By Robert Pedowitz, DO, FACOFP
Medical Director
On behalf of Family Practice of CentraState, we hope you are staying healthy and well, and enjoying the holiday season.
It has certainly been a very long and difficult year for all of us, and the next few months may continue to be challenging, but the good news is that with the approval and release of two vaccines and many effective treatments, we are starting to see the light at the end of the tunnel in our battle against COVID-19. Many people have asked, “Should I get this vaccine?” The answer is yes! Our physicians and staff are getting the vaccine and we strongly encourage you to do so as well.
With that said, you may have additional questions about the vaccines and I would like to provide you some answers. If you still have any concerns, please reach out to your physician or provider for further discussion.
As you may know, coronavirus (SARS-CoV-2) is a highly contagious disease that spreads easily from person to person whether symptomatic or not. Although most people who become infected only develop mild to moderate symptoms, the percentage of people who develop severe or life-threatening symptoms has overwhelmed healthcare systems throughout the U.S. and the rest of the world. Mathematically, there are simply not enough ICU beds, ventilators or healthcare personnel to treat all those who need advanced care. So, we can all do our part to reduce the number of infections by getting a vaccine that is safe and effective.
The short answer is technology. In January 2020, the first novel coronavirus genome sequence was made publicly available. Scientists with the knowledge and ability had everything they needed to begin vaccine development. In addition, advances in manufacturing platforms, protein engineering and gene synthesis make it possible to develop vaccines more quickly and with precision. Since the Pfizer and Moderna vaccines have not needed to use live viruses to grow, which can take several months to years, and by producing the vaccines simultaneously as the trials were conducted, the production amount became greater and at a faster rate than what we experienced in the past. Both vaccines are messenger RNA (mRNA) vaccines, which is a newer technology but has been researched for years but finally implemented to develop vaccines that prevent infections. These vaccines do not alter DNA, or anything involving our genetics or development. Messenger RNA vaccines function on the premise that mRNA coded for coronavirus antigen can be delivered to human cells and, once there, can be used for production of antigen within the cell. This is unique in that it leads to a robust immune response without the introduction of live, killed or subunit portions of coronavirus. However, because mRNA is highly vulnerable in the body and can be quickly degraded, it needs the protection of a tiny fat bubble for delivery. This delivery method is also a new way to deliver vaccines into the body that has not been previously used in commercial vaccines.
Yes. All vaccines, including COVID-19 vaccines, must go through a rigorous approval process that involves different phases of clinical trials or scientific study. If, at any point, a significant side effect or risk occurs, the study is stopped and the event is investigated before the study can proceed. Clinical trials evaluate investigational COVID-19 vaccines in tens of thousands of study participants to generate the scientific data and other information needed by the Food and Drug Administration (FDA) to determine safety and effectiveness. These clinical trials are conducted according to the rigorous standards set forth by the FDA. Clinical trials also provide additional information on common short-term side effects and risks, examine the relationship between the dose administered and the immune response, and provide initial information about the effectiveness of the vaccine. In phase 3 trials, the vaccine is generally administered to thousands of people in randomized, controlled studies involving broad demographic groups — giving scientists critical information on effectiveness and the immune response in people who receive the vaccine compared to those who receive a control, such as a placebo. The FDA’s evaluation for emergency use authorization (EUA) for a COVID-19 vaccine includes chemistry, manufacturing and control information. Sufficient data must be submitted to ensure the quality and consistency of the vaccine. The FDA uses all available tools and information — including records reviews, site visits and previous history — to assess compliance with current best manufacturing practices.
Yes. Once any COVID-19 vaccine receives its EUA, it will be considered safe. Both the Pfizer and Moderna vaccines have been approved for emergency use authorization from the FDA. Safety and effectiveness data for the Pfizer and Moderna vaccines are available on the FDA website. Once the EUA is issued, the vaccine development process is not complete. The FDA expects the vaccine manufacturer to continue active follow-up for safety — including deaths, hospitalizations, and other serious or clinically significant adverse events — among individuals who receive the vaccine under an EUA to inform ongoing benefit-risk determinations to support continuation of the EUA. It is important to note that if an adverse event occurs in reaction to a vaccine, it typically happens immediately or within seven days of the vaccination.
These vaccines can be given to just about anyone, including those with chronic medical conditions including autoimmune diseases, food and environmental allergies. There is no evidence they affect fertility, and they may be recommended by physicians for women who are pregnant or breast feeding, though this is only after discussion regarding benefits vs. risk. Also, the vaccines are currently approved for ages 16 and up, and there are ongoing studies in children under the age of sixteen.
At this time, the vaccines may present minimal side effects that include pain, soreness and redness at the injection site; body aches, fatigue, headaches, and mild fever that may present for up to 48 hours following the injection. From personal experience, and having already supervised hundreds of vaccines administered to health care professionals, the side effects have mostly involved pain at the injection site and nothing serious. Though there have been only a few reported cases of anaphylaxis (severe reaction) around the world, it is still considered rare and the vaccine is very safe overall.
The initial phase of the vaccines is to administer them to health care professionals and residents of long-term care facilities. This will take a few weeks, likely at least into early to mid-January. The CDC has outlined their recommendations of vaccines after that based on tiers (related to one’s risk of getting COVID-19 related complications if infected). However, each State will determine how and to whom they want to distribute the vaccine per phase. It is believed that the next phase will involve adults over the age of 65 who have chronic medical conditions. This should occur sometime between January and February. There will likely be several sites around New Jersey that will be set up to administer large amounts of vaccines, in the number of hundreds to thousands per day. It is not known yet who will be contracted to administer the vaccines, but it will be done in coordination with hospitals, physicians, community health centers, as well as pharmacies. We do not yet know if we will be giving the vaccines in the offices, as that is yet to be determined by NJ Department of Health. However, we are engaged in the process and will provide education and guidance as more information is shared with us.
We encourage you to continue to follow guidance from the CDC, NJ Department of Health, and from us, as we all work together to combat COVID-19. Please hang in there a few more months, as we are getting closer to the end, and the ability to experience a more “normal” routine. Thank you for your continued trust in Family Practice of CentraState.
Wishing you a safe and happy holiday season!
