COVID-19 Vaccine Clinical Guidance
The ACR has developed guidance for rheumatology providers on the use of the COVID-19 vaccines for patients with rheumatic and musculoskeletal diseases. All recommendations are based on current knowledge and will be revised as circumstances and evidence evolve. View the latest version online.
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COVID-19 Vaccines: Separate the Myths from the Facts
Myth: The new COVID-19 vaccines were developed too quickly to be safe.
Facts
- Scientists have been working on vaccines against other coronaviruses, including SARS and MERS, for years. Because of this existing research, the process to develop new vaccines against the coronavirus that causes COVID-19 was faster than in the past.
- All vaccines approved by the U.S. Food & Drug Administration (FDA) must go through three phases of clinical trials to prove they are safe and effective. COVID-19 vaccines are no exception. In the past, each trial phase was completed before the next one began. To speed up the process to test COVID-19 vaccines, the three trial phases overlapped.
- All COVID-19 vaccines were tested in tens of thousands of volunteer patients. Because this disease rapidly spread throughout the population, clinical trials for the vaccines had an abundance of volunteers of different ages, races, sexes and ethnicities.3
Myth: The new COVID-19 vaccines cause infertility and miscarriage.
Facts
- According to the CDC, all the COVID-19 vaccines are safe for anyone 12 or older, and the Pfizer/BioNTech vaccine has received emergency use approval for use in children who are 5–11. The vaccines are also safe for both men and women who may want to start a family now or in the future. No COVID-19 vaccine causes fertility problems in either men or women.4
- In 2021, a safety monitoring program reported that 4,800 people had a positive pregnancy test after receiving their first vaccine dose.5
- In another 2021 study, no men became infertile after COVID-19 vaccination. Some men in the study even had significant increases in semen volume, sperm concentration and sperm motility (movement) after their second dose of vaccine.6
- Vaccination against COVID-19 during pregnancy does not increase your chances of miscarriage. A September 2021 study of more than 105,000 pregnancies found that rates of miscarriage, also called spontaneous abortion, were about the same between women who were vaccinated and those who were not.7
Myth: COVID-19 vaccines contain tissue from aborted fetuses.
Facts
- The mRNA vaccines against COVID-19 do not contain cells or tissue from aborted fetuses and were not developed with fetal cell lines. Neither the Pfizer-BioNTech nor Moderna mRNA vaccines contain fetal cells.8
- Fetal cell lines are cells grown in a laboratory. These cells have been replicated thousands of times and were originally taken from elective abortions that took place decades ago. The Johnson & Johnson vaccine was developed using a fetal cell culture, PER.C6, which was originally taken from tissue from an elective abortion in 1985. However, the final vaccine does not contain any fetal cells.9
- Fetal cells from decades-old fetal cell lines have been used to develop many common, over-the-counter drugs, including acetaminophen (Tylenol), diphenhydramine (Benadryl), loratadine (Claritin) and magnesium hydroxide (Maalox).10
Myth: When you get a COVID-19 vaccine shot, a microchip is inserted into your body.
Facts
- The mRNA vaccines against COVID-19 do not contain microchips or any other tracking technology device. These vaccines stimulate your immune system to recognize COVID-19 infection and make the antibodies to attack it. They allow your body to develop immunity to this new coronavirus, so you can fight it more effectively.11
- The ingredients contained in all three COVID-19 vaccines are posted on the CDC’s website. None contain metals, magnets or microelectronics of any kind.12
Myth: mRNA vaccines change a person’s DNA, fundamentally altering what makes them human.
Fact
- mRNA vaccines do not alter your DNA. The vaccines deliver codes to your immune system cells to allow them to recognize a protein on the surface of the coronavirus that causes COVID-19, but vaccines do not affect or change your body’s DNA.11
Myth: The COVID-19 vaccine will infect me with COVID-19.
Facts
- The vaccines do not contain live coronavirus and cannot make you sick with COVID-19. These mRNA vaccines are made with a technology that has been tested for years. They train your immune system to recognize a protein on the surface of the coronavirus and produce the antibodies to Fight it. Other types of vaccines, such as a flu shot, use a weakened version of the virus to train your immune system, but mRNA vaccines do not.11
- COVID-19 vaccines can cause side effects and most are mild. You may have pain, redness or swelling on your arm where you get the injection. You may later feel tired or have mild nausea, headaches, muscle pain, chills or a slight fever. These side effects are signs your body’s immune system is reacting normally to the vaccine and building immunity to COVID-19. The side effects do not mean you have COVID-19. Serious side effects to the vaccine are extremely rare.13
Myth: If I’m vaccinated, I can’t catch COVID-19.
Fact
- Vaccination prevents most, but not all, infections. It’s still possible to get a breakthrough infection of COVID-19 after you’ve been fully vaccinated. However, vaccinated people who get a breakthrough infection are less likely to have severe illness or symptoms, and less likely to be hospitalized or die due to COVID-19.14
Myth: If I’ve already had COVID-19, natural immunity protects me. I don’t need to get a vaccine.
Facts
- If you’ve been previously infected with COVID-19, getting a vaccine boosts your antibody production and protects you from reinfection more than natural immunity alone. A 2021 study compared vaccinated people in Kentucky who had been previously infected with COVID-19 with unvaccinated people in Kentucky who had been previously infected with COVID-19. Unvaccinated people were 2.34 times more likely to be reinfected with COVID-19 than those who were vaccinated.15
Myth: I heard that VAERS has concealed thousands of reports of deaths linked to the COVID-19 vaccine. The vaccine is risky and dangerous.
Facts
- Anyone can report information to the Vaccine Adverse Event Reporting System (VAERS). Some VAERS reports may contain incomplete or unverified information. There is no way to ensure any reported reaction to a COVID-19 vaccine—even a death—is accurate. Even if a person died after they had been vaccinated, VAERS data cannot determine if the vaccine caused their death.10
- In July 2021, VAERS’ administrators corrected the total number of deaths after COVID-19 vaccination reported on its site after 6,286 foreign deaths were erroneously added to the number of U.S. deaths. VAERS corrected this error, according to an investigation by the news agency Reuters.16
- The CDC’s website reports that more than 423 million doses of the COVID-19 vaccines were administered between Dec. 14, 2020, and Nov. 1, 2021, in the U.S., and VAERS has received 9,367 reports of deaths among people who have received a vaccine—or 0.0022%.17
- Make sure you visit the VAERS website, not private websites that may mimic it. The privately run website openvaers.com posts raw data on vaccine adverse events, including deaths, pulled from VAERS, with no proof that the vaccines caused these deaths. As of November 2021, this private site claims there are “18,078 COVID Vaccine Reported Deaths.” A news investigation found the individual behind OpenVAERS is “an anti-vaccine conspiracy theorist.”18
Myth: The COVID-19 vaccine can cause serious heart conditions in children or teens.
Facts
- The CDC reports that it is actively monitoring and evaluating reports of young people, particularly male adolescents, developing myocarditis (i.e., inflammation of the heart muscle) and pericarditis (i.e., inflammation of the tissue lining the heart) within a week after receiving one of the mRNA vaccines to determine if a relationship exists.
- The CDC reports that these reactions are rare, and adolescents who develop either myocarditis or pericarditis after vaccination respond well to medication and rest. Patients are able to resume their normal activities quickly.
- The CDC continues to recommend COVID-19 vaccination to all people age 5 and older, and the agency stresses that the benefits of vaccination outweigh any possible risks.19
References
- COVID-19 vaccinations in the United States. U.S. Centers for Disease Control and Prevention. 2021 Oct 18.
- Estimates of vaccine hesitancy for COVID-19. U.S. Centers for Disease Control and Prevention. 2021 May 26–Jun 7.
- Developing COVID-19 vaccines. U.S. Centers for Disease Control and Prevention. 2021 Sep 8.
- COVID-19 vaccines for people who would like to have a baby. U.S. Centers for Disease Control and Prevention. 2021 Aug 11.
- Shimabukuro TT, Kim SY, Myers TR, et al. Preliminary findings of mRNA COVID-19 vaccine safety in pregnant persons. New Engl J Med. 2021 Jun 17;384(24):2273–2282.
- Gonzalez DC, Nassau DE, Khodamoradi K. Sperm parameters before and after COVID-19 mRNA vaccination. J Amer Med Assoc. 2021 Jun 17;326(3):273–274.
- Kharbanda EO, Haapala J, DaSilva M, et al. Spontaneous abortion following COVID-19 vaccination during pregnancy. J Amer Med Assoc. 2021 Sep 8;326(16):1629–1631.
- Are the vaccines made with fetal cells? Institute for Clinical Systems Improvement. 2021 Mar 3.
- Zimmerman RK. Helping patients with ethical concerns about COVID-19 vaccines in light of fetal cell lines used in some COVID-19 vaccines. Vaccine. 2021 Jul 13;39(31):4242–4244.
- Myths and facts about the vax. Debunking common COVID-19 vaccine myths. U.S. Air Force Surgeon General Congressional and Public Affairs. 2021 Sep 22.
- Myths and facts about COVID-19 vaccines. U.S. Centers for Disease Control and Prevention. 2021 Oct 4.
- Interim clinical considerations for use of COVID-19 vaccines currently approved or authorized in the United States: Appendix C. U.S. Centers for Disease Control and Prevention. 2021 Sep 27.
- Possible side effects after getting a COVID-19 vaccine. U.S. Centers for Disease Control and Prevention. 2021 Sep 30.
- COVID-19 vaccine breakthrough case investigation and reporting. U.S. Centers for Disease Control and Prevention. 2021 Oct 15.
- Cavanaugh AM, Spicer KB, Thoroughman D, et al. Reduced risk of re-infection with SARS-CoV-2 after COVID-19 vaccination—Kentucky, May–June 2021. MMWR Morb Mortal Wkly Rep. 2021 Aug 13;70(32):1081–1083.
- Fact Check: 6,000 VAERS reports were deleted for being foreign entries, CDC says. Reuters.com. 2021 Aug 2.
- Selected adverse events reported after COVID-19 vaccination. U.S. Centers for Disease Control and Prevention. 2021 Nov 5.
- Khandelwal D, Backovic N, Miller E, et al. California woman behind anti-vax site outperforming government database. Logically.ai. 2021 Aug 12.
- Myocarditis and pericarditis after mRNA COVID-19 vaccination. U.S. Centers for Disease Control and Prevention. 2021 Nov 12.