The drug-making companies announced on Monday that Pfizer and BioNTech’s small COVID-19 vaccine dose is safe and generates powerful responses from the immune system of children aged 5 to 11 years.
The news came as a miracle for parents who are concerned about getting their kids vaccinated as they began the new academic year with in-person learning amidst the increase of cases fueled by the delta variant across the country.
Pfizer Vaccine Is Likely To Be Approved For Kids Under 12 Years
Pediatric infections remain high to a concerning level with new cases crossing 243,000 during 9th September week. This was the highest since the pandemic’s beginning, said the American Academy of Pediatrics.
The data that is set to be submitted to the US Food and Drug Administration includes around 2,200 kids. Last week, the CEO Albert Bourla said that they are trying to submit the data to the FDA for children 5-11 years by the end of September. If the FDA takes the same time as they did for the age group 12-15 years, the vaccine will be available by Halloween.
The Food and Drug Administration’s top vaccine regulator, Dr. Peter Marks, had announced last month that they are working as fast as they can to approve vaccines for children under 12 years of age when they receive data from the companies.
On August 23, he said that they want to make sure what they will be approving is right for children.
A Pfizer board member and former FDA head, Scott Gottlieb told CNBC, that the availability of vaccines depends on how long the Food and Drug Administration takes to review. It can be a four-week or six-week review. They are trying to make the vaccines available for children latest by October end.
Two dose programs consisting of 10 micrograms were tested by the company. This was the third part of the dosage used for adults. These two doses were administered three weeks apart. Bodies of the subjects tolerated the doses and produced an immune response similar to people between 16 to 25 years of age.
According to the Centers for Disease Control and Prevention, vaccines’ side effects in adults and teenagers include chills, fatigue, fever, muscle pain, headache, and nausea.
In a press release announcing the results, Bourla said that the company is eager to expand vaccine protection to the younger fragment of the population, especially as the highly infectious data variant poses a major threat to children.
They did not reveal detailed information about the trial, including if myocarditis was experienced by any of the kids, which is a rare heart condition witnessed in many young adults and adolescents.
Epidemiologists have been concerned about cases in kids since the news about school reopening was announced. Since younger kids are not eligible to receive the vaccines, they are more prone to infection. Experts advise that unless more children are vaccinated, there should be strict mandates for preventive measures.
The Mayo Clinic’s community pediatrician, Dr. Nusheen Ameenuddin, said that the cases and hospitalizations rising in children because of the delta variant is extremely scary. Ameenuddin said that the pandemic never ended, it just needed a match to reignite.
Experts note though that the hospitalization rate among children is lower than that of adults. In August, out of 520,000 deaths caused by COVID-19, less than 500 were children, according to the CDC data.
So far in the US, for people younger than 12, the FDA has approved the Pfizer-BioNTech vaccine, while vaccines of the Moderna and Johnson & Johnson are yet to win full approval.
The FDA will likely release its decision on administering booster shots to certain groups of the population sometime around this week.
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