Top News

FDA’s Warning Against The Use Of Off-Label Covid-19 Vaccine

What’s The Case?

The Covid-19 pandemic has been tough on everyone. Many people lost their source of livelihood. A major portion of the population suffered from a serious illness and had to be admitted to a hospital. The worst scenario that prevailed was the death of closed ones.

Overall, the time has been very difficult to spend. The lockdown helped to control the spread, but it cannot remain in place forever. The country has to survive, and people have to feed their families. There is no alternative than to leave the comfort of the house and go out to earn some dollars.

FDA’s Warning Against The Use Of Off-Label Covid-19 Vaccine

One thing that is going to help everyone in this situation is the vaccine. Many pharmaceutical companies are on a mission to get their vaccines on the market. This will happen after the Food & Drug Administration has approved their usage.

The FDA recently granted its approval to Pfizer/BioNTech for their Covid-19 vaccine for the age group of 16 and above. The vaccines have also been authorized for children who fall under the category of 12 and 16 years of age.

The doses must be prescribed by the doctor only after he or she has conducted a thorough check on the patient.

The Delta variant is spreading at a faster pace. This is creating the situation of panic and anxiety among the parents of children who are not yet eligible for the vaccine. One way they see to get out of the situation is to get their children vaccinated just like they have got themselves vaccinated.

This is exactly what is being dealt with by the authorities.

Dr. Janet Woodcock, the Acting Commissioner of Food & Drug Administration, emphasized this point. She said that since the clinical trials were underway, the vaccines are not recommended for children who are 12 years or younger.

The data relates to the number of doses, intervals that should be maintained between different doses, and what should be the power of every dose of vaccine.

A vaccine is released in the market only after certain data has been studied and got approved by the relevant authority. Since the results of the clinical trials are awaited, the vaccine has not been recommended and authorized for children who are below 12 years of age.

The American Academy of Pediatrics understands what parents are going through. It has urged them to remain calm. The results have been successful till now. Every age group that got access to vaccines has shown good performance.

This has been possible only after the clinical trials were a success and their data was studied carefully.

The off-label practice would make parents skip this step and get their children vaccinated before the data of clinical trials is studied and this can be dangerous for the children. Doses are different for every age group. For example, the doses that are given to adults have higher power as compared to the doses that are given to children.

You Might Also Read: BioFit real reviews

Dr. Yuonne Maldonado, the Chairperson of the American Academy of Pediatrics Committee, has strongly advised the physicians to not discuss any calculations with the parents of children. Parents often take a step based on what their physician says. This harms their health and puts more pressure on the medical community.

The calculations related to the number of doses and power of the doses are shared based on the doses that adults were given.

A dose would deliver the expected benefits only if the data of the ongoing trial is studied carefully before releasing the vaccine in the market.

The Group Reality

Other companies that are working in the same direction are Moderna, and Johnson & Johnson. All three companies namely Pfizer, Moderna, and Johnson & Johnson are expected to receive the data of their clinical trials by the end of September 2021.

The first phase that is being worked upon is for the age group of 5-11 years. This will be followed by the age group of 2-5 years.

Till then, Dr. Lee Savio Beers, the President of the American Academy of Pediatrics, has urged all eligible citizens to get vaccinated at the earliest. This will ensure that the spread of the Covid-19 is controlled.

Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

To Top