Over the course of the pandemic, we’ve been keeping a pulse on the status of vaccine trials and preliminary data, and we are working closely with our Vaccine Task Force to craft helpful guidance for senior living providers when a vaccine receives authorization. Here is a download of what we know to date about current vaccine trials:
The Trump Administration’s Operation Warp Speed established a goal of developing a COVID-19 vaccine within 14 months, an accelerated process in comparison to the typical six-year timeframe. The mission of the program was to deliver 300 million doses of a safe and effective vaccine by January 1, 2021.
Of the 44 vaccines currently in clinical trials, several are nearing completion and preliminary data looks promising for both safety and efficacy. There are three main types of vaccines under development in the United States: classical recombinant protein vaccines, viral-vectored vaccines, and the newer mRNA technology. The two trials that are most advanced in the process are both using mRNA technology:
- Pfizer’s mRNA BNT162b2 vaccine started phase III clinical trials July 27 and has administered vaccines to 42,000 participants out of a target of 44,000 (including second doses to more than 35,000 participants). Reactogenicity (side-effects) were mostly mild to moderate and increased with the second dose. Based on Phase I trial data, immunogenicity was good, with rapid increase in binding and neutralizing antibodies seven days after the second dose, comparable to that of convalescent sera. Vaccine safety classified as fine.
- Moderna’s mRNA-1273 also started Phase III trials on July 27 and has administered doses to 30,000 participants (including second doses to 25,000 participants). Based on Phase I trial data, reactogenicity were mostly mild to moderate and increased with the second dose. Immunogenicity was good, with rapid increase in binding and neutralizing antibodies seven days after the second dose, comparable to that of convalescent sera. Older adults had a similar response to young adults. Vaccine safety classified as fine.
The FDA indicated that it would consider vaccines for emergency use authorization (EUA) once data is available for a two-month period after the vaccines have been administered. Based on this timeline, the FDA is likely to consider EUA release of one or more COVID-19 vaccines by mid-November or early December.
On October 16, the HHS Pharmacy Partnership for Long-Term Care Program was announced, which established a partnership with CVS and Walgreens for the complete management of the COVID-19 vaccination process for long-term care communities. The deadline to opt-in to the program is Friday, November 6. Of Argentum members surveyed, 2 out of 3 providers indicated that opting into this program is their first preference for resident vaccine management, while more than 3 out of 4 indicated it was their preference for employee vaccine management.
The above information on vaccine trials was disseminated via the American College of Medical Toxicology (ACMT) webinar, “Update on COVID-19 Vaccine Clinical Trials: Are We There Yet?,” from October 28, 2020, featuring Evan Anderson, MD, Professor, Pediatrics and Medicine, Emory University School of Medicine. Dr. Anderson is the principal investigator coordinating several vaccine trials for different manufacturers.