omicron variant 2 is estimated to account for more than 99% of cases in the U.S. as of Jan. 15. The move to restrict these treatments avoids exposing patients to side effects, such as injection site reactions or allergic reactions from specific treatment agents that are not expected to provide benefit to patients who have been infected with or exposed to Omicron variant.
The FDA advises that there are several other therapies, including Paxlovid,TM sotrovimab, Veklury® (remdesivir), and molnupiravir, that are expected to work against Omicron and that are authorized or approved to treat patients with mild-to-moderate disease who are also at high risk for progression to severe disease. The FDA also suggests that healthcare providers consult the National Institutes of Health’s COVID-19 Treatment Guidelines to assess which treatments are advised for their patients.
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Pfizer and BioNTech begin new Omicron vaccine trial
A new clinical study that will examine the prospects for an Omicron-specific vaccine has been launched by Pfizer Inc. and BioNTech.
According to a press release by the two companies dated Jan. 25, the trial will include healthy adults ages 18-55 to evaluate the safety, tolerability, and immunogenicity of an Omicron-based vaccine candidate.
The study will have three cohorts examining different regimens of the current vaccine and an Omicron-based vaccine. The study will draw upon some participants from the companies’ Phase 3 COVID-19 booster study and is part of ongoing efforts to address Omicron and determine the potential need for variant-based vaccines.
“While current research and real-world data show that boosters continue to provide a high level of protection against severe disease and hospitalization with Omicron, we recognize the need to be prepared in the event this protection wanes over time and to potentially help address Omicron and new variants in the future,” said Kathrin U. Jansen, PhD, senior vice president and head of vaccine research and development at Pfizer. “Staying vigilant against the virus requires us to identify new approaches for people to maintain a high level of protection, and we believe developing and investigating variant-based vaccines, like this one, are essential in our efforts towards this goal.”
The study will evaluate up to 1,420 participants across the three cohorts, according to officials:
- Patient Cohort 1: Those who received two doses of the current vaccine 90-180 days prior to enrollment; during the study, participants will receive 1-2 doses of the Omicron-based vaccine.
- Patient Cohort 2: Those who received three doses of the current vaccine 90-180 days prior to enrollment; during the study, participants will receive one dose of the current vaccine or the Omicron-based vaccine.
- Patient Cohort 3: Vaccine-naïve (those without immunity due to not being vaccinated) participants will receive three doses of the Omicron-based vaccine.
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