FDA staff speak out on 2 COVID vaccines for children ahead of advisory meetings

This week, the Food and Drug Administration (FDA) will review key recommendations that would give older children a second COVID-19 vaccine — Moderna — for the primary series and open up vaccination for the first time to younger children.

Ahead of a 2-day meeting this week, FDA staff released in-depth reviews, which said the vaccines were safe and effective.

In international developments, European health officials today warned that COVID-19 cases are likely to rise in the coming weeks as the BA.4 and BA.5 subvariants become more dominant across the world. continent.

Busy week for vaccine advisory groups

Tomorrow, the FDA’s Vaccines and Related Biologicals Advisory Committee (VRBPAC) will consider emergency use of Moderna’s vaccine in children ages 6 to 17.

The vaccine would be given in two doses of 100 micrograms, as for adults, in adolescents aged 12 to 17 years and in two doses of 50 micrograms in children aged 6 to 11 years. For young people aged 6 months to 5 years, the dosage is 25 micrograms.

Then the next day, VRBPAC will consider amending the emergency use authorizations for the Moderna and Pfizer-BioNTech vaccines, allowing them to be used in children aged 6 months to 5 years, a much-anticipated decision that opens up vaccination. to younger Americans. (The Pfizer vaccine is already approved for emergency use for children 5 years and older.)

In a staff analysis of data released June 10 ahead of the meeting, FDA staff said the Moderna vaccine elicited a similar immune response in children ages 6 months to 17 years old as in adult trials. . They said the side effect profiles were similar for children and adults, although fever was more often reported in young children.

Both mRNA vaccines have been associated with rare cases of heart inflammation. In their analysis, FDA staff said the risk was known, but Moderna’s trials were not large enough to characterize the frequency in pediatric age groups.

Meanwhile, in a similar assessment of data from Pfizer-BioNTech vaccine trials in children under age 5, FDA staff said the vaccine appears to be effective in preventing the disease. The primary series for young children is 3 micrograms, one-tenth the adult dose, given in three divided doses.

If VRBPAC approves both vaccines for emergency use in pediatric groups and the FDA accepts its advisory group’s decision, the next step is for the Centers for Disease Control and Prevention (CDC) advisory group to review the data. and to make formal recommendations. The Advisory Committee on Immunization Practices (ACIP) is due to meet June 17-18.

Pending clearances from the FDA and CDC, White House officials said vaccinations for young children would likely begin as soon as June 21. Federal officials said 10 million doses for young children, made up of vaccines from both companies, will begin shipping as soon as the vaccines receive FDA clearance.

Masking and travel tips

In other US developments:

  • Cases continue to rise slowly, with the 7-day average of daily new cases increasing by 4% over the past week, according to a Washington Post analysis, which also indicated that hospitalizations increased by 2% and deaths increased by 38%.
  • As COVID-19 cases rise with the biggest burden moving east to west, Las Vegas-area health officials have recommended that people wear masks indoors and stay informed vaccination against COVID-19. In a June 10 statement, the Southern Nevada Health District said Clark County has reached community high for COVID-19.
  • International air travelers no longer have to present a negative COVID-19 test before flying to the United States, the CDC said in a June 10 announcement. The new policy came into effect yesterday.

ECDC warns against increasing BA.4 and BA.5

In an update today, the European Center for Disease Prevention and Control (ECDC) said many countries have seen an increase in BA.4 and BA.5 subvariant weeks. BA.5 is already dominant in Portugal, where the variant has fueled a rise in COVID-19 cases. Although viruses are thought to have a growth advantage, early findings do not suggest that the diseases are more severe.

As in previous waves, spikes in cases can lead to more hospitalizations, intensive care unit admissions and deaths.

The ECDC has urged countries to remain vigilant for signals of spreading subvariants and to monitor case levels, especially in the elderly, and markers of severe disease.

In other global developments:

  • In China, mass testing is underway in Beijing after officials linked a large group to a popular bar, according to Reuters.
  • Sanofi today announced that its next-generation booster it developed with GSK showed a strong immune response against subvariants, including Omicron. The vaccine is modeled after the beta variant and contains GSK’s adjuvant. In a phase 3 study, the vaccine provided a significant increase in antibody titers in adults who had previously received mRNA vaccines. In a related study involving 247 people in a French hospital that compared Sanofi’s second-generation booster with the Pfizer-BioNTech booster and the first-generation Sanofi-GSK booster, the new Sanofi-GSK booster elicited a stronger immune response. strong, including against Omicron.

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