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Largest Vaccine Manufacturers Seek Emergency Use Approval From FDA

Largest Vaccine Manufacturers Seek Emergency Use Approval From FDA

This is the latest in Covid-19 vaccine developments. Many have asked for FDA approval for the vaccination of children. The age group is 6 months to 5 years. This comes at a time when the Omicron variant of the virus is in circulation in several countries.

Largest Vaccine Manufacturers Seek Emergency Use Approval From FDA

Initially, the FDA had requested vaccine major Pfizer to roll out the vaccinations for kids below 5 years. Now, the vaccine majors have requested, seeking quick emergency use. In the coming few days, EUA submission will be completed, if reports from sources are to be believed. The giants will soon be submitting all the medical data to the European Medicine Agency.

Largest Vaccine Manufacturers Seek Emergency Use Approval From FDA

The FDA vaccine advisory committee will be again meeting on Feb 15 to discuss it. The doctors and pediatricians are more concerned about the safety of the vaccines for the kids. A lot of research is underway on vaccines for children. Many steps need to be cleared before vaccines can be declared safe for kids. It is a matter of high priority for the government at present, owing to soaring numbers. So, see the trajectory.

Everybody wants the agencies to decide and check if they could give the vaccines to their own children and their relatives as well. The vaccines have to be tested again and again under laboratory conditions, to check for safety as well as efficacy. The Pfizer and BioNTech vaccine has already been authorized for children aged 5 years. Now, it is to be seen if the same can affect children younger than that in a positive manner.

The agency is looking for all the data first. There is an urgency, but not at the cost of the health of the kids. Since the pandemic started around 25 months back, more than 11 million children have tested positive. This January, there were around 3 million cases. Many pediatricians have seen parents worried for their kids due to the same.

Most doctors and pediatricians from the health fraternity are looking for a robust vaccine that is safe yet effective for children that young. The companies are continuously working on the 3-dose vaccine for the kids. In December, Pfizer had conducted trials, in which 2-dose vaccines did not show much efficacy in 2–5-year-olds. However, it did show efficacy in under 2 years.

The vaccine’s third dose may be given at least eight weeks apart after completion of the second dose. Data on the same is still under review. Hospitalizations due to the Omicron scare have increased manifold in children aged 5 years and below. The vaccine majors want to come up with vaccines so that the parents can be less stressed out.

FDA also believes that 3 doses of the vaccine may be required for kids till 4 years. It can and should offer protection from the variants that are yet to come as well. If initially, two doses of the vaccine are authorized, it will show a lot of efficacies. Later the third dose can be introduced, believes the health fraternity.

For all kids from and above the age of 12 years, the vaccine regulators and manufacturers have ascertained the dose as 30 mcg. For kids between 5-11 years, it’s down to 10 mcg. And, for the kids who are younger than that, it has to be much lower. It seems that the permission or approval may come in by the end of the month of February.

It is to be seen what course the variants that are in circulation taken by that time. It is very important to ascertain the course, without much delay. 

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