The COVID-19 vaccine, a small stab in the arm and a giant step forward for mankind. This is a triumph. Most vaccines have taken decades to develop, but this vaccine has moved from conception to large-scale implementation within a year. The specific viral RNA sequence required to design the vaccine wasn’t known until January 2020 and within less than a year we have a COVID-19 vaccine. There is a lot of credit to go around: to the scientists who shared data and who developed the underlying methods to create a vaccine, to the clinical trialists who performed high-quality work in the setting of a global pandemic, to the thousands of participants who volunteered to take part in clinical trials, and to the governments that helped create performance standards and a market for the vaccine. And now as the vaccines become available, in order to ensure their success, the scientific world will rely on the public accepting the vaccine as the COVID-19 epidemic continues to rage. A return to normalcy depends on the success of vaccines to prevent the disease and limit further spread of infection.
The two COVID-19 vaccines: Pfizer and Moderna, currently approved in the U.S. are mRNA vaccines and while mRNA technology is new, it is not unknown as research has been ongoing for more than a decade. It’s important to note that mRNA vaccines do not contain a live virus nor do they pose the risk of causing disease in the vaccinated person. mRNA vaccines take advantage of the innate process that cells use to make proteins in order to trigger an immune response and build immunity to SARS-CoV-2, the virus that causes COVID-19. While both vaccines are equally effective, Moderna differs from Pfizer in the fact that it can remain stable for 30 days at two-eight degree Celsius (the temperature of a standard medical refrigerator). In contrast, the Pfizer vaccine needs to be kept at a much lower temperature, posing a slight issue with its distribution as hospitals scramble to find containers that can maintain colder temperatures.
Today we have part of the answer for both vaccines and are strongly encouraged by the results so far. Both the vaccines have been studied in tens of thousands of volunteers, including older individuals, prior to being given emergency-use authorization approval by the FDA. Both vaccines produced results reporting 95% effectiveness in preventing COVID-19 disease among thousands of clinical trial participants. However, while these are most definitely immediate successes, there is still no long term data to inform us about the duration of protection given by these vaccines. Both individuals who receive the vaccine and trial volunteers will be followed for over two-three years to get an answer to this question.
The main point to emphasize is that both the vaccines are safe despite minor side effects as is the case with many other long-standing vaccines. In the clinical trials commonly reported side effects were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever. Side effects such as these typically began within two days of vaccination and quickly resolved one-two days later. Additionally, it is important to be aware of the fact that more people experienced these side effects after the second dose than after the first dose.
More recently, it has been reported that some people have experienced severe allergic reactions — also known as anaphylaxis — after getting a COVID-19 vaccine. As an example, an allergic reaction is considered severe when a person needs to be treated with epinephrine or an EpiPen© or if they need go to the hospital to seek medical treatment. The CDC recommends that people with a history of severe allergic reactions not related to vaccines or injectable medications — such as allergies to food, pet, venom, environmental causes, or latex — should still get vaccinated. People with a history of allergies to oral medications or a family history of severe allergic reactions, or alternatively those who might have a milder allergy to vaccines (no anaphylaxis) — should also still get vaccinated. If an individual has a severe allergic reaction after administration of the first shot, they should refrain from receiving their second dose. Currently, the CDC is monitoring all reports of severe allergic reaction.
As the supply of the COVID-19 vaccine in the U.S. is expected to be limited at first, the CDC recommends that the vaccine initially be allocated to healthcare personnel and long-term care facility residents. And why is this?
Healthcare personnel continue to be on the front line of the nation’s fight against this pandemic. By providing care to those who are or might be infected with COVID-19, healthcare personnel are at an exceptionally high risk of being exposed to and getting sick with COVID-19. As of December 3, 2020, there were more than 249,000 confirmed COVID-19 cases and 866 deaths among healthcare personnel alone.
Alternatively, providing vaccine to long-term care facility (LTCF) residents will help save the lives of those who are most at risk of dying from COVID-19. LTCF residents include adults who reside in facilities that provide a range of services, including medical and personal care, to persons who are unable to live independently. The communal nature of LTCFs and the population served (generally older adults often with underlying medical conditions) puts facility residents at increased risk of infection and severe illness from COVID-19. By November 6, 2020, approximately 569,000-616,000 COVID-19 cases and 91,500 deaths were reported among LTCF residents and staff members accounting for 39% of deaths nationwide.
While the current supply of the COVID-19 vaccine is limited, it is expected to dramatically increase in the weeks and months to come. As vaccine availability increases, vaccination recommendations will expand to include more groups of people. The ultimate goal is for everyone to be able to easily get a COVID-19 vaccination as soon as large quantities of the vaccine are available.
The American people need not worry that cost will be an obstacle to getting vaccinated against COVID19. The vaccine doses purchased with U.S. taxpayer dollars will be given out to the public without necessitating further costs to the individual.
Additionally, both vaccines require 2 doses. The two differ slightly due to the fact that the Pfizer vaccine is indicated for people 16 years and older and the Moderna vaccine is indicated for people 18 years and older. While there have been no specific studies in pregnant women or those who are breastfeeding, currently, there is no data that would warrant a contraindication to its use in these women. These are not live vaccines. So, if a pregnant woman or a woman who is breast feeding is part of a group (e.g., healthcare personnel) who is recommended to receive a COVID-19 vaccine, she should discuss potential benefits and risks of vaccination with her healthcare provider before ultimately making a decision.
We have a tall mountain to climb but the trail in the mountain has already been carved for us by the tens of thousands of volunteers that participated in the COVID-19 trials. It is now up to us to conquer the mountain and ascend to the top of its peak. However, in order for the dream to become a reality, the vaccine needs to be part of a comprehensive program that includes continued widespread mask usage and social distancing.
By Indira Brar, MD
Senior Staff Infectious Diseases, Henry Ford Hospital
Medical Director of HIV Services, Henry Ford Hospital
Medical Director of F6 (Inpatient Infectious Diseases)
Associate Clinical Professor, Wayne State School of Medicine.