In an early analysis of safety data for coronavirus vaccines, researchers from the Centers for Disease Control and Prevention found no evidence that the vaccines Pfizer-BioNTech or Moderna pose serious risks during pregnancy.
The findings are preliminary and cover only the first 11 weeks of the U.S. vaccination program. But the study, which contains self-reported data on more than 35,000 people who received one of the vaccines during or shortly before pregnancy, is the largest yet on the safety of coronavirus vaccines in pregnant people.
During the clinical trials of the vaccines, pregnant women were excluded. It let patients, doctors and experts know if the shots could be administered safely during pregnancy.
“There is a lot of concern about whether it is safe and whether it would work and what to expect in terms of side effects,” said Dr. Stephanie Gaw, a specialist in maternal fetal medicine at the University of California, San Francisco, said.
The new data, dr. Gaw said, showing that “many pregnant people get the vaccine, at this stage there is no significant increase in adverse effects on pregnancy, and that side-effect profiles are very similar to non-pregnant people.”
“I think it’s all very reassuring,” she said, “and I think it would be more advisable for public health providers and officials to get the vaccine during pregnancy.”
Covid-19 carries serious risks during pregnancy. Pregnant women who develop symptoms of the disease are more likely to become seriously ill and more likely to die than non-pregnant women with symptoms.
Because of these risks, the CDC has recommended that coronavirus vaccines be made available to pregnant women, but it also suggests that they consult with their physicians when deciding on vaccination.
The new study, published Wednesday in The New England Journal of Medicine, is largely based on self-reported data from V-safe, the CDC’s coronavirus safety monitoring system. Program participants use a smartphone app to complete regular surveys about their health and side effects they may experience after receiving a Covid-19 vaccine.
The researchers analyzed the side effects reported by V-safe participants who received the Pfizer or Moderna vaccine between 14 December 2020 and 28 February 2021. They focused on 35,691 participants who said they were pregnant when they took the vaccine or became pregnant shortly thereafter.
After vaccination, pregnant participants reported the same common side effects as non-pregnant women, the researchers found: injection site pain, fatigue, headache and muscle aches.
What you need to know about the vaccination of Johnson & Johnson in the USA
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- On April 13, 2021, US health authorities called for an immediate halt to the use of the single-dose Covid-19 vaccine from Johnson & Johnson after six recipients in the United States had a rare disease within one to three weeks after vaccination. .
- Al 50 state, Washington DC and Puerto Rico has temporarily discontinued use of the vaccine or recommended providers. The U.S. military, federal vaccination sites, and a number of private companies, including CVS, Walgreens, Rite Aid, Walmart, and Publix, also suspended the injections.
- Less than one in a million Johnson & Johnson vaccinations are now being investigated. If there is indeed a risk of blood clots due to the vaccine – which has not yet been determined – the risk is very low. The risk of getting Covid-19 in the United States is much higher.
- The disruption could hamper the country’s vaccination efforts at a time when many states are facing an increase in new cases and trying to address vaccine hesitation.
- Johnson & Johnson also decided to delay the explosion of its vaccine in Europe amid concerns about rare blood clots, but later decided to resume its campaign after the European Union’s drug regulator said a warning label should be added. South Africa, devastated by a more contagious virus variant that emerged there, suspended the use of the vaccine and Australia announced it would not buy any doses.
Women who were pregnant were slightly more likely to report pain at the injection site than women who were not, but less likely to report the other side effects. They were also slightly more likely to report nausea or vomiting after the second dose.
Pregnant V-safe participants were also given the opportunity to sign up for a special registry that tracked pregnancy and baby outcomes.
By the end of February, 827 of those enrolled in the pregnancy registry had completed their pregnancies, of which 86 percent resulted in a live birth. The rate of miscarriage, prematurity, low birth weight, and birth defects were consistent with those reported before the pandemic in pregnant women.
“This study is critical for pregnant individuals,” Dr. Michal Elovitz, a specialist in maternal fetal medicine at the University of Pennsylvania, said in an email. “It is very reassuring that there were no acute events in pregnant individuals during the study,” she said.
But the report has several limitations and much more research is needed, experts said. Entries for the oversight programs are voluntary and the data is self-reported.
Since the study period covered only the first few months of the U.S. vaccination campaign, the vast majority of those enrolled in the pregnancy registry were health workers. There are no data yet on the outcomes of pregnancy of people who were vaccinated during the first trimester of pregnancy.
“I think we can feel more confident about recommending the vaccine during pregnancy, and especially with pregnant people who are at risk of having Covid,” said Dr. Gaw said. ‘But we do it should wait for more data for complete pregnancy results of vaccines early in pregnancy. ”