The FDA approves the Omicron vaccine for children 6 months and older

Oliver Harris, 9 months, cries after receiving a vaccine for the coronavirus disease (COVID-19) at Northwell Health’s Cohen Children’s Medical Center on June 22, 2022 in New Hyde Park, New York, United States. REUTERS/Shannon Stapleton

Shannon Stapleton | Reuters

The Food and Drug Administration on Thursday approved updated Covid shots targeting the Omicron variant for children 6 months and older.

Eligibility rules vary depending on whether children are conceived modern‘s or Pfizer‘s original vaccines as their primary series.

Here are the eligibility criteria:

  • Children aged 6 months to 5 years who received Moderna’s two-dose primary series are now eligible for an omicron booster dose two months after their second dose.
  • Children ages 6 months to 4 years who have not yet received their third dose of Pfizer’s primary series will now receive the Omicron shot as their third dose.
  • But children in the same age group who have already completed Pfizer’s three-dose primary series cannot currently receive the Omicron shot as a booster or fourth dose.

The FDA said in a statement that it has not approved Omicron shots for children who have already received three doses of Pfizer’s vaccine because the agency is still awaiting supporting data for the booster dose. That data is expected in January and the FDA will review it as soon as possible, the agency said.

The Centers for Disease Control and Prevention must approve the vaccinations before pharmacies and doctors can start administering them.

dr Peter Marks, head of the FDA’s vaccine division, told parents in a statement that the agency carefully reviewed the shots before approving them. dr Robert Califf, head of the FDA, said it’s important for people to stay up to date on their vaccinations this winter as immunity to the virus wanes.

“As this virus has changed and immunity to previous COVID-19 vaccinations is waning, there will be greater benefits for individuals, families and public health as more people keep up to date on COVID-19 vaccinations by they help prevent serious illnesses. hospital admissions and deaths,” Califf said in a statement.

The approvals come as Covid infections and hospitalizations surge after the Thanksgiving holiday. US health officials are strongly encouraging everyone who is eligible to get vaccinated against Covid and the flu as respiratory viruses surge this season, straining hospital emergency rooms.

The new shots target the subvariant omicron BA.5 and the original Covid strain. US health officials expect the new shots to offer superior protection compared to the original vaccines, which only target the original strain of Covid. However, available data on efficacy and immune response in adults are mixed.

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Omicron BA.5 has been displaced by subvariants BQ.1 and BQ.1.1, which together now account for a majority of infections in the US. The new vaccines are unlikely to do as well against the BQ subvariants as BA.5 because they are more immune-preventable, although they are still expected to provide good protection against serious diseases.

The FDA approved the vaccines based on adult immune response data for similar vaccines developed by Pfizer and Moderna targeting the original omicron BA.1 variant. The safety data are also based on data from BA.1 clinical studies as well as previous studies in which the original vaccine was evaluated as a booster dose.

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