Is The COVID-19 Vaccine Safe? A Medical Doctor Says Yes

Is The COVID-19 Vaccine Safe?

Coronavirus vaccines have been the best hope in order for the coronavirus pandemic to end. The United States Food and Drug Administration (FDA) began authorizing the emergency use of a COVID-19 vaccine. This article breaks down the following questions:

• What is the process that companies must go through to ensure the production of a safe vaccine?
• How long after getting the vaccine is it effective?
• Are the coronavirus vaccines safe?
• What kind of side effects of the COVID-19 vaccines should I be concerned about?

This article consists of an interview with Dr. Ramin Ahmadi, MD, MPH. Dr. Ahmadi is the Chief Medical Officer for Graduate Medical Education Global LLC and a former assistant professor of medicine at Yale School of Medicine.

What are the benefits of receiving the coronavirus vaccine?

COVID-19 can cause serious illness and even death for some people. Since there’s no way of knowing how coronavirus will affect you, it’s best to simply prevent the spread of it. One way of doing so is getting vaccinated. The COVID-19 vaccine is safe and effective and has the following benefits:

• Help protect you by creating an antibody response in your body without you having to become sick with COVID-19.
• Might prevent you from getting COVID-19. Or, if you get COVID-19, the vaccine might keep you from becoming seriously ill or from developing serious complications.
• Help protect people around you from COVID-19, particularly people at increased risk of severe illness from COVID-19.

Does the COVID-19 vaccine have side effects? If so, is the COVID-19 vaccine safe

A COVID-19 vaccine can cause mild side effects, including:

• Pain, redness, or swelling where the shot was given
• Fever
• Fatigue
• Headache
• Muscle pain
• Chills
• Joint pain

Most reactions to the vaccine happen within the first few days after vaccination and last no more than three days. 

If you do experience side effects after getting a COVID-19 vaccine, it doesn't mean that you have COVID-19. Just take some time to rest. If you develop a fever, stay home. However, it's not necessary to get a COVID-19 test or quarantine.

If you have a reaction that prevents you from being able to eat, sleep, or work, contact your doctor. Also, contact your doctor if you have a reaction that lasts longer than three days.

Signs of an allergic reaction include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness. If you have any of these signs, seek care immediately.

Q&A Interview: Ramin Ahmadi, MD, MPH

What is the process that the FDA, Pfizer, and Moderna have to go through to determine that the COVID-19 vaccine is safe?

Some people are concerned that since the mRNA vaccine is a new technology, it has not been tested on enough people to prove it is safe. 

The Process Of Developing A Vaccine:

Once a company has tested their vaccine in animals and has promising data, they contact the FDA to get approval for a new vaccine, the company has to apply in the form of an IND: Investigational New Drug.  

Next, the FDA will evaluate it. This evaluation includes an assessment of the preclinical data. As part of the assessment, the FDA determines whether these tests were conducted according to “Good Laboratory Practices.” 

FDA also conducts an assessment of the product, its quality and safety, and the technology used to manufacture it, to determine whether it is reasonably safe for testing of the vaccine to move forward in people.

Then, the vaccine is moved to the clinical trial phase. This stage is called “Clinical Development” and consists of three phases under the oversight of the FDA. Each phase has more volunteers for the vaccine: 

• Phase 1: has 20-100 volunteers.
• Phase 2: has hundreds, and various doses are tested in phase 2.
• Phase 3: has thousands of people, and generates important information on effectiveness and safety.

In this last phase, the number of infections in the vaccine group as compared with the placebo arm. If the differences reach above a certain level, ethically they have to stop the trial and give the vaccine to everyone.

Essentially, the number of cases of the disease in the vaccinated group as compared to the number in the control group to see whether the vaccine reduces the incidence of disease. If the efficiency is above certain levels then the trial has to stop.

Why is it important for people to get the COVID-19 vaccine?

8 out of every 10 COVID deaths are people over the age of 65. Vaccinating people over the age of 65 will practically eliminate 80% of COVID-related deaths and hospitalizations. The healthcare workforce and essential workers are also a priority. 

The sooner we vaccinate those who are at risk the sooner we end this pandemic.

Should young and healthy people get the vaccine? Should older or immunocompromised people get the vaccine?

It is the population of people 60 and older that we need to prioritize to have the greatest impact on reducing the mortality of this virus. 

There are many reasons a person might be immune-compromised, with a spectrum including everything from diabetes to AIDS. 

Each case has to be assessed. If the person’s immunity can respond to the vaccine and develop a resistance to the COVID-19 infection then they should receive it. Diabetic patients are a good example of those who must be prioritized for vaccination.

Why do some vaccines cause reactions such as fever or fatigue?

Every good vaccine stimulates the immune system. During the course of this stimulation, some inflammatory substances are released in the body and cause symptoms like aches, fatigue, or fever.

Are there any side effects of the COVID-19 vaccines? Are mild reactions anything to be worried about?

To date, we don’t have any data that suggests that the COVID-19 vaccines have a significant side effect that would prohibit their use.

How long after getting the vaccine does it take to become effective in preventing COVID-19?

The trial that was assessing immunity after vaccination showed that full immunity developed seven days after patients received the second shot. It has also been shown that protective immunity builds up within four weeks of the first dose, and in some cases appears to develop even earlier.

Why do we need two doses of the Pfizer and Moderna vaccines? What happens if you just get one dose?

During the vaccine study phase, the majority of the recipients developed the neutralizing antibody after the second dose. Developing critical antibodies is only one part of immunity against the virus. 

Memory cells and other immune cells also have to be recruited and developed. While it is possible to become immune after one dose, the second dose ensures that the body has developed the necessary immunity for increased efficacy.

Does getting the COVID-19 vaccine prevent me from spreading the virus to others? Or does it just prevent me from getting sick with coronavirus? 

Getting the COVID-19 vaccination prevents both infection from the virus and the spread of it.

Should I get the first vaccine that becomes available or wait until different companies produce additional COVID-19 vaccines?

If you are a priority group and someone with high risk then you should get vaccinated at the very first opportunity.

Learn more about the coronavirus vaccine:

• COVID-19 Vaccine Update: When will a COVID-19 vaccine be available?
• Moderna vs. Pfizer-BioNTech COVID Vaccine - Which Is Best?
• Where & How To Get A Coronavirus COVID-19 Vaccine In NYC?
• When will the COVID Vaccine be Available in all 50 states?

Sources:

https://www.mayoclinic.org/diseases-conditions/coronavirus/in-depth/coronavirus-vaccine/art-20484859