Silver Spring, Maryland. The Commissioner of the Food and Medicines Administration, Dr. Marty Makary, said Wednesday that the decision of whether a pregnant woman must obtain a Covid vaccine should reach a conversation with her doctor, not a federal government recommendation.
Makary participated in the announcement of the Secretary of Health and Human Services Robert F. Kennedy Jr. on Tuesday that revoked the recommendation of the centers for the control and prevention of diseases that the covid shots are offered to pregnant women and healthy children.
“The data on the reinforcement of the Covid vaccine in pregnant women are a mixed data set,” Makary said in an interview. “Now, I think the decision should be between a doctor and a pregnant woman, but the idea that the government has to tell her what to do in this in an area where there are mixed data.”
That statement, that the data is mixed, are not backed by evidence, vaccine experts say.
CDCs do not demand vaccination. For decades, his panel of experts in independent vaccines, called immunization practices advisory committee, has recommended vaccination for certain data -based groups. The panel then passes recommendations to the director of the CDC to support. (For example, CDC advises pregnant women to obtain an inactivated influenza vaccine during the flu season). The United States General Surgeon established the Committee in 1964.
Tuesday’s decision omitted the usual process of consulting the CDC Vaccine Advisory Committee and make the director of the firm CDC formally. (The CDC currently has no director).
CDC recommendation plays a key role in determining what vaccines should free insurance companies for patients.
Covid risks during pregnancy
Ob-gyns quickly gave alarms about access to the patient to the vaccine.
According to CDCs, pregnant women have a higher risk of serious COVID complications compared to people who are not pregnant.
In the apogee of the Covid pandemic, doctors reported an unprecedented increase in hospitalized pregnant women and in critical condition after Covid infections.
Dr. Jesse Goodman, a professor of medicine and infectious diseases at Georgetown University and former chief scientist of the FDA, said he is not aware of any “mixed” data about the Covid vaccine in pregnant women.
“I am aware of multiple studies that have demonstrated the benefit of Covid vaccines in the protection of pregnant women, who have a very high risk of more serious Covid results,” he said. “Several studies have also shown that maternal immunization helps protect against diseases and hospitalizations in babies of less than 6 months.”
Dr. Paul Offit, director of the Vaccine Education Center of the Children’s Hospital in Pennsylvania, said that pregnant women have 1½ to twice more likely to be hospitalized and die from Covid infections.
“It seems that the burden of proof by not recommending pregnancy is in you to demonstrate that it is no longer a value,” said Offit, added that federal health officials had not provided evidence to put an end to the recommendation.
Goodman added that if there are concerns about a specific study, the FDA must review the data and inform about it.
“We give people accurate information and freedom of choice,” he said.
Until Wednesday, the CDC had not updated its website to align with the new recommendations.
Kennedy’s announcement on Tuesday, flanked by Makary and the director of the National Health Institutes, Dr. Jay Bhattacharya, caught the attention to what he lacked: CDC officials.
When asked about the people involved in revoking the recommendation of the Covid vaccine, Makary said that “many scientists” were consulted, but did not respond if anyone was from the CDC.
“I did not organize that discussion, but there were many individual discussions and group discussions, and I was part of those discussions, and they certainly asked me for my opinion,” he said. “The FDA has a very clear role in the approval of products based on the data presented to the FDA. CDCs have a role in the issuance of recommendations. Therefore, this was really an advertisement of the CDC in consultation with many scientists.”
He also refused to say if the Department of Health and Human Services will make some data on how he reached their public decision.
“Well, look, the tradition, the system we have, is a system by which Congress gives us a position as the main drug regulator of the nation, and that is to approve or not approve drugs based on the data presented to the FDA,” Makary said. “Therefore, our work has always been to review the data that is sent and then make a decision in this regard. Now, these data are sometimes made public, the companies make it public. We encourage the total transparency of those data. Often make public the data once the medications are approved.”
The American College of Obstetricians and Gynecologists said it was “extremely disappointed” by Kennedy’s announcement.
“We have seen firsthand how dangerous Covid infection can be during pregnancy and for newborns that depend on maternal antibodies of the protection vaccine,” he wrote in a statement on Tuesday. “We also understand that despite the change in HHS recommendations, science has not changed. It is very clear that Covid infection during pregnancy can be catastrophic and lead to important disability.”
