Do you still need a COVID vaccine for your child?

June 14, 2021-COVID-19 test vaccine Be careful with young children. Determining how to approve them and who needs to get them can be even more difficult.

So far, vaccine Available to Americans over the age of 12, they have passed the FDA’s regulatory checks using an accelerated authorization process called the Emergency Use Authorization (EUA).

EUA sets low standards of effectiveness and vaccine It may be safe and effective based on just a few months of data.

However, as the number of cases of COVID has plummeted in the United States and children have historically not seen far more serious cases than adults, a committee of FDA expert advisors has stated that the FDA has set vaccines for this age group on the same basis. I was asked to discuss if I could consider it at.

In other words, is COVID an emergency for children?

There’s another wrinkle in the mix — Heart inflammation, this is Very rare side effects associated with vaccination. It seems to occur more often in teens and young adults. So far, Myocarditis And Pericarditis It seems to occur in 16 to 30 people for every 1 million doses given.

However, some wonder if it could eventually upset the balance between children’s interests and risks if it was linked to a shot.

As a result, some experts on the FDA’s advisory board on vaccines and related biopharmacy have taken the time to study shots more thoroughly before being administered to millions of children. I asked the FDA to do it.

Different vaccine studies in children?

Clinical research on vaccines for teens and adults relies on some simple math.Researchers take two groups of similar people, vaccinate half of them and vaccinate the other half placebo, Then wait to see which group has the more symptomatic infection. To date, vaccines have dramatically reduced the risk of becoming severe with COVID in all age groups tested.

However, the rapid decline in COVID infections in the United States can make it more difficult for researchers to perform similar types of experiments on children.

The FDA is exploring a variety of approaches to determine if a vaccine is effective in children, including what is called an “immune cross-linking test.”

In bridging trials, researchers do not look for infections. Rather, look for proven signs that someone has developed immunity, such as antibody levels. We then compare these biomarkers to the immune response of young adults who have shown excellent protection against infection.

The main advantage of bridging research is speed.How is it possible to take a snapshot Immune system It responds to the vaccine within a few weeks of the last dose. What are the drawbacks? Researchers don’t know exactly what to look for to determine how much protection a shot produces.

It becomes even more difficult because the child’s immune system is still developing, so it may be difficult to resemble an adult directly.

He is responsible for the Pediatric Infectious Diseases Division at Tufts Medical Center in Boston and is the FDA’s Vaccine and Related Biological Products Advisory Board.

Would you like to speed up the introduction of vaccines or collect more data?

The plunge in infection rates in the United States also means that it may be more difficult for the FDA to justify granting vaccines on the market for emergency use for children under the age of 12.

At a recent Advisory Board meeting, authorities asked the Panel if they should consider a COVID vaccine for children under EUA or Biologics Authorization Application (BLA), also known as Full Approval.

BLA usually means that the agency will consider one or two years of data on the new product instead of two months of data. Emergency use also enables products on the market under looser standards — they may be safe and effective rather than proven to be safe and effective. ..

Members of some committees see the United States not yet feel in an emergency with COVID and the FDA allows the vaccine to be used in children who have not undergone the highest levels of scrutiny. Said he couldn’t.Unfavorable Events like myocarditis Come to light.

“I just want to make sure that the price paid to vaccinate millions of children justifies the side effects, but I don’t think we know that yet,” says Meissner.

Others have admitted that there is little risk to children now that infectious diseases are declining. However, the situation can change as varieties spread, schools reopen, and colder temperatures drive people indoors.

The FDA needs to decide whether to act based on where we are or where we will be in the coming months.

“I think it’s a multi-million dollar problem right now,” said CDC medical epidemiologist Dr. Hannah Kirking, MD, who submitted new, unpublished data on the effects of COVID on children to the FDA’s advisory board. It states that it did.

A prospective study that tracks how COVID travels within the home in weekly tests from New York City and Utah shows that children are almost as easy to catch and infect COVID as adults, but usually Cases are often overlooked because they are less ill than adults.

Kirk also presented the results of blood tests from samples across the country looking for evidence of past infections. In these studies, about 27% of children under the age of 17 had antibodies to COVID. This is most of all ages.That is, more than one in four children already have nature Immunity..

So the main benefit of vaccination of a child may be to protect others, but it’s still a risk, but a small one.

Some experts felt that it was not a good reason to justify the mass distribution of vaccines to children and that it might not be acceptable from a regulatory point of view.

“The FDA can only approve medical products in a population if the benefits outweigh the risks. In that population“Dr. Peter Dosi, an assistant professor of pharmaceutical medical services research at the University of Maryland School of Pharmaceutical Sciences, said.

“If the benefits don’t outweigh the risks of the children, we can’t show them to them. It’s an end,” adds editor Doshi. BMJ..

There is another way to give children access to the vaccine: through extended access or compassionate use programs. Because most childhood COVID deaths are in children with underlying illness, Doshi et al. Vaccinated millions before becoming more thorough in order to vaccinate children at high risk of complications. Before inoculating, he said it made sense to allow increased access to study.

“It’s not a particularly attractive option for the industry because you don’t have the money to make money. Your medicine can’t be commercialized under expanded access. The most you can get is the manufacturing cost, it’s Not many, “he says.

Art Kaplan, a professor of bioethics at New York University’s Langone Medical Center in New York City, said the debate over influenza vaccination follows the same policy. The benefit / risk ratio is balanced for children. The main value of protecting them is to protect others.

“The flu rarely kills young people, but you’re really trying to protect the older, which is a classic example,” he says.

In addition, the idea that children take risks with vaccines for personal gain is oversimplified, he says.

“Yes, you may be vaccinated to prevent harm to others, but others are benefiting you. It’s not a one-way street. I think it’s a bit morally distorted.” Kaplan says. It benefits children and adults alike. “

Members of other committees felt it was too early to fully clarify COVID and said the FDA should approve vaccines for children as early as other age groups.

“We still believe in an emergency. If this virus invades children, I think it will happen. It will give an incubator to change it,” said Associate Professor Obeta. Dr. Fuller says. He holds a PhD in Microbiology and Immunology from the University of Michigan School of Medicine.

For the benefit of the world, Americans need to vaccinate their children to prevent the virus from mutating and creating new, potentially more dangerous variants, according to Fuller.

Comparison of risks to safety

Dr. Beth Thielen, MD, a pediatric infectious disease specialist and virologist at the University of Minnesota School of Medicine, said he did not follow the committee’s discussions, but about once a month, he gave children very ill due to the virus. I am treating.Infectious disease or Pediatric multisystem inflammatory syndrome (MIS-C), an inflammatory reaction that develops after infection.

She is worried about how the virus has already changed and notes that the types of illnesses currently seen in children are different from what she saw in the first few months. Pandemic..

“In the last few months, I’ve actually seen some cases of severe lung disease that resembles adult diseases in children,” says Thielen. “We believe that young people may have more serious illnesses, which greatly increases the risk of unvaccination.”

But she also knows that no one has a crystal ball, and now everything seems to be heading in the right direction with COVID. This makes the risk and benefit considerations more ambiguous.

“The question in my mind is, what is the risk of side effects from the vaccine?” She says. .. “I think we really need to know what a vaccine safety profile looks like to children, because vaccines are small and now we have a good understanding of what the risk of illness looks like. Because.

For now, Thielen says he is watching for more answers at the next meeting of the CDC Immunization Advisory Board.