At least 266.6 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of Monday afternoon, Dec. 6, 2021, including more than 5.27 million deaths. Healthcare officials in the United States have reported more than 50.1 million positive COVID-19 cases and more than 809,000 deaths. Source: www.worldometers.info/coronavirus
At least 7.81 billion individual doses of COVID-19 vaccine have been administered worldwide as of Monday afternoon, including at least 470 million in the United States. Source: GitHub
Drug combo receives EUA for young pediatrics
A previously authorized Emergency Use Authorization (EUA) for the drugs bamlanivimab and etesevimab to be administered together to treat mild and moderate cases of COVID-19 has been expanded by the U.S. Food and Drug Administration (FDA) to include certain high-risk pediatric patients of all ages.
According to officials with Eli Lilly and Company, which manufactures bamlanivimab, the extended use allows for the drugs to also be administered for post-exposure prophylaxis.
The expanded authorization is based on safety and efficacy data of pediatric and infant patients in a phase 2/3 clinical trial who are at high risk for severe disease progression.
“With the FDA’s decision to allow use of bamlanivimab with etesevimab in children and infants, Lilly can now offer treatment and prevention options to high-risk individuals of any age,” said Daniel Skovronsky, MD, PhD, chief scientific and medical officer at Lilly, and president of Lilly Research Laboratories, in a prepared statement. “Our mission since the start of the pandemic has been to offer crucial support by developing therapeutic options that could prevent hospitalization and death for as many people as possible.”
When administered together, bamlanivimab and etesevimab retain neutralization activity against the Delta variant, which is still reportedly the predominant strain found within the United States.
Lilly has performed pseudovirus and authentic virus studies to confirm that bamlanivimab with etesevimab retain neutralization activity against the Delta variant.
Lilly is also working quickly to understand neutralization activity of our therapies on the Omicron variant of concern, officials said.
To date, more than 700,000 patients have been treated with bamlanivimab or bamlanivimab and etesevimab, potentially preventing more than 35,000 hospitalizations and at least 14,000 deaths during the worst of the pandemic, said Lilly officials.
For more information about the use of bamlanivimab and etesevimab together for the treatment of mild to moderate COVID-19 and prevention of COVID-19 in high-risk pediatric and infant patients under the FDA’s EUA, view the Fact Sheet for Healthcare Providers.
FDA committee recommends EUA for new antiviral
An investigational oral antiviral medicine for the treatment of mild to moderate COVID-19 in diagnosed adults who are at high risk for severe disease and/or hospitalization has been recommended for an Emergency Use Authorization by the U.S. Food and Drug Administration’s (FDA’s) Antimicrobial Drugs Advisory Committee (AMDAC).
According to officials at Merck, a company that produces the drug, the AMDAC voted that the known and potential benefits of molnupiravir outweigh its known and potential risks for this patient group if they are within five days of symptom onset.
“With the continued spread of the virus and the emergence of variants, additional treatments for COVID-19 are urgently needed,” said Dr. Dean Y. Li, executive vice president and president at Merck Research Laboratories, in a prepared statement. “We are grateful to the members of the Advisory Committee who reviewed our application, as well as to the patients and investigators who participated in our clinical trials, and we will continue to work with the FDA as the agency completes its review.”
The EUA application is based on positive results from a planned interim analysis of a Phase 3 clinical trial, including data from all randomized patients. The trial evaluated molnupiravir in non-hospitalized adult patients with mild to moderate COVID-19 with symptom onset within five days prior to randomization who were at high risk for progressing to severe COVID-19 and/or hospitalization.
At the planned interim analysis, which was the primary efficacy analysis of the study, treatment with molnupiravir significantly reduced hospitalizations and death through Day 29 following randomization.
Among the findings:
- 14.1% of patients in the placebo group were hospitalized or died, compared to 7.3% of patients who received molnupiravir who were hospitalized;
- In the interim analysis, no patients who took molnupiravir died, compared to eight patients who received placebo.
- The efficacy benefit with molnupiravir treatment was consistent across important patient subgroups, including patients infected with virus variants of concern (Delta, Gamma, and Mu).
Reports predict vaccine for youngest children soon
Vaccines for children who are younger than 5 years old are expected to be approved early in 2022, according to a recent report by NPR. Trials for these pediatrics are reportedly split into two groups: those ages 2-5 and those ages 6 months to 2 years.
In an interview with NBC News, Albert Bourla, chief executive officer at Pfizer Inc. recently said that the company expects to have results about the effectiveness of its vaccines in children younger than 5 years by the end of 2021.
According to a report by Business Insider, officials at Moderna and Johnson & Johnson have also confirmed that their companies are planning to conduct trials for vaccine effectiveness in younger children.
New-style vaccine from Novavax on the horizon
Officials with Novavax Inc. have announced that the company has submitted its vaccine under the Pandemic Special Access Route to the Health Sciences Authority (HSA) in Singapore for interim authorization. The recombinant nanoparticle protein-based vaccine works by injecting patients with a tiny amount of the virus.
The application for use includes clinical data from two Phase 3 clinical trials that included a total of nearly 50,000 participants in the United States, Mexico, and United Kingdom. A trial in the U.S. and Mexico demonstrated 100% protection against moderate and severe disease and 90.4% efficacy while a trial in the U.K demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha variant, and 89.7% efficacy overall.
The Novavax vaccine recently received approval for Emergency Use Authorization (EUA) in Indonesia and the Philippines, and the companies have filed for an EUA in India and for Emergency Use Listing with the World Health Organization (WHO).
Novavax has also announced regulatory filings for the vaccine in the U.K., Australia, New Zealand, Canada, the European Union, and with the WHO.
A Biologics License Application submission in South Korea has also been conducted, and Novavax officials expect to submit a package to the U.S. Food & Drug Administration by the end of 2021.