Pfizer-BioNTech Covid-19 vaccine for young children meets FDA criteria, agency says – .

Pfizer-BioNTech Covid-19 vaccine for young children meets FDA criteria, agency says – .

The Food and Drug Administration has said that Pfizer’s Covid-19 vaccine Inc.

In a report released Friday, the agency flagged the risk of heart inflammation, including vaccine-associated myocarditis, but said the overall benefits, in preventing Covid-19 disease and hospitalizations, the outweigh the risk of heart disease.

The agency confirmed data, which the companies published earlier today, showing that the vaccine was 90.7% effective in preventing symptoms of Covid-19 in a study of children in this age group. , information that health authorities are likely to take into account when considering whether to allow the footage to be used.
The vaccine has been shown to be safe and tolerable, the companies said in a document they submitted to the FDA and the agency posted online Friday morning.

In early October, Pfizer and BioNTech asked the FDA to approve the vaccine for children aged 5 to 11.

The documents were released ahead of a scheduled meeting Tuesday of a committee of vaccine experts advising the FDA.

The panel, the Vaccines and Related Biological Products Advisory Committee, will meet to review the evidence for the vaccine’s safety and effectiveness in children, and vote to recommend whether the FDA should allow use.

As the FDA prepares to make a decision on whether to authorize Pfizer’s Covid-19 vaccine for children ages 5 to 11, public health officials and pediatricians share their research with families to assure parents hesitant about the safety of the vaccine. Photo: John Locher / Associated Press

If the vote is in favor, FDA clearance could follow in a few days. And if the Centers for Disease Control and Prevention subsequently signs off, millions of young children could receive a Covid-19 vaccine for the first time.

There are more than 28 million children between the ages of 5 and 11 in the United States, according to the American Academy of Pediatrics.

The risk of severe Covid-19 is much lower in children than in adults. Still, many have been hospitalized and at least 542 children aged 17 and under have died from Covid-19, according to the Centers for Disease Control and Prevention.

Vaccination can also help prevent children from transmitting the virus, according to many health experts.

Pfizer and BioNTech said in September that their vaccine was generally well tolerated and induced strong immune responses in a study of nearly 2,270 children aged 5 to 11. Each child received two doses three weeks apart and each injection contained one third of the dose used. for adolescents and adults.

The vaccine induced levels of neutralizing antibodies in young children that were comparable to those seen in people aged 16 to 25 who served as a control group in the study, the companies said.

Pfizer-BioNTech Covid-19 compound being mixed for trial in children under 12 in August.

Daniel Lozada for the Wall Street Journal

The Pfizer-BioNTech paper contained new data from the same study showing that immune responses appeared to protect children from disease. The researchers found that three children who received the vaccine fell ill with Covid-19, compared to 16 cases who received a placebo, resulting in an efficacy of 90.7%, according to the companies.

Researchers found no cases of heart inflammation, including myocarditis in children in the study. The companies, however, said the study was too small to detect this potential risk.

Health officials said there was an increased risk of myocarditis with Covid-19 vaccines from Pfizer and Moderna Inc.,

especially in men under 30.

The FDA said in its paper that it conducted a risk-benefit analysis in light of the risk of myocarditis.

When the incidence of Covid-19 is low, such as in June, the predicted number of vaccine-associated myocarditis cases leading to hospitalizations was higher than the predicted number of Covid-19 hospitalizations averted for males and both sexes combined, the agency mentioned.

Yet when Covid-19 was more prevalent, as in September, the benefits of the vaccine outweighed the risks, the agency said.

And even when the incidence of the disease is low, other factors favored the vaccine, including its potential to prevent Covid-19 which causes complications in out-of-hospital children, the FDA said.

Pfizer has also tested the vaccine at an even lower dose in children as young as six months old.

Pfizer’s vaccine was approved in December 2020 for people 16 and older, with approval extended in May to adolescents 12 and older.

Earlier this week, the Biden administration laid out plans to distribute the Pfizer vaccine to children in doctors’ offices, pharmacies and schools if regulators allow injections.

Moderna and Johnson & Johnson have studied their Covid-19 vaccines in children, but currently their injections are only allowed for people 18 years of age and older.

Write to Peter Loftus at [email protected] and Jared S. Hopkins at [email protected]

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