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Additional vaccine dose receives FDA approval for immunocompromised people

Additional vaccine dose receives FDA approval for immunocompromised people Additional vaccine dose receives FDA approval for immunocompromised people
Additional vaccine dose receives FDA approval for immunocompromised people Additional vaccine dose receives FDA approval for immunocompromised people

What's new?

For people with severely weakened immunity that are more susceptible to severe COVID-19, FDA has authorized additional vaccine dose.

On 12 August 2021, the United States Food and Drug Administration (US-FDA) modified the emergency use authorizations (EUAs) for COVID-19 to enable the use of an additional dose in certain immunocompromised people, particularly those who have received solid organ transplants or those who have conditions that are believed to have a similar level of immunocompromise. However, it does not apply to people who don't have a severely weakened immune system.

Immunocompromised people are highly vulnerable to severe COVID-19. After reviewing the available data thoroughly, the US-FDA said that this susceptible group might benefit from the 3rd dose of the coronavirus vaccine. This approval permits clinicians for boosting immunity in specific immunocompromised people requiring additional protection from COVID-19. At this time, other completely vaccinated people are well protected and don't require an additional dose of the coronavirus vaccine.

Individuals who have a weakened immune system similar to individuals who have received solid organ transplantation exhibit a diminished ability to fight infections and other detrimental diseases, and they are particularly susceptible to infections, including SARS-CoV-2. The US-FDA assessed information on the use of 3rd dose of vaccines in these people and revealed that the administration of 3rd vaccine doses might raise protection in this population. Counselling of these people should be done for maintaining physical precautions to aid prevent SARS-CoV-2.

Furthermore, the close contacts of immunocompromised people must get vaccinated. It is suggested that immunocompromised people should talk about monoclonal antibody therapy options with their health care provider. During this public health emergency, the US-FDA has approved monoclonal antibody therapies for emergency use for adult patients and pediatrics (age 12 and older weighing at least 40 kgs or about 88 pounds) with positive findings of direct viral testing, and those who are at elevated risk for advancing to severe SARS-CoV-2 and/or hospitalization.

Notably, 1 authorized product includes usage for preventative (prophylaxis) therapy after being exposed to SARS-CoV-2. But, this product should not be regarded as a substitute for vaccination. Currently, the vaccines are approved for emergency utilization in people aged twelve years and older and for emergency utilization in people aged eighteen years and older. Both the vaccines are administered as a series of 2 shots.

The vaccine approvals have been altered for allowing for an extra or 3rd dose to be given at least twenty-eight days following the 2-dose regimen of the same vaccine to people eighteen years of age or older (age twelve years or older for the vaccine) who have received solid organ transplantation, or those who are diagnosed with the conditions that are believed to have a similar level of immunocompromise.

Source:

FDA

Article:

Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals

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