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The Epoch Times
The Epoch Times
11 Feb 2023


NextImg:Top US Officials Discussed 'Adverse Event Issue' With COVID-19 Vaccines and Pregnancy: Emails

Top U.S. health officials were concerned with an “adverse event issue” concerning COVID-19 vaccines being injected during pregnancy, according to newly disclosed emails.

On May 14, 2021, officials with the U.S. Food and Drug Administration (FDA) and U.S. Centers for Disease Control and Prevention (CDC) were exchanging emails about language concerning the co-administration of COVID-19 vaccines with other vaccines during pregnancy.

“Please let me know if you want to connect about the adverse event issue later today. Seems like work is still ongoing, but let me know,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, wrote to colleagues at both agencies.

Dr. Amanda Cohn, chief medical officer of the CDC’s National Center for Immunizations and Respiratory Diseases, replied.

“We have a meeting with Rochelle at 3:30 about if we should say anything or wait until we have more definitive information … I will let you know where we land,” Cohn wrote. Dr. Rochelle Walensky is the head of the CDC.

“I’m not sure there is a right answer,” Cohn added.

The emails (pdf) were obtained by the nonprofit Judicial Watch, which sued the U.S. government for failing to appropriately respond to a Freedom of Information Act request for messages regarding adverse events, deaths, and/or injuries caused by the COVID-19 vaccines.

Adverse events include health issues such as arthritis or heart inflammation.

No other emails about the “adverse event issue” were included in the latest tranche obtained by the nonprofit.

“I respectfully decline to comment,” Marks told The Epoch Times in an emailed statement when asked what the issue was.

Cohn and the CDC did not respond to requests for comment.

The CDC currently recommends virtually all Americans aged 6 months and older, including pregnant women, get a COVID-19 vaccine and multiple booster shots.

The original trials did not include enough information “to make conclusions about the safety of the” vaccines from Pfizer, Moderna, and Johnson & Johnson, according to FDA documents.

Authorities have relied on observational data, including a study from the CDC, a corrected version of which was published in October 2021.

Pfizer conducted a post-authorization trial of its vaccine in pregnant women that was labeled completed in mid-2022 but results have not been reported publicly as of yet.

“We think that part of the reason is because the results are so bad,” Linda Wastila, a professor at the University of Maryland, told The Epoch Times.

Pfizer did not respond to a request for comment.

The FDA vaccine advisory committee met on Dec. 10, 2020, to consider whether to advise the FDA to authorize Pfizer’s vaccine.

During the meeting, officials revealed that two postvaccination cases of severe allergic shock (anaphylaxis) had been recorded in the United Kingdom out of 6,000 doses administered on the day the events occurred.

“At this point, we are seeking further information from the MHRA under our confidentiality agreement to learn more about this and to really tease that out,” Marion Gruber, an FDA official at the time, told the panel.

The Medicines and Healthcare products Regulatory Agency (MHRA) is the British equivalent of the FDA.

The newly obtained set of emails showed U.S. and UK officials discussing the cases of anaphylaxis throughout December, including as early as Dec. 9, 2020.

Marks wrote that it would “be very helpful if our Office of Vaccines could receive additional details” from MHRA “under the terms of our mutual confidentiality agreement.” Jonathan Mogford, a UK official, sent back data, adding, “If I can just remind—information shared under our confidentiality agreement.”

The MHRA declined to provide a copy of the confidentiality agreement, and the FDA did not respond to emailed questions about the pact.

“It again took a lawsuit for the Biden administration to hand over, albeit heavily redacted, information regarding the safety of the COVID vaccines that the public has every right to know,” Judicial Watch President Tom Fitton said in a statement. “This disturbing batch of new documents have uncovered a secret confidentiality agreement tied to COVID vaccine safety issues and emails that raise new questions about the vaccines and pregnancy.”

The Epoch Times has submitted Freedom of Information Act requests to try to uncover more information about the adverse event issue and the confidentiality agreement. Previous requests have unearthed secret data on COVID-19 vaccines, including showing how the CDC  identified hundreds of potential safety issues with the Pfizer and Moderna vaccines.

People with a history of severe allergic reaction to any vaccine were excluded from Pfizer’s trial and people with a history of allergic reactions to any components of the Moderna vaccine were excluded from Moderna’s trial. No such exclusions were reported for the Johnson & Johnson trial.

The fact sheets for all three vaccines in the United States were updated to include warnings about severe allergic shock, including saying the vaccine should not be administered to people with a known history of severe allergic reaction to any components of the shot.