More than 275.6 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of Monday evening, including more than 5.37 million deaths. Healthcare officials in the United States have reported nearly 52 million positive COVID-19 cases and more than 828,000 deaths. Source: www.worldometers.info/coronavirus
More than 8.47 billion individual doses of COVID-19 vaccine have been administered worldwide as of Monday afternoon, including at least 495 million in the United States. Source: GitHub
GSK drug possibly effective against Omicron
Xevudy (sotrovimab), an investigational COVID-19 neutralizing monoclonal antibody, could be a beneficial treatment against the Omicron variant, according to officials at GlaxoSmithKline (GSK), the drug’s manufacturer.
Although the drug is not yet widely available in the United States, the European Commission (EC) has granted marketing authorization to the company to promote the product for early treatment of COVID-19. It is currently approved in the European Union (EU) for those ages 12 years and older who weigh at least 40kg who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.
The grant of the marketing authorization in the EU is a result of the positive opinion issued by the European Medicines Agency’s Committee for Human Medicinal Products (CHMP).
“Given recent pre-clinical data from our own labs, as well as that of other independent labs demonstrating that sotrovimab retains activity against the rapidly spreading Omicron variant and all other currently tested variants of concern and interest, we remain confident in the critical role of sotrovimab and look forward to further contributing to the fight against this pandemic,” said George Scangos, PhD, chief executive officer at Vir Biotechnology Inc., a commercial-stage immunology company that began a partnership with GSK in April 2020 to conduct research and develop solutions against COVID-19. “The grant of the marketing authorization in the European Union for sotrovimab marks yet another important milestone in our efforts to combat COVID-19, as it allows us to expand access across multiple countries working to address this challenge.”
The recent news about the drug’s effectiveness against Omicron comes as laboratory studies suggest that antibody drugs produced by Regeneron and Eli Lilly, so-called “go-to” treatments to date against COVID-19, suggest that these drugs are not a very effective treatment for the new variant.
The antibody binds to an epitope on the SARS-CoV-2 (COVID-19) virus shared with SARS-CoV-1 (SARS) virus, indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop, according to a recent statement by GSK officials.
According to a report by the Associated Press, supply of sotrovimab in the U.S. is extremely limited, with additional doses not expected to be available until the week of Jan. 3.
After pausing distribution in November to conserve supply, the U.S. Department of Health & Human Services (HHS) is shipping 55,000 doses to state health departments. An additional 300,000 are expected in January, according to the AP report.
The HHS has said that distribution is based on levels of infections and hospitalizations, and state leaders are being asked to conserve the drug for the highest-risk patients who are most likely to have Omicron infections. High-risk patients are said to include seniors and those with serious health problems, such as obesity, heart disease, diabetes, and immune system disorders.
| Related: COVID-19 Vaccines: What You Need to Know
Moderna reports positive booster results vs. Omicron
New data on Moderna’s COVID-19 vaccine has shown preliminary neutralizing antibody evidence against the Omicron variant following the booster shot.
According to a statement released by the company on Dec. 20, the currently authorized 50-µg booster increased neutralizing antibody levels against Omicron approximately 37-fold compared to pre-booster levels. A 100-µg dose increased neutralizing antibody levels approximately 83-fold compared to pre-booster levels.
“These data showing that the currently authorized Moderna COVID-19 booster can boost neutralizing antibody levels 37-fold higher than pre-boost levels are reassuring,” said Stéphane Bancel, chief executive officer at Moderna.
The company is expected to continue to advance booster candidates to address emerging variants of concern (VOC), a strategy that reportedly includes evaluating the prototype vaccine at the authorized booster dose (50 µg); higher dose (100 µg), multivalent candidates that incorporate previous VOCs also at 50 µg and 100 µg; and VOC-specific booster candidates. Booster candidates are being evaluated in ongoing Phase 2/3 studies of approximately 300-600 participants per arm, according to Moderna officials.
