FDA authorizes omicron vaccine for youths as young as 6 months

The Food and Drug Administration on Thursday authorized updated Covid shots that concentrate on the omicron variant for kids as young as 6 months old.

The eligibility rules vary depending on whether children received Moderna‘s or Pfizer‘s original vaccines as their primary series.

Listed here are the eligibility criteria:

• Children 6 months through 5 years old who received Moderna’s two-dose primary series at the moment are eligible for an omicron booster two months after their second shot.

• Kids ages 6 months through 4 years old who haven’t yet received the third dose of Pfizer’s primary series will now receive the omicron shot as their third dose.

• But kids in the identical age group who’ve already accomplished Pfizer’s three-dose primary series cannot get the omicron shot as a booster, or fourth dose, at the moment.

The FDA, in an announcement, said it didn’t authorize omicron shots for those children who already received three doses of Pfizer’s vaccine since the agency continues to be waiting on supporting data for the booster dose. That data is anticipated in January and the FDA will review it as quickly as possible, the agency said.

The Centers for Disease Control and Prevention must log off on the shots before pharmacies and physicians can start administering them.

Dr. Peter Marks, head of the FDA’s vaccine division, told parents in an announcement that the agency fastidiously reviewed the shots before authorizing them. Dr. Robert Califf, head of the FDA, said it is important for people to stay awake to this point on their shots this winter because immunity against the virus wanes.

“As this virus has modified, and immunity from previous COVID-19 vaccination wanes, the more individuals who sustain to this point on COVID-19 vaccinations, the more profit there will likely be for people, families and public health by helping prevent severe illnesses, hospitalizations, and deaths,” Califf said in an announcement.

The authorizations come as Covid infections and hospitalizations are increasing within the wake of the Thanksgiving holiday. U.S. health officials are strongly encouraging everyone who’s eligible to get vaccinated against Covid and the flu as respiratory viruses surge this season, putting strain on hospital emergency departments.

The brand new shots goal the omicron BA.5 subvariant and the unique Covid strain. U.S. health officials expect the brand new shots to supply superior protection compared with the unique vaccines, which only goal the unique Covid strain. However the available efficacy and immune response data for adults has been mixed.

Omicron BA.5 has been displaced by the BQ.1 and BQ.1.1 subvariants, which taken together now make up a majority of infections within the U.S. The brand new shots likely won’t perform as well against the BQ subvariants compared with BA.5 because they’re more immune evasive, though they’re still expected to supply good protection against severe illness.

The FDA authorized the shots based on adult immune response data for similar vaccines developed by Pfizer and Moderna that concentrate on the unique omicron BA.1 variant. The security data can also be based on BA.1 clinical trial data in addition to previous trials that evaluated the unique vaccine as a booster.