Pfizer submit Phase III data of COVID-19 vaccine for children 5-11 to FDA

News

Pfizer submit Phase III data of COVID-19 vaccine for children 5-11 to FDA

Pfizer submit Phase III data of COVID-19 vaccine for children 5-11 to FDA.

Pfizer has submitted the Phase III clinical data of the COVID-19 vaccine for children aged 5 to 11 to FDA, and it is expected to start vaccination at the end of October.

Pfizer/BioNTech announced on Tuesday that they have submitted Phase III clinical data of the COVID-19 vaccine for children aged 5 to 11 to the Federal Food and Drug Administration (FDA) for preliminary review, and stated that they will seek Emergency Use Authorization (EUA) in the next few days.

If the previous adult vaccination is as smooth as that of adolescents, it is expected that it will be authorized by the FDA for child vaccination at the end of October.

Pfizer has recruited 4,500 children between the ages of 6 months and 11 years old as volunteers in 26 U.S. states and nearly 100 clinical trial sites in Finland, Poland and Spain for the COVID-19 vaccine for the age group of 5 to 11 years old.

Among these volunteers, 2268 children were between 5 and 11 years old. Among these people, about half of the volunteers received two doses of the vaccine 21 days apart, and the remaining half received the vaccine. Placebo.

In terms of vaccine dose, people 12 years and older receive two doses of 30 micrograms of vaccine, children 5 to 11 years old are given 10 micrograms, and children 6 months to 4 years old are given a dose of 3 micrograms.

The results of Phase III clinical trials show that the vaccine can produce powerful antibodies in children to resist virus damage. Up to the present position, there has been no negative news in the Phase III clinical trials of children.

Pfizer submit Phase III data of COVID-19 vaccine for children 5-11 to FDA.

Most American parents unwilling to vaccinate children

Since the beginning of the school season in the United States since last month, coupled with the invasion of the Delta variant virus, the number of children infected with the COVID-19 virus has soared. At its peak, it exceeded 240,000 cases per week, and now it has fallen to about 200,000 per week. However, the number of deaths is relatively small. According to data from the American Academy of Pediatrics, since the outbreak last year, a total of 480 children have died from the COVID-19, accounting for less than 0.1% of all deaths.

Therefore, a poll shows that many American parents are unwilling to vaccinate their children.

In a poll conducted by the Kaiser Family Foundation in April this year, many parents were asked whether they would vaccinate their children if the COVID-19 vaccine is approved for use in children.

Among the parents of children aged 5 to 11:

27% said they would vaccinate their children “immediately”
32% said they would wait to see how it works
19% said they only plan to vaccinate their children when requested by school
19% said that their children would never get vaccinated.

In July 2021, a survey of children’s health conducted by the CS Mott Children’s Hospital National Opinion Survey in Michigan Medicine found similar results.

Among the parents of children aged 3 to 11: