The United States on October 29 authorised the Pfizer COVID-19 vaccine for children aged 5-11, paving the way for 28 million young Americans to soon get immunised.
The decision came after a high-level medical panel advising the government this week endorsed the shots, ruling that the known benefits outweighed the risks of side-effects.
The US follows only a handful of other countries including China, Chile, Cuba and the United Arab Emirates (UAE) that are inoculating younger children with various vaccines.
"As a mother and a physician, I know that parents, caregivers, school staff and children have been waiting for today's authorisation. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy," acting Food and Drug Administration (FDA) chief Janet Woodcock said in a statement.
The vaccine rollout should begin in earnest after the Centers for Disease Control and Prevention (CDC) convenes a panel on November 2 to further discuss clinical recommendations.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
Pfizer and its partner BioNTech announced this week the US government had bought 50 million more doses as it works to protect children, including eventually those under five.
In a clinical trial involving more than 2,000 participants was found to be more than 90 percent effective at preventing symptomatic disease. The vaccine's safety was also studied in more than 3,000 children, and no serious side effects have been detected in the ongoing study.
In this age group, the vaccine is given as two shots three weeks apart, dosed at 10 micrograms — a third what is given to older age groups.
Severe COVID-19 is rarer in children than adults, but far from non-existent.
According to the CDC, there have been 8,300 COVID-19 hospitalizations of children aged 5-11 since the start of the pandemic, and 146 deaths. There have also been more than 5,000 paediatric cases of multisystem inflammatory syndrome in children (MIS-C), a rare but highly serious post-viral complication, including 46 deaths.
Ongoing safety monitoring
Health authorities will continue to monitor for potentially highly rare side-effects, like myocarditis and pericarditis (heart inflammation and inflammation around the heart). The clinical trials were too small to detect these, but the hypothesis is they will be exceedingly rare, because the effect is thought linked to testosterone levels.
In male teens and young adults, the most affected group the effects occur mostly after the second dose of an mRNA vaccine at a rate of a few dozens per million. Most of the cases have fully resolved.
COVID-19 itself can cause more severe forms of myocarditis, potentially more frequently, depending on the level of transmission within a community.
Beyond protecting children’s own health, epidemiologists think vaccinating this group will help bring an end to disruptions to school and other activities.
But most of the panellists at a meeting of experts called by the FDA on October 25 said they would not support mandates in this age group. Instead, the decision whether to get vaccinated should depend on factors such as the child's risk factors and should be left to families, they said.
The US is emerging from its latest coronavirus wave, driven by the Delta-variant. But cases remain high, particularly in colder northern states that are lagging in their vaccination rate.
Almost 58 percent of the total population is now fully vaccinated.