FDA Continues to Recommend COVID mRNA Shots for Pregnant Women and Children with ‘Risk Factors’

A paper authored by Food and Drug Administration (FDA) Commissioner Dr. Marty Makary and vaccine chief Dr. Vinay Prasad says FDA will continue to recommend the COVID mRNA injections for many Americans considered to be “at risk” for severe illness, a category that includes pregnant women, those who have been recently pregnant, and children above the age of six months.

For those with no “risk factors,” the health officials say more clinical trials are needed before licenses can be granted.

In the paper, titled “An Evidence-Based Approach to Covid-19 Vaccination” and published Tuesday at New England Journal of Medicine (NEJM), Makary and Prasad write:

For all healthy persons — those with no risk factors for severe Covid-19 — between the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted. Insofar as possible, when approving a Covid-19 vaccine for high-risk groups, the FDA will encourage manufacturers to conduct randomized, controlled trials in the population of healthy adults as part of their postmarketing commitment.

The authors add, nevertheless, that “FDA anticipates that it will be able to make favorable benefit–risk findings for adults over the age of 65 years and for all persons above the age of 6 months with one or more risk factors that put them at high risk for severe Covid-19 outcomes, as described by the CDC.”

As indicated in the CDC figure below, “risk factors” include asthma, cancer, gestational diabetes, Down syndrome, mental health issues, obesity, physical inactivity, and pregnancy and recent pregnancy.

“The FDA’s new Covid-19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science,” Makary and Prasad assert. “The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk. These clinical trials will inform future directions for the FDA, but more important, they will provide information that is desperately craved by health care providers and the American people.”

The paper was published a week after Makary said during an interview with The Charlie Kirk Show that “there’s no data” that COVID shots actually help children.

“There's no data,” he emphasized. “There's no good randomized control data that the current version, the latest formulation of the COVID shot, is necessary for young, healthy children. Other countries have already recommended against it. Other leading countries in Europe have recommended against it for young, healthy children.”

While some doctors say the FDA is taking a step in the right direction, others are alarmed that the COVID mRNA shots are not simply being halted entirely.

A Senate subcommittee hearing Wednesday provided the most recent exposé of the corruption in U.S. health agencies that served to hide from Americans the risks of cardiac inflammation and other injuries associated with the COVID shots.

“I'd like to ask what evidence there is for any COVID vaccine in children, whether healthy or not,” Dr. Jane Orient, executive director of the Association of American Physicians and Surgeons (AAPS), said in comments to Lumen-News.

“Young persons were not dying from COVID, except possibly a few who had other serious or fatal diseases,” she argued, adding, even so, that “it is generally not a good idea to vaccinate sick people.”

Orient observed the possible dangers of participation in randomized controlled trials (RCTs) to obtain more data on the COVID shots:

Long-term effects on fertility, birth defects, or cancer cannot possibly be known at present. And reports of serious adverse effects, including death, that just happen to follow COVID vaccines are only increasing and are well past the threshold that would have gotten another product withdrawn from the market, even with no proof of a causal relationship. No "abundance of caution" here!

“Remember that the subjects in RCTs are human beings, not lab rats,” she asserted. “What is the justification for exposing them to unknown risks to test something that will not benefit them?”

Orient further pointed out that, “unlike during the early panic, we now have approved treatments for COVID, along with the repurposed drugs that worked well, when given early, even if they failed in critically ill hospitalized patients.”

“If this is to be tested in children, the informed consent needs to be scrutinized very critically,” she warned.

In his testimony during the Senate hearing, OB/GYN Dr. James Thorp focused on reports of injuries to pregnant women who received the COVID injections. He cited a 2021 NEJM study, with 21 authors, who claimed the miscarriage rate in pregnant women who received the shot was 12.6%.

“But the raw data revealed an 82% miscarriage rate in women vaccinated during the first trimester,” Thorp asserted. “This figure mirrors the effects of chemical abortion drugs such as RU-486.”

“Also, in the same journal edition, on the same day, an op-ed appeared by CDC Director Rochelle Walensky and journal editor-in-chief Eric Rubin,” Thorp continued – underscoring the conflicted relationship between a top federal health official and a science journal editor.

“These publications were riddled with conflicts of interest and deliberate misrepresentations intended to coerce pregnant women into taking vaccines,” he added.

“So the news leak was a lie,” Dr. Mary Talley Bowden also lamented on the X platform about the FDA’s plan. “The shots will continue to be given to children and pregnant women.”

The Centers for Disease Control and Prevention (CDC) still recommends the COVID shots for everyone six months and older:

Referring to the prevailing U.S. COVID shot policy as “the most aggressive” of the Western nations, Makary and Prasad view the new FDA policy as a positive step.

“While all other high-income nations confine vaccine recommendations to older adults (typically those older than 65 years of age), or those at high risk for severe Covid-19, the United States has adopted a one-size-fits-all regulatory framework and has granted broad marketing authorization to all Americans over the age of 6 months,” they argue, adding that this U.S. policy “has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations.”

“We reject this view,” the health officials state.

Still, Bowden added that “America cannot get healthy again as long as these shots are still being pushed onto children!”