Physician and former Commissioner for the Food and Drug Administration (FDA) Dr. Scott Gottlieb said on March 1, 2021 that he sees promising signs suggesting that COVID vaccines are effective in their ability to protect vaccinated individuals against severe COVID disease and reduce person-to-person spread of the virus. A member of the Board of Directors for Pfizer, a major producer of COVID-19 vaccine, he cautioned that early data looks positive, but some uncertainty remains.

 

Pfizer developed its vaccine with German BioNTech, and received one of three emergency use authorizations from the FDA. Moderna has also received this authorization, as well as Johnson & Johnson. The emergency use authorization was issued after the vaccine makers demonstrated a reduction in severe cases and deaths among the vaccinated population. Johnson & Johnson’s clinical trials found a 74% reduction in participants developing asymptomatic infections. That finding, according to Dr. Gottlieb, “is a pretty good indication that there’s a reduction in transmission.” The rate for reduction in severe symptoms and death was higher, and was seen at 95% for both Pfizer and Moderna. Continued precautions are recommended for both vaccinated and non-vaccinated individuals.

 

In late February 2021, Moderna announced that it is working with the United States government to test a booster shot that is aimed at protecting recipients against a COVID-19 variant that first emerged in South Africa, which studies suggest is more resistant to existing vaccines. Moderna shipped the new COVID-19 test vaccine to the National Institutes of Health. The vaccine – which Moderna is calling mRNA-1273.351 – is ready for early stage testing to determine if it can be used as a booster shot against the South African strain, also known as B.1.351. Moderna found that its current two-dose regimen generates a weaker immune response against the South African strain, though the company said antibodies in patients still remain above levels that are expected to provide protection against the virus. The vaccines utilize mRNA, a messenger ribonucleic acid. These molecular couriers carry genetic messages that cause an immunized person’s cells to build a specific protein found in Coronavirus, which in turn causes the body to produce antibodies, thus immunizing the patient. The use of mRNA in vaccines is a new technology that has only been utilized effectively in recent years.

 

“I think most people agree … people who are vaccinated are less likely to transmit the infection if they do become infected themselves,” Dr. Gottlieb said, while adding he expects more information “within the next month or two.” White House Chief Medical Advisor Dr. Anthony Fauci is asking Americans to get vaccinated before potentially new and even more dangerous variants of the virus emerge, and to continue to practice the precautions of wearing masks, good hand hygiene, and social distancing.

 

In its most recent effort, Moderna plans to evaluate three approaches to increasing COVID immunity. The first will use variant-specific booster shots, such as mRNA-1273.351, but at a lower dose than the original vaccine. The second approach will combine the original vaccine with a variant-specific vaccine into a single shot. The final approach will administer a third shot of the original vaccine at a lower dosage. Moderna also plans to test the original vaccine and the new booster shot as a two-dose regimen in people without coronavirus antibodies.

 

Dr. Fauci explained that vaccine booster trials will occur both in people who have already been vaccinated and those who haven’t. The first testing cohort will include volunteers in Seattle and Atlanta who were vaccinated last year as part of Moderna’s phase one clinical trials. Half of those volunteers will receive one dose of Moderna’s COVID-19 vaccine and one dose of the booster, while the other half will just receive the booster. Investigators will then see if both the original COVID-19 strain and the spreading variant have been neutralized. A second cohort will consist of unvaccinated volunteers in Seattle, Atlanta, Cincinnati, and Nashville. Individuals will be randomized to receive six different vaccination strategies made up of Moderna’s original vaccine and its new booster. The study is expected to launch in mid-March. Dr. Fauci emphasized that while the testing trials are ongoing, the public should continue to get vaccinated as quickly as possible.

 

As always, it is important to include your consultant pharmacist as a participant in development of immunization policies, strategies, and education. They can provide your facility with the latest information on benefits of vaccinations and the necessity of training staff and residents alike about the protections that vaccines provide. You can also obtain the CDC’s Frequently Asked Questions and Answers about COVID-19 Vaccinations for Healthcare Professionals at this link: COVID-19 Vaccine FAQs for Healthcare Professionals | CDC.

 

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