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Food and Drug Administration-FDA-Media Call-Third COVID-19 Vaccine

Food and Drug Administration-FDA-Media Call-Third COVID-19 Vaccine

Meeting Link: https://youtu.be/m_eSKpm19zk

The meeting was held on 28TH of February 2021 to discuss the emergency use authorization (EUA) issued for the Janssen Biotech Inc. COVID-19 vaccine for individuals 18 years and older. Dr Janet Woodcock, the Acting FDA Commissioner, and Dr. Peter Marks, Director of FDA Center for Biologics Evaluation and Research, were in attendance.

The meeting discusses the process for approval of a vaccine, including a thorough review of the data by the agency career staff and input from external scientific and public health experts. The scientific and medical review staff reviewed hundreds of pages of technical data about this vaccine thoroughly, efficiently, and transparently.

The FDA determined that the Janssen vaccine’s known and potential benefits outweigh the known and potential risks. There is clear evidence that the vaccine is effective in preventing the virus. The transparency around the research should assure the public that this vaccine met the FDA’s rigorous standards for quality, safety, and efficacy.

Dr Marks noted that evaluating vaccines does not end with authorization. Vaccine manufacturers should continue studying their vaccines and move forward toward licensure. Active follow-up for safety, including monitoring for any significant adverse events to inform ongoing benefit-risk assessments, is also required.

The vaccine should not be given to individuals with a known history of severe allergic reactions to its components. The most common allergens are polysorbate 80 and polyethene glycol. Appropriate medical treatment should be available during an acute anaphylactic reaction.

Impact

The authorization expands the availability of vaccines, one of the best tools for preventing Covid-19. This helps to fight the pandemic. Authorization of this vaccine, coupled with continued public health measures and progress in treatment, holds promise to battle the pandemic further

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Food and Drug Administration-FDA-Media Call-Third COVID-19 Vaccine

Attend the meeting of a Government body at the local, state, regional or national level. This may be a city council, county commission, state or national legislature meeting. Submit a formal report on the proceedings to include the observations of the meeting and possible impacts on the health of the associated community.

Students may also attend such meetings virtually. Access your community’s online archives to see if they have recorded meetings that you may watch. Meetings may be no older than 90 days. The URL must be included in the written report. Meetings may be local, state or national.

Food and Drug Administration-FDA-Media Call-Third COVID-19 Vaccine

Food and Drug Administration-FDA-Media Call-Third COVID-19 Vaccine

 

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