September 17, 2021

COVID-19 Weekly Newsletter: Updates on Vaccines for Children and Potential Authorization for Booster Shots

Amid continued spread of the Delta variant and sobering new studies about the toll COVID-19 has exacted on medical staff, vaccine manufacturers and public health leaders continue to seek solutions — including efforts to authorize booster shots and vaccines for children and to increase global access to vaccines.

Update on Approvals for Booster Shots, Vaccines for Younger Children

One of the mRNA vaccine manufacturers plans to file for Food and Drug Administration (FDA) emergency use authorization in early October for its vaccine to be used for children ages 5 to 11. In November, it plans to seek the same, for children under the age of 5. According to data from the American Academy of Pediatrics, the number of new child cases of COVID-19 has risen sharply in recent weeks, with nearly 500,000 new cases of Covid-19 in children recorded.

On September 15, the mRNA vaccine manufacturer also announced it would file an emergency use authorization for its booster shot. This announcement came after data was released showing its booster reduces the possibility of a breakthrough infection. In the meantime, on September 17, the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) will review data submitted by the mRNA vaccine manufacturer to authorize its use as a booster. Data gathered from Israel and United States by the vaccine manufacturer suggests, similar to the other vaccines, that the vaccine’s efficacy wanes over time and there is an increased chance of breakthrough infections. Next week, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss clinical recommendations for the need of booster shots. World Health Organization (WHO) scientists oppose plans for a booster shot until vaccine supplies are sufficient to allow other countries struggling to obtain vaccines to vaccinate their citizens.

1 in 500 Americans Died Due to COVID-19

As of today, 19 months into the pandemic, 670,032 Americans have lost their life to COVID-19. Currently, one in four hospitals have their intensive care units at least 95% full, COVID-19 cases in children are on the rise, and roughly 1900 deaths are being recorded daily.

WHO to Give Africa 30% Of the Vaccines It Needs by February

The World Health Organization (WHO) hopes to provide Africa 30% of the vaccines it needs by February. This target still falls short of the goal African leaders had of having 60% vaccine coverage. Countries have been urged, including the United States, to lift export bans and restrictions on vaccine materials and finished product to give other countries the chance to buy COVID-19 vaccines. The U.S. does not have an official ban on exports, but since President Biden invoked the Defense Production Act earlier this year companies have prioritized U.S. manufacturing and use of COVID-19 vaccines.

Centralizing Clinical Trials Could Save Time and Resources — and Lives

A former FDA Commissioner published a compelling argument that when a widespread health crisis strikes, having a centralized system of coordinated clinical trials could help figure out which treatments are useful and which are useless much faster than the current approach of numerous, small, disparate research efforts. He points to the U.K.’s Randomized Evaluation of COVID-19 Therapy (RECOVERY) trial as an example of a successful centralized approach.

Biases and Confounding in Observational Studies of COVID-19

Despite best intentions, observational studies of various interventions tried for treatment or prevention of COVID-19 may be increasing confusion rather than clarity. A recent review explains the unintended biases and confounding that creep in due to the lack of double-blinding, randomization of subjects or interventions, and absence of control groups. For example, the survivor bias, selective reporting, and unaccounted-for factors that influence the outcomes would all skew the results in unknown ways and render them, strictly speaking, uninterpretable. By detailing these pitfalls, the article aims to help clinicians and researchers to direct their efforts into studies that are more likely to produce high-quality, actionable evidence.

Guidelines for Clinical Management of COVID-19 Proliferate, Sometimes Disagree

An examination of 66 clinical guidelines issued around the world for the management of COVID-19 found that their quality varied widely. The authors estimated that less than a quarter of these guidelines were sufficiently reliable to be used in clinical practice. Many specific recommendations in the guidelines lacked objective data-based support, and several recommendations diverged between different guidelines.

Supporting Medical Staff Is Crucial to Nation’s Health

According to the data gathered by the Physicians Foundation, almost two-thirds of the U.S. physicians experience the burnout this year, a drastic increase from pre-pandemic years. Another large study also documented the burden of the pandemic on doctors, nurses, medical assistants, lab technicians, social workers and other health care workers. The American Nurses Association (ANA) is sounding alarm about the increased stress among nurses and the worsening shortage of qualified nursing staff. The Association of American Medical Colleges (AAMC) further detailed the looming crisis due to the widening gap between the supply and growing demand for primary and specialty care physicians.

Airborne Transmission

A new review article in Science describes the current state of knowledge about respiratory viruses’ transmission through aerosols. The authors discuss environmental factors, infectious potential, and protective measures for indoor and outdoor aerosols.

Large Meetings Without Preventive Measures Carry High COVID-19 Risk

A recent case study investigated by CDC reminds us that large gatherings over an extended period of time remain high-risk sources of COVID-19 infection if no masking, vaccination or testing is required of attendees. The Delta was the predominant but not the only variant found in that case study examining primary as well as secondary infected individuals. A separate article in Nature documents the ability of the Delta variant to evade immune responses, leading the authors to conclude that “continued infection control” is warranted in the “post-vaccination era.”

mRNAs History Lesson

The journal Nature published an engaging history of mRNA vaccines, starting from the discovery of mRNAs in the early 1960s to the present day. The article presents both the science and the scientists behind this life-changing product.

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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