COVID-19 Update September 1, 2022: FDA Authorizes Omicron-Specific Booster

On Wednesday, the Food and Drug Administration authorize the first subvariant-specific “redesign” of the COVID-19 vaccine, with the rollout projected to begin as early as next week.

Each day, the U.S. records an average of 90,000 new infections of COVID-19 and 475 new deaths, largely driven by the COVID-19 Omicron subvariants BA.4 and BA.5. According the Arizona Department of Health Services (ADHS) COVID-19 data dashboard, there were 8,661 new cases of COVID and 67 newly reported deaths this week in Arizona.

The Centers for Disease Control and Prevention (CDC) published a study late last week that demonstrated the U.S. has experienced a greater drop in life expectancy in the past two years than at any point since the Second World War. KJZZ reports that the drop in average Arizonan life expectancy fell below the national average of 77 to 76.3.

Federal officials are banking on the COVID-19 vaccine booster to curb the consistently high cases and deaths as winter approaches. The New York Times reports that the boosters are “bivalent” — containing a combination of the original formula and one targeting BA.5. Both Pfizer and Moderna have produced the new vaccine, with the Moderna option only available to adults 18 and older, while the Pfizer vaccine will be available to individuals as young as 12.

The New York Times also notes that as the campaign for the bivalent shots ramps up, much of the localized infrastructure for COVID-19 vaccine distribution has closed or the funding has dried up. Additionally, with the virus’s death toll falling far below other peaks of the pandemic, Americans are less interested than ever in receiving vaccine boosters.

But many Americans might express more alarm if they knew that they had been infected by Omicron. According to a study published in JAMA Network Open last week, more than half of adults with a recent COVID-19 Omicron infection were aware of their infection when it took place. Physician’s Weekly reports that researchers found 56% of participants that had been infected were unaware, and only 10% reported having any symptoms, which they attributed to something other than the coronavirus.

Last week, Moderna Inc. sued Pfizer and its partner BioNTech SE, accusing the companies of infringing on intellectual property owned by Moderna. According to the Wall Street Journal, the lawsuit concerns the messenger RNA (mRNA) technology developed and patented by Moderna several years ago, including a modification that circumvents immune responses to the vaccine’s presence. From Moderna Chief Executive Stephane Bancel:

We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the COVID-19 pandemic.

Pfizer denies these claims, arguing that the COVID-19 vaccine Comirnaty was developed using BioNTech’s proprietary mRNA technology. In a statement to Inside Health Policy, the company said it would “vigorously defend” against Moderna’s allegations, and BioNTech agreed:

BioNTech also values and respects valid and enforceable intellectual property rights of others and remains confident in its intellectual property. It is an unfortunate but rather regular occurrence that other companies make allegations that a successful product potentially infringes their intellectual property rights, even more so here after witnessing the historic accomplishments of a vaccine like [Comirnaty].