FDA approves COVID booster for babies with no trial data

Americans clearly have become aware that COVID-19 poses little threat to most people while the mRNA vaccines don’t prevent infection while evidence grows that they pose the risk of serious adverse events, including death, that have been downplayed or ignored by the government and medical establishment.

 

By Art Moore

The evidence for that is the fact that, according to the CDC, less than 13% of Americans age 5 and older have received the new bivalent booster targeting the omicron subvariants.

Children are the most immune from COVID-19, with, statistically, virtually no chance of serious illness or death.

Nevertheless, the Food and Drug Administration on Thursday approved the bivalent mRNA booster for children aged 6 months to 4 years.

FDA Commissioner Robert Califf said “we encourage parents and caregivers of those eligible” to get their children vaccinated for COVID-19, “especially as we head into the holidays and winter months where more time will be spent indoors.”

The final decision to grant emergency use authorization of the booster for babies lies with the CDC. But during the pandemic the agency has never gone against the FDA’s recommendation.

Only 6.4% of children under 2 years of age and 9.3% of those between 2 and 4 have received the first dose of the COVID vaccine. And just 2.7% of children under 2 and 4.6% ages 2 to 4 have completed the three-dose series.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, declared the vaccines “remain the best defense against the most devastating consequences of disease caused by the currently circulating omicron variant, such as hospitalization and death.”

“Based on available data, the updated, bivalent vaccines are expected to provide increased protection against COVID-19,” he said.

“Parents and caregivers can be assured that the FDA has taken a great deal of care in our review, and we encourage parents of children of any age who are eligible for primary vaccination or a bivalent COVID-19 vaccine booster dose to consider seeking vaccination now as it can potentially help protect them from COVID-19 during a time when cases are increasing,” said Marks.

However, there is no clinical data supporting the efficacy of the bivalent booster. Federal regulators acknowledged they authorized the shot based on data from eight mice and other updated vaccines. And the safety data came from the old vaccines.

At a roundtable Wednesday in the nation’s capital led by Sen. Ron Johnson, R-Wis., acclaimed cardiologist Dr. Peter McCullough was among the health scientists calling for the COVID-19 vaccines to be immediately withdrawn.

McCullough said there is no scientific support for the vaccines reducing transmission, explaining they provide no immunity in the nose, where the viral load begins. The only hope for any efficacy is that they would reduce severity of disease, but there is no clinical trial data to support that, he said.

“I think it has to be said, the pathway to preventing any more harm is all the vaccines need to be pulled off the market and withdrawn,” said McCullough. “That needs to happen immediately. All the vaccine mandates should be dropped immediately.”

Dr. Ryan Cole, a Mayo Clinic-trained pathologist, explained that the SARS-CoV-2 virus “has mutated ahead of our efforts” to bring a targeted vaccine to the market “and it always will.”

“We don’t have a vaccine for HIV 40 years later because it has a spike protein that is always mutating,” he explained.

The Wuhan strain, on which the original COVID mRNA vaccine was based, was long ago “extinct” he said, and the BA.5 and BA.4 omicron variants, on which the new bivalent booster is based, are “almost extinct.”

“We are taking an approach with an infectious agent that is always moving ahead of us,” Cole said.

David Gortler, a former senior adviser on drug safety to the FDA commissioner said the COVID-19 vaccine product labeling needs to be updated to reflect the lack of safety and efficacy.

See Gortler’s remarks: