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There are a couple different vaccines that are expected to be cleared for kids under 12, with Pfizer-BioNTech likely to be the first available.

Pfizer-BioNTech

In March 2021, Pfizer-BioNTech began studying the effects of its vaccine on children 6 months to 11 years old.

This study evaluates the safety, tolerability, and immunogenicity (immune response) of the vaccine on a two-dose schedule (approximately 21 days apart) in three age groups:

  • 5 to 11 years
  • 2 to 5 years
  • 6 months to 2 years

Moderna

Also in March 2021, Moderna began a two-part study to evaluate vaccination use in kids ages 6 months to 11 years old. Children received two doses of the Moderna vaccine 28 days apart.

Researchers tested different dose levels in a randomized, placebo-controlled expansion study to evaluate vaccine safety and effectiveness. (Randomized means that participants were assigned doses randomly. Some received the actual vaccine, while others received a placebo.)

The study was conducted in collaboration with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority.

Johnson & Johnson (Janssen)

There are no current J&J trials in this age group.

As of October 2021, more than 6 million children have tested positive for COVID-19 since the beginning of the pandemic.

In February 2021, the American Academy of Pediatrics (AAP) President Lee Savio Beers, MD, FAAP, urged federal officials to begin enrolling children in COVID-19 vaccine research studies as soon as safely possible because we “cannot allow children to be an afterthought” in vaccine development.

Vaccines are critical to reducing the rates of infection, hospitalizations, and deaths from COVID-19 and other vaccine-preventable diseases.

Thankfully, severe complications from COVID-19 are rare in children, but there are hidden complications that may not be recognized.

The longer the coronavirus remains at pandemic levels, the greater the risk of developing virus variants, which may become more virulent (stronger) and deadly.

Research must be continued to evaluate the long-term outcomes of both having COVID-19 and getting the vaccine.

In mid-October 2021, among the 24 U.S. states reporting and New York City, children ranged from 1.6 to 4.2 percent of their total cumulated hospitalizations. According to the data, 0.1 to 2.0 percent of all their child COVID-19 cases resulted in hospitalization.

Among 45 U.S. states reporting plus Puerto Rico, Guam, and New York City, children were 0.00 to 0.26 percent of all COVID-19 deaths, with 7 states reporting 0 child deaths.

Though these numbers seem low, not all states are reporting, so it’s impossible to know the most accurate rates.

No one truly knows how severe their case of COVID-19 might be, therefore it’s best to be vaccinated to reduce the severity risk. Children with chronic medical conditions such as asthma or obesity are at an even greater risk.

Also, with rising COVID-19 case rates, more quarantining and isolation are required, which prohibits children from attending school and having social interactions. This includes extracurricular activities, which are key to their development.

The mental health burden from COVID-19 should also be taken into consideration.

Also, children are integral members of our societies and families. They can transmit the infection to vulnerable members of our population. Children under 15 years old make up about a quarter of the world’s population, so their adequate protection is important to eliminate this pandemic.

Our children are our future. They deserve to be protected from COVID-19.

The vaccine doesn’t give someone the disease. It helps your body produce the antibodies needed to protect against serious complications should you be exposed to or develop COVID-19.

A person who has recovered from COVID-19 does have natural immunity, and those fully recovered will likely have up to 8 months of immunity, according to research.

The longer the coronavirus remains active, more virulent strains may develop. Having some immunity (whether natural or vaccine-induced) will prove beneficial.

We know the current vaccines have high immunogenicity (ability to produce a response from the immune system). Vaccination can still serve as a benefit for those who have had a previous infection because it can help maintain effective antibody levels (when antibody levels from natural immunity begin to decrease).

As the vaccine is studied longer, it’s becoming apparent that boosters will likely be needed to maintain the antibody protection over time. Someone who has natural immunity from a previous infection may also eventually need a booster to remain protected.

I wouldn’t recommend intentionally exposing oneself to COVID-19 to contract the infection to develop natural immunity. There are serious complications associated with COVID-19, and you never know if you will have a serious case or not.

Pfizer’s study includes 4,500 children across several countries. The research is studying vaccine effectiveness in different age groups.

Moderna’s test group has 6,750 children, ages 6 months to 11 years old.

J&J currently isn’t conducting trials in this age group.

Currently used vaccines are dosed differently based on age, so it’s possible the same might happen with the COVID-19 vaccine. The research will study the most appropriate dose for each age group.

