A U.S. government committee voted to allow the Pfizer / BioNTech vaccine to be administered to children between the ages of five and 11.
Food and Drug Administration (FDA) experts backed the move on Tuesday, paving the way for emergency clearance within weeks.
In September, the company said its test data showed the Covid vaccine was safe for children of that age group.
The United States is already giving it to those aged 12 and over. The latest decision affects some 28 million US children.
The FDA’s Advisory Committee on Vaccines and Related Biological Products ruled Tuesday that the benefits of taking the vaccine outweigh the risks.
The FDA is expected to approve the committee’s findings, paving the way for the CDC director to recommend vaccinations begin early next month.
Test data from the company submitted to regulators in September said the shots produced a “robust” antibody immune response in that age group.
Children in that age group are given a vaccine with one third of the dosage given to adults.
Regulators, however, also had to weigh the risk of heart inflammation, a very rare side effect of Pfizer and Moderna vaccines.
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Official U.S. data shows 160 children between the ages of five and 11 have died of Covid-19 since the start of the pandemic. In total, the country has recorded nearly 740,000 deaths from the virus.
But millions have contracted the disease, thousands of whom have ended up in hospital. The United States has also reported more than 5,000 cases of a rare inflammatory disease linked to Covid infections, which killed 46 children.
On Monday, Moderna announced it would submit test data to regulators after a study found that its Covid vaccine produced a “robust neutralizing antibody response” in children aged six to 11. .
The UK has just started rolling out vaccines for children between the ages of 12 and 15. The country’s medical directors recommend a dose of the vaccine for children of that age group, although approaches differ in other countries.
This is a historic decision that could affect practice in other countries, not just the United States.
Some nations, such as Israel, have already hinted that they intend to follow suit.
The US regulator has carefully weighed the pros and cons and says it is appropriate to vaccinate younger children against Covid.
While most children are unlikely to get seriously ill if they contract the coronavirus, they could still be infectious, even without symptoms.
The vaccine could prevent them from spreading the virus to others.
And some young children can still get sick with Covid. The vaccine would also protect against this.
The world will be watching how the launch goes with the Pfizer coup and what impact it has on the pandemic.
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Related topics
- Coronavirus vaccines
- Pfizer
- Impact of the COVID-19 pandemic on children
- United States
- Coronavirus pandemic
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