WASHINGTON: US regulators urged drug makers to apply for permission for emergency two-dose regimen of the vaccine Covid-19 for children 6 months to 5 years pending data in the course of three doses, aimed to clear the way for a shot as soon as the end of February, a person who familiar with the matter told the Associated Press on Monday.
Enterprise applications is expected to be delivered as soon as Tuesday.
Pfizer initial data have shown the vaccine – which is given to children younger at one-tenth the firepower adults – safe and generate an immune response.
Pfizer announced last year but shot two doses proved less effective in preventing Covid-19 at the age of children aged 2-5, and regulators encourage companies to add a third dose to the study of the belief that another dose of vaccine effectiveness will increase as a booster dose conducted on adults.
Now, the food and drug administration to encourage companies to submit their application based on data from two doses for a potential approval in February, and then to come back for additional authorization after having data from all three dose study, which is expected in March, people familiar with the matter.
Two-step authorization process can mean that small children can be vaccinated more than a month earlier than previous estimates, assuming the FDA and the centers of disease control and prevention Greenlight the Shots.
The person spoke on condition of anonymity to discuss sensitive regulatory issues.
The person said the decline in effectiveness of two doses of the vaccine was not unexpected given the emergence of highly contagious Omicron variant of Covid-19.
Allow younger children vaccinated with two doses of the previous shot will ultimately accelerate when they could get stronger protection than the third dose.
That would be welcome news for parents of small children, the last remaining age group without approval Covid-19 shots.
Small children are less likely than adults to develop serious complications or die because Covid-19, but the incidence of the disease between age groups have risen on a national surge of variants Omicron.
Most cases and deaths occur among the elderly, especially those who were not vaccinated.
Accelerate authorization pediatric vaccine against Covid-19 has become a priority for more than one year rule of Biden, who believed them to reopen and maintain a center-open schools and daycare centers – and to liberate the parents were occupied by childcare responsibilities to return to the labor force.
Vaccines for children ages 5-12 is approved by U.S.
regulators In November, despite slower absorption shot from the U.S.
Officials Pfizer primary series given three weeks apart.
The third dose for young children is being studied for the administration of at least two months after the second dose.