FDA Advisory Panel Recommends Pfizer COVID-19 Vaccine for Children 5-11 Years Old

An advisory panel of the U.S. Food and Drug Administration voted Tuesday to grant emergency authorization to Pfizer’s two-dose COVID-19 vaccine for children between the ages of 5 and 11 years old.

Pfizer and its German-based partner BioNTech are seeking permission to inoculate children in this age group with a lower dose than what is currently given to people ages 12 and older. 

 

The advisory panel voted 17-to-0, with one person declining to 

vote, that the benefits of the vaccine outweigh any potential risks of any side effects such as myocarditis, an inflammation of the heart. The rare condition has been detected mostly among boys and young men who were immunized with either Pfizer or the two-shot Moderna vaccine.

Pfizer says clinical trials showed its vaccine was nearly 91 percent effective in preventing symptomatic COVID-19 among 5-to-11-year-old children.

The FDA is expected to accept the panel’s recommendation as soon as this week. The issue will then be taken up next week by an advisory panel of the Centers for Disease Control and Prevention, which will decide whether or not to recommend the vaccine and how it should be administered.

If both agencies grant final approval, as many as 28 million young Americans will be eligible to receive the Pfizer vaccine. The White House says it has established a network of pediatricians, pharmacies and other health care providers to quickly distribute the shots. 

Moderna said earlier this week that a low dose of its COVID-19 vaccine is safe for children between 6 and 11 years of age in clinical trials. The company says preliminary results show the antibody levels in the children were at the same level as those seen in young adults who received a full dose. 

In a related development, new guidelines issued Tuesday by the CDC say people 18 or older who are moderately or severely immunocompromised may need to get a fourth jab of a Pfizer or Moderna vaccine. People in these categories include those who are being treated for cancers of the blood, certain organ transplant and stem cell recipients, have advanced or untreated HIV, or are taking high-dose drugs that may suppress their immune systems. 

The CDC has already approved a third shot of either vaccine for those 65 or older six months or more after completing the original two-shot regimen. 

An apparent standoff is developing in Australia over whether unvaccinated tennis players will be able to enter the country to participate in next year’s Australian Open. Prime Minister Scott Morrison said Wednesday that unvaccinated players will be granted exemptions as long as they spend two weeks in quarantine after their arrival. 

But Victoria state Premier Daniel Andrews said hours later that his government would not apply for such exemptions. The Grand Slam tournament is staged annually in Melbourne, Australia’s second-largest city and the capital of Victoria state. 

Melbourne and its 5 million residents just recently emerged from its latest lockdown period after Victoria state reached its goal of fully vaccinating 70 percent of its citizens 16 and older.

Australia has been largely successful in containing the spread of COVID-19 through aggressive lockdown efforts at the start of the pandemic, but a rapid outbreak of new infections in Sydney triggered by the delta outbreak back in June spread across Australia and forced authorities in several cities to impose strict lockdown orders. 

Meanwhile, Greg Hunt, Australia’s health minister, announced Wednesday that beginning November 1, all fully-vaccinated residents will be able to travel overseas without needing a special exemption. Hunt said fully vaccinated residents also will be able to return without restrictions, meaning thousands of Australians who have been stranded overseas since the country closed its borders to all international travel in March 2020 in the early days of the pandemic.

Some information for this report came from the Associated Press, Reuters and Agence France-Presse. 

  


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