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 coadministration 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.
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 didn’t respond to requests for comment.
The original trials didn’t include enough information “to make conclusions about the safety of the” vaccines from Pfizer, Moderna, and Johnson & Johnson, according to FDA documents.
Pfizer conducted a post-authorization trial of its vaccine in pregnant women that was labeled completed in mid-2022 but results haven’t been reported publicly as of yet.
Confidentiality Agreement
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, stating, “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 didn’t 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.”
People with a history of severe allergic reactions 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 shouldn’t be administered to people with a known history of severe allergic reaction to any components of the shot.
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