Test tube with positive Omicron COVID-19 test blood sample and vaccine bottle in the medical laboratory.

COVID-19 Updates: Omicron a Variant of Concern, Pfizer Reports Vaccine Effectiveness for Kids, and More

Test tube with positive Omicron COVID-19 test blood sample and vaccine bottle in the medical laboratory.

Diagnosis tracker

At least 262.3 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of Monday afternoon, including more than 5.22 million deaths. Healthcare officials in the United States have reported more than 49.2 million positive COVID-19 cases and more than 800,000 deaths. Source: www.worldometers.info/coronavirus

Vaccine tracker

At least 7.81 billion individual doses of COVID-19 vaccine have been administered worldwide as of Monday afternoon, including at least 454 million in the United States. Source: GitHub

WHO calls Omicron “variant of concern”

The newly identified Omicron COVID-19 variant has been designated by officials with the World Health Organization (WHO) as a variant of concern.

According to a press release issued Nov. 28, the guidance on the status of the variant comes from the WHO’s Technical Advisory Group on Virus Evolution (TAG-VE). Evidence shows that Omicron has several mutations that could impact how the virus behaves, how easily it spreads, and the severity of illness it can cause.

According to the WHO, researchers in South Africa and globally are conducting studies to better understand the variant. More concrete details are expected to be available in the next two weeks.

While it is not yet certain whether Omicron is more transmissible compared to other variants, numbers of positive cases have risen in areas of South Africa. It is also undetermined how severe infections with this variant could be, but preliminary data suggest that there are increasing rates of hospitalization in South Africa, according to the WHO.

There is currently no information to suggest that symptoms associated with Omicron are different from other variants. Initial reported infections were among younger adults who tend to have more mild symptoms.

Preliminary evidence also suggests there could be an increased risk of reinfection with Omicron as compared to other variants of concern, the WHO has advised. Efforts are underway to assess and understand the potential impact on existing vaccines and efforts such as masking and social distancing.

Corticosteroids and IL6 Receptor Blockers will remain effective for managing patients with severe COVID-19, WHO officials said. Other treatments will be assessed to see if they are still as effective.

The WHO encourages enhanced surveillance and sequencing of COVID-19 cases, sharing genome sequences on publicly available databases, reporting initial cases or clusters, and performing field investigations and laboratory assessments to better understand if Omicron has different transmission or disease characteristics and the impact on public health.

WHO officials are also urging healthcare leaders to assess for and address any inequities related to access to vaccines to ensure that vulnerable groups receive their first and second doses, alongside equitable access to treatment and diagnostics.

Related CE course: Emerging Infectious Diseases

Pfizer reports longer-term vaccine effectiveness for kids

Longer-term analysis of the safety and efficacy of the vaccine manufactured by Pfizer Inc. and BioNTech among children ages 12-15 years old show 100 percent effectiveness beyond four months after inoculation.

According to data recently released by both companies, the updated findings from a Phase 3 trial show that a two-dose series of 30-µg per dose produced optimal results measured seven days through more than four months after the second dose.

Additionally, the adverse event profile was generally consistent with other clinical safety data for the vaccine, with no serious safety concerns observed in individuals with at least six months of safety follow-up after the second dose, officials said.

“As the global health community works to increase the number of vaccinated people around the world, these additional data provide further confidence in our vaccine’s safety and effectiveness profile in adolescents,” said Albert Bourla, chairman and chief executive officer at Pfizer. “This is especially important as we see rates of COVID-19 climbing in this age group in some regions, while vaccine uptake has slowed. We look forward to sharing these data with the [U.S. Food & Drug Administration (FDA)] and other regulators.”

According to the companies’ officials, the findings are the first and only disclosed longer-term data demonstrating the safety and efficacy of a COVID-19 vaccine in this age group.

These longer-term follow-up data will form the basis for a planned supplemental Biologics License Application to be submitted to the FDA to expand approval of the vaccine for use in patients ages 12 years and older.

The companies also plan to submit these data to pursue regulatory approvals for this age group in other countries where emergency use authorizations or equivalents were initially granted.

The trial included 2,228 participants. From the 30 confirmed symptomatic cases of COVID-19 in the trial with and without evidence of prior infection, 30 cases of COVID-19 were in the placebo group and zero cases were in the Pfizer-BioNTech vaccine group, corresponding to vaccine efficacy of 100 percent.

Efficacy was consistently high across gender, race, and ethnicity demographics as well as obesity and comorbidity status, officials said.

Related webinar course: COVID-19 Vaccines: What You Need to Know

NY governor declares state of emergency

New York Gov. Kathy Hochul has announced that the state will take urgent action to boost hospital capacity and address staffing shortages ahead of potential spikes in COVID-19 cases this upcoming winter after reports of a new global variant have surfaced.

The order allows the state’s department of health (DOH) to limit non-essential, non-urgent procedures for in-hospitals or systems with limited capacity  percent staffed bed capacity or as determined by the DOH based on regional and healthcare utilization factors.

The order will also enable the state to acquire any critical supplies to combat the pandemic more quickly. The new protocols are expected to begin Dec. 3 and will reportedly be re-assessed based on the latest COVID-19 data Jan. 15.

“We’ve taken extraordinary action to prevent the spread of COVID-19 and combat this pandemic,” Hochul said in a prepared statement. “While the new Omicron variant has yet to be detected in New York State, it’s coming. In preparation, I am announcing urgent steps today to expand hospital capacity and help ensure our hospital systems can tackle any challenges posed by the pandemic as we head into the winter months.”

The Hochul Administration also continues to focus on boosting vaccination rates by bolstering the state’s network of vaccine access points, working to expand testing supplies, acting on a comprehensive plan to vaccinate school-aged children, proving vaccine incentive programs, combating vaccine misinformation campaigns, increasing vaccine awareness, deploying pop-up vaccines in targeted low-vaccination areas, and implementing vaccine requirements for healthcare workers.

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