Throughout the year, there are lots of monthly or weekly observances — for cancer awareness, heart, Alzheimer’s and many more. But in this time of pandemic as we anxiously await a COVID-19 vaccine, few observances are more timely than August’s National Immunization Awareness Month.
Fall and winter flu season is also coming right up, hence the August observance of the benefits of vaccinations. So regardless of where your patients are working or going to school at this challenging time, that’s another reason to be focused on immunizations.
Speaking briefly of the annual flu vaccine, current CDC guidelines call for an appropriate type of flu vaccination for everyone 6 months of age and older, with rare exception. Immunization is particularly important for people who are at high risk of serious complications from influenza, already at risk for COVID-19. See People at High Risk of Developing Flu-Related Complications for a full list of age and health factors that confer increased risk.
Here’s a CDC link to the vaccine types, supplies and availability options for the 2020-21 flu season. The webpage also provides more in-depth information about the antigen derived from the flu viruses, and how to answer questions for those patients who have a history of egg allergy.
A COVID-19 vaccine update
Russian claimed Aug. 11 that the country had approved the world’s first COVID-19. The scientific community says the jury’s still out on its status and effectiveness, having been tested in just 76 persons; Russia admitted that the vaccine can’t be used widely until at least Jan. 1, presumably so they can complete proper clinical trials. But it is hopefully just one indication of how many people and organizations are working on a vaccine, as well as continuing to hone the treatment methodologies used to reduce the death rate.
What we DO know: A U.S.-based Phase 3 clinical trial begins
The National Institutes of Health recently announced that a Phase 3 clinical trial has begun of a COVID-19 investigational vaccine, evaluating if the vaccine can prevent symptomatic COVID-19 in adults.
The vaccine, known as mRNA-1273, was co-developed by the Cambridge, MA-based biotechnology company Moderna, Inc., and the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH. The trial, to be conducted at U.S. clinical research sites, is expected to enroll approximately 30,000 adult volunteers who do not have COVID-19. The NIH Coronavirus Prevention Network (CoVPN) will participate in conducting the trial.
Volunteer participants sought
The trial is designed to evaluate the safety of mRNA-1273 and to determine if the vaccine can prevent symptomatic COVID-19 after two doses. As secondary goals, the trial also aims to study whether or not the vaccine can prevent severe COVID-19 or laboratory-confirmed SARS-CoV-2 infection with or without disease symptoms. Among other objectives, the trial also seeks to answer if the vaccine can prevent death caused by COVID-19 and whether just one dose can prevent symptomatic COVID-19.
Trial volunteers will receive two intramuscular injections approximately 28 days apart. Participants will be randomly assigned 1:1 to receive either two 100 microgram (mcg) injections of mRNA-1273 or two shots of a saline placebo. The trial is blinded, so the investigators and the participants won’t know who is assigned to which group.
Adult volunteers interested in joining the study can visit www.coronaviruspreventionnetwork.org, or ClinicalTrials.gov and search identifier NCT0440427.
Continue to encourage face coverings, distancing and isolation
Proper face coverings, social distancing and isolation should still be encouraged as ways to help mitigate the spread of SARS-CoV-2, said NIAID Director Anthony S. Fauci, MD. But he added that “we urgently need a safe and effective preventive vaccine to ultimately control this pandemic. Results from early-stage clinical testing indicate the investigational mRNA-1273 vaccine is safe and immunogenic, supporting the initiation of a Phase 3 clinical trial. This scientifically rigorous, randomized, placebo-controlled trial is designed to determine if the vaccine can prevent COVID-19 and for how long such protection may last.”
Toolkits for reaching parents, patients, other healthcare professionals (National Immunization Awareness Month (CDC)
COVID-19: Helping people and communities plan and respond (CDC)
Volunteering for the Phase 3 mRNA-1273 COVID-19 study (Details, online application)
Videos on how clinicians can explain the value and safety of vaccines (“How I Recommend” video series, by subject or clinician type, CDC)
Interactive Vaccine Guide (patients and other adults, CDC)