Some promising news for pregnant people

Syringes are prepared for doses of the Pfizer Covid-19 vaccine at a clinic on April 9, 2021 in Los Angeles, California.
A version of this story appeared in the April 22 edition of CNN's Coronavirus: Fact vs. Fiction newsletter. Sign up here to receive the need-to-know headlines every weekday.

(CNN)The Pfizer/BioNTech and Moderna vaccines don't appear to pose any serious risks during pregnancy, an early analysis of real-world data from the United States shows.

The early findings may offer some reassurance to pregnant people in the US and help other countries make better informed decisions about how to include them in vaccination programs. The analysis only looked at Pfizer and Moderna shots, which are both based on newer mRNA technology, so the findings are not relevant to vaccines such as those made by AstraZeneca or Johnson & Johnson.
The Centers for Disease Control and Prevention (CDC) had long advised that while there was a lack of data in this area, pregnant people should still be offered Covid-19 shots, stressing that they are "unlikely to pose a specific risk" for people who are pregnant. Some other countries have excluded pregnant people from their programs. The UK recently reversed its stance on the issue and is now making Pfizer and Moderna shots available to people who are pregnant.
    Health authorities around the world, including the CDC, have warned that pregnant women with Covid-19 are at increased risk for severe illness and may be at increased risk for adverse outcomes, such as preterm birth. The new data, along with existing research showing mRNA vaccines are effective in pregnant and breastfeeding people, suggest that the benefits of the vaccines outweigh the risks.
      The analysis, published Wednesday in the New England Journal of Medicine, looked at the data of more than 35,000 pregnant people who had reported their health status through CDC reporting systems, including a smartphone app, and followed up with a group of 3,958 pregnant participants who had received an mRNA vaccine. It found that adverse outcomes, including pregnancy loss and preterm births, were not significantly higher in people who had been given a vaccine.
      And in more good news, the study found that vaccine recipients who were pregnant actually experienced common post-inoculation symptoms less frequently, including headache, muscle aches, chills and fever. The most common side effect was pain at the injection site, which appeared to occur more frequently in people who were pregnant.
      The researchers say more long-term studies are needed to assess the safety of the Covid-19 vaccine during pregnancy, and that this research should include follow up with a large population who are vaccinated early in pregnancy.


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        J&J told to clean up its troubled Baltimore plant
        The US Food and Drug Administration (FDA) has said new production of Johnson & Johnson's Covid-19 vaccine remains paused at the Emergent BioSolutions facility, where millions of potential doses were contaminated, and the agency and company are working through a list of potential quality issues.
        Based on security camera footage and direct observation, the FDA issued a report saying that procedures to prevent cross-contamination weren't followed during production or documented; components and product containers were not handled or stored in a way to prevent contamination; procedures to assure drug substances are manufactured at the appropriate quality, strength and purity were "inadequate"; and employees weren't properly trained.
        The building used to manufacture the vaccine drug substance wasn't a suitable size or design to facilitate cleaning and proper operations, it said, also noting peeling paint, unsealed bags of medical waste, residue on walls and damaged floors and rough surfaces that "do not allow for adequate cleaning and sanitization." Emergent said it was "committed to working with the FDA and Johnson & Johnson to quickly resolve the issues identified."
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        The Indian capital, New Delhi, is facing a shortage of intensive care unit beds, Delhi's Health Minister Satyendra Jain told reporters on Thursday, adding the city had just 26 ICU beds vacant. The lack of oxygen supplies also remains a pressing problem.
        "Yesterday, all night, there was a crisis. In many hospitals, oxygen was almost depleted, so we had to distribute a little bit among all of them. If the oxygen crisis ends in the next one or two days we will be able to increase the number of beds as well," he said.
        Biden has reached his vaccination goal. The next step will be harder
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        The Kaiser Family Foundation said in a report this week that the US is likely to reach a "tipping point" on vaccine enthusiasm in the next two to four weeks. "Once this happens, efforts to encourage vaccination will become much harder, presenting a challenge to reaching the levels of herd immunity that are expected to be needed."
        The country needs around 75-80% of its population to be vaccinated to reach herd immunity, the President's chief medical adviser, Dr. Anthony Fauci, has said. A slowing vaccine demand now, experts say, could give dangerous coronavirus variants the opportunity to continue to mutate, spread and trigger new surges -- and delay the country's return to a semblance of normalcy.

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