SARS COVID 2: Vaccine Safety

Should I get the coronavirus vaccination?

We are all so tired of the coronavirus. How tempting to race to get in line for the vaccine. Before we do, let’s learn more about it.

Viruses are parasites that cannot reproduce by themselves. They require a host such as your healthy cells.  The entire infectious virus particle consists of nucleic acid and an outer shell of protein. The virus we are concerned with, SARS-Cov 2 has a protein shell that contains spikes. Those spikes are the mechanism for how it attaches to and invades healthy cells.

How was the coronavirus vaccine created?

Every virus is a little different so a vaccine needs to be designed for each virus. In the past we have used conventional vaccines to keep the viruses from replicating. The vaccine was made from weakened pathogens. The weakened virus is injected into the body and the body’s immune response is activated. The body now recognizes the infection as a foreign agent and it is primed to respond more rapidly and effectively in the future. The process of collecting the viruses, adapting them to grow in the lab and shipping them around the world can take months. The whole process including testing takes years. For example, the measles virus was first isolated in 1954. A vaccine was first tested in 1958 and the first vaccine was licensed in 1963.  So…almost 10 years!

To combat the coronavirus we needed to respond very quickly. The number of deaths continued to increase. We needed a vaccine before the end of the year. The Trump administration called in the major pharmaceutical companies to work with government agencies through Operation Warp Speed.

Over the past decade, major technological innovation and research investments have enabled “mRNA” to become a promising therapeutic tool in the field of vaccine development. Promising, but no vaccines had been licensed yet, using this method. These vaccines work by using mRNA or messenger RNA, which is the molecule that essentially puts DNA instructions into action.  An RNA vaccine consists of an mRNA strand contained within a lipid nanoparticle. The strand is coded for a disease-specific antigen.

Since a lot of the work to create these vaccines is done through computer modeling, the development process is faster than growing and attenuating live viruses. Once Chinese scientists posted the virus’s genetic sequence on the internet, researchers were quick to create computer models of the virus and then work backward to develop the mRNA strand.

Both companies raced through phase 1, phase 2, and phase 3 trials in order to get the product to market quickly. Phase 3 studies include large numbers of people and are needed before applying for Emergency Use Authorization (EAU)

For the case of SARS-Cov 2, scientists replicated the S-protein spike. That spike is how the Covid virus attaches to and invades our cells. Once the spike was isolated, scientists made computer models to map the spike and create the mRNA strand. The vaccine with the mRNA strand is injected into the body and the cells use the genetic information in the strand to produce the antigen. This antigen is recognized by the immune system as a foreign invader and your immune system responds as appropriate. Your immune system has been trained and will recognize a future virus quickly and destroy it before it has a chance to multiply. According to researchers, the mRNA information does not linger long in your body. Once the instructions have been passed to the protein-making machinery in the cells, enzymes degrade the strand.

Did the trials do a good job of evaluating the new vaccine?

In the past, vaccine studies were criticized for not representing the target populations. Both Moderna and Pfizer used participants from all age groups and allowed preexisting medical conditions such as HIV and Hep C as long as the disease was stable. They made sure all racial and ethnic groups were represented. The Pfizer study included 9.1% Black or African American and 28% Hispanic or Latino. The Moderna study included 10% Black or African American and 20% Hispanic or Latino.

This table summarizes the information presented to the FDA for the two vaccines that have received Emergency Use Authorization (EUA). The Moderna vaccine was 94.5% effective overall and 100% effective for severe disease . Eleven people in the Moderna trial who got the vaccine and contracted the coronavirus (CV+) had a mild or moderate case. No one had a severe case.  The Pfizer vaccine was 95% effective overall and 87.5% effective for severe disease. There were 8 people who took the virus who were (CV+) and one person who had a severe case. These numbers compare favorably to childhood vaccines where they look for efficacy around 80%-90%.

Summary of Efficacy information presented to FDA for EUA

Manufacturer Method Sample size Efficacy (CV+ indicates a positive coronavirus test) Notes
Moderna 2 doses – Day  0 and Day 28. CV test 14 days later 30,000

15,000 vaccine 15,000 placebo

185 CV+ in placebo group and 11 CV+ in vaccine group.

Disease free 94.5%

 

None of the CV+ in the vaccine group had severe symptoms.
Pfizer 2 doses – Day 0 and Day 21. CV test 7 days later. 43,651

21823 vaccine 21828 placebo

162 CV+ in placebo group and

8 CV+ in vaccine group. Disease free 95%

One of the CV+ in vaccine group had severe symptoms

Ok, the numbers look good, but is it safe?

Although the efficacy numbers look good, the most important question to answer about a vaccine is whether it’s safe. There were a number of serious incidents from both trials. Yes, there is risk, especially if you are prone to allergic reactions.

  • Six participants in the Pfizer study died. Two from the vaccine group and four from the placebo group. None were related to the vaccine.
  • Eleven participants in the Moderna study died. Six from the vaccine group and 7 from the placebo group. One death in the placebo group was related to Covid-19. The others were unrelated.
  • Four people from the vaccine group in the Pfizer trial developed Bell’s Palsy. Three people from the Moderna vaccine group developed Bell’s Palsy. One person taking the placebo also developed it. Those numbers are comparable to the incidence of Bell’s Palsy in the general population. The FDA is monitoring the situation.
  • There were a large number of side effects cited in the EUA application for both vaccines. There is a good chance you will experience uncomfortable symptoms as if you had the flu. In most cases the symptoms disappeared over a day or two.
  • For more information on adverse reactions and side effects to the Moderna vaccine review their application to the FDA for emergency authorization. https://www.fda.gov/media/144452/download
  • For more information on adverse reactions and side effects to the Pfizer vaccine review their application to the FDA for emergency authorization. https://www.fda.gov/media/144245/download

Are there other reasons to be concerned?

There was a very unsuccessful vaccine licensed through EUA in the US. In 1918, there had been over 500,000 deaths from the Swine Flu (H1N1) in the US. In January 1976 several soldiers at Fort Dix complained of a respiratory illness and a couple of cases were diagnosed as the swine flu from 1918. The CDC insisted that everyone get vaccinated. A vaccine was produced using a EUA and 46,000 people were vaccinated. Over 4,000 experienced devastating side effects including death. The anticipated pandemic never materialized.

There were 362 cases of Guillen Barre Syndrome. Guillain-Barré Syndrome (GBS) is a rare disorder where the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis. While its cause is not fully understood, the syndrome often follows infection with a virus or bacteria. Each year in the United States, an estimated 3,000 to 6,000 people develop GBS. Most people fully recover from GBS, but some have permanent nerve damage.

The National Academy of Medicine, formerly known as Institute of Medicine, conducted a scientific review of this issue in 2003 and found that people who received the 1976 swine flu vaccine had an increased risk for developing GBS.

What other questions should we be asking?

  • One of the oft-cited concerns is that our DNA may be altered through the action of the vaccine.
    • According to the CDC and the vaccine manufacturers, mRNA vaccines do not interact with our DNA.
    • mRNA never enters the nucleus of the cell, which is where our DNA (genetic material) is kept.
    • The cell breaks down and gets rid of the mRNA soon after it is finished using the instructions.
  • Will employees be forced to take the vaccination?
    • According to the EEOC employers can force employees to get a vaccination.
    • Dorit Reiss, a professor at the University of California Hastings College of Law, said that private businesses have pretty extensive rights. “Requiring a vaccine is a health and safety work rule, and employers can do that,” Since this vaccine was authorized under an emergency agreement, though, the situation may be different.
    • Others, such as attorney Robert Barnes, disagree. He doesn’t think you can force a person to change their body chemistry against their will. Forced vaccinations as a condition of employment could violate HIPAA laws and also disability laws. Especially for a virus that has a recovery rate between 95% and 99%.
    • The Secretary of Health and Human Services may make the determination.
  • If employees are required to get vaccinations, what about customers?
    • Quantas airlines will require customers on international flights to be vaccinated.
  • If you get the vaccine and have severe side effects, can you sue?
    • You can not sue the vaccine manufacturer. In February, Health and Human Services Secretary Alex Azar invoked the Public Readiness and Emergency Preparedness Act. The 2005 law empowers the HHS secretary to provide legal protection to companies making or distributing critical medical supplies, such as vaccines and treatments unless there’s “willful misconduct” by the company. The protection lasts until 2024.
  • How often do you need to get vaccinated?
    • That has not yet been determined. The fact that the mRNA strand leaves the body so quickly may indicate a shorter protection span. Both companies are continuing to monitor the trial participants.

What will you do?

Making informed decisions about the coronavirus is difficult because we have mixed medicine and politics. Some of us feel the government has no right to demand we wear a mask while others challenge and threaten unmasked people in stores. News coverage is suspect as they are always pushing an agenda. The vaccine could help us feel safer if we trusted it.  It seems to work but there are side effects as there are with many vaccines. Should we risk it? The latest information on the side effects from vaccinations given over the last 2 weeks remains hopeful. As of Dec. 19th, 272,000 doses had been delivered. A little more than 3,000 people had mild to severe reactions; could not return to work, had to see a doctor. That’s a little over 1%. Not as good as we want but not too bad. If you are prone to allergies, you especially want to be careful. We will update this information as more results become available.

 

References

https://www.medicalnewstoday.com/articles/how-do-mrna-vaccines-work
https://www.phgfoundation.org/briefing/rna-vaccines
https://www.health.harvard.edu/blog/why-are-mrna-vaccines-so-exciting-2020121021599
https://en.wikipedia.org/wiki/RNA_vaccine
https://www.historyofvaccines.org/timeline#EVT_100726
https://www.modernatx.com/mrna-technology/science-and-fundamentals-mrna-technology
https://www.youtube.com/watch?v=35Idb_lCU4o&list=PLnIki7dGIv7GHHQjl1zI48mkT0wAvLLgB&index=1 COVID-19 Vaccines: MODERNA | PFIZER/BIONTECH | ASTRAZENECA
https://www.nejm.org/doi/full/10.1056/nejm199711133372006#:~:text=Informed%20consent%2C%20with%20specific%20reliance,of%20Medical%20Sciences%20(1993).
https://www.bitchute.com/video/C8IDeuGOSR8i/   (EUA 1976 swine flu)
https://link.theepochtimes.com/mkt_app/thousands-negatively-affected-after-getting-covid-19-vaccine_3625914.html

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