The Pfizer-BioNTech Covid-19 vaccine trials on children aged 12 to 15 years old is 100 percent effective, paving way for mass use soon.
The trial involved just 2,260 children.
The company announced on Wednesday that in a Phase 3 trial of children between the ages of 12 and 15, the vaccine ‘demonstrated 100 percent efficacy and robust antibody responses’.
But no vaccine that’s been widely used has wound up being 100 percent effective, and it is unlikely that Pfizer’s Covid-19 shot will be perfectly protective to the general population of adolescents if millions receive it.
And while some experts argue that vaccinating children under 18 will be critical to getting the United States to herd immunity by vaccinating 75 percent of the population, others argue that the benefits of inoculation don’t outweigh the risks of coronavirus to children.
So far, children under 18 account for less than 12 percent of U.S. COVID-19 cases and it is exceedingly rare for them to die of the infection. Only 331 kids under 18 have died of COVID-19, compared with more than 550,000 adults.
In the trial of 2,260 adolescents aged 12 to 15, there were 18 cases of COVID-19 in the group that got a placebo shot and none in the group that got the vaccine, resulting in 100 percent efficacy in preventing COVID-19, according to Pfizer.
It’s virtually impossible that this efficacy will remain so high if the shot is used in the general population, most children do not develop symptoms or only become mildly ill even if they do catch Covid.
So far, real-world data suggests that Pfizer’s vaccine is about 90 percent effective in adults. That’s excellent protection, but falls just short of its 95 percent efficacy in its trial.
Most COVID-19 vaccines being rolled out worldwide are for adults, who are at higher risk from the virus. Pfizer’s vaccine is currently authorized for ages 16 and older.
Pfizer and its German partner BioNTech in the coming weeks plan to ask the US Food and Drug Administration and European regulators to allow emergency use of the shots starting at age 12.
‘We share the urgency to expand the use of our vaccine,’ Pfizer CEO Albert Bourla said in a statement.
Vaccinating children could be controversial because it is likely to be focused on protecting older people rather than the children themselves.
Other vaccines given to children, such as for measles and meningitis, protect against diseases that are very dangerous and potentially deadly to children, but the same is not true of Covid.
Kids had side effects similar to young adults, the company said.
The main side effects are pain, fever, chills and fatigue, particularly after the second dose. The study will continue to track participants for two years for more information about long-term protection and safety.
Other vaccine makers, AstraZeneca and Johnson & Johnson are also planning its own paediatric studies.