It can take years before we know about the long-term side effects of a vaccine, but the benefits and safety of the current COVID-19 vaccines are already apparent.

Clinical development of vaccines is a three-phase process:

  • Phase 1. Small groups of people get the trial vaccine.
  • Phase 2. The clinical study is expanded. The vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended.
  • Phase 3. The vaccine is given to thousands of people and tested for efficacy and safety.

Many vaccines undergo additional phase 4 testing. These are ongoing studies after the vaccine is approved and licensed.

The Food and Drug Administration (FDA) continues to oversee the vaccine’s production to ensure continuing safety. Monitoring of the vaccine and of production activities, including periodic facility inspections, must continue as long as the manufacturer holds a license for the vaccine product.

We have already seen in a short amount of time the devastating effects of COVID-19. Vaccines play an integral part in preventing the severity of infections, and the benefits far outweigh the potential risks of the vaccine.

Every individual may be affected differently by vaccines. In general, most people who receive any version of a COVID-19 vaccine have commonly reported local or systemic side effects, which are an indication of immune system response.

These symptoms include:

  • local (at the injection site):
    • pain
    • redness
    • swelling
  • systemic (general body symptoms):
    • tiredness
    • headache
    • muscle pain
    • chills
    • fever
    • nausea

People in the same family may respond differently. Any vaccinated child should be monitored closely following their vaccines, and supportive care should be provided including rest, hydration, or over-the-counter fever or pain relievers. (Use them based on your child’s age or weight and after consulting with their pediatrician.)

Though the potential side effects of the COVID-19 vaccine are mild, there are very serious side effects associated with getting COVID-19 itself. These side effects may require hospitalization and can have long-term effects.

Most children who get COVID-19 fully recover, though a small percentage may have serious complications. These complications include:

MIS-C is a condition where several of a child’s organ systems can be inflamed, including the heart, lungs, kidneys, brain, and gastrointestinal system. The median age of children with MIS-C is 9 years old.

Myocarditis is inflammation of the heart, which is a complication of both COVID-19 and the vaccine as well. However, children with myocarditis after getting the COVID-19 vaccine usually recover quickly. An elevated risk of myocarditis among mRNA COVID-19 vaccines has been observed, particularly in males ages 12 to 29 years — not in younger children.

The benefit of the COVID-19 vaccine has been shown to outweigh the risks.

There is a rare chance that the COVID-19 vaccine can cause a severe allergic reaction (as with any other vaccine or medication). Symptoms of a severe reaction include:

  • difficulty breathing
  • swelling of the face and throat
  • fast heart rate
  • bad rash all over the body
  • dizziness and weakness

Anyone who experiences these symptoms following the vaccine should seek emergency medical attention. Researchers and healthcare professionals regularly assess the safety of vaccines even after the FDA has approved them.

There’s a myth about the vaccine affecting fertility, which comes from the knowledge that the spike protein in the COVID-19 vaccine is the same as a protein known as syncetin-1, which plays a role in human reproduction.

The concern is that the immune reaction induced by the vaccine will cause a reaction against the syncetin-1 protein, causing sterility.

A September 2021 study reviewed the embryo implantation rates in people who had natural immunity from either coronavirus infection or the vaccine, and those who were unvaccinated. There was no difference in their pregnancy rates. Therefore, the infertility claims were unfounded.

Currently, there’s no peer-reviewed evidence showing that any vaccine (including the COVID-19 vaccine) affects fertility in males or females, or menstruation.

The National Institutes of Health is encouraging more research to determine whether the COVID-19 vaccine has an effect on menstruation. As of October 2021, five studies were opened. Two of those studies will look at the effect of vaccines on specific populations, including adolescents.

The Centers for Disease Control and Prevention (CDC) as well as professional medical organizations are currently recommending the COVID-19 vaccine for all pregnant people and for those who plan to become pregnant in the future, especially due to the increase in variant cases.

The risk of infection in these populations is much greater than the potential risks of the vaccine.

Currently, two companies (Pfizer and Moderna) are studying vaccine efficacy in children as young as 6 months old.

Vaccines undergo several phases of testing to determine their safety. The phase 3 clinical trial evaluates how well an investigational vaccine can prevent the disease it’s intended for.

Once phase 3 is complete, the companies must apply for FDA approval — which may take time. Emergency use authorization (EUA) may be granted sooner, which would make the vaccine available for this age group sooner.