FDA says Pfizer jab is safe for babies

Pfizer’s three-dose Covid vaccine for infants and toddlers is safe and effective, US health authorities claim.

Pfizer’s three-dose Covid vaccine for infants and toddlers is safe and effective, US health authorities claim.

The Food and Drug Administration released on Sunday his analysis of Pfizer’s application for emergency use authorization to expand its vaccine to children aged six months to four years, ahead of a pivotal meeting Wednesday where an independent panel of experts will vote on the request.

Wednesday’s advisory committee meeting on Vaccines and Related Biologics will also consider whether to approve the Moderna vaccine for children under five, which the FDA said Friday was safe and effective based on the analysis of the drug’s vaccines. company submitted data.

The FDA typically accepts the recommendation of: the panel† If approved, the vaccines could be available to about 19 million additional children starting next week.

Surveys show less than one in five parents of children under five in the US are eager to get their children vaccinated immediately.

About four in 10 say they plan to wait and see how the vaccine works for others, while 27 percent say they will “absolutely not” have their child vaccinated.

“Data available support the effectiveness of the primary series of Pfizer-BioNTech Covid-19 three-dose vaccine in preventing Covid-19 in the six-month to four-year-old age group,” the FDA said.

Pfizer’s data was based on a study of 4,526 children, two-thirds of whom received the injection of three micrograms — originally two doses, later increased to three doses, three weeks apart — and the remaining third a placebo.

Of the entire study group, only 10 cases of symptomatic Covid were reported.

Among children aged six to 23 months, there were three cases: one in the vaccine group and two in the placebo group.

In the age group of two to four years, there were a total of seven cases – two in the vaccine group and five in the placebo group.

This translates to an overall effectiveness of 80.4 percent, according to Pfizer.

In the younger group this was 75.6 percent and in the older group 82.4 percent.

The FDA warned that “final conclusions” about the effectiveness of the three-dose series were limited by the “small number of cases.”

But the regulator said tests for neutralizing antibodies showed the vaccine elicited an immune response at least as strong as that seen in young adults, the key requirement for effectiveness.

According to the FDA and Pfizer, there were no serious side effects associated with the vaccine.

The most commonly reported reactions in the younger group were irritability, somnolence, decreased appetite, and injection site tenderness. In the older group, the most commonly reported reactions were injection site pain, fatigue, and injection site redness.

Most reactions were “mild to moderate in severity” and typically lasted one to two days.

No cases of myocarditis or pericarditis were reported among the test participants, but the FDA acknowledged that the sample size was too small to quantify the frequency of the unusual reaction in this age group.

The FDA admitted that while heart inflammation, which is most commonly seen in young men ages 16 to 17, has usually been associated with “rapid resolution of symptoms,” the “long-term consequences of vaccine-associated myocarditis, if any, are yet to be seen.” are determined” .

“The risk of vaccine-associated myocarditis/pericarditis in children aged six months to four years is unknown at this time,” it said.

The FDA emphasized the need for a vaccine in young children given the “uncertainty” of the pandemic.

“In infants and children aged six months to four years, the number of Covid-19 hospitalizations and deaths is higher than among children and adolescents aged five to 17 years, and comparable to those aged 18-25 years, which the benefit of an effective Covid-19 vaccine in this age group,” it said.

Of the approximately 84 million Covid cases reported to date in the US, 3.3 percent were in children ages 0 to 4.

According to the Centers for Disease Control and Prevention (CDC), one million deaths have been attributed to Covid, with 202 among children in this age group — or just 0.02 percent.

From December 2021 to May 2022, when Omicron reigned supreme, 535 children aged six months to four years were admitted to intensive care.

The paper notes that of the children in this age group with Covid-associated hospitalization, half had one or more underlying conditions — most commonly obesity, which was also associated with an increased risk of serious disease.

Last week, the FDA said data from clinical trials conducted by Moderna suggested the vaccine’s efficacy against symptomatic Covid was 51 percent in infants aged six months to two years and 37 percent in children aged two to five years.

The numbers are lower than those recorded in adult clinical trials, but that’s only because the trials for the very young children were conducted during a wave linked to the Omicron variant, the FDA said.

“Although the VE (vaccine efficacy) … in children aged six months to five years is lower than that observed in the pivotal studies in adults or older pediatric patients, it is very consistent with the actual vaccine effectiveness observed against Omicron in adults,” he said. the FDA. in a statement.

Although Moderna’s vaccine has been shown to be less effective against the Omicron variant, it remains very good at protecting against severe cases of the disease, the FDA said.

Therefore, the FDA concluded that Moderna’s data “administered” the vaccine in two doses of 100 micrograms each in adolescents aged 12 to 17 years, 50 micrograms in children aged six to 11 years, and 25 micrograms in children aged six months to five. year.

In the United States, Moderna’s vaccine is currently only allowed for people ages 18 and older.

frank.chung@news.com.au

— with AFP

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