COVID-19 Weekly Newsletter: Full FDA Approval

Faegre Drinker Biddle & Reath LLP

The COVID-19 vaccine approval process reached a major milestone, but the fourth U.S. wave of the COVID-19 virus has prompted some sobering projections about the future of the pandemic.

COVID-19 Vaccine Receives Full FDA Approval

On August 23, the Food and Drug Administration (FDA) granted full approval to one of the mRNA COVID-19 vaccines that has been circulating under an emergency use authorization (EUA) since December. The application included four additional months of efficacy and safety data, confirmation of trial results and an outline of the manufacturing processes. More than 44,000 people were followed for six months. While the formal approval is specific to individuals 16 and older, the vaccine is still available under EUA for children 12-15 years old. Shortly after full approval was granted, many employers and local and state governments announced vaccine mandates for employees. In addition, on Wednesday, the manufacturer of the other mRNA COVID19 vaccine applied for full FDA approval. Results of their final study showed the vaccine to have 93% efficacy and that efficacy remaining durable through six months after the second dose.

100,000 More COVID-19 Related Deaths Anticipated

According to a recent modeling study, by the end of the year the U.S. is projected to have 100,000 more COVID-19 deaths. This summer marks the fourth wave of the pandemic, heavily fueled by the highly contagious delta variant. This week, over 100,000 Americans are hospitalized with COVID-19, nearly six times higher than seen two months ago, and far worse than last August numbers. According to the study conducted by the Los Angeles County Department of Public Health, infection and hospitalization rates among unvaccinated people were 4.9 and 29.2 times, respectively, than those fully vaccinated.

Vaccination Prevented up to 140,000 Deaths in the U.S.

A recent study of the vaccine roll-out in the United States has estimated that vaccinations may have prevented more than 139,000 deaths in the U.S. Researchers collected data (from government public websites and statements) on the speed of vaccination in each state from late December 2020 to mid-May 2021, and developed a statistical model that was then used to compare vaccination numbers with changes in COVID deaths. Within these five months an overall reduction in death rates was noted, with variations in rates among states.

Delta’s Difference

Recent studies confirm that the Delta variant of SARS-CoV-2 proliferates in a host in greater numbers and in a shorter time than previous versions of the virus. As a result, individuals carrying Delta become contagious before they realize it or before they go through any testing after a potential exposure. This acceleration prior to detection allows the virus to spread from person to person faster than the original (“ancestral”) strain of the virus. In unvaccinated individuals, this may cause the COVID-19 disease. Currently available vaccines prevent the disease with high probability, while their prevention against infection is less robust, adding to the possibility that people would pass on the virus unwittingly.

Delta’s Spread

The widely available PCR or antigen tests can diagnose a SARS-CoV-2 infection (recent or present) but cannot specify the strain of the infecting virus. To determine the strain, a more in-depth genomic analysis is required, and only a limited number of laboratories in the U.S. have the appropriate equipment and legal framework to conduct such analyses. The Centers for Disease Control and Prevention (CDC) monitors and keeps a database of circulating strains. The CDC data indicates that in the U.S., by mid-August 2021, the Delta had essentially outcompeted out all the other variants, although the picture may continue changing, as even newer, troubling variants are emerging, including in the U.S.

Clean Air, Clean Lungs

A systematic review published by the European Respiratory Society presents compelling evidence that the health of our lungs is inextricably linked to the quality of the air we breathe. Data from laboratory tests, animals and humans all point to air pollution as causing respiratory illnesses, exacerbating cardiovascular and other conditions, weaening our immune systems, making individuals more susceptible to COVID-19 — and contributing to that disease’s severity and deadliness.

Mask Use in Asthma

One of the falsehoods that has made rounds on social media is that masks are counter-indicated for people with asthma. In fact, the opposite is true. Correctly fitted masks made from appropriate materials, such as cloth, allow full breathing, and, moreover, they protect the wearer not only from SARS-CoV-2 but also from air pollutants and other respiratory viruses — which, in the absence of a mask, could exacerbate asthma. The Asthma and Allergy Foundation of America (AAFA) issued a detailed explanation of these issues,, as did the World Health Organization (WHO). Some medical boards are taking steps to minimize the spread of misinformation and unjustified exemptions related to mask use.

To Understand, Prevent and Heal

Intense work continues in the research and medical communities to understand the nature and underlying mechanisms of numerous pathologies associated with COVID-19 in order to correctly diagnose, detect, prevent and treat them. For example, these researchers reviewed available viral tests and the possibility to determine infectivity. In addition, several recent publications summarized the knowledge accumulated to date about disorders caused by a SARS-CoV-2 infection as well as recommendations for their clinical management, in particular for the following:

Stopping the ‘Infodemic’

Researchers are suggesting that epidemiological control principles be applied to the “infodemic” of misinformation. The key measures they recommend include:

  • Establishing an active surveillance system that is enabled to monitor and react to potential and emerging misinformation contagions.
  • Characterizing misinformation and deception “strains” according to their genesis, virulence, transmission modes preventative measures.
  • Reacting rapidly with evidence, engagement and explanations.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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