Editor’s Note: Find the latest COVID-19 news and guidance at the Medscape Coronavirus Resource Center.
Pregnant women can be safely vaccinated with Pfizer-BioNTech and Moderna vaccines for COVID-19, according to surveillance data from the U.S. Centers for Disease Control and Prevention (CDC).
More than 30,000 women who received these vaccines have reported pregnancies through the CDC’s V-Safe voluntary information system, and their complication rates are not significantly different from those of unvaccinated pregnant women, said Tom Shimabukuro , MD, MPH, MBA, Deputy Director of the CDC Office of Immunization.
“Overall, the data is reassuring when it comes to vaccine safety in pregnant women,” she said. Medscape Medical News.
Shimabukuro presented the data during a March 1 meeting of the Advisory Committee on Immunization Practices (ACIP), a group of health experts selected by the secretary of the U.S. Department of Health and Human Services.
The CDC has included pregnancy along with other underlying conditions that qualify people to receive vaccines at the third priority level (phase 1c).
“There is evidence that pregnant women receiving COVID-19 have an increased risk of serious illness and complications from serious illness,” Shimabukuro explained. “And there is also evidence that pregnant people receiving COVID-19 may be at increased risk of having adverse effects on pregnancy.”
The American College of Obstetrics and Gynecology recommends that “COVID-19 vaccines should not be retained in pregnant women.”
In contrast, the World Health Organization recommends vaccines only for those pregnant women who have a high risk of exposure to SARS-CoV-2 (for example, health workers) or who have comorbidities that add to the risk of serious illness ”.
According to these manufacturers, there was not enough information available in the fundamental trials of Moderna and Pfizer vaccines to assess risk in pregnant women. Pfizer has announced a follow-up trial of its vaccine in healthy pregnant women.
Analyze surveillance data
To better assess whether Pfizer or Moderna vaccines cause problems during pregnancy or childbirth, Shimabukuro and colleagues analyzed data from V-Safe and the Vaccine Adverse Event Information System (VAERS). .
The CDC encourages providers to inform people who get vaccinated about the V-Safe program. Participants may voluntarily enter their data through a website and may receive follow-up text messages and phone calls from the CDC to request additional information at various times after vaccination. It is not a systematic survey and the sample is not necessarily representative of everyone who is vaccinated, Shimabukuro noted.
At the time of the study, V-Safe recorded 55,220,364 reports of people receiving at least one dose of the Pfizer or Moderna vaccine through Feb. 16. women who received the Modern vaccine.
Analyzing the data collected up to January 13, 2021, the researchers found that systemic and local reactions were similar between pregnant and non-pregnant women aged 16 to 54 years.
Most women reported pain, and some reported swelling, redness, and itching at the injection site. Of the systemic reactions, fatigue was the most common, followed by headache, myalgias, chills, nausea, and fever. Systemic reactions were more frequent with the second dose of Pfizer; fatigue affected most pregnant and non-pregnant women. Data on the second dose of Moderna were not available.
The CDC enrolled 1,815 pregnant women for additional follow-up, including 275 completed pregnancies and 232 live births.
Rates of “interest” results were no higher among these women than in the general population.
Table. Pregnancy results
| Result | Background Rate,% |
Vaccinated Women, % |
|---|---|---|
| Involuntary abortion | 26 | 15 |
| Death death | 0.6 | 1 |
| Gestational diabetes | 7-14 | 10 |
| Preeclampsia or gestational hypertension | 10-15 | 15 |
| Eclampsia | 0.27 | 0 |
| Intrauterine growth restriction | 3-7 | 1 |
| Premature birth | 10.1 | 10 |
| Congenital anomaly | 3 | 4 |
| Small for gestational age | 3-7 | 4 |
| Neonatal death | 0.38 | 0 |
Unlike V-Safe, VAERS data, combined by the CDC and the U.S. Food and Drug Administration (FDA), comes from spontaneous reports of adverse events. The sources of these reports are varied. “This could be the health care provider,” Shimabukuro said. “He could be the patient himself. He could be a child caregiver.”
Only 154 VAERS reports as of February 16 concerned pregnant women, and of these, only 42 (27%) corresponded to specific pregnancy conditions, and the other 73% represented the types of adverse events reported by pregnant women. in the general population of people vaccinated headache and fatigue.
Of the 42 pregnancy-related events, 29 miscarriages or miscarriages occurred, with the remainder divided among 10 other pregnancy and neonatal conditions.
“When we examined these results and compared the reporting rates, based on the known background rates of these conditions, we saw nothing unexpected or worrying regarding the pregnancy or the specific conditions of the newborn.” , Shimabukuro said about VAERS data.
The CDC did not collect data on fertility. “We’ve done a lot of work with other vaccines,” Shimabukuro said. “And only from a biological basis, we have no evidence that vaccination, in general alone, causes fertility problems.”
In addition, Shimabukuro noted that the COVID-19 vaccine manufactured by Janssen / Johnson & Johnson did not receive emergency authorization from the FDA in time to include it in the current report, but is being tracked for future reports.
Vaccination can benefit infants
In addition to new safety data, experts continue to remind doctors and the public that vaccination during pregnancy could benefit offspring. Nonpregnant babies of pregnant women receiving the COVID-19 vaccine could be protected from the virus during the first months of their lives, Anthony Fauci, MD, tsar of the White House COVID-19, said in a session today informative.
“We’ve seen it with a lot of other vaccines,” Fauci said. “This is a great way to protect the mother during pregnancy and also to transfer the protection of the baby, which will last for a few months after delivery.”
Fauci also noted that the same vaccine platform used in Johnson & Johnson’s COVID-19 vaccine was successfully used for Ebola in pregnant women in Africa.
ACIP. COVID-19 vaccine safety update. Filed March 1, 2021. Report
Shimabukuro tea has not reported any relevant financial relationships.
Lindsay Kalter contributed to the reporting of this story.
Laird Harrison writes about science, health, and culture. His work has appeared in national magazines, newspapers, public radio and websites. He is working on a novel about alternative realities in physics. Harrison teaches writing in the writers ’grotto. Visit him at www.lairdharrison.com or follow him Twitter: @LairdH
Follow Medscape on Facebook, Twitter, Instagram and YouTube.