Pfizer on Tuesday asked the Food and Drug Administration to provide emergency use authorization for its children under 5 years of age to vaccinate.
The move kicks off the process of the FDA reviewing the data, submitting it to independent consultants and possibly approving the vaccine in the coming weeks. Fda independent advisers are scheduled to hold a public hearing in February.
The data will then be submitted to an independent consultant at the Centers for Disease Control and Prevention for another review, and finally, potential recommendations from CDC Director Rochelle Walensky — all of which could be made within this month.
So far, Pfizer's two doses of the vaccine are available for anyone over the age of 5. Anyone over the age of 12 can inject the booster after five months. Moderna and Johnson & Johnson are available for adults.
Pfizer announced in December that its vaccine was safe and effective for children under 5 years of age, but determined that two doses of therapy were less effective for children aged 2, 3 and 4 than adults. The dose for children under 5 years of age is one-tenth of the dose for adults.
On Tuesday, Pfizer again submitted data for two doses of the vaccine, but is expected to get the data soon, making it a three-dose vaccine that could be more effective in preventing the disease.
Pfizer expects to get more information on the effectiveness of the three-dose therapy in March or April, but the immune process will begin much earlier before the first two doses are approved in February.
The third dose will be taken at least eight weeks after the second dose.
Albert Bourla, chairman and CEO of Pfizer, said in a press release on Tuesday: "With the surge in the number of children under the age of 5 hospitalized for the coronavirus, our shared goal with the FDA is to prepare for future mutation surges and provide parents with an option to help protect their children from the virus." ”
"Ultimately, we believe that children aged 6 months to 4 years need three doses of the vaccine to achieve a high degree of protection against current and potential future variants. If two doses of the vaccine are approved, parents will have the opportunity to begin a COVID-19 vaccine series for their child while waiting for a potential authorization of a third dose. ”
Some parents of young children have longed for approval so that they can protect their children from serious diseases. Children under the age of 5 now spend nearly half of their lives in the outbreak, and for many parents, their unvaccinated status is a huge stressor.
According to the latest weekly report from the American Academy of Pediatrics (AAP) and the Association of Children's Hospitals (CHA), about 808,000 children tested positive for COVID-19 last week, below the peak of 1.15 million in the week ending Jan. 20.
However, the tissues warn that pediatric infection rates remain "extremely high" and still twice as high as the peak level of the delta surge in the summer of 2021.
Since the outbreak, a total of 11.4 million children have tested positive for the virus. During the surge in variants in Omikeron, there was a "sharp rise" in child CORONAVIRUS cases, with more than 3.5 million child cases reported in January.
Still, because children are unlikely to get seriously ill from COVID-19, many parents choose not to vaccinate them, even if they qualify.
According to a survey conducted in January by KFF, a nonpartisan health nonprofit, nearly 70 percent of eligible children ages 5 to 11 have not yet been vaccinated. It's unclear how many parents will choose to vaccinate children under 5 years of age when vaccines become available.
But experts point out that there are many reasons why children are vaccinated, including their own health and the health of the surrounding communities.
According to the CDC, unvaccinated adolescents aged 12 to 17 are 11 times more likely to be hospitalized than vaccinated adolescents.
While young children are unlikely to end up hospitalized, it is still possible. They can also be vectors of transmission, infecting other high-risk adults in the community.
Both delta and the Opichron surge have left paediatric wards in hospitals completely covered, and doctors often plead with communities to increase vaccination rates.