According to the recent data, neutralizing antibodies against Omicron were assessed in a pseudovirus neutralization titer assay conducted at laboratories established by the National Institute of Allergy and Infectious Diseases’ Vaccine Research Center and Duke University Medical Center.
All groups had low neutralizing antibody levels in the Omicron assay prior to boosting. At Day 29 post-boost, the authorized 50-µg booster increased neutralizing geometric mean titers against Omicron to 850, which is approximately 37-fold higher than pre-boost levels.
At Day 29 post-boost, the 100-µg booster increased neutralizing GMT to 2,228, which is approximately 83-fold higher than pre-boost levels. The multivalent candidates boosted Omicron-specific neutralizing antibody levels to similarly high levels at both 50 µg and 100 µg.
The company also announced the safety and tolerability data from the 100-µg Phase 2/3 study of the booster dose: A 100-µg booster was generally safe and well tolerated. The frequency and nature of solicited systemic and local adverse events seven days after receiving a booster were generally comparable to those seen after the two-dose primary series. There was a trend toward slightly more frequent adverse reactions following the 100-µg booster relative to the authorized 50 µg booster.
Pfizer vaccine for younger children hits snag
An ongoing clinical trial to evaluate the efficacy and safety of the Pfizer Inc./BioNTech COVID-19 vaccine in children ages 6 months to younger than 5 years will be amended and prolonged after data showed concerns about efficacy.
According to a statement released by the two companies, the study will now include evaluating a third dose of 3 µg at least two months after the second dose in an effort to provide high levels of protection in this young age group.
A pre-specified immunogenicity analysis was conducted on a subset of the study population one month following the second dose. Compared to the 16- to 25-year-old population in which high efficacy was demonstrated, non-inferiority was met for the 6- to 24-month-old population, but not for the 2- to under 5-year-old population in this analysis. No safety concerns were identified and the 3-µg dose demonstrated a favorable safety profile in children 6 months to younger than 5 years of age.
If the three-dose study is successful, Pfizer and BioNTech expect to submit data to regulators to support an Emergency Use Authorization (EUA) for children 6 months to under 5 years of age in the first half of 2022.
Pfizer and BioNTech also plan to evaluate a third dose of the 10-µg formulation in children 5 to under 12 years of age, according to a recent press release. Furthermore, the companies have initiated a low-dose sub-study of a third dose of 10 µg or 30 µg in approximately 600 adolescents aged 12- to 17, to assess safety and immunogenicity.
These updates were informed by the effectiveness data for three doses of the vaccine for people 16 years and older, and the early laboratory data observed with Delta and other variants of concern, including Omicron, which suggest that people vaccinated with three doses of a COVID-19 vaccine may have a higher degree of protection.
These changes have reportedly been endorsed by and agreed upon with the U.S. Food & Drug Administration and the European Medicines Agency.
“Test to stay” method encouraged for school children
Despite the rising cases of COVID-19 across the U.S. due to the Omicron variant, officials at the U.S. Centers For Disease Control & Prevention (CDC) have suggested that schools consider utilizing a new strategy known as “Test to Stay” to potentially help schools function more normally. The strategy is intended to prevent students from having to undergo lengthy quarantines if they’ve been exposed to the virus at school.
Test to Stay combines contact tracing and serial testing to allow asymptomatic school-associated close contacts who are not fully vaccinated and do not test positive for the virus to continue in-person learning, according to the CDC. Because fully vaccinated close contacts are not required to quarantine following exposure, they would not be included in Test to Stay.
Students who participate in Test to Stay wear masks while in school and stay home to isolate if they develop symptoms or test positive for the virus.
Studies conducted in Illinois and California found that both the patient diagnosed with COVID-19 and the close contact had to be properly masked at the time of exposure to qualify for Test to Stay, the CDC explains. If schools are considering implementing Test to Stay, they are advised to also have robust contact tracing in place and access to testing resources, as well as other layered prevention strategies.
Because Test to Stay can be resource intensive, it may not be a viable option for every school, the CDC notes.