February 05, 2021

COVID-19 Weekly Newsletter: Vaccinations Surpass Infection Rate

Encouraging signs continue in the COVID-19 response, as the federal government looks to fine-tune the vaccine distribution process and additional vaccine options seem poised to enter the market.

More People Vaccinated Than the Number of Infected

As of yesterday, 27.9 million Americans had received at least one dose of the Pfizer or Moderna vaccine. This passes the total number of COVID-19 cases in the United States, which is 26.5 million. Israel, the United Kingdom, and the United Arab Emirates have also crossed the same threshold. This progress comes as the post-holiday new infections and hospitalizations are starting to fall and vaccine roll-out is steadily increasing.

Pharmacies to Get Vaccines Directly From the Feds

The Biden administration announced earlier this week the federal government would directly ship COVID-19 vaccines to retail pharmacies. Currently, pharmacies are getting their vaccine supply from the state, and the administration’s hope is the change will reduce shipping times. The federal government is currently sending 10 million doses of the vaccine per week to states compared to the one million they plan to send to pharmacies. This change could substantially broaden access, as 90% of the American population lives within five miles of a pharmacy

Johnson & Johnson Files for FDA Emergency Use Authorization for One-Dose Vaccine

On February 4, Johnson and Johnson (J&J) filed its application for Food and Drug Administration (FDA) emergency use authorization (EUA). If granted, this would be the third COVID-19 vaccine EUA in the United States. Since it is a one-dose vaccine, it does not require someone to return for a second dose to be fully immunized, like what is required by the Moderna and Pfizer vaccines. Though the efficacy appears to be lower than the other two vaccines, it still is above the World Health Organization’s recommended threshold. FDA's Vaccines and Related Biological Products Advisory Committee’s (VRBPAC) will meet on February 26 to review the data and decide whether to recommend FDA issue an EUA for the vaccine.

Russia’s Sputnik V Vaccine Shown To Be Safe and Effective

Back in August 2020, Russia granted provisional approval of their COVID-19 vaccine — designated Sputnik V — for high-risk groups based upon phase 1/2 clinical trial data. At the time this approval was deemed as highly controversial by the scientific and medical communities, especially without phase 3 clinical data. This week it looks like this gamble paid off following the results of a phase 3 clinical trial in which the vaccine has been shown to be safe and effective, demonstrating 91.6% efficacy against COVID-19.

FDA Pulls Back on Effectiveness of Convalescent Plasma

The FDA announced that, after reviewing data collected in randomized controlled trials, it will no longer authorize the use of plasma with weak antibodies to treat hospitalized COVID-19 patients as the data does not support its effectiveness.

Senate Paves the Way for Reconciliation and Biden Stimulus Package

Early Friday morning, following 15 hours of debate and hundreds of filed amendments, Vice President Kamala Harris cast the tie-breaking vote to pass a budget plan that will allow Democrats to advance President Biden’s $1.9 trillion COVID-19 relief legislation. The budget unlocks a legislative tool known as reconciliation which will allow the massive package to clear the Senate without bipartisan support.

Transmission of COVID-19 Driven by Individuals Aged 20-49

Researchers have used cell phone mobility data from over 10 million individuals, as well as COVID-19 mortality data, in a large longitudinal study that concluded that most sustained, resurgent COVID-19 transmission in the U.S. after mid-2020 is driven by individuals aged 20-49. Percent transmission from teens and children were significantly lower. The study suggests a potentially impactful role of mass-vaccinating 20-49 year-olds with transmission-reducing vaccines to reduce probability of resurgences and decrease death rates.

Any such campaigns, in addition to those currently occurring worldwide, would need to happen in addition to non-pharmaceutical interventions such as social distancing, which has had demonstrated impact on reducing transmission and death, and which would reduce the possibility of transmission overtaking and overwhelming vaccine production, distribution and application.

More COVID-19 Insights

FDA-Regulated Products

Government & Regulatory Affairs

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Additional Resources

Global 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.

Tracking Fraud Related to the COVID-19 Pandemic

Tracking federal and state law enforcement and regulatory actions taken against bad actors who have exploited the COVID-19 emergency to defraud consumers and payers.

Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.
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