Physician Experts Brief Press on Safety and Efficacy of COVID-19 Vaccines
On the morning of Aug. 26, the Arlington, Va.-based Infectious Diseases Society of America (IDSA) conducted a media briefing featuring two IDSA fellows. The two fellows were Kathryn M. Edwards, M.D., professor of pediatrics at Vanderbilt University School of Medicine and a scientific director at Vanderbilt Vaccine Research Program; and Walter A. Orenstein, M.D., professor and associate director, Emory Vaccine Center, professor in the department of medicine, division of infectious diseases at Emory University School of medicine, and director at the Emory-UGA Center of Excellence for Influenza Research and Surveillance (CEIRS), and fellow IDSA. Amanda Jezek, senior vice president of public policy and government regulations of IDSA moderated.
Orenstein kicked off the briefing saying that “Vaccines are some of our most effective prevention tools. The only human disease ever eradicated—smallpox—was eradicated with a vaccine. Most vaccine-preventable diseases of childhood are reduced by more than 90 percent and some, like polio and measles, have been eliminated in the U.S. by the use of vaccines.”
“The immune system functions like an army or police force,” he continued. “Its job is to prevent the invader, for example a virus, from invading in the first place by creating a wall. For humans, this means antibodies, which are proteins, which bind to the invader and prevent it from gaining cells; the antibodies also kill the invader. In addition, it has mechanisms that destroy the invader after initially invading cells in the body but before disease can occur. This is known as cell-mediated immunity, in which affected cells in the body are destroyed before the invader can enter enough cells to cause disease.”
Orenstein explained that “What a vaccine does is give the immune system practice. For example, messenger RNA vaccines (mRNA) against COVID-19 contain the genetic code to induce protection of a protein on the surface of the SARS-CoV-2 virus, called a spike protein, or S protein, the immune system detects this as foreign and makes antibodies against the spike protein, as well as inducing cell-mediated immunity.”
“One would never send an army into battle without training. Vaccines help train the immune system to be prepared to repel an invader like a virus,” he added.
Next, Edwards took over, and said that, “As Dr. Orenstein mentioned, we have three vaccines approved for use in the U.S. Two are mRNA vaccines made by Pfizer and Moderna and one is an adenoviral vector vaccine made by Johnson & Johnson (J&J). As Dr. Orenstein mentioned, they are all directed to the spike protein that is critical in the actual anchoring of the virus to the host cell and in the initiation of infection. All three of these vaccines were initially evaluated in very large trials, enrolling over 30,000 participants. All three were shown to be very effective in preventing disease caused by laboratory-confirmed SARS-CoV-2 virus. Although the vaccines were shown to cause local pain and swelling, and some fever and fatigue in many of the vaccines, very few serious side effects after vaccination were detected in these large trials. Based on these reassuring safety and efficacy data, the three vaccines were given Emergency Use Authorization (EUA) approval and the Advisory Committee on Immunization Practices (ACIP) issued guidelines for use. They were universally recommended for all adults, no preference was given, and recently, as Dr. Orenstein mentioned, the Pfizer vaccine has been granted a full license by the FDA and it is anticipated that the other two vaccines will apply and receive that in the future.”
“As time has gone on, millions of doses of vaccines have been given and have continued to be highly effective in preventing serious disease and hospitalization due to SARS-CoV-2,” she continued. “The local side effects noted in the early studies have been confirmed in larger populations who have received the vaccine. In addition, more uncommon side effects have been noted in a few vaccine recipients as more individuals have been vaccinated.”
Edwards asked, “How have these uncommon adverse events been detected? How have we carefully assessed vaccine safety? Well, first, the CDC implemented an app on cell phones to allow you to monitor adverse events after vaccination in the COVID vaccine recipients. This system is V-safe and individuals report adverse events to this V-safe system. And those adverse events that are severe, individuals are contacted to determine the nature and the extent of these reactions.”
She continued “Second, both providers and vaccine recipients are encouraged to report adverse events to the Vaccine Adverse Event Reporting System (VAERS), these reports are meticulously reviewed on a daily basis and patterns of adverse events are carefully sought.”
“Third, large medical care groups assess vaccine safety for their computerized data bases with their links to immunization and medical care visits,” Edwards said. “This system called the Vaccine Safety Datalink (VSD), more precisely predicts whether vaccine adverse events are occurring in those recipients and whether they are more common than would be seen and whether signals of adverse events are detected.”
Edwards then said that, “Finally, the clinical immunization safety assessment, which I am a part, is a consortium of CDC vaccine experts and vaccine scientists and medical specialists from seven academic medical centers who are available on a 24/7 basis to address questions that providers have about adverse events and to try to determine whether those adverse events are related to the vaccine or other ongoing conditions and what to do about subsequent vaccination efforts. A daily call has been held every day, including the weekends, since the start of vaccinations to be responsive to providers.”
Additionally, Edwards added that “Some rare events have been detected and confirmed in the systems. They are indeed rare, but include anaphylaxis after the mRNA vaccines, Guillain-Barre after adenoviral vaccines, thrombosis after J&J, and myocarditis after mRNA vaccines. But these are indeed rare, a few in a million vaccine recipients, all are very uncommon and far fewer in number than the complications seen with COVID infection.”
When the briefing opened for press questions, Healthcare Innovation asked, “Do you endorse hospital worker vaccinations and/or mandates?”
Edwards chimed in, saying, “Absolutely. Hospital workers can be a source of contagion to their patients. So, I think that vaccines should be given to all hospital workers, they should have already received them, I would hope, and I certainly endorse them. All my family members and my grandchildren are all vaccinated, and I am a strong proponent of vaccination of everyone, barring a medical or contraindication.”
Orenstein then responded that “I would agree with that as well. I think mandates are something also to consider in that group. Vaccinating healthcare workers is not only good for them, it’s good for the patient population and their families as well. There’s a lot of confusion on the mandate issue. We don’t allow drunk driving, not just to prevent the driver from getting injured but others. And so, we need to remember that there are not only individual benefits for vaccination but community benefits as well, that’s why we have school mandates for many of the childhood vaccines—to protect the vaccine-ee, as well as the rest of the community.”
Jezek added that “IDSA officially supports vaccination requirements. We are requiring our own staff to be vaccinated against COVID-19.”
