Vaccine safety and the new COVID-19 vaccine

December 30, 2020

We’ve reached new milestones in the fight against COVID-19: Two vaccines to protect people against the COVID-19 virus have received emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA), and other COVID-19 vaccines are in line to be reviewed and approved. EUA is an approval that allows products to be used in certain situations, like in a public health emergency. The FDA protects the public’s health by ensuring the safety and effectiveness of medicines, vaccines and other products.

The first phase of COVID-19 vaccinations has started. Health care
providers are among the first people to receive the vaccine as part of this
phase. As more vaccine doses become available, everyone will have the
opportunity to get the vaccine.

Here’s why having a COVID-19 vaccine is important for the health of
people across the country and around the world.

What is a vaccination?

A vaccination is a shot that contains a vaccine. A vaccine helps
protect you from certain diseases. When you get a vaccine, you develop
antibodies to protect you from a certain disease. Antibodies are cells in the
body that fight off infection.

Why are vaccines so important?

Vaccines can protect you by making you immune to certain diseases.
Immunity helps to prevent you from getting a particular disease.

For many years, vaccines have had a very important role in public
health. Because of vaccines, people no longer get a deadly disease called
smallpox. Vaccines have helped to bring other diseases to an all-time low.
These include wild polio virus, measles, diphtheria and whooping cough.

Vaccines can also help protect you from common illnesses or make your
symptoms less serious. For example, getting a flu
can help reduce your risk of getting the flu, having serious flu
complications and needing treatment in a hospital.

Are vaccinations safe?

The U.S. has a vaccine safety program that closely monitors the safety
of vaccines. Data show that the current vaccine supply in the U.S. is the
safest and most effective in history.

Scientists help make sure vaccines are as safe as possible by doing a great
deal of research and testing before they are tested in people. Then vaccines
get further in-depth testing with:

Clinical trials.
These are studies that test vaccines in volunteers to see if they can be used
for the general public. Once clinical trials are done, the FDA reviews the
research and decides whether to approve the vaccine. The Advisory Committee on
Immunization Practices (ACIP) also reviews the data before the vaccine can be recommended
for use. The ACIP’s recommendations are then sent to the CDC for approval.

Post-licensure safety
These are ongoing studies done after a vaccine is approved and
being used. They continue to monitor vaccine safety. They may also study how
the vaccine works in certain populations who may not have been as involved in
clinical trials.

The FDA and CDC have taken even more safety monitoring steps for the
COVID-19 vaccine to help make sure it is as safe as possible.

Are vaccines safe during pregnancy?

Vaccine recommendations for pregnant people are developed with very high safety standards to protect you and your baby. Certain vaccines are safe and recommended before and during pregnancy. These vaccines can keep you and your baby healthy. Some vaccines are not recommended during pregnancy.

The antibodies you develop after getting a vaccine cross the placenta
and help protect your baby from serious diseases early in life. The placenta
grows in your uterus (womb) and supplies your baby with food and oxygen through
the umbilical cord. Vaccines also help protect you from diseases you can get
and give to your newborn.

If you’re planning a pregnancy or you’re pregnant, talk to your provider to be sure you’re up to date on your vaccines. Some vaccines are given before pregnancy, like the measles, mumps and rubella (MMR) vaccine. Some vaccines can be given during pregnancy, like the flu shot. If you’re pregnant, it’s very important to get the flu shot to protect you and your baby.

Why is the COVID-19 vaccine important?

The COVID-19 virus can have serious, life-threatening complications.
The COVID-19 vaccine is an important tool to help stop the pandemic. This
vaccine works with your immune system so your body is ready to fight the virus
if you are exposed. The COVID-19 vaccine:

  • Can help keep you from getting COVID-19
  • May help prevent serious illness if you do get
  • May help protect people around you from getting
    exposed to COVID-19 from you

Getting the vaccine and following safety precautions – like wearing a
mask and social distancing – are the best protection against the virus.

Can pregnant people get the COVID-19 vaccine?

Pregnant people are at higher risk for serious illness with COVID-19. Pregnant people who get COVID-19 may also be at higher risk for pregnancy problems, like preterm birth. But so far, pregnant people have not participated in the clinical trials for the COVID-19 vaccine. So more research is needed on the safety of the COVID-19 vaccine in pregnant people. These studies are being planned.

The ACIP has recommended that the first vaccine to be approved can be
used in people ages 16 and older for the prevention of COVID-19. This vaccine
is being offered to health care providers as part of the phase 1 recommendations.
According to the CDC and the American College of Obstetricians and
Gynecologists (ACOG), pregnant or breastfeeding people who meet the ACIP criteria,
such as health care staff during phase 1, may choose to get the vaccine. The
FDA and CDC have systems in place to monitor safety in pregnant people who get
the COVID-19 vaccine.

While more research is needed, experts believe that mRNA vaccines are
unlikely to pose a risk to pregnant or breastfeeding people. mRNA vaccines work
by teaching cells in the body how to make a protein that triggers an immune
response against COVID-19. So far, the first COVID-19 vaccines being developed are
mRNA vaccines. These vaccines do not contain live coronavirus.

It’s a personal choice whether to get the COVID-19 vaccine if you’re
pregnant. It’s a good idea to talk to your provider to help you make this

What is the vaccination schedule?

The new vaccines have two doses. The second dose must be given a few weeks
apart after the first shot. Once you receive the first dose of the vaccine,
it’s important to get the second dose. After two doses, these vaccines are 95%
effective in preventing COVID-19 illness.

Some people have side effects that might last a day or two after
getting a vaccine. These are normal signs that your body is building
protection. In clinical trials of the COVID-19 vaccine, side effects included:

  • Pain or swelling in the arm where the shot was
  • Fatigue (being very tired)
  • Chills
  • Muscle or joint pain
  • Headaches
  • Fever

What is herd immunity?

Herd immunity is when enough people have protection from an infection or
disease and the spread of the disease is unlikely. People can get immunity from
an infectious disease either because they got that infection or because they
received the vaccine. When herd immunity happens the whole community is
protected even if some people don’t have their own protection. Experts don’t
know what percentage of people would need to get vaccinated for herd immunity
to COVID-19.