Vaccine makers asked to expand safety studies on children

Vaccine makers asked to expand safety studies on children

WASHINGTON — At the urging of federal regulators, two coronavirus vaccine manufacturers are expanding the size of their studies in children aged 5 to 11 — a precautionary measure aimed at detecting rare side effects including heart inflammatory problems that can cause 30 Have turned into vaccinated people under the age of one.

Appearing at a televised town-hall-style meeting in Ohio last week, President Biden said emergency approval for pediatric vaccines would come “soon.” The White House declined to be more specific on the timeline, and it was unclear how much the study’s expansion, if any, would have an impact on authorizing vaccines for young children.

Several people familiar with the trials said that the Food and Drug Administration had indicated to two vaccine makers, Pfizer-BioNtech and Moderna, that the size and scope of their pediatric studies, as initially envisioned, should be able to detect rare side effects. were insufficient. These include myocarditis, an inflammation of the heart muscle, and pericarditis, an inflammation of the lining around the heart.

Questions about vaccination of children – including those under the age of 12 – are of great interest to parents and teachers. Regulators will need to balance the potential side effects of coronavirus vaccination against the risks of COVID-19.

Members of the Centers for Disease Control and Prevention advisory committee have said that the benefits of shots for people over the age of 12 far outweigh the risks, including heart problems. Children 12 years of age and older have been eligible for the Pfizer shot for months, while studies on the safety of the Pfizer and Moderna vaccines for younger children are ongoing.

The FDA has asked companies to include 3,000 children in the age group of 5 to 11 years, according to the group of young children for whom the first results were expected. people familiar with the situation. Two people said that for that age group is twice the original number of study participants envisioned in the Pfizer trial. According to a government website, the study initially sought to enroll 4,500 patients under the age of 12, divided into 5 to 11-year-olds and two younger age groups.

A spokesman for Moderna, Ray Jordan, confirmed that the company intends to expand its testing “to enroll a larger safety database, thereby increasing the chances of detecting rare events,” and that “winter 2021/ It is expected to seek emergency authorization in “early 2022”.

The Moderna trial began recruiting patients in March with the aim of enrolling 6,795 participants under the age of 12, evenly divided into three age groups, including 6- to 11-year-olds. . Mr Jordan said the company was “actively discussing” a proposal with the FDA to expand the study.

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Pfizer is on a faster timetable than Moderna, and may be able to meet the FDA’s expectations on a larger trial size and still file a request to extend emergency authorization of its vaccine through the end of September. It will most likely take at least a few weeks for regulators to review all the safety and efficacy data.

Pfizer previously said it expected results for the 5 to 11-year-old group in September, followed soon after by results for the 2- to 5-year-olds. The results for the youngest children between 6 months and 2 years are expected in October or November. A spokesperson said Monday that the company had no updates on its timetable.

Stephanie Cacomo, a spokeswoman for the FDA, declined to offer specifics. “While we cannot comment on individual interactions with sponsors, we generally work with sponsors to ensure that the number of participants in clinical trials is sufficient to detect safety indications. be of size,” she said in an email.

In June, the CDC published data showing that the two vaccines could cause myocarditis and pericarditis in more than 1,200 Americans, including about 500 who were younger than 30. Symptoms usually appeared within two weeks and were more common in young men and boys. The rate was low: less than 13 cases per million second dose administered.

The researchers said most cases were mild and cleared up quickly. and Dr. Paul A. Offit, an infectious disease expert who previously served on the CDC’s Advisory Committee on Immunization Practices, which makes recommendations on vaccine use in the United States, noted that infection with the coronavirus also posed a risk.

If expanding trials delays authorizing vaccines for pediatric use, he said, it would also put children at risk. “There is always a human price to pay for knowledge,” he said. About heart ailments, he said: “It is rare. It is usually short-lived and self-resolving. This is also the result of natural infection.”

CDC data showed 12.6 cases per million second dose, and researchers estimated that out of a million second doses given to boys ages 12 to 17 years old, the vaccine caused a maximum of 70 myocarditis cases. but will contain 5,700 virus infections, 215 hospitalizations and two deaths. Kovid-19 itself can lead to heart problems in youth.

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The FDA authorized the Pfizer vaccine on an emergency basis for children ages 12 to 15 in April; So far, the Moderna vaccine has only been approved for people 18 years of age and older. The agency attached warnings about potential heart problems to the vaccines fact sheet in June.

Many public health experts argue that the risk to children has been overlooked by focusing so much on hospitalizations and deaths among older Americans infected with the coronavirus. The American Academy of Pediatrics reported last week that more than four million American young children and adolescents had tested positive for the virus and that 349 had died since the start of the pandemic.

Mr Biden’s attempt to impose a general timeline on potential authorization for children under the age of 12 was unusual, and risks setting expectations for regulators to resolve the highly sensitive matter too soon. Mr Biden and members of his administration have said they do not want to interfere or be seen as influencing the work of regulators at the FDA – something that former President Donald J. Trump tried repeatedly last year as the agency reviewed coronavirus drugs. and comments.

Government regulators and scientists have been disrupted in recent months by a patchwork of sometimes weak data collection systems for vaccine side effects in the United States, forcing them to lean on a program called the Vaccine Adverse Event Reporting System. A 30-year-old federal watchdog. System that relies on self-reported cases from patients and health care providers. That dilemma has increased pressure on companies to conduct more rigorous studies in children.

“There is a clear and well-defined risk of delaying the availability of these vaccines in young children,” said Dr. Steven Black, an emeritus professor of pediatrics at Cincinnati Children’s Hospital Medical Center and co-director of the Global Vaccine Data Network. , a consortium that conducts research on the safety of vaccines.

Dr Black said given how rare the conditions are, increasing the size of the study may not allow regulators to better track the prevalence of heart problems.

“The way we will go about it is to roll out the vaccine and see what happens,” he said. “Passive reporting would probably be great because I think we’re vulnerable to the issue. We know how to look for it. Physicians know how to look for it.”

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