On Tuesday, Pfizer-BioNTech requested the Food and Drug Administration (FDA) to expand the use of its Coronavirus vaccine to kids ages six months to five years. The request from the pharmaceutical corporation included statistics on the effectiveness and safety of two shots of the Coronavirus vaccine, though the company announced that it is planning to submit statistics for the 3rd shot in the coming months. The company further added that the booster shot would be considered part of the primary vaccination series.
The Food and Drug Administration will consider the request of Pfizer, which will review the statistics and may authorize the vaccine for the age group by the February end, a source familiar with the plan told NBC News. In addition, the Vaccines and Related Biological Products Advisory Committee is scheduled to meet on 15th February to offer guidance on pediatric shots. In October, the panel also set up to discuss the request of Pfizer to approve its vaccine for children five to eleven.
Pfizer-BioNTech asked the US FDA to expand the use of its Coronavirus vaccine to kids ages six months to five years. The request included statistics on the effectiveness and safety of two vaccine shots, though the drug company plans to submit statistics for a booster shot pic.twitter.com/1EC7OUcG06
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Albert Bourla, the CEO of Pfizer, stated that as hospitalizations of kids under five due to Coronavirus skyrocketed, the mutual goal with the FDA is to prepare for any future virus variant surges and provide American parents with an option to help protect their kids from the deadly virus. According to the statistics of NBC News, there are approximately 19.5 kids under age five in the United States and Puerto Rico.
Two Doses Did Not Generate Strong Immune Response
The vice-chair of the committee on infectious diseases for the American Academy of Pediatrics, Dr. Sean O’Leary, said that kids under five are the only group in the United States unauthorized to receive a Coronavirus vaccine. So while the COVID-19 is not as severe in kids as in adults, several children in this age group face hospitalization, and some even die.
In December, the company revealed that two shots did not generate a strong enough immune response in the current trial of kids ages two to under five. The booster shot is still under consideration, but it would be similar to the first two doses and administered two months after the second shot. On Tuesday, the company said no safety concerns were reported with the initial two shots.
The Kaiser Family Foundation released a survey on Tuesday that reveals that three in ten parents of kids under age five say they will vaccinate their kid right away just after the vaccine authorization for the age group, up from one in five in July. Additionally, the kids’ dosage is lower at three micrograms than the ten microgram shots administered to children five to eleven. The thirty microgram shots were administered to everybody ages twelve and up.