Today an FDA panel made the historic vote to recommend the authorization for emergency use of the first COVID-19 vaccine in the United States, bringing real hope that the pandemic's end may be in sight.
The first vaccine recommended to be authorized, made by Pfizer, is expected to begin arriving as early as this weekend to health care institutions in Connecticut including UConn Health as part of the state's COVID-19 Vaccination Program's Phase 1a distribution and roll-out plan.
"We are very much ready to receive shipments as early as this weekend," says Dr. Kim Metcalf, Primary Vaccine Coordinator for UConn Health and its COVID-19 Vaccine Program. She serves as Associate Vice President of Pharmacy and Ancillary Services for UConn Health.
The newly approved Pfizer vaccine requires two doses to be administered several weeks apart. The two doses are recommended to be received approximately 21 days apart. The CDC and the Connecticut Department of Health have determined that the first available vaccines will be allocated for those highest risk for COVID-19 including long term care facility residents and their care providers, along with health care workers.
UConn Health is one of four initial Connecticut health care institutions receiving the first shipments of the COVID-19 vaccine in Phase 1a. At this time UConn Health is responsible for vaccinating only health care workers including its own health care employees and other community health care workers working in the surrounding towns of Avon, Canton, and Farmington.
"We are very proud of the fact that we have been selected as one of the four prepositioned health organizations to be administering the first wave of these vaccines. We have been chosen as one of the frontier organizations," said UConn Health CEO Dr. Andy Agwunobi.
"I do want to express how important it is for health care workers to get vaccinated," said Dr. David Banach, UConn John Dempsey Hospital Epidemiologist and Infectious Diseases expert. "This is really how we are going to turn the corner in this pandemic. The world is looking at us."
Infectious Diseases Pharmacist Specialist, Dr. Jeff Aeschlimann, couldn't agree more. "We hope to reduce any hesitation to getting the vaccines."
This new type of messenger RNA (mRNA) vaccine, injected into the upper arm muscle, works by giving instructions for our cells to make a harmless piece of what is called the "spike protein" which is found on the surface of the virus that causes COVID-19. Our bodies' immune system recognizes that the protein should not be there and produces antibodies, as well as T-cells and B-cells that will remember how to fight the virus that causes COVID-19 if we are infected in the future. This protects you from infection by the SARS-CoV-2 virus that causes COVID-19.
The Pfizer vaccine was authorized by the FDA for emergency use because large Phase III clinical trial research results showed it to be 95 percent effective in preventing COVID-19 infection across age, race and ethnicity demographics. Plus, efficacy in adults over 65 years of age was over 94 percent. To date, there haven't been any serious safety concerns with the vaccine, and the data from the Phase III study have demonstrated that the COVID-19 vaccine has been well tolerated. The reported post-vaccine side effects have been minimal. Like all vaccines, the new COVID-19 mRNA-based vaccine by Pfizer can cause side effects, although not everybody gets them. Most people who received the vaccine and experienced side effects described them as "mild" or "moderate" in intensity and the side effects resolved within a few days after vaccination. In the Phase III clinical trial, the most frequent adverse reactions in participants were pain at the injection site, fatigue, headache, muscle pain or joint pain, chills, or fever.
"We believe it is very important to get the vaccine," said Agwunobi. "We've got to turn this around and get back to normality. I fully intend to receive the vaccine myself.
Agwunobi added: "You hear across the world so many countries and so many people that don't have the option to get vaccinated. This is a privilege to be able to get these vaccines, one we are very thankful for."
On December 17, the FDA will meet to consider emergency use authorization of another mRNA-based COVID-19 vaccine made by the company Moderna. If approved, it is expected to also arrive to UConn Health for initial distribution to health care workers in late December. The Moderna vaccine also requires a two dose administration but the two doses are to be separated by approximately 28 days.
The next two phases (Phase 1b and 1c) of the state's COVID-19 Vaccination Program roll-out, expected as early as mid-January, will expand vaccination allocation and distribution to essential workers, adults with high-risk medical conditions, and adults over 65 years of age.
However, UConn Health experts stress even following the two-dose vaccination it is advised that people should still take precautions to prevent themselves from getting or spreading COVID-19 infection until more people are vaccinated over the coming months. Precautions include continuation of frequent handwashing, wearing a mask, and safe social distancing.
