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FDA Approval For A Vaccine Booster Dose

Everyone in the United States is waiting for the Friday meeting of the Food and Drug Administration (FDA) about a third booster dose of the Sars-COV-2 virus. One expert, however, said that the effectiveness of the booster would not be discussed.

FDA Approval For A Vaccine Booster Dose

There is still a conflict of opinion about the third booster dose of the Civod-19 vaccine and whether it is necessary at all. Dr. Francis Collins, Director of the National Institutes of Health in the United States, pointed out that there is still no clear answer on whether the third booster dose of the Covid-19 vaccine is necessary though there is a lot of data still to be studied and analyzed.

FDA Approval For A Vaccine Booster Dose

The conflict of opinion continues to be felt all across the United States. United States President Joe Biden, along with a team of experts, feels that the third booster dose will further increase immunity and reduce the risk of hospitalization and death due to Covid-19. A group of international vaccine experts, including experts from both the FDA as well as the World Health Organization, wrote in a magazine early this week that the currently available evidence does not support the requirement for a booster vaccine given to the public at this time.

Meanwhile, vaccination has progressed across the United States and presently 54% of Americans have received both doses of the vaccine. Many experts feel that the introduction of a booster dose vaccine at this stage will distract attention from the present need of getting more of the public to receive both the initial doses.  

Pfizer has started manufacturing their booster dose after having applied for FDA approval. Many health centers are getting ready to administer the booster dose of the Covid-19 vaccine as and when it gets approved. But there are many unanswered questions. Lori Tremmel Freeman, Chief Executive officer of the National Association of the County and City Health officials, summed up the questions on everyone’s mind: What would be the targeted age group for the booster dose, at what interval would they be given, and were there any identified groups to be prioritized for the booster. 

The different variants of the Sars-COV-2 virus have infected more than 41.5 million Americans and caused the death of 666,000 already in the 9 months of this year. Former commissioner of the FDA Dr. Scott Gottlieb said people have become numb to the tragedy. There have been more cases among the young which has reached 1.9 million including the United States and Canada. What is noteworthy is this high level of infection is 400,000 more than last year when there were no vaccinations for the young.

Dr. Gottlieb feels Covid-19 cases are likely to increase in the northeast where schools have been reopened. But, he pointed out, the severity may not be as severe as the South of the United States as the northeastern region has had more prior vaccinations which are likely to provide a higher degree of protection from the disease.

The FDA has, in the meantime allowed emergency use of a new form of treatment for Covid-19.  This is the Eli Lilly Monoclonal antibody treatment which injects 2 lab-made antibodies into people in order to boost immunity from Cord-19. Doctors have already used Eli Lilly on people with mild infection of Covid-19 who were at risk of becoming severely infected. The FDA’s extended emergency use permission means this can be used on people with limited effects of vaccines, the unvaccinated, and people with immunocompromised conditions.  How far this treatment will prove remains to be seen. 

The outcome of the Friday FDA meeting also remains to be seen.    

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