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Are They Testing COVID-19 Vaccines On Newborns?

Why do some people think that we will soon be testing COVID-19 vaccines on newborn babies?

Robert F. Kennedy, Jr is wrong that COVID-19 poses virtually no risk to healthy children

The usual suspects…

Kennedy Says That COVID Poses Virtually No Risk to Healthy Children

Before we look at the claim that they will be testing COVID-19 vaccines on newborn babies, let’s take a look at Robert F. Kennedy, Jr‘s other claim – that “COVID poses virtually no risk to healthy children?”

Is that true?

The CDC reports that over 300 children have died with COVID-19.
The CDC reports that over 300 children have died with COVID-19.

Considering how many kids have died with COVID-19 and MIS-C, a complication of COVID-19, it is easy to see that claim isn’t true.

It’s true that kids are at less risk than adults, but still, a lot of kids have died with COVID-19.

And many of them have been otherwise healthy children without any risk factors. And for half of kids who have died with risk factors, they have common conditions like asthma and obesity.

Are They Testing COVID-19 Vaccines On Newborns?

And the COVID-19 vaccine testing on newborns?

Not surprisingly, studies are being done to make sure COVID-19 vaccines are safe and effective for newborns and infants.

More trials in kids are planned for the Johnson & Johnson COVID-19 vaccine.

Study COV2004, for example, the one about pregnant women and their infants, will “assess the safety, reactogenicity and immunogenicity of Ad26.COV2.S in adult participants in the second and/or third trimester of pregnancy.”

“For adult participants, the total study duration from screening until the last follow-up visit will be between 13 to 17 months. The study will consist of a screening phase (1 to 28 days), vaccination phase (1 to 3 months) and a follow up phase (up to 12 months post-partum [PP]). For neonates/infants (born to adult participants who received vaccination) the total study duration from birth until the last follow-up visit will be approximately 12 months. Safety assessments will include immunogenicity assessments, physical examination, vital signs, clinical safety laboratory assessments, medical, obstetric and delivery history, neonate safety assessment, adverse events (AEs), serious adverse events (SAEs).”

A Study of Ad26.COV2.S in Healthy Pregnant Participants (COVID-19)

The newborns and infants in the study aren’t actually getting a COVID-19 vaccine though.

Their mothers are…

What about Study COV3006?

“COV3006 – A randomized, double-blind, placebo-controlled study to evaluate the safety, reactogenicity, and immunogenicity of different dose levels of Ad26.COV2.S administered as a two-dose regimen followed by a booster in healthy children from birth to 17 years inclusive.”

FDA Briefing Document Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19

This is a proposed study of their new COVID-19 vaccine.

Will it really include newborns and younger infants?

Possibly.

Keep in mind that the youngest infants in pediatric COVID-19 vaccine trials so far are six months though. And we give very few vaccines to newborns – just hepatitis B, BCG, and OPV.

In this Phase 2/3, two-part, open-label, dose-escalation, age de-escalation and randomized, observer-blind, placebo-controlled expansion study to evaluate the safety, tolerability, reactogenicity, and effectiveness of mRNA-1273 SARS-CoV-2 vaccine in healthy children 6 months to less than 12 years of age the placebo is a 0.9% sodium chloride (normal saline) injection.
In this Phase 2/3, two-part, open-label, dose-escalation, age de-escalation and randomized, observer-blind, placebo-controlled expansion study to evaluate the safety, tolerability, reactogenicity, and effectiveness of mRNA-1273 SARS-CoV-2 vaccine in healthy children 6 months to less than 12 years of age the placebo is a 0.9% sodium chloride (normal saline) injection.

Will COVID-19 vaccines even work when given to newborns and younger infants?

They should.

The only vaccines that don’t work well until kids are older are polysaccharide vaccines. And some live vaccines because of interference from maternal antibodies.

There is also no reason to expect that they won’t be safe when given to younger kids, but that’s the whole point of these clinical trials, to confirm that COVID-19 vaccines are indeed safe and effective for younger infants and children.

Still, if newborns and younger infants can get some immunity from their vaccinated mothers when they are pregnant via passive immunity, then they can likely wait until about six months to get vaccinated themselves. Or at least until two months when most vaccines typically give a better immune response.

The other thing you should notice about Robert F. Kennedy‘s post?

He is trying to scare folks by calling it an ‘experimental vaccine‘ and implying that they have a lot of risks.

They don’t.

COVID-19 vaccines are safe, with few risks, and are obviously necessary.

“We don’t really know what that magical point of herd immunity is, but we do know that if we get the overwhelming population vaccinated, we’re going to be in good shape. We ultimately would like to get and have to get children into that mix.”

Anthony Fauci

Necessary for kids and adults.

More on COVID-19 Vaccines

Last Updated on March 21, 2021

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