September 24, 2021

COVID-19 Weekly Newsletter: Domestic and International Vaccine News

Clinical trials and public health recommendations relating to booster vaccines and potential vaccines for children under the age of 12 continue to be front and center in the United States’ domestic COVID-19 response. Meanwhile, the U.S. continues to support the international vaccination effort, and travel policies continue to shift in response to the latest COVID-19 developments.

CDC Weighs in on Booster Vaccines

On Thursday, September 23, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) met to discuss its clinical recommendations for the need of booster shots. This comes after the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) reviewed the data submitted by one of the mRNA vaccine manufacturers last week and decided boosters were not needed for the general public at this time — and were only necessary for those with high risk of severe illness and underlying medical conditions, long-term care facility residents, individuals 65 and older, and people whose occupations put them at risk (such as health care workers). CDC’s ACIP voted in favor of all of VRBPAC’s recommendations, except for its recommendation to provide boosters to people with occupational risks. However, CDC Director Dr. Rochelle Walensky overruled the advisory panel and voiced her support of approving boosters for such individuals.

A Potentially Dangerous New Variant is Emerging

With the Delta variant accounting for almost 100% of new cases, a new variant currently named R.1 has caught the attention of scientists. R.1 carries several mutations that are linked to reducing the effectiveness of neutralizing antibodies and increasing virus transmission. Currently designated by the World Health Organization (WHO) as a “Variant Under Monitoring,” the R.1 variant of COVID was first detected in Japan and has now spread to at least 35 countries. It has been detected in 47 U.S. states. According to a CDC Report, a COVID-19 outbreak back in March 2021 at a Kentucky nursing facility was traced back to the R.1 variant, which included four possible reinfections. At the time of the outbreak 90% of the residents and 50% of the staff at the facility had received two doses of vaccine. Unvaccinated individuals were three to four times more likely to be infected than vaccinated individuals, and roughly 87% of vaccinated individuals were protected against symptomatic illness.

WHO Estimates Pandemic Could End in March 2022

WHO Department of Public Health Director María Neria stated the COVID-19 pandemic could end in March 2022 as long as immunization of countries with low vaccine rates and availability is addressed.

U.S. to Donate More Vaccine Doses

With the goal to vaccinate 70% of the world population, President Biden announced during a vaccine summit on the margins of the United Nations General Assembly this week that the U.S. will donate another 500 million vaccine doses to bolster availability in poorer countries throughout the world. This additional purchase of vaccines increases the U.S. commitment to 1.1 billion vaccine doses through 2022. While significant, five billion more doses will be needed to meet the 70% vaccination goal.

Updates and Changes to U.S. Travel Policies

The Biden administration announced this week it will relax travel bans instituted by presidential proclamations and put in place new travel policies. Starting in November 2021, all adult travelers flying to the U.S. must provide proof of vaccination and proof of a negative COVID test taken no more than three days before boarding their flight to the U.S. Unvaccinated U.S. citizens, children ineligible to be vaccinated, or those able to obtain an exception to the vaccination requirement (e.g., children, vaccine trial participants, and those with important reason to travel and lack of access to vaccination) must produce a negative test within one day of departure. They must also take a second test after arrival. In addition, travelers will need to provide information to airlines to allow for contact tracing. It was also announced that the U.S. land borders will remain closed to nonessential travel through October 21. Read more analysis of these travel restrictions from Faegre Drinker professionals.

COVID-19 Vaccine for 5- to 11-Year-Olds Shown to Be Safe and Effective

One of the mRNA vaccine manufactures announced this week that its Phase 2/3 clinical trial data has demonstrated that its COVID-19 vaccine is safe and created a strong antibody response in kids between the ages of 5 and 11. While the dose given to 5- to 11-year-olds was one-third smaller than the dose given to individuals 12 and older, the antibody response observed was similar. Side effects were also similar to those in the higher age group. It is expected that a request for emergency use authorization (EUA) will be submitted to the U.S. Food and Drug Administration (FDA) by the end of September. National Institute of Allergy and Infectious Diseases (NIAID) Director Dr. Anthony Fauci stated that the vaccine could be made available for 5- to 11-year-olds by the middle of October. The other mRNA vaccine manufacturer is still collecting clinical trial data and is expected to announce results in approximately three weeks. For children under five years old, the results are expected later this year.

Post-COVID Pulmonary Conditions

Many COVID-19 survivors experience post-COVID fatigue, shortness of breath, “mental fog” and other symptoms. Respiratory difficulties are at the top of the list among the numerous post-COVID sequelae. A recent large study determined that almost 10% of those with respiratory complications have a Post Covid Pulmonary Fibrosis (PCF).

Medical Masks: History Lessons And A 2021 Update

The use of face masks to protect against infection is not new, as was described in various reviews over the years, including in the following:

The most recent brief review positions the challenges of our times in that long history, and exhorts the readers to learn from past successes and failures, in order to support everyone’s health going forward.

Bringing us to the present day, the September 2021 FDA guidance provides detailed information about available types of simple and sophisticated physical barriers (including surgical masks, face shields and air-purifying respirators) that are recommended for use in specific situations, and describes the level of protection expected of each. And CDC reminds us that masks for the general population should be selected based on the anticipated level of risk in the environment where the mask is to be worn, and that an incorrect position or a loose fit would render even the costliest mask useless.

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.

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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