Key Takeaways:

•  No pregnant or lactating woman received the COVID-19 vaccine in the United States prior to the FDA approval in December 2020.
• It was not possible to receive COVID-19 vaccines in the U.S. prior to the FDA approval since the first vaccination in the U.S. was conducted on December 14, 2020.
• In the United States, the FDA issued "emergency use authorizations (EUA)" for Pfizer-BioNTech and Moderna COVID-19 vaccine on December 11, 2020, and December 18, 2020, respectively.

Introduction:

• This report provides the number of pregnant or lactating women who received the COVID-19 vaccine in the United States prior to the FDA approval in December 2020. It also offers brief insights into the factors that influenced the negative perception of pregnant women towards the COVID-19 vaccine. Below is an overview of the findings, as well as an explanation of the methodology used.

Findings

• In the United States, the Food and Drug Administration (FDA) approved the Pfizer-BioNTech vaccine on December 11, 2020, and the Moderna COVID-19 vaccine on December 18, 2020. These were "emergency use authorizations (EUA)," and not recommendations.
• Recommendations came later, from the Center for Disease Control and Prevention (CDC), on April 23, 2021, after comprehensive clinical tests and observations were conducted on over 35,000 pregnant lactating women that had received the Pfizer-BioNTech and Moderna vaccines.
• Children and women were excluded from the initial U.S. clinical trials of COVID-19 vaccines, which is typical of experimental vaccine trials/research. However, after observing over 10,000 women vaccinated between December 2020 and February 2021, the FDA reported that there were no 'red flags' yet.
• COVID-19 developers, such as Pfizer, said that they were following the FDA's guidance when they excluded pregnant women from the trials.
• Before the approval, both pregnant women and the government were reluctant to administer COVID-19 vaccines because there was no data on their efficacy or safety. While the U.K. government was totally against the pre-research vaccination of pregnant women, the U.S., took a less cautious path by allowing lactating and pregnant women to make their own decisions.
• Regardless of the choices made by pregnant women in the U.S., there was no chance that they received any vaccines since the first vaccination in the U.S. was administered on December 14, 2020.

Research Strategy