POST Online Media Lite Edition



 

NEWLY REPORTED COVID-19 CASES (11.19.2021, 4:50pm CEST, WHO):   India 11,106    Brazil 11,977    United Kingdom 46,858    Russia 37,156    Turkey 22,234    France 19,840    Argentina 1,553    Germany 52,970    Spain 3,932    Columbia 2,257    Italy 10,645    Mexico 3,836    Ukraine 20,050    Poland 23,242    Philippines 1,297    Malaysia 6,380    Netherlands 23,680    Peru 1,370    Thailand 6,855    Czechia 13,374    Canada 2,448    Romania 3,076    Chile 2,611    Serbia 3,219    Sweden 1,210    Portugal 2,398    Vietnam 10,223    Kazakhstan 1,272    Austria 14,212    Hungary 11,289    Greece 7,276    Georgia 4,278    Bulgaria 2,785    Belarus 1,844    Slovakia 7,418    Azerbaijan 2,124    Croatia 7,270    Bolivia 1,119    Ireland 4,646    Lithuania 1,847    Denmark 4,013    South Korea 3,034    Slovenia 3,662    Latvia 1,221    Laos 1,401    China 31    New Zealand 200    Australia 1,302   

FDA says robust safety data needed before COVID-19 vaccine approval for kids

Christian Fernsby |
As schools around the country are re-opening for in-person learning and families are returning to their busy school year schedules, we know many parents are anxious about the pandemic and protecting their children, Acting FDA Commissioner Janet Woodcock and Peter Marks director of the FDA’s Center for Biologics Research and Evaluation said.

Article continues below




"Many parents have questions about COVID-19 and when vaccines will be available for children younger than 12 years of age.

"Many of our team at the FDA are parents and grandparents themselves, and our team shares the same concerns as many in our country about protecting our loved ones from COVID-19.

"We are therefore also eager to see COVID-19 vaccines available for young children. We also know that we all share the interest in making sure this process is done with safety at top of mind. As regulators, we recognize we have an important task ahead of us that will require us to act expeditiously while undertaking an extremely meticulous and thoughtful review once we receive requests to authorize a COVID-19 vaccine for emergency use or submissions for approval of a COVID-19 vaccine for this population.

"We know there have been questions and public commentary on the process surrounding vaccines for young children, so we think it’s important to share information about the process and the necessary considerations involved to provide greater clarity to the public about this effort.

"It’s important that the public recognize that, because young children are still growing and developing, it’s critical that thorough and robust clinical trials of adequate size are completed to evaluate the safety and the immune response to a COVID-19 vaccine in this population. Children are not small adults – and issues that may be addressed in pediatric vaccine trials can include whether there is a need for different doses or different strength formulations of vaccines already used for adults.

"We have to let the science and data guide us. The FDA is working around the clock to support the process for making COVID-19 vaccines available for children.

"Until we authorize or approve a vaccine for this younger population, it’s especially important that parents and others who interact closely with children under 12 years of age get vaccinated, wear masks, and follow other recommended precautions so that we can protect those who cannot yet protect themselves through vaccination."


What to read next

FDA continues to ensure safety and effectiveness of authorized COVID-19 vaccines
World-first COVID-19 alternating dose vaccine study launches in UK
WHO validates Sinovac COVID-19 vaccine for emergency use