Pfizer-BioNTech announced on Monday that their COVID-19 vaccine is safe and effective among children between ages five and 11.
Data from late-stage clinical trials showed that the vaccine – which was given in a smaller dose – induced a ‘robust’ immune response among youngsters during late-stage clinical trials.
Levels of neutralizing antibodies among five-to-11 year-olds were similar to those seen 16-to-25 year-olds, the companies said in a
Pfizer scientists also described the vaccine as being ‘safe and well-tolerated’ in children under age 12.
The U.S. pharmaceutical giant and its German partner firm said they plan to apply for emergency use authorization with the U.S. Food and Drug Administration (FDA) this month and will also soon seek authorization in Europe.
This means that, if the FDA determines the shot is safe and effective, kids may be authorized to receive the vaccine by Halloween.
Parents are split 50/50 about whether or not they will inoculate their children because COVID-19 cases are generally mild in children and pediatric deaths make up just 0.1 percent of all Covid deaths.
Pfizer announced Monday that its COVID vaccine is safe for children aged between five and 11
‘We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,’ said Dr Ugur Sahin, CEO and co-founder of BioNTech in the press release.
The safety profile and immunogenicity data in children aged five to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.’
According to clinicaltrials.gov, Pfizer’s study in younger children worked similarly to the way it did in older children and adults.
About half of the ages five-to-11 group were given two doses 21 days apart and the other half were given placebo shots.
The team then tested the safety, tolerability and immune response generated by the vaccine, likely by measuring antibody levels in the young subjects
COVID-19 hospitalizations and deaths have surged in the United States in recent months due to the highly contagious Delta variant. Pediatric cases are also up, particularly as children under 12 are all unvaccinated, but there is no indication that, beyond being more transmissive, the Delta virus is more dangerous in kids.
A rapid authorization could help mitigate a potential surge of cases in the fall, especially with schools already open nationwide.
The companies’ vaccine, called Comirnaty, is already authorized for use in children as young as 12 in many countries, including the United States. The vaccine was originally authorized for emergency use in people 16 or older in the United States in December 2020 and received full U.S. approval in that age group last month.
The 5-to-11 year olds were given two shots of a 10-microgram dose of the vaccine, one-third the dose size that has been given to people 12 and older.
The companies expect data on how well the vaccine works in children 2-to-5 years of age and children 6 months-to-2 years of age as soon as the fourth quarter of this year.
Unlike the larger clinical trial the drugmakers previously conducted in adults, the 2,268 participant pediatric trial was not primarily designed to measure the vaccine’s efficacy by comparing the number of COVID-19 cases in vaccine recipients to those who received a placebo.
Instead, the trial compares the amount of neutralizing antibodies induced by the vaccine in the children to the response of older recipients in the adult trial.
A Pfizer spokesperson said the companies may later disclose vaccine efficacy from the trial but there had not been enough cases of COVID-19 yet among the participants to make that determination.
The vaccine was around 95 percent effective in the adult clinical trial, but Pfizer has said that immunity wanes some months after the second dose. U.S. regulators are expected to authorize a third, booster dose of the vaccine for older and high-risk Americans early this week.
The companies said the vaccine was well-tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age.
Both the Pfizer and Moderna vaccines have been linked by regulators to rare cases of heart inflammation in adolescents and young adults, particularly young men. Pfizer said they did not see any instances of heart inflammation in the trial participants.
However, despite promising results, many parents are not enthusiastic about vaccinating their children.
In a recent poll, conducted by the Kaiser Family Foundation, parents were asked if they would get their child immunized once a COVID-19 vaccine is authorized and available for their child’s age group.
Only about three in 10 parents – 29 percent – of children under 18 said they would get their child vaccinated ‘right away.’
The poll also found 15 percent only plan to vaccinate their children if the school requires it and 19 percent said their child will definitely not be getting vaccinated.
What’s more, although children can contract COVID-19 and pass the disease on to others, they tend to not get very ill.
Tips to Find Low Priced Luxury Holiday Package Deals Fast