The Phase 2/3 examine enrolled 2,268 youngsters who had been 5 to 11 years of age and got a two-dose routine of 10 micrograms 21 days aside. A smaller dose than the 30 microgram dose is used for folks 12 and older.
The antibody responses within the members given 10 microgram doses had been similar to these recorded in a earlier Pfizer-BioNTech examine in folks 16 to 25 years of age immunised with 30 microgram doses.
“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our Covid-19 vaccine. We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorisation, especially as we track the spread of the Delta variant and the substantial threat it poses to children,” Pfizer Chairman and Chief Executive Officer, Albert Bourla, stated within the assertion.
Further, the Covid-19 vaccine was discovered to be nicely tolerated, with uncomfortable side effects usually similar to these noticed in members 16 to 25 years of age.
The knowledge will likely be submitted “as soon as possible” to the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and different regulators, Pfizer stated.
The firm can be anticipated to quickly share the results of the trial on youngsters aged 2-5 years of age and kids 6 months to 2 years of age.
The new knowledge comes as youngsters made up an elevated portion of instances in lots of US states and oldsters are anxious to get their youngsters vaccinated, particularly as colleges reopen.
“Since July, pediatric cases of Covid-19 have risen by about 240 per cent in the US — underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorisation of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency,” Bourla stated.