COVID-19 vaccine safety: Answering FAQ and dispelling myths
The development of highly effective vaccines against the COVID-19 virus is an astounding feat of scientific innovation
The COVID-19 pandemic has impacted almost everyone in the United States, resulting in countless losses of lives due to the virus. The necessary countermeasures to combat the spread of the coronavirus, including lockdowns, have devastated families, businesses and the livelihood of so many hard-working Americans across so many industries.
Amid all the negative things that happened in 2020, it is remarkable that there has been positive news with the development of safe and highly effective vaccines against the COVID-19 virus. It is an astounding feat of scientific innovation, powered by free-market capitalism.
In order to return to normalcy, we need 70%-85% of our population to achieve immunity. Vaccines are our best shot to defeat this pandemic, save precious lives and recover our economy. Vaccine hesitancy among the public is an important hurdle to overcome. In the era of social media and the internet, it is unavoidable that there are rumors and myths that sow doubt in peoples’ minds about the COVID vaccines. It is important to disseminate information to leaders across the corrections industry to dispel myths and to arm them with education to encourage their staff and the public to be vaccinated.
Different stages of vaccine development
To realize how great this achievement is, we need to understand how vaccines are developed and the usual timeline of this process.
Once the virus causing the disease is identified, scientists test various vaccine candidates in animals. If successful, they move to Phase I and II trials, during which scientists test the vaccine in a small number of healthy volunteers to make sure the vaccine is safe, and that it produces antibodies. Phase III involves thousands of study participants involving different age, gender and race groups who are then randomly assigned to receive either vaccine or placebo (no vaccine). They are then followed for months to see if the vaccine protects them from getting infected.
In the past, the vaccine development process has taken several decades (e.g., Hepatitis B, polio, whooping cough, measles and Ebola). In some cases, we had to wait more than a century before we had successful vaccines such as for Typhoid and Meningitis. It should also be noted that vaccine development is not always successful. For example, even after decades of research, we have not developed successful vaccines for several diseases including HIV and Hepatitis C.
Successful development of vaccines within a year
Severe Acute Respiratory Syndrome – Coronavirus 2 (SARS-CoV2) was identified to be the virus responsible for the new outbreak and the genetic sequence of the virus was released in mid-January 2020. Within a few weeks, scientists were able to build candidate vaccines using the genetic sequencing information.
After the preclinical stage, Phase I/II clinical trials began in April 2020 and Phase II/III clinical trials began in July 2020. All three phases of the vaccine trials were completed within a year.
By December 2020, the FDA authorized two vaccines against COVID-19 for emergency use in the United States. Compared to the usual timeline of vaccine development, this is a great achievement in response to the global pandemic.
Public trust is key for the successful implementation of vaccine programs. Some may wonder if there were any corners cut to develop the vaccines in such a short span of time. Clinical trial data has been published online to promote transparency and gain public trust. Even though the vaccines were developed within a year, all the necessary steps were carried out and have been independently verified by several scientific committees including the FDA, the Centers for Disease Control (CDC), the World Health Organization and regulatory medical authorities of several countries worldwide. All the data about the vaccine development and approval process are available online for anyone to review. It is important for community leaders to reassure their employees and the public about the safety of the vaccines.
Aim of the COVID-19 vaccines
SARS-CoV2 binds to our nose, throat and lung tissue using spike proteins on its surface (see Figure 1). If the spike proteins are coated by antibodies, they cannot attach to our cells to cause the disease. Hence, the goal of all COVID-19 vaccines is to teach our immune system to make antibodies against these spike proteins. After vaccination, our immune cells will respond to any new virus exposure with robust production of antibodies that will prevent the virus from attaching to our cells.
The Pfizer-BioNTech and Moderna COVID-19 vaccines are mRNA vaccines (Messenger Ribonucleic acid). Messenger RNAs (mRNA) contain the templates to make proteins in our body. To create the vaccines, scientists built an mRNA template for the virus spike protein and covered it in a lipid nanoparticle. The vaccines are not made from live virus or dead/inactivated virus. Since the vaccine does not contain the virus (live or dead), it can be made in the lab without using any eggs or animal tissue. Once injected, the mRNA is taken up by our muscle cells and lymph nodes where the ribosomes (our protein manufacturing plant inside the cell) use the mRNA template to make the viral spike protein. These viral spike proteins are then used by our immune cells to teach themselves how to make antibodies. Within 8-12 hours, the mRNA template disintegrates within our body. It cannot replicate and since it is not a virus, it cannot cause infection. It also cannot go inside our nucleus and hence cannot alter our DNA.
Clinical trial data
The Pfizer-BioNTech vaccine study included 43,548 patients randomly assigned to receive either the vaccine or placebo and then were followed to see if they got COVID-19 infections. Patients who were 16 years or older were included and they received two doses 3 weeks apart. Among those who received the vaccine, 8 got symptomatic COVID-19 infection and 1 person got a severe infection. In the placebo group, 162 got symptomatic COVID-19 infection and 9 developed severe infections. In this study, the Pfizer vaccine was 95% effective in preventing symptomatic and severe COVID-19 infections.
The Moderna vaccine study included 30,420 patients who were 18 years or older and received two doses 4 weeks apart. Among the vaccine recipients, 11 developed the symptomatic COVID-19 infection and no one got a severe infection. Among those who received a placebo, 185 patients got symptomatic COVID-19 infection and 30 developed a severe infection. In this study, the Moderna mRNA vaccine was 94.1% effective in preventing symptomatic and severe COVID-19 infections. Patients got some protection as early as 12-14 days after the first dose and strong protection 10-14 days after the second dose.
The two mRNA vaccines are similar in terms of safety and effectiveness. The main difference is that Pfizer-BioNTech requires ultra-cold freezers (-70 C) for storage. The Moderna vaccine can be stored at -20 C.
Safety of COVID-19 vaccines
Many patients reported some local reactions including pain, swelling and redness after the vaccines. Most of these were mild and improved within a couple of days. It is also common to develop a low-grade fever, muscle aches, joint aches and headache after the vaccine doses. Symptoms tend to be mild to moderate and improve within a couple of days. The symptoms of fever, fatigue and muscle aches are not unexpected and are signs that the body is responding to the vaccines and producing antibodies.
Patients should be educated that symptoms are common, especially after the second dose. This is because the immune system responds quicker and stronger to the second dose as it has already learned how to make antibodies after the first dose.
Among patients who had COVID-19 infections, these symptoms may appear after the first dose as the immune system has some memory from the recent infection. COVID-19 vaccines will boost the immune system of those with the COVID-19 infection, providing them better protection against reinfection. It should be emphasized that the symptoms are not due to any impurities or adverse reactions to the vaccine components.
In the two vaccine studies, there were no cases of severe anaphylactic reactions. A CDC report from January 22, 2021, notes that 0.03% (1266/4041396 vaccine doses) reported adverse events after receiving the Moderna COVID-19 vaccine, with only 10 cases of anaphylaxis (2.5 per million). The Pfizer-BioNTech COVID-19 vaccine had a rate of 11.1 anaphylaxis per million vaccine doses. Anaphylaxis to the vaccine has been reported mainly among patients who have a known allergy history of anaphylaxis. Hence, patients with a known history of severe allergy/anaphylaxis should be monitored for at least 30 minutes after the vaccine. Vaccination sites are recommended to be equipped with medicines (epinephrine injections) and be able to manage cases of anaphylaxis.
Vaccines in the pipeline
The Johnson & Johnson vaccine, which just received approval in the United States, is made of a viral vector (Adenovirus 26) with a template for making spike protein inside. The viral vector cannot multiply and cause disease. The altered adenovirus (common cold virus) is just used as a vehicle to deliver the template for COVID-19 spike protein. It has shown promising results in clinical trials and has the advantage that it requires only a single dose.
Novavax is another vaccine that is expected to be approved soon. It is made of spike protein nanoparticles and has to be given in two doses. Development and availability of these vaccines are important to ensure adequate supply and provide equitable access of vaccines to all.
Globally, the vaccine developed by Oxford/AstraZeneca and manufactured by Serum Institute of India is a leading candidate for the developing world as it is cheaper and easy to store.
Viruses mutate as they multiply and spread. Thousands of mutations have been documented in the SARS-CoV2 virus and the majority of them have no impact on how the virus spreads or causes disease. However, scientists have identified few variants that can spread much more easily between people.
Over the past few months, the UK variant has taken over the majority of infections in the United Kingdom. It has been identified in several states across the United States. Other variants identified so far include a South African variant and a Brazil variant. Fortunately, the available vaccines protect us from these mutant strains. But it is an ongoing battle against the mutating virus. It is important that we accelerate vaccination at a much higher rate than the virus can mutate. In effect, we are in a race with a constantly mutating virus and our best defense is getting as much of our population vaccinated as quickly as possible.
answering COVID vaccine FAQ and addressing myths
How good are the COVID-19 vaccinations?
The Pfizer-BioNTech and Moderna vaccines are approximately 95% effective in preventing symptomatic and severe COVID-19 infections.
How long will it give protection?
Scientists expect the vaccines to give protection for up to a year.
I already had a COVID-19 infection. Should I get the COVID-19 vaccine?
Yes. We know that those who had COVID-19 infection have some protection for up to 3 months. However, those with mild or asymptomatic infections have lesser protection and we have seen them infected again. It is recommended to receive vaccines to boost the protection level to protect against re-infections and possibly variant strains.
Can I stop wearing masks after receiving two doses of vaccines?
No. The purpose of wearing masks is not only to protect us but to prevent the spread to others. Vaccines will protect us from getting symptomatic and severe infections, but we might still be able to spread the virus to others who are not vaccinated yet. Until we have data about how good vaccines are to prevent the spread of infections, we have to wear the masks and maintain physical distancing, even after vaccinations.
Is it safe to get vaccinated if I have an autoimmune disorder or weak immune system due to steroids or cancer therapy?
The Pfizer-BioNTech and Moderna vaccines are mRNA vaccines and do not contain live virus. Both are safe in people with autoimmune or cancer or other immunosuppressive conditions.
Myth: I read online that COVID-19 vaccines cause infertility?
There is a lot of misinformation online about COVID-19 vaccines and infertility. COVID-19 vaccines do not cause infertility. Pregnant women can safely take the COVID-19 vaccines after discussing with their healthcare team.
Myth: COVID-19 vaccines will alter my DNA.
Both mRNA vaccines are just templates for making the viral spike protein. Approximately 8-12 hours after a vaccine injection, they disintegrate in our body. They do not go inside our nucleus and cannot alter our DNA.
Myth: COVID-19 vaccines contain fetal tissue.
Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines are not made from live or dead virus. So, they don’t need any cells or eggs to grow the virus to make the vaccines. They are mRNA vaccines and are made without using eggs, animal tissue or fetal tissue.
Importance of vaccination
It is important for all of us to encourage our colleagues, jail staff, inmates, family members and the general public to get vaccinated as soon as possible so we can all get back to normal life, including how we operate how correctional facilities and the court system. Vaccine hesitancy is a real threat to all of us because if the virus keeps spreading and mutating, there is a possibility that a mutant strain resistant to the vaccine will emerge.