FDA to hold meeting in regards to the vaccines for pediatric use


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The third wave of the coronavirus pandemic needs to be avoided completely. The FDA looks all set to take care of children worldwide during this pandemic and achieve a vaccine for pediatric use as soon as possible.

The world is sharing its perspective on COVID  19 vaccine development since July 2020. The pandemic has grown in proportion worldwide creating havoc. It not only impacted the health but also the socio-economic process of the various nations. Millions of cases have been surging on a high rise. The nations are trying their level best to flatten the curve of the coronavirus high rise of cases. The loss of lives has been really devastating. There are many people who are helping the affected people for global recovery. It is important to be optimistic about the pandemic and have a hope that it will definitely end. There is a certain amount of progress that can be seen with vaccines and treatments of novel coronavirus. 

Why COVID vaccine still not available to children?

COVID 19 has affected all age groups. Mortality and morbidity are several times higher in adults particularly those above the age of 50 years. Children are found to be either asymptomatic or suffering from mild infections. The general practice is first to evaluate any new vaccine in older people and to check their efficacy and effectiveness in the older population. The population and age reduction is then done slowly and steadily to assess the safety and effectiveness in the pediatric population. Now, we have started to evaluate vaccines in children. Initially, the vaccines were only given to the old and elderly age group. There are some clinical trials underway to test the effectiveness and efficacy of the COVID 19 vaccines in children.

Vaccines phases 

The phases of vaccine development include the following trials:

The Preclinical Phase Trial: Vaccine development in laboratory animals 

The Phase 1 Clinical Trial: Assess vaccine safety, immune response and determine the right dosage. The Phase 1 Clinical Trial is of short duration and with a small number of participants. 

The Phase 2 Clinical Trial: Assess vaccine safety and availability of immune response. The Phase 2 Clinical Trial is for a short duration with few hundred participants. 

The Phase 3 Clinical Trial: Determine vaccine effectiveness against the disease and safety in a larger group of people. It is carried out with thousands of participants. 

A new analysis finds the global COVID19 death toll is very much higher than previously estimated results. The data is showing promising efficacy rates of COVID -19 vaccines in teens. 

Teenagers respond well to COVID 19 vaccine 

New data shows that COVID19 vaccine efficacy in teenagers could help boost momentum. There is a lagging vaccination effort in terms of vaccines for children. However, we should be more careful when it comes to children. There is an urgency of vaccines among the children and trials should be started with the adolescents since they are able to bear the vaccine medicines. In adolescents ages 12-17, the Moderna’s vaccine appears to be 96% effective while FDA is preparing to authorize the Pfizer and Biotech vaccines as well. Experts hope encouraging data can help young people vaccinate and lead to a normal school experience soon. In Phase 2 /3 trial, data shows that Moderna’s Vaccine is well tolerated among the kids, and the majority of the side effects were mild to moderate. 

FDA recognized the importance of the COVID vaccine for pediatric use.

Vaccines continue to be important for the COVID19 pandemic. The FDA has authorized three vaccines of EAU(Emergency Authorization Use) for emergency use which have met the rigorous standards of quality, safety, and effectiveness. FDA recognizes the critical next step of making vaccines available for pediatric use. 

Tags : #FDA #thirdwaveofcoronavirus #pediatricvaccine #COVIDinchildren #medicircle #myhealth

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