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Pregnant women can be vaccinated safely with the Pfizer-BioNTech and Moderna vaccines for COVID-19, suggest surveillance data from the United States Centers for Disease Control and Prevention (CDC).
More than 30,000 women who received these vaccines reported pregnancy through the CDC’s V-Safe voluntary reporting system, and their complication rates are not significantly different from those of unvaccinated pregnant women, said Tom Shimabukuro, MD, MPH, MBA, vice director of the CDC’s Office of Immunization Security.
“Overall, the data is reassuring with regard to the safety of the vaccine in pregnant women,” he 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 United States Department of Health and Human Services.
The CDC included pregnancy along with other underlying conditions that qualify people to be offered vaccines at the third priority level (Phase 1c).
“There is evidence that pregnant women who receive COVID-19 are at an increased risk of serious illness and complications of serious illness,” explained Shimabukuro. “And there is also evidence that pregnant women taking COVID-19 may be at increased risk of adverse pregnancy outcomes.”
The American College of Obstetrics and Gynecology recommends that “COVID-19 vaccines should not be denied to pregnant women”.
On the other hand, the World Health Organization recommends vaccines only for pregnant women who are “at high risk of exposure to SARS-CoV-2 (for example, healthcare professionals) or who have comorbidities that increase the risk of serious illness “.
There was not enough information available from the main trials of the Moderna and Pfizer vaccines to assess risk in pregnant women, according to these manufacturers. Pfizer announced a follow-up test for its vaccine in healthy pregnant women.
Analyzing Surveillance Data
To better assess whether Pfizer or Moderna vaccines cause problems in pregnancy or childbirth, Shimabukuro and colleagues analyzed data from V-Safe and the Vaccine Adverse Event Notification System (VAERS).
The CDC encourages providers to inform people who vaccinate about the V-Safe program. Participants can voluntarily enter their data through a website and can receive text messages and follow-up phone calls from the CDC requesting additional information at various times after vaccination. It is not systematic research and the sample is not necessarily representative of everyone who gets the vaccine, noted Shimabukuro.
At the time of the study, V-Safe recorded 55,220,364 notifications from people who received at least one dose of the Pfizer or Moderna vaccine by February 16. This included 30,494 pregnancies, of which 16,039 were in women who received the Pfizer vaccine and 14,455 in women who received the Modern vaccine.
Analyzing the data collected until January 13, 2021, the researchers found that local and systemic reactions were similar between pregnant and non-pregnant women aged 16-54 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, myalgia, chills, nausea and fever. Systemic reactions were more common 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.
The “interest” outcome rates were no higher among these women than in the general population.
Table. Pregnancy results
| Result | Background To assess, % |
Vaccinated Women, % |
|---|---|---|
| Miscarriage | 26 | 15 |
| Stillborn | 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 |
In contrast to V-Safe, VAERS data, co-managed by the CDC and the United States 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,” said Shimabukuro. “It may be the patient himself. He may be a caregiver for children.”
Only 154 VAERS reports as of February 16 related to pregnant women, and of these, only 42 (27%) were for specific pregnancy conditions, with the other 73% representing the types of adverse events reported for the general vaccinated population. , such as headache and fatigue.
Of the 42 pregnancy-related events, there were 29 spontaneous abortions or spontaneous abortions, with the remainder divided between 10 other pregnancy and neonatal conditions.
“When we looked at these results and compared the notification rates, based on the known background rates for these conditions, we saw nothing unexpected or worrying about pregnancy or specific neonatal conditions,” said Shimabukuro of the VAERS data.
The CDC did not collect data on fertility. “We work a lot with other vaccines,” said Shimabukuro. “And just from a biological point of view, we have no evidence that vaccination, just in general, causes fertility problems.”
In addition, Shimabukuro noted that the COVID-19 vaccine made by Janssen / Johnson & Johnson has not received emergency clearance from the FDA in time to be included in the current report, but is being tracked for future reports.
Vaccination can benefit babies
In addition to the new safety data, experts continue to remind doctors and the public that vaccination during pregnancy can benefit offspring. Unborn babies of pregnant women who received the COVID-19 vaccine can be protected from the virus during the first few months of their lives, White House Secretary-General COVID-19, Anthony Fauci, MD, said in an interview today.
“We saw this with many other vaccines,” said Fauci. “This is a very good way to get protection for the mother during pregnancy and also a transfer of protection for the baby, which will last for a few months after birth.”
Fauci also noted that the same vaccine platform used in the Johnson & Johnson COVID-19 vaccine has been used successfully for ebola in pregnant women in Africa.
ACIP. Security update for the COVID-19 vaccine. Presented on March 1, 2021. Report
Shimabukuro has reported no relevant financial relationships.
Lindsay Kalter contributed to the reporting of this story.
Laird Harrison writes about science, health and culture. His work appeared in national magazines, newspapers, public radio and websites. He is working on a novel about alternative realities in physics. Harrison teaches writing at the Writers’ Cave. Visit him at www.lairdharrison.com or follow him on Twitter: @LairdH
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