I had mild nervousness and major excitement when it came time for me to get my first COVID-19 vaccine. Admittedly, this is new for all of us but an incredibly big step toward a better future. If we all want a better future, the end of people losing their lives to this awful virus, and a chance to take off that contentious mask (way down the road) then why are many of us resistant to the very thing that should help us?
To understand where we are going, let’s look at where we’ve been. It was 1796 when Edward Jenner developed the first successful widely talked about vaccine by taking the pus from one's blisters and putting it into the person. This innovation led to the eradication (complete destruction) of the deadly Smallpox virus.
Most people do not think twice about the common vaccines of infancy and childhood such as the vaccines for varicella (chickenpox), measles, mumps, and rubella to name a few. These diseases are usually widely controlled and mostly nonexistent in vaccinated persons. I recall having chickenpox as a child and it was a horrendous experience. In fact, I still have scars that haven’t completely faded due to my itchy battle with this villain. However, because of the vaccine, I do not have to worry about my children suffering from chickenpox.
As adults, the most common vaccination is the influenza vaccine (flu vaccine). This is a vaccine that changes from year to year depending on the strains of the virus. Nearly 50% of the American population receive one which results in less spread of the flu, fewer hospitalizations due to flu complications, and fewer symptoms in persons who do get the flu if they have been vaccinated.
Now let’s talk about where we are and where we are going with special contributors on this very important topic. One contributor is Dr. Khaleel Ashraf of Hematology & Oncology Associates of Alabama who happens to also be my wonderful collaborating physician. Nurse Practitioner, Rachel Messer of Hematology & Oncology Associates of Alabama also joins in contributing. She is my colleague, friend, and the chairperson of our practice’s COVID Task Force. Finally, Dr. Eima Zaidi is a respected infectious disease specialist of Birmingham Infectious Disease and Infusion who I have had the pleasure of knowing for several years. I presented the contributors with questions and they provided answers that you can trust regarding the COVID-19 vaccine.
What’s all this about the COVID-19 Vaccine?
1. The COVID-19 vaccines are manufactured by two companies, Pfizer and Moderna. You have to be 16 years old to receive the Pfizer vaccine and 18 years old to receive the Moderna vaccine. Why is this?
Dr. Zaidi- In the Moderna vaccine trial, the participants recruited were 18 years and older whereas in the Pfizer trial the participants recruited were 16 years and older. Hence these vaccines are approved for the ages based on the way the trials were conducted.
2. If the vaccines do the same thing, why are they on two different schedules with the Pfizer vaccine being two doses given three weeks apart and the Moderna vaccine being two doses given four weeks apart?
Dr. Zaidi- This was how the clinical trials of the two vaccines were conducted. However, according to the CDC, the timing of the 2nd shot doesn’t have to be exact and can be given four days earlier or later for both the vaccines.
3. If vaccines usually take years to make, how did this one get made so quickly and should I be concerned about its safety?
NP Messer- There are several reasons this vaccine was able to be produced quickly, but no corners were cut! Given the extent of the global pandemic, there was global cooperation from the scientific community, a wealth of funding and any applications related to COVID were moved to the front of the line for review. Scientists also were not starting their research from scratch. COVID-19 is a specific type of virus from the coronavirus family which has been being studied for years. Recruitment of trial participants was done quickly as so many people were eager to volunteer. Although the trial participants are continuing to be monitored, any significant side effect from a vaccine would be evident in a matter of weeks to short months. After this time period passed and all the data was reviewed by the FDA, the Moderna and Pfizer vaccines were made available to the public. There are several other vaccines in development as well.
4. What long term effects should we expect from the vaccine?
Dr. Zaidi- These vaccines were developed at a record pace however, there were no corners that were cut. These were rigorous clinical trials and no safety concerns were identified despite the sped-up production. Tens of thousands of people in these trials were observed for two months after the final dose to make sure there were no uncommon side effects and there were none.
5. If I’ve already had COVID-19 do I still need the vaccine and if so how long should I wait before receiving it?
Dr. Zaidi- Getting COVID-19 infection might offer some natural protection from reinfection but it is not clear how long this protection lasts. However, there is good evidence that the reinfection is rare in the first three months of contracting Covid 19. Hence the recommendation is to wait until 90 days after your diagnosis to get a Covid 19 vaccine.
