This week’s newsletter details the latest developments in the process of approving COVID-19 vaccines for children ages 5-11, a vaccine that produced promising clinical results, and new studies revealing insights about COVID-19 immunity and symptoms.
FDA VRBPAC Recommends COVID-19 Vaccine for Children
On Wednesday, October 27, the Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted in favor of authorizing one of the mRNA COVID-19 vaccines for children ages 5-11. A recent analysis suggested the vaccine's benefits outweigh the risks of adverse side effects to kids. The government already has bought an additional 50 million pediatric doses of the vaccine.
Drug Manufacturer To License Manufacturing of COVID-19 Pill
This week, a biopharmaceutical and a biotechnology company announced they had granted a royalty-free license that will allow their COVID-19 antiviral drug to be manufactured and sold in more than 100 low- and middle-income countries.
Following Delta Variant’s Surge, Average Number of Cases in U.S. Have Dropped
The rate of COVID-19 cases, hospitalizations and deaths have significantly dropped in the U.S. Over the last week, the U.S. averaged approximately 69,000 new cases a day, down about 60% from a peak of the Delta-driven wave (127,531 per day) reached in mid-September, according to Johns Hopkins University data.
Promising Protein-Based Vaccine Seeking Approval
A U.S. biotechnology company is seeking emergency authorization of its SARS-CoV-2 spike protein-based vaccine, submitting an application this week in the United Kingdom. Data from a large clinical trial in the U.K. demonstrated the vaccine was over 96% effective against the original SARS-CoV-2 strain, 100% protective against moderate and severe disease and greater than 90% effective overall. The company’s filing marks the first protein-based COVID-19 vaccine submitted to the U.K.’s Medicines and Healthcare Products Regulatory Agency for authorization. The company expects to complete additional regulatory filings in key markets, including Europe, Canada, Australia, New Zealand the World Health Organization and other markets around the world shortly following the U.K. submission. In the U.S., they expect to submit the complete package to the FDA by the end of the year.
Cases, Deaths and Vaccinations by the Numbers
A Centers for Disease Control and Prevention (CDC) Data Tracker shows that unvaccinated individuals are several-fold more likely to get COVID-19 and even more likely to die from it, compared to vaccinated individuals. As of last week, only 36% of all people were fully-vaccinated globally.
The highest percentage of completed vaccinations was recorded in the United Arab Emirates (over 85%), and the lowest in Africa (5%). The percentage of fully vaccinated individuals last week was:
- 73% in Canada
- 65% in Israel
- 60% in Australia
- 57% in the U.S.
- 51% in Europe (with 66% in the U.K.)
- 49% in South America (with 53% in Brazil)
- 32% in Russia
- In Asia, the overall count was 40%, with China at 72% and India at 21%
How Long Does Immunity Against SARS-CoV-2 Last?
The history of SARS-CoV-2 infection in the human population is not long enough to measure how long-lasting the immunity is. Nevertheless, this virus’ circulation and evolutionary trajectory could be modeled using data available for SARS-CoV-2 combined with that from similar viruses. Using this method, researchers estimated that if SARS-CoV-2 becomes endemic (meaning the virus is not eradicated but rather persists somewhere in the population, even if at a baseline level), then reinfection can be expected within a period of time between three months and five years, with a median at 16 months.
Loss of Taste, Smell in COVID Patients Depends on Viral Load
A retrospective study found that the incidence of loss of taste and/or smell in COVID-19 patients was associated with higher viral loads in those patients. The good news is that over 90% of the patients recovered their olfactory and gustatory faculties within three months.
Additional ResourcesGlobal COVID-19-Related Patent Office Status and Deadline Extension Updates
Information regarding the status of each foreign patent office and the availability of extensions of time in each jurisdiction.Government Actions: COVID-19
Tracking executive orders, legislation, and other government actions related to COVID-19 by state and major locality across the U.S.Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.