6. Why is it a two-dose vaccine series instead of one dose?
Dr. Zaidi- During the trials for the vaccine, protection was assumed to be less after only one shot, and hence a second shot was given for the vaccination to provide 95% protection.
7. How soon after having the vaccine can I see my family and friends?
Dr. Zaidi- You can see your family and friends but not for at least a week after the second dose in order to give your immune system time to produce protective antibodies. However, the vaccines were designed to determine whether the vaccinated people are protected from the illness, not to find out whether they could still spread the virus. In the meantime, everyone, even vaccinated people will need to wear a mask and will need to think of themselves as possible silent spreaders until herd immunity has been achieved which will not happen until at least 70-85% of the population is vaccinated.
8. What is meant by COVID-19 Vaccine and herd immunity?
Dr. Ashraf- Although it is impossible to know with certainty what the limit will be until we reach it and transmission stops, having a good estimate is important. Unfortunately, the precise number is unknown. Early estimates varied from 60-70% of people inoculated for herd immunity, however more recent data, especially in light of more infectious strains, suggest over 90% of the population needs to get vaccinated before achieving herd immunity.
9. How long does it take the vaccine to take effect?
NP Messer- Both the Pfizer and Moderna vaccine reached full efficacy, around 95%, two weeks after the second dose. Even once you reach this point, you should continue to mask and social distance until widespread vaccination is complete.
10. What does it mean that this is an mRNA virus and vaccine?
Dr. Zaidi- COVID-19 vaccines are mRNA vaccines which means that it gives instruction to our cells to make a harmless piece of ‘spike protein’. The spike protein is found on the surface of the Covid-19 virus. This tricks our immune system to trigger an immune response to the virus’s spike protein and produce protective antibodies. The mRNA vaccines do not contain a live virus and don’t carry a risk of causing a disease in a vaccinated person. The mRNA from the vaccine never enters the nucleus of the cell and doesn’t affect or interact with the person’s DNA.
11. What's the duration of protection and revaccination?
Dr. Zaidi- Since the vaccines are so new this is not known for sure. Based on the other viruses that are similar to coronavirus that causes COVID-19, the COVID-19 vaccines might be able to protect people for a couple of years. This is just an educated guess. More data will be needed in the future to know this for sure.
12. How worried should I be about the new strain? How is it different from the current strain?
Dr. Zaidi- A more contagious form of COVID-19 strain has been circulating in the US. This new mutant, B.1.1.7 is about 50% more transmissible than the previous form and has about 23 new mutations. Apart from greater transmissibility, the variant behaves like the earlier form.
This means that the people will need to religiously adhere to the precautions like social distancing, hand hygiene, mask-wearing and improved ventilation. So far Pfizer COVID-19 vaccine will cover the variant strain according to the company. For the Moderna vaccine, the trials are underway and the results are expected to be available in February 2021.
13. What can you tell us about the side effects of the vaccine?
Dr. Ashraf- Across RNA-based vaccine candidates, observed side effects reported to date have been similar to those experienced with the seasonal influenza vaccination, but maybe more common given the two-dose schedule for most COVID-19 mRNA vaccines:
Pain at the injection site (up to 60%)
Fever (up to 50%)
Headache (up to 42%)
Fatigue (up to 28%)
Joint pain (up to 24%)
14. Is it true that the COVID-Vaccine causes Bell’s Palsy?
Dr. Ashraf- In the Moderna vaccine trial, four individuals out of 30,000 reported facial paralysis, three who had received the vaccine, and one who received the placebo. Four of the 43,000 participants in the Pfizer trial developed facial nerve paralysis, all in the vaccine arm of the trial. Bell’s palsy, which is a specific form of sudden weakness in one side of the face (and very rarely both sides), occurs for various reasons and is due to swelling of the facial nerve, which is responsible for moving many muscles of the face. Most cases are self-limiting with complete recovery. While there appears to be a slight increase in Bell’s palsy among those who received vaccine versus placebo, the numbers are too small to make a direct correlation. Also, of note, in the general population, having nothing to do with Covid-19 nor the Covid-19 vaccine, approximately 40,000 individuals develop Bell’s palsy annually in the United States, or approximately 1 in 10,000. In both groups of vaccine trial participants, the rate (1 in 10,000) was commensurate with the incidence of sudden facial paralysis in the general population.
15. How does the COVID-19 vaccine compare to the flu vaccine?
Dr. Ashraf- Flu vaccine is a single shot and provides on average 44% protection against seasonal influenza or the flu. Both Moderna and Pfizer vaccines require two shots and provide 95% protection against COVID-19. Flu vaccine could use inactivated virus (the flu shot) or live attenuated virus (nasal spray flu vaccine). COVID-19 vaccine is made using the mRNA technology, whereby the instruction to make just a component of the virus (spike protein) is injected. This mRNA code can not cause COVID-19 and is not incorporated into the genetic code.
16. How is the distribution of the vaccines organized and when can I expect to get it?
NP Messer- All the states vary some on how they have set up their vaccine distribution plan. In Alabama, vaccine distribution has been divided into four phases. Phase 1a includes healthcare workers and residents in long term care facilities. On January 18, Alabama will also start vaccinating some residents in Phase 1b, including those over 75 years old and first responders. Phase 1b will also include other front line workers and those living in congregate settings. Once Phase 1b is complete, Alabama will move to Phase 1c which includes residents 65-74 and those under 65 with high-risk medical conditions. Phase 2 will include anyone who did not qualify for a previous phase. More information about Alabama’s allocation plan can be found at https://www.alabamapublichealth.gov/covid19/vaccine.html.
Considerations for Special Populations
17. Is there a vaccine for children and adolescents being prepared? What are the unique complications associated with creating a vaccine for this population?
Dr. Zaidi- So far no coronavirus vaccine has been approved for children. New vaccines are typically tested on adults first before researchers launch trials on children. The trials on children as young as 12 are underway by Pfizer and Moderna. If these trials have good results the companies will then recruit children younger than 12. The FDA will then have to review these results before the vaccine can be approved for emergency use authorization on children.
18. Should people with preexisting conditions like high blood pressure, diabetes and COPD receive the vaccine?
NP Messer- Absolutely! Patients with these and other preexisting conditions are those who have the highest chance of having a more severe COVID infection and have a higher chance of being in the hospital or even dying. Because of this, patients with preexisting conditions are prioritizing in the vaccine allocation plan, and in the state of Alabama are in Phase 1c.
19. Should you get the COVID-19 vaccine if you are pregnant?
Dr. Ashraf- Pregnant individuals are more likely to have certain manifestations of severe illness associated with COVID-19 infection such as ICU admission, mechanical ventilation, and death especially if they have comorbidities like diabetes and hypertension. Also, the effect of COVID-19 infection on the developing fetus is unknown. While the COVID-19 trials excluded pregnant women, most expert societies currently favor vaccinating pregnancy and lactating mothers. The decision has to be individualized and the timing of vaccination needs to be discussed with your obstetrician.
Considerations for immunocompromised persons.
20. Can the vaccine be given to immunocompromised persons?
Dr. Ashraf- Though there were no immunocompromised patients enrolled in the trial the thought is that it is acceptable for them to take it. However, the specific efficacy and safety of a COVID-19 vaccine has not been established in the immunocompromised patient populations including those receiving chemotherapy.
21. Why might some immunocompromised persons, including cancer patients not respond to the vaccine?
Dr. Ashraf- In order to get optimal protective immunity following the vaccine a healthy host (person) is needed. Persons without an intact immune system may lack certain immune cells which would make them unable to generate a full immune response. However, as a hematologist and oncologist, I still recommend that immunocompromised persons receive the vaccine. This includes patients with cancer. Prior experience with inactivated or killed virus vaccines have demonstrated some efficacy in immunocompromised patients, leading some societies to recommend vaccination of this population.
22. What is known about the safety and efficacy of protein-based or killed (inactivated virus) vaccines in immunocompromised persons?
Dr. Ashraf- Vaccine safety encompasses acute and long-term side effects associated with a vaccine. Based on experience with other recombinant protein-based and inactivated (killed) virus-based vaccines, no major side effects or unique side effects have been reported in immunocompromised patients. Common acute side effects associated with COVID-19 vaccines reported to date include low-grade fever, myalgias, headache, nausea, fatigue, and soreness/redness at the injection site. These acute side effects were more pronounced after the booster dose (2nd vaccine dose) in some of the trials. Long-term side effects have not been defined for COVID-19 vaccines and will be available once phase 3 trials have completed long term follow up in healthy volunteers.
23. If immunocompromised patients were not included in the vaccine trials and are less likely to respond to a COVID-19 vaccine, should they still receive it? What is the timing in relation to chemotherapy, transplant, antibody therapy, splenectomy etc? Should higher vaccine doses or multiple vaccine types be used?
Dr. Ashraf- The risks and benefits for immunocompromised patients receiving a COVID-19 vaccine should be weighed on a case-by-case basis, with consideration of the incidence of infection in the community. This will depend on the approved vaccine formulation available, the level of immunosuppression the patient has received, and the underlying reason for immunosuppressive therapy (e.g., cancer treatment, transplantation). If plans to proceed with the COVID-19 vaccine are made, vaccination is recommended at least 2-4 weeks prior to the planned immunosuppressive therapy, transplant, or splenectomy. If the patient is receiving or has received immunosuppressive therapy, consider vaccination 6 months after the patient has been taken off therapy to increase the likelihood of developing immunity. After hematopoietic cell transplantation, inactivated vaccines have generally shown low incremental risks and have not caused or worsened graft-versus-host disease; thus, inactivated vaccines are generally started after 3-6 months. If COVID-19 infection rates are low in a community and a given patient is expected to have improved immune status in upcoming months, clinical judgment is appropriate when weighing the desire for protection as early as possible versus delaying vaccination to give the best chance for response. These recommendations may change, based on the results of the approved vaccine trials. Most experts recommend vaccination as long as the vaccine is safe for use, even if the expected protection rate is lower than the general population.
Importantly, vaccination does not change required precautionary behaviors such as masking, social distancing, and frequent hand hygiene. Influenza vaccination should also be administered to immunocompromised patients to reduce the burden of influenza infection and possible dual infection with COVID-19. Finally, all healthcare workers and household contacts should receive a COVID-19 vaccine when available to help protect immunocompromised patients, similar to the recommendations for influenza.
Whether or not an immunocompromised patient is known to have been previously infected with COVID-19 should not affect the decision of whether to vaccinate. Although some immunity is anticipated from experiencing a COVID-19 clinical infection, this immunity may be insufficient or wane, especially in immunocompromised hosts. However, increased side effects could be seen with vaccination, similar to what is observed with the second dose in a two-dose vaccine series.
Until more is known, different COVID-19 vaccines should not be given to the same patient. Although measuring titers may eventually be helpful to assess response, more information is needed. Giving more inoculations or higher doses of an approved COVID-19 vaccine is not recommended at this time.
So back to my first COVID--19 vaccine. I received the vaccine by Moderna and the injection itself was simple and I only had mild discomfort. I received my vaccine early in the morning and by late afternoon, I experienced tiredness that caused me to go to bed early that night. I felt fine when I woke up the next morning with the exception of soreness to the arm that received the vaccine. This soreness lasted for about two days and was resolved. I had no further side effects from dose one. I will receive dose two in about two weeks and I’ll chronicle that in my stories on social media. Side effects following the second dose are expected to be more pronounced but maybe not too bad.
None of us asked for a coronavirus pandemic, but thanks to research and science we can see a brighter future through vaccination just as we did with polio, tetanus, mumps, and more.
What other questions do you have? Do you feel more comfortable regarding the COVID-19 vaccine now? Do you feel more knowledgeable about the COVID-19 vaccine now?
Information about the contributors
Khaleel K. Ashraf, MD is board certified in hematology and oncology as well as internal medicine. He is a partner at Hematology & Oncology Associates of Alabama where he has practiced since 2008. He also participates in research and is a member of many organizations. For more information please visit www.hoaallc.com.
Rachel E. Messer, CRNP is a board-certified Family Nurse Practitioner and an Advanced Oncology Certified Nurse Practitioner (AOCNP) at Hematology & Oncology Associates of Alabama where she has served since 2015. She has been instrumental in keeping our practice moving forward regarding the COVID-19 pandemic. For more information please visit www.hoaallc.com.
Eima Zaidi, MD is board certified in infectious disease and internal medicine. She completed her infectious disease fellowship training at the University of Connecticut. She has practiced in Birmingham, Alabama since 2009 and is a part of Birmingham Infectious Disease and Infusion. For more information please visit www.bhminfusion